MIVACRON; MIVACRON IN DEXTROSE 5% IN PLASTIC CONTAINER (INJECTABLE) MIVACURIUM CHLORIDE
NDA Applicant: ABBOTT      NDA No.: 020098  Prod. No.: 001 RX (EQ 2MG BASE/ML) NDA No.: 020098  Prod. No.: 002 DISC (EQ 0.5MG BASE/ML)

Patents	Expiration	Patented Use
Pat. No. 4761418 [Extended 173 days (0.5 years)] Novel compounds Claim Types: Compound; Composition; Method of use	Jan 22, 2006

IPRIVASK (INJECTABLE) DESIRUDIN RECOMBINANT
NDA Applicant: CANYON      NDA No.: 021271  Prod. No.: 001 RX (15MG/VIAL)

Patents	Expiration	Patented Use
Pat. No. 4801576 Method of inhibiting blood clotting with desulfatohirudins Claim Types: Method of use	Jan 31, 2006
Pat. No. 5733874 Stable dry powders Claim Types: Formulation	Mar 31, 2015
Exclusivity	Expiration	Exclusivity Description
Exclusivity Code: NCE - New chemical entity	APR 04,2008

NICOTROL (INHALANT) NICOTINE
Drug Classes: CNS, MISCELLANEOUS
NDA Applicant: PHARMACIA AND UPJOHN      NDA No.: 020714  Prod. No.: 001 RX (4MG/CARTRIDGE)

Patents	Expiration	Patented Use
Pat. No. 4800903 Nicotine dispenser with polymeric reservoir of nicotine Claim Types: Device; Formulation; Process	Jan 31, 2006
Pat. No. 5167242 Nicotine-impermeable container and method of fabricating the same Claim Types: Device	Jun 8, 2010
Pat. No. 5400808 Nicotine-impermeable container and method of fabricating the same Claim Types: Device; Process	Jun 8, 2010
Pat. No. 5501236 Nicotine-impermeable container and method of fabricating the same Claim Types: Device	Jun 8, 2010
Pat. No. 6098632 Nicotine-impermeable container and method of fabricating the same Claim Types: Device	Jun 8, 2010

MAXAQUIN (TABLET) LOMEFLOXACIN HYDROCHLORIDE
Drug Classes: ANTIBACTERIALS, MISCELLANEOUS
NDA Applicant: PHARMACIA      NDA No.: 020013  Prod. No.: 001 RX (EQ 400MG BASE)

Patents	Expiration	Patented Use
Pat. No. 4528287 [Extended 522 days* (1.4 years)] 6-Fluoro-1, 4-dihydro-4-oxo-7-substituted piperazinylquinoline-3-carboxylic acids and the method for preparing the same Claim Types: Compound; Composition; Method of use	Feb 21, 2006	U-36: Methods of treating bacterial illnesses

FLOMAX (CAPSULE) TAMSULOSIN HYDROCHLORIDE
Drug Classes: ANTIHYPERTENSIVES
NDA Applicant: BOEHRINGER INGELHEIM      NDA No.: 020579  Prod. No.: 001 RX (0.4MG)

Patents	Expiration	Patented Use
Pat. No. 4772475 Controlled-release multiple units pharmaceutical formulation Claim Types: Product-by-process	Feb 27, 2006
Pat. No. 4868216 Sulfamoyl-substituted phenethylamine derivatives and process of producing them Claim Types: Method of use	Sep 19, 2006	U-181: Producing alpha adrenergic antagonistic action in a host
Pat. No. 4703063 [Extended 5 years] Sulfamoyl substituted phenethylamine derivatives and process of producing them Claim Types: Compound; Composition	Oct 27, 2009

EFIDAC 24 PSEUDOEPHEDRINE HYDROCHLORIDE (TABLET, EXTENDED RELEASE) PSEUDOEPHEDRINE HYDROCHLORIDE
NDA Applicant: ALZA      NDA No.: 020021  Prod. No.: 002 OTC (240MG)

Patents	Expiration	Patented Use
Pat. No. 4801461 Pseudoephedrine dosage form Claim Types: Device	Mar 14, 2006

EFIDAC 24 PSEUDOEPHEDRINE HYDROCHLORIDE/BROMPHENIRAMINE MALEATE (TABLET, EXTENDED RELEASE) BROMPHENIRAMINE MALEATE; PSEUDOEPHEDRINE HYDROCHLORIDE
NDA Applicant: ALZA      NDA No.: 019672  Prod. No.: 001 OTC (16MG;240MG)

Patents	Expiration	Patented Use
Pat. No. 4662880 Pseudoephedrine, brompheniramine therapy Claim Types: Device	Mar 14, 2006
Pat. No. 4801461 Pseudoephedrine dosage form Claim Types: Device	Mar 14, 2006
Pat. No. 4810502 Pseudoephedrine brompheniramine therapy Claim Types: Device	Mar 14, 2006

PERIOCHIP (TABLET) CHLORHEXIDINE GLUCONATE
Drug Classes: ANTISEPTICS/DISINFECTANTS
NDA Applicant: DEXCEL PHARMA      NDA No.: 020774  Prod. No.: 001 RX (2.5MG)

Patents	Expiration	Patented Use
Pat. No. 5002769 Compositions for the sustained-release of chlorhexidine Claim Types: Formulation; Method of administration	Mar 16, 2006

NOVANTRONE (INJECTABLE) MITOXANTRONE HYDROCHLORIDE
Drug Classes: ANTINEOPLASTICS
NDA Applicant: SERONO INC      NDA No.: 019297  Prod. No.: 001 RX (EQ 20MG BASE/10ML(2MG/ML))

Patents	Expiration	Patented Use
Pat. No. 4820738 1,4-bis(substituted-amino)-5,8-dihydroxy-anthraquinones and leuco bases thereof Claim Types: Method of use	Apr 11, 2006	U-98: A method of inducing regression of leukemia cell growth in a mammal
Exclusivity	Expiration	Exclusivity Description
Exclusivity Code ODE: Orphan Drug	OCT 13,2007	Treatment of progressive-relapsing multiple sclerosis.
Exclusivity Code ODE: Orphan Drug	OCT 13,2007	Treatment of secondary-progressive multiple sclerosis.

NOVANTRONE (INJECTABLE) MITOXANTRONE HYDROCHLORIDE [GENERIC AP]
Drug Classes: ANTINEOPLASTICS
NDA Applicant: SERONO INC      NDA No.: 019297  Prod. No.: 002 RX (EQ 25MG BASE/12.5ML (2MG/ML)); 003 RX (EQ 30MG BASE/15ML (2MG/ML))

Patents	Expiration	Patented Use
Pat. No. 4820738 1,4-bis(substituted-amino)-5,8-dihydroxy-anthraquinones and leuco bases thereof Claim Types: Method of use	Apr 11, 2006
Exclusivity	Expiration	Exclusivity Description
Exclusivity Code ODE: Orphan Drug	OCT 13,2007	Treatment of progressive-relapsing multiple sclerosis.
Exclusivity Code ODE: Orphan Drug	OCT 13,2007	Treatment of secondary-progressive multiple sclerosis.

PRAVACHOL (TABLET) PRAVASTATIN SODIUM [GENERIC AB]
Drug Classes: HYPERLIPIDEMIA; CARDIOVASCULAR-RENAL
NDA Applicant: BRISTOL MYERS SQUIBB      NDA No.: 019898  Prod. No.: 002 RX (10MG); 003 RX (20MG); 004 RX (40MG); 008 RX (80MG)

Patents	Expiration	Patented Use
Pat. No. 4346227 [Extended 1598 days (4.4 years)] ML-236B Derivatives and their preparation Claim Types: Compound	Apr 20, 2006 *PED
Pat. No. 5030447 Pharmaceutical compositions having good stability Claim Types: Formulation	Jan 9, 2009 *PED
Pat. No. 5180589 Pravastatin pharmaceuatical compositions having good stability Claim Types: Formulation; Process	Jan 9, 2009 *PED
Pat. No. 5622985 Method for preventing a second heart attack employing an HMG CoA reductase inhibitor Claim Types: Method of use	Oct 22, 2014 *PED	U-335: Use of pravastatin sodium for secondary prevention of coronary events in men and women who have had a myocardial infarction and have normal cholesterol levels
Exclusivity	Expiration	Exclusivity Description
Exclusivity Code: I - New Indication	Apr 29,2006 PED	I-370: Treatment of heterozygous familial hypercholesterolemia in children, ages 8-13 years, with recommended dose of 20mg once daily and in adolescents, ages 14-18 with a recommended dose of 40mg once daily

PRAVIGARD PAC (COPACKAGED) (TABLET, TABLET) ASPIRIN; PRAVASTATIN SODIUM
Drug Classes: CARDIOVASCULAR-RENAL; HYPERLIPIDEMIA
NDA Applicant: BRISTOL MYERS SQUIBB      NDA No.: 021387  Prod. No.: 001 RX (81MG,N/A;N/A,20MG); 002 RX (81MG,N/A;N/A,40MG); 003 RX (81MG,N/A;N/A,80MG); 004 RX (325MG,N/A;N/A,20MG); 005 RX (325MG,N/A;N/A,40MG); 006 RX (325MG,N/A;N/A,80MG)

Patents	Expiration	Patented Use
Pat. No. 4346227 [Extended 1598 days (4.4 years)] ML-236B Derivatives and their preparation Claim Types: Compound	Apr 20, 2006 *PED
Pat. No. 5030447 Pharmaceutical compositions having good stability Claim Types: Formulation	Jan 9, 2009 *PED
Pat. No. 5180589 Pravastatin pharmaceuatical compositions having good stability Claim Types: Formulation; Process	Jan 9, 2009 *PED
Pat. No. 5622985 Method for preventing a second heart attack employing an HMG CoA reductase inhibitor Claim Types: Method of use	Oct 22, 2014 *PED	U-335: Use of pravastatin sodium for secondary prevention of coronary events in men and women who have had a myocardial infarction and have normal cholesterol levels

HEPSERA (TABLET) ADEFOVIR DIPIVOXIL
NDA Applicant: GILEAD      NDA No.: 021449  Prod. No.: 001 RX (10MG)

Patents	Expiration	Patented Use
Pat. No. 4724233 Therapeutical application of phosphonylmethoxyalkyl adenines Claim Types: Method of use	Apr 21, 2006	U-470: Therapy in chronic hepatitis B virus infection
Pat. No. 4808716 9-(phosponylmethoxyalkyl) adenines, the method of preparation and utilization thereof Claim Types: Compound	Apr 25, 2006
Pat. No. 5663159 DS* DP* Prodrugs of phosphonates Claim Types: Compound; Method of use	Sep 2, 2014	U-470: Therapy in chronic hepatitis B virus infection
Pat. No. 6451340 DS* DP* Nucleotide analog compositions Claim Types: New polymorph, salt or hydrate; Method of use; Process; Product-by-process; Formulation	Jul 23, 2018	U-470: Therapy in chronic hepatitis B virus infection
Exclusivity	Expiration	Exclusivity Description
Exclusivity Code: NCE - New chemical entity	SEP 20,2007

LUPRON DEPOT (INJECTABLE) LEUPROLIDE ACETATE
Drug Classes: ANTERIOR PITUITARY/HYPOTHALMIC FUNCTION; ANTINEOPLASTICS
NDA Applicant: TAP PHARM      NDA No.: 020011  Prod. No.: 001 RX (3.75MG/VIAL)

Patents	Expiration	Patented Use
Pat. No. 4728721 Polymer, production and use thereof Claim Types: Excipient; Process	May 1, 2006
Pat. No. 4849228 Polymer, production and use thereof Claim Types: Formulation	Jul 18, 2006
Pat. No. 5575987 Method of producing sustained-release microcapsules Claim Types: Formulation	Sep 2, 2013
Pat. No. 5716640 Method of producing sustained-release microcapsules Claim Types: Formulation; Process	Sep 2, 2013
Pat. No. 5631021 Method for producing microcapsule Claim Types: Product-by-process	May 20, 2014

LUPRON DEPOT; LUPRON DEPOT-4 (INJECTABLE) LEUPROLIDE ACETATE
Drug Classes: ANTINEOPLASTICS
NDA Applicant: TAP PHARM      NDA No.: 020517  Prod. No.: 001 RX (22.5MG/VIAL); 002 RX (30MG/VIAL)

Patents	Expiration	Patented Use
Pat. No. 4728721 Polymer, production and use thereof Claim Types: Excipient; Process	May 1, 2006
Pat. No. 4849228 Polymer, production and use thereof Claim Types: Formulation	Jul 18, 2006
Pat. No. 5814342 Prolonged release microcapsules Claim Types: Formulation; Process	Feb 1, 2011
Pat. No. 5480656 Prolonged release microcapsules Claim Types: Formulation	Jan 2, 2013
Pat. No. 5643607 Prolonged release microcapsules Claim Types: Formulation; Process	Jan 2, 2013
Pat. No. 5716640 Method of producing sustained-release microcapsules Claim Types: Formulation; Process	Sep 2, 2013
Pat. No. 5575987 Method of producing sustained-release microcapsules Claim Types: Formulation	Nov 19, 2013
Pat. No. 5631020 Method for producing microcapsule Claim Types: Product-by-process; Process	May 20, 2014
Pat. No. 6036976 Sustained release microspheres and preparation thereof Claim Types: Product-by-process	Dec 13, 2016

LUPRON DEPOT (INJECTABLE) LEUPROLIDE ACETATE
Drug Classes: ANTERIOR PITUITARY/HYPOTHALMIC FUNCTION; ANTINEOPLASTICS; ESTROGENS/PROGESTINS
NDA Applicant: TAP PHARM      NDA No.: 019732  Prod. No.: 001 RX (7.5MG/VIAL)

Patents	Expiration	Patented Use
Pat. No. 4728721 Polymer, production and use thereof Claim Types: Excipient; Process	May 1, 2006
Pat. No. 4849228 Polymer, production and use thereof Claim Types: Formulation	Jul 18, 2006
Pat. No. 5575987 Method of producing sustained-release microcapsules Claim Types: Formulation	Sep 2, 2013
Pat. No. 5716640 Method of producing sustained-release microcapsules Claim Types: Formulation; Process	Sep 2, 2013
Pat. No. 5631020 Method for producing microcapsule Claim Types: Product-by-process; Process	May 20, 2014
Pat. No. 6036976 Sustained release microspheres and preparation thereof Claim Types: Product-by-process	Dec 13, 2016

LUPRON DEPOT-3 (INJECTABLE) LEUPROLIDE ACETATE
Drug Classes: ANTERIOR PITUITARY/HYPOTHALMIC FUNCTION; ANTINEOPLASTICS
NDA Applicant: TAP PHARM      NDA No.: 020708  Prod. No.: 001 RX (11.25MG/VIAL)

Patents	Expiration	Patented Use
Pat. No. 4728721 Polymer, production and use thereof Claim Types: Excipient; Process	May 1, 2006
Pat. No. 4849228 Polymer, production and use thereof Claim Types: Formulation	Jul 18, 2006
Pat. No. 5814342 Prolonged release microcapsules Claim Types: Formulation; Process	Feb 1, 2011
Pat. No. 5480656 Prolonged release microcapsules Claim Types: Formulation	Jan 2, 2013
Pat. No. 5643607 Prolonged release microcapsules Claim Types: Formulation; Process	Jan 2, 2013
Pat. No. 5716640 Method of producing sustained-release microcapsules Claim Types: Formulation; Process	Sep 2, 2013
Pat. No. 5575987 Method of producing sustained-release microcapsules Claim Types: Formulation	Nov 19, 2013
Pat. No. 5631020 Method for producing microcapsule Claim Types: Product-by-process; Process	May 20, 2014
Pat. No. 6036976 Sustained release microspheres and preparation thereof Claim Types: Product-by-process	Dec 13, 2016

LUPRON DEPOT-PED (INJECTABLE) LEUPROLIDE ACETATE
NDA Applicant: TAP PHARM      NDA No.: 020263  Prod. No.: 002 RX (7.5MG/VIAL); 005 RX (11.25MG/VIAL); 006 RX (15MG/VIAL)

Patents	Expiration	Patented Use
Pat. No. 4728721 Polymer, production and use thereof Claim Types: Excipient; Process	May 1, 2006
Pat. No. 4849228 Polymer, production and use thereof Claim Types: Formulation	Jul 18, 2006
Pat. No. 5575987 Method of producing sustained-release microcapsules Claim Types: Formulation	Sep 2, 2013
Pat. No. 5716640 Method of producing sustained-release microcapsules Claim Types: Formulation; Process	Sep 2, 2013
Pat. No. 5631020 Method for producing microcapsule Claim Types: Product-by-process; Process	May 20, 2014
Pat. No. 6036976 Sustained release microspheres and preparation thereof Claim Types: Product-by-process	Dec 13, 2016

LUPRON DEPOT-PED (INJECTABLE) LEUPROLIDE ACETATE
NDA Applicant: TAP PHARM      NDA No.: 020263  Prod. No.: 003 DISC (3.75MG/VIAL,7.5MG/VIAL); 004 DISC (7.5MG/VIAL,7.5MG/VIAL)

Patents	Expiration	Patented Use
Pat. No. 4728721 Polymer, production and use thereof Claim Types: Excipient; Process	May 1, 2006
Pat. No. 4849228 Polymer, production and use thereof Claim Types: Formulation	Jul 18, 2006
Pat. No. 5575987 Method of producing sustained-release microcapsules Claim Types: Formulation	Sep 2, 2013
Pat. No. 5716640 Method of producing sustained-release microcapsules Claim Types: Formulation; Process	Sep 2, 2013
Pat. No. 6036976 Sustained release microspheres and preparation thereof Claim Types: Product-by-process	Dec 13, 2013
Pat. No. 5631020 Method for producing microcapsule Claim Types: Product-by-process; Process	May 20, 2014

ACTIVELLA (TABLET) ESTRADIOL; NORETHINDRONE ACETATE
Drug Classes: ESTROGENS/PROGESTINS
NDA Applicant: NOVO NORDISK INC      NDA No.: 020907  Prod. No.: 001 RX (1MG;0.5MG)

Patents	Expiration	Patented Use
Pat. No. RE36247 Method of hormonal treatment for menopausal or post-menopausal disorders involving continuous administration of progestogens and estrogens Claim Types: Method of use; Formulation	May 2, 2006

EXOSURF NEONATAL (FOR SUSPENSION) CETYL ALCOHOL; COLFOSCERIL PALMITATE; TYLOXAPOL
NDA Applicant: GLAXOSMITHKLINE      NDA No.: 020044  Prod. No.: 001 DISC (12MG/VIAL;108MG/VIAL;8MG/VIAL)

Patents	Expiration	Patented Use
Pat. No. 4826821 Lung surfactant compositions Claim Types: Formulation	May 2, 2006
Pat. No. 5110806 Lung surfactant compositions Claim Types: Formulation	May 2, 2006

PREMPHASE 14/14 (TABLET) ESTROGENS, CONJUGATED; MEDROXYPROGESTERONE ACETATE
Drug Classes: ESTROGENS/PROGESTINS; CONTRACEPTIVES
NDA Applicant: WYETH PHARMS INC      NDA No.: 020527  Prod. No.: 002 RX (0.625MG,0.625MG;N/A,5MG)

Patents	Expiration	Patented Use
Pat. No. RE36247 Method of hormonal treatment for menopausal or post-menopausal disorders involving continuous administration of progestogens and estrogens Claim Types: Method of use; Formulation	May 2, 2006
Pat. No. 5547948 Controlled release of steroids from sugar coatings Claim Types: Formulation	Jan 17, 2015

PREMPRO (TABLET) ESTROGENS, CONJUGATED; MEDROXYPROGESTERONE ACETATE
Drug Classes: ESTROGENS/PROGESTINS; CONTRACEPTIVES
NDA Applicant: WYETH PHARMS INC      NDA No.: 020527  Prod. No.: 001 RX (0.625MG;2.5MG); 003 RX (0.625MG;5MG)

Patents	Expiration	Patented Use
Pat. No. RE36247 Method of hormonal treatment for menopausal or post-menopausal disorders involving continuous administration of progestogens and estrogens Claim Types: Method of use; Formulation	May 2, 2006	U-284: Menopausal and postmenopausal disorders (including vasomotor symptoms associated with menopause, and vulvar and vaginal atrophy) and osteoporosis
Pat. No. 5547948 Controlled release of steroids from sugar coatings Claim Types: Formulation	Jan 17, 2015
Exclusivity	Expiration	Exclusivity Description
Exclusivity Code: D - New Dosing Schedule	MAR 12,2006	D-79: New lower starting dose for treatment of moderate to severe vasomotor symptoms and/or moderate to severe symptoms of vulvar and vaginal atrophy associated w/ the menopause

PREMPRO (TABLET) ESTROGENS, CONJUGATED; MEDROXYPROGESTERONE ACETATE
Drug Classes: ESTROGENS/PROGESTINS; CONTRACEPTIVES
NDA Applicant: WYETH PHARMS INC      NDA No.: 020527  Prod. No.: 004 RX (0.45MG;1.5MG)

Patents	Expiration	Patented Use
Pat. No. RE36247 Method of hormonal treatment for menopausal or post-menopausal disorders involving continuous administration of progestogens and estrogens Claim Types: Method of use; Formulation	May 2, 2006
Pat. No. 5547948 Controlled release of steroids from sugar coatings Claim Types: Formulation	Jan 17, 2015
Exclusivity	Expiration	Exclusivity Description
Exclusivity Code: D - New Dosing Schedule	MAR 12,2006	D-79: New lower starting dose for treatment of moderate to severe vasomotor symptoms and/or moderate to severe symptoms of vulvar and vaginal atrophy associated w/ the menopause
Exclusivity Code: D - New Dosing Schedule	JUN 04,2006	D-81: New lower starting dose for the prevention of postmenopausal osteoporosis
Exclusivity Code: NP - New product	MAR 12,2006

PREMPRO (TABLET) ESTROGENS, CONJUGATED; MEDROXYPROGESTERONE ACETATE
Drug Classes: ESTROGENS/PROGESTINS; CONTRACEPTIVES
NDA Applicant: WYETH PHARMS INC      NDA No.: 020527  Prod. No.: 005 RX (0.3MG;1.5MG)

Patents	Expiration	Patented Use
Pat. No. RE36247 Method of hormonal treatment for menopausal or post-menopausal disorders involving continuous administration of progestogens and estrogens Claim Types: Method of use; Formulation	May 2, 2006
Pat. No. 5547948 Controlled release of steroids from sugar coatings Claim Types: Formulation	Jan 17, 2015
Exclusivity	Expiration	Exclusivity Description
Exclusivity Code: D - New Dosing Schedule	JUN 04,2006	D-81: New lower starting dose for the prevention of postmenopausal osteoporosis
Exclusivity Code: NS - New strength	JUN 04,2006

PREMPRO (PREMARIN;CYCRIN) (TABLET) ESTROGENS, CONJUGATED; MEDROXYPROGESTERONE ACETATE
NDA Applicant: WYETH PHARMS INC      NDA No.: 020303  Prod. No.: 001 DISC (0.625MG,0.625MG;2.5MG,2.5MG)

Patents	Expiration	Patented Use
Pat. No. RE36247 Method of hormonal treatment for menopausal or post-menopausal disorders involving continuous administration of progestogens and estrogens Claim Types: Method of use; Formulation	May 2, 2006	U-284: Menopausal and postmenopausal disorders (including vasomotor symptoms associated with menopause, and vulvar and vaginal atrophy) and osteoporosis
Pat. No. 5210081 Alkali metal 8,9-dehydroestrone sulfate esters Claim Types: Composition	Feb 26, 2012

FERIDEX I.V. (INJECTABLE) FERUMOXIDES
Drug Classes: DIAGNOSTICS, RADIOPAQUE & NONRADIOACTIVE
NDA Applicant: ADV MAGNETICS      NDA No.: 020416  Prod. No.: 001 RX (EQ 11.2MG IRON/ML)

Patents	Expiration	Patented Use
Pat. No. 4827945 Biologically degradable superparamagnetic materials for use in clinical applications Claim Types: Diagnostic or surgical method; Method of use	May 9, 2006	U-144: Biologically degradable superparamagnetic materials for use in clinical applications
Pat. No. 4951675 Biodegradable superparamagnetic metal oxides as contrast agents for MR imaging Claim Types: Diagnostic or surgical method	Aug 28, 2007	U-143: Biodegradable superparamagnetic metal oxides as contrast agents for mr imaging
Pat. No. 5055288 Vascular magnetic imaging method and agent comprising biodegradeable superparamagnetic metal oxides Claim Types: Composition	Oct 8, 2008
Pat. No. 5102652 Low molecular weight carbohydrates as additives to stabilize metal oxide compositions Claim Types: Formulation; Diagnostic or surgical method; Method of use; Process	Feb 6, 2009
Pat. No. 5219554 Hydrated biodegradable superparamagnetic metal oxides Claim Types: Composition	Jun 15, 2010
Pat. No. 5248492 Low molecular weight carbohydrates as additives to stabilize metal oxide compositions Claim Types: Formulation; Diagnostic or surgical method; Method of use; Method of improving a formulation	Sep 28, 2010

GASTROMARK (SUSPENSION) FERUMOXSIL
Drug Classes: DIAGNOSTICS, MISCELLANEOUS
NDA Applicant: ADV MAGNETICS      NDA No.: 020410  Prod. No.: 001 RX (EQ 0.175MG IRON/ML)

Patents	Expiration	Patented Use
Pat. No. 4827945 Biologically degradable superparamagnetic materials for use in clinical applications Claim Types: Diagnostic or surgical method; Method of use	May 9, 2006	U-170: Method of obtaining an mr image using the composition/drug product as a contrast agent
Pat. No. 5069216 Silanized biodegradable super paramagnetic metal oxides as contrast agents for imaging the gastrointestinal tract Claim Types: Diagnostic or surgical method	May 9, 2006	U-171: Methods of using the compound/drug product as an oral contrast agent in magnetic resonance imaging of the gastrointestinal tract
Pat. No. 5055288 Vascular magnetic imaging method and agent comprising biodegradeable superparamagnetic metal oxides Claim Types: Composition	Oct 8, 2008
Pat. No. 5219554 Hydrated biodegradable superparamagnetic metal oxides Claim Types: Composition	Jun 15, 2010

FLOLAN (INJECTABLE) EPOPROSTENOL SODIUM
Drug Classes: ANTIHYPERTENSIVES
NDA Applicant: GLAXOSMITHKLINE      NDA No.: 020444  Prod. No.: 001 RX (EQ 0.5MG BASE/VIAL); 002 RX (EQ 1.5MG BASE/VIAL)

Patents	Expiration	Patented Use
Pat. No. 4883812 [Extended 1347 days (3.7 years)] Treatment of hypertension using prostacyclin Claim Types: Method of use	May 12, 2006	U-185: Method of treating hypertension
Exclusivity	Expiration	Exclusivity Description
Exclusivity Code ODE: Orphan Drug	APR 14,2007	Treatment of secondary pulmonary hypertension due to intrinsic precapillary pulmonary vascular disease.

PYTEST; PYTEST KIT (CAPSULE) UREA, C-14
Drug Classes: DIAGNOSTICS - RADIOPHARMACEUTICALS
NDA Applicant: BALLARD MEDCL      NDA No.: 020617  Prod. No.: 001 RX (1uCi); 002 RX (1uCi)

Patents	Expiration	Patented Use
Pat. No. 4830010 [Extended 1260 days (3.5 years)] Methods for the diagnosis of gastrointestinal disorders Claim Types: Diagnostic or surgical method Comments: Extension applies to MERETEK and BREATHTEK, but not PYTEST for which this patent is also listed. For PYTEST, the Orange Book expiration date is incorrect. The actual expiration date is May 16, 2006.	May 15, 2006	U-195: Method for the diagnosis of gastrointestinal disorders by urea isotoac or nitrogen labeled carbon

NEUTREXIN (INJECTABLE) TRIMETREXATE GLUCURONATE
Drug Classes: ANTINEOPLASTICS
NDA Applicant: MEDIMMUNE ONCOLOGY      NDA No.: 020326  Prod. No.: 001 RX (EQ 25MG BASE/VIAL)

Patents	Expiration	Patented Use
Pat. No. 4694007 Use of trimetrexate as antiparasitic agent Claim Types: Method of use	May 20, 2006	U-91: Alternative therapy to trimethoprim-sulfamethoxazole for treatment of moderate-to-severe pneumocystis carinii pneumonia in immunocompromised and aids patients
Pat. No. 6017922 Thermally stable trimetrexates and processes for producing the same Claim Types: New polymorph, salt or hydrate; Composition	May 18, 2018

NASAREL (SPRAY, METERED) FLUNISOLIDE
Drug Classes: CORTICOSTEROIDS-INHALATION/NASAL
NDA Applicant: IVAX RES      NDA No.: 020409  Prod. No.: 001 RX (0.029MG/SPRAY)

Patents	Expiration	Patented Use
Pat. No. 4782047 Aqueous steroid formulations for nasal administration Claim Types: Formulation; Method of use	May 22, 2006
Pat. No. 4983595 Aqueous steroid formulations for nasal administration Claim Types: Formulation	May 22, 2006
Pat. No. 4933168 Stable, crystalline flunisolide Claim Types: New polymorph, salt or hydrate; Formulation; Method of use	Jun 12, 2007

ADVIL, CHILDREN'S (SUSPENSION) IBUPROFEN [Has competitive generic]
NDA Applicant: WYETH CONS      NDA No.: 019833  Prod. No.: 002 RX (100MG/5ML)

Patents	Expiration	Patented Use
Pat. No. 4788220 Pediatric ibuprofen compositions Claim Types: Formulation	May 29, 2006 *PED

METROGEL (GEL) METRONIDAZOLE [GENERIC AB]
Drug Classes: ANTIBACTERIALS, MISCELLANEOUS; DERMATOLOGICS
NDA Applicant: GALDERMA LABS LP      NDA No.: 019737  Prod. No.: 001 RX (0.75%)

Patents	Expiration	Patented Use
Pat. No. 4837378 Topical metronidazole formulations and therapeutic uses thereof Claim Types: Formulation; Method of use	Jun 6, 2006

METROGEL-VAGINAL (GEL) METRONIDAZOLE
Drug Classes: ANTIBACTERIALS, MISCELLANEOUS; ANTIPROTOZOALS
NDA Applicant: 3M      NDA No.: 020208  Prod. No.: 001 RX (0.75%)

Patents	Expiration	Patented Use
Pat. No. 4837378 Topical metronidazole formulations and therapeutic uses thereof Claim Types: Formulation; Method of use	Jun 6, 2006
Pat. No. 5840744 Intravaginal treatment of vaginal infections with buffered metronidazole compositions Claim Types: Formulation; Method of use; Drug in a container	Jan 15, 2008	U-370: Intravaginal treatment of vaginal infections with buffered metronidazole compositions
Pat. No. 5536743 Intravaginal treatment of vaginal infections with buffered metronidazole compositions Claim Types: Formulation; Method of use	Jul 16, 2013	U-137: Method of treating bacterial vaginosis

SPECTRACEF (TABLET) CEFDITOREN PIVOXIL
Drug Classes: CEPHALOSPORINS
NDA Applicant: PURDUE PHARMA LP      NDA No.: 021222  Prod. No.: 001 RX (200MG)

Patents	Expiration	Patented Use
Pat. No. 4918068 Cephem compounds Claim Types: Compound; Composition	Jun 13, 2006
Pat. No. 4839350 DS* DP* [Extended 1036 days (2.8 years)] Cephalosporin compounds and the production thereof Claim Types: Compound; Composition	Apr 14, 2009
Pat. No. 5958915 Antibacterial composition for oral administration Claim Types: Formulation; Method of improving a formulation	Oct 14, 2016
Exclusivity	Expiration	Exclusivity Description
Exclusivity Code: NCE - New chemical entity	AUG 29,2006

MACROBID (CAPSULE) NITROFURANTOIN; NITROFURANTOIN, MACROCRYSTALLINE [GENERIC AB]
Drug Classes: ANTISEPTICS,URINARY TRACT; ANTIBACTERIALS, MISCELLANEOUS
NDA Applicant: PROCTER AND GAMBLE      NDA No.: 020064  Prod. No.: 001 RX (75MG;25MG)

Patents	Expiration	Patented Use
Pat. No. 4772473 Nitrofurantoin dosage form Claim Types: Formulation	Jun 16, 2006
Pat. No. 4798725 Sustained release capsule Claim Types: Formulation; Process	Jun 16, 2006

SINEMET CR (TABLET, EXTENDED RELEASE) CARBIDOPA; LEVODOPA [GENERIC AB]
Drug Classes: EXTRAPYRAMIDAL MOVEMENT DISORDERS
NDA Applicant: BRISTOL MYERS SQUIBB      NDA No.: 019856  Prod. No.: 001 RX (50MG;200MG); 002 RX (25MG;100MG)

Patents	Expiration	Patented Use
Pat. No. 4832957 Controlled release combination of carbidopa/levodopa Claim Types: Formulation	Jun 16, 2006
Pat. No. 4900755 Controlled release combination of carbidopa/levodopa Claim Types: Formulation	Jun 16, 2006

PROPECIA (TABLET) FINASTERIDE [GENERIC AB]
Drug Classes: ANDROGENS/ANABOLIC STEROIDS
NDA Applicant: MERCK      NDA No.: 020788  Prod. No.: 001 RX (1MG)

Patents	Expiration	Patented Use
Pat. No. 4760071 [Extended 328 days (0.9 years)] 17.beta.-N-monosubstituted carbamoyl-4-aza-5.alpha.-androst-1-en-3-ones which are active as testosterone 5.alpha.-reductase inhibitors Claim Types: Compound; Composition; Method of use	Jun 19, 2006
Pat. No. 5886184 Finasteride processes Claim Types: New polymorph, salt or hydrate; Product-by-process; Process	Nov 19, 2012
Pat. No. 5547957 Method of treating androgenic alopecia with 5-.alpha. reductase inhibitors Claim Types: Method of use	Oct 15, 2013	U-236: Treating male pattern baldness with 0.05 to 3.0 mg/day
Pat. No. 5571817 Methods of treating androgenic alopecia with finasteride [17.beta.-N-mono-substituted-carbamoyl-4-aza-5-.alpha.-androst-1-en-ones] Claim Types: Method of use	Nov 5, 2013	U-259: Treatment of androgenic alopecia by oral administration of drug substance

PROSCAR (TABLET) FINASTERIDE [GENERIC AB]
NDA Applicant: MERCK      NDA No.: 020180  Prod. No.: 001 RX (5MG)

Patents	Expiration	Patented Use
Pat. No. 4760071 DS* DP* [Extended 328 days (0.9 years)] 17.beta.-N-monosubstituted carbamoyl-4-aza-5.alpha.-androst-1-en-3-ones which are active as testosterone 5.alpha.-reductase inhibitors Claim Types: Compound; Composition; Method of use	Jun 19, 2006	U-262: Treating benign prostatic hypertrophy with finasteride
Pat. No. 6046183 DP* Method of synergistic treatment for benign prostatic hyperplasia Claim Types: Method of use; Composition	Mar 20, 2011	U-577: Treatment of benign prostatic hyperplasia with finasteride in combination with doxazosin
Pat. No. 5886184 DS* Finasteride processes Claim Types: New polymorph, salt or hydrate; Product-by-process; Process	Nov 19, 2012
Pat. No. 5942519 Prevention of precipitated acute urinary retention Claim Types: Method of use	Oct 23, 2018	U-280: Treating precipitated acute urinary retention with finasteride

ZOCOR (TABLET) SIMVASTATIN [GENERIC AB]
Drug Classes: HYPERLIPIDEMIA
NDA Applicant: MERCK      NDA No.: 019766  Prod. No.: 001 RX (5MG); 002 RX (10MG); 003 RX (20MG); 004 RX (40MG); 005 RX (80MG)

Patents	Expiration	Patented Use
Pat. No. 4444784 [Extended 1704 days (4.7 years)] Antihypercholesterolemic compounds Claim Types: Compound; Composition; Method of use	Jun 23, 2006 *PED	U-59: Method of treating hypercholesterolemia
Pat. No. RE36481 HMG-CoA reductase inhibitors Claim Types: Compound; Composition; Method of use	Jan 10, 2008 *PED	U-300: Indicated for the reduction of elevated total and LDL cholesterol levels in patients with primary hypercholesterolemia
Pat. No. RE36520 HMG-CoA reductase inhibitors Claim Types: Compound; Composition; Method of use	Nov 26, 2009 *PED	U-300: Indicated for the reduction of elevated total and LDL cholesterol levels in patients with primary hypercholesterolemia
Exclusivity	Expiration	Exclusivity Description
Exclusivity Code: I - New Indication	Apr 18,2006 PED	I-350: Treatment of heterozygous familial hypercholesterolemia in adolescent boys and girls at least one year postmenarchal, ages 10 to 17 years, with a recommended dosing range of 10 to 40mg once daily
Exclusivity Code: I - New Indication	APR 16,2006	I-390: Use in patients at high risk coronary events due to existing coronary heart disease, diabetes, peripheral vessel disease, stroke history, other CV disease to reduce risk total mortality by reducing coronary death, reduce nonfatal MI & stroke

COVERA-HS (TABLET, EXTENDED RELEASE) VERAPAMIL HYDROCHLORIDE [Has competitive generic]
Drug Classes: CALCIUM CHANNEL BLOCKERS
NDA Applicant: SEARLE, GD LLC      NDA No.: 020552  Prod. No.: 001 RX (180MG); 002 RX (240MG)

Patents	Expiration	Patented Use
Pat. No. 5141752 Delayed drug delivery device Claim Types: Device	Jun 27, 2006
Pat. No. 5190765 Therapy delayed Claim Types: Formulation	Aug 14, 2007
Pat. No. 6146662 System for delaying drug delivery up to seven hours Claim Types: Formulation; Method of administration	Aug 14, 2007	U-366: Method for the treatment of cardiovascular disease through the administration of a calcium blocking vasodilator in a delayed release formulation
Pat. No. 4946687 Dosage form for treating cardiovascular diseases Claim Types: Device	Oct 2, 2007
Pat. No. 5200196 Improvement in pulsed drug therapy Claim Types: Formulation	Jan 22, 2008
Pat. No. 5030456 Dosage form for treating cardiovascular diseases Claim Types: Formulation	Nov 7, 2008
Pat. No. 5082668 Controlled-release system with constant pushing source Claim Types: Device	Jan 21, 2009
Pat. No. 5785994 Method for administering drug to gastrointestinal tract Claim Types: Method of administration	Oct 22, 2009	U-315: Method for administering drug to gastrointestinal tract
Pat. No. 5232705 Dosage form for time-varying patterns of drug delivery Claim Types: Formulation	Aug 31, 2010
Pat. No. 5160744 Verapmil therapy Claim Types: Formulation; Method of administration	Jun 27, 2011
Pat. No. 5252338 Therapy delayed Claim Types: Method of administration	Jun 27, 2011
Pat. No. 6096339 Dosage form, process of making and using same Claim Types: Process; Formulation; Method of use	Apr 4, 2017	U-365: Method for the treatment of cardiovascular disease through the administration of a calcium blocking vasodilator in our extended, controlled release formulation

MIRAPEX (TABLET) PRAMIPEXOLE DIHYDROCHLORIDE
Drug Classes: CNS, MISCELLANEOUS; EXTRAPYRAMIDAL MOVEMENT DISORDERS
NDA Applicant: BOEHRINGER INGELHEIM      NDA No.: 020667  Prod. No.: 001 RX (0.125MG); 002 RX (0.25MG); 003 RX (1MG); 005 RX (1.5MG); 006 RX (0.5MG) NDA No.: 020667  Prod. No.: 004 DISC (1.25MG)

Patents	Expiration	Patented Use
Pat. No. 4843086 Tetrahydro-benzthiazoles, the preparation thereof and their use as intermediate products or as pharmaceuticals Claim Types: Method of use	Jun 27, 2006	U-231: Use in Parkinson's disease
Pat. No. 4886812 [Extended 1564 days (4.3 years)] Tetrahydro-benzthiazoles, the preparation thereof and their use as intermediate products or as pharmaceuticals Claim Types: Compound; Composition	Mar 25, 2011

ZOLOFT (CONCENTRATE) SERTRALINE HYDROCHLORIDE [GENERIC AB]
Drug Classes: ANTIDEPRESSANTS
NDA Applicant: PFIZER      NDA No.: 020990  Prod. No.: 001 RX (EQ 20MG BASE/ML)

Patents	Expiration	Patented Use
Pat. No. 4536518 [Extended 1228 days* (3.4 years)] Antidepressant derivatives of cis-4-phenyl-1,2,3,4-tetrahydro-1-naphthalenamine Claim Types: Compound; Composition; Method of use	Jun 30, 2006 *PED	U-286: Depression
Pat. No. 5744501 Method for treating late luteal phase dysphoric disorder Claim Types: Method of use	Jan 6, 2009	U-461: Method of treatment of late Luteal Phase Dysphoric Disorder (PMDD) using sertraline
Pat. No. 5789449 Treatment of symptoms associated with premenstrual disorders Claim Types: Method of use	Jan 6, 2009	U-460: Method of treating psychiatric symptoms associated with premenstrual disorders using sertraline
Pat. No. 5248699 Sertraline polymorph Claim Types: New polymorph, salt or hydrate; Composition; Method of use	Feb 13, 2013 *PED
Pat. No. 6727283 DP* Sertraline oral concentrate Claim Types: Formulation; Process; Method of use	Apr 11, 2020 *PED	U-580: Treatment of disorders of the serotonergic system such as depression and anxiety-related disorders
Pat. No. 7067555 DP* Sertraline oral concentrate Claim Types: Process; Formulation	May 10, 2020 *PED
Exclusivity	Expiration	Exclusivity Description
Exclusivity Code: I - New Indication	FEB 07,2006	I-261: Treatment of social anxiety disorder

ZOLOFT (TABLET) SERTRALINE HYDROCHLORIDE [GENERIC AB]
Drug Classes: ANTIDEPRESSANTS
NDA Applicant: PFIZER      NDA No.: 019839  Prod. No.: 001 RX (EQ 50MG BASE); 002 RX (EQ 100MG BASE); 005 RX (EQ 25MG BASE) NDA No.: 019839  Prod. No.: 003 DISC (EQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**); 004 DISC (EQ 200MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**)

Patents	Expiration	Patented Use
Pat. No. 4536518 [Extended 1228 days* (3.4 years)] Antidepressant derivatives of cis-4-phenyl-1,2,3,4-tetrahydro-1-naphthalenamine Claim Types: Compound; Composition; Method of use	Jun 30, 2006 *PED	U-12: Method of treating [a] human suffering from depression
Pat. No. 5744501 Method for treating late luteal phase dysphoric disorder Claim Types: Method of use	Jan 6, 2009	U-461: Method of treatment of late Luteal Phase Dysphoric Disorder (PMDD) using sertraline
Pat. No. 5789449 Treatment of symptoms associated with premenstrual disorders Claim Types: Method of use	Jan 6, 2009	U-460: Method of treating psychiatric symptoms associated with premenstrual disorders using sertraline
Pat. No. 4962128 Method of treating anxiety-related disorders using sertraline Claim Types: Method of use	May 2, 2010 *PED	U-152: Method of treating anxiety related disorders including obsessive compulsive disorder
Pat. No. 5248699 Sertraline polymorph Claim Types: New polymorph, salt or hydrate; Composition; Method of use	Feb 13, 2013 *PED
Exclusivity	Expiration	Exclusivity Description
Exclusivity Code: I - New Indication	FEB 07,2006	I-261: Treatment of social anxiety disorder

FERTINEX (INJECTABLE) UROFOLLITROPIN
Drug Classes: INFERTILITY
NDA Applicant: SERONO      NDA No.: 019415  Prod. No.: 004 DISC (150 IU/AMP); 005 DISC (75 IU/AMP)

Patents	Expiration	Patented Use
Pat. No. 4845077 Method of inducing ovulation Claim Types: Method of use	Jul 4, 2006	U-408: For inducing ovulation in conjunction with a gonadotropin releasing factor antagonist and recruiting oocytes for in-vitro fertilization
Pat. No. 5767067 Follicle stimulating hormone and pharmaceutical compositions containing same Claim Types: Composition	Jun 16, 2015

AROMASIN (TABLET) EXEMESTANE
Drug Classes: HORMONAL/BIOLOGICAL RESPONSE MODIFIERS
NDA Applicant: PHARMACIA AND UPJOHN      NDA No.: 020753  Prod. No.: 001 RX (25MG)

Patents	Expiration	Patented Use
Pat. No. 4904650 DS* DP* Substituted androsta-1,4-diene-3,17-diones Claim Types: Compound; Composition; Method of use	Jul 7, 2006
Pat. No. 4808616 DS* DP* [Extended 1729 days (4.7 years)] 6-substituted androsta-1,4-diene-3,17-diones Claim Types: Compound; Composition; Method of use	Apr 1, 2011	U-658: Treatment of advanced hormone-dependent breast cancer
Exclusivity	Expiration	Exclusivity Description
Exclusivity Code: I - New Indication	OCT 05,2008	I-495: Adjuvant tx of postmenopausal women with estrogen-receptor positive early breast cancer who have received 2 to 3 yrs of tamoxifen and are switched to AROMASIN for completion of a total of 5 consecutive yrs of adjuvant hormonal therapy
Exclusivity Code ODE: Orphan Drug	OCT 21,2006	Treatment of advanced breast cancer in postmenopausal women whose disease has progressed following tamoxifen therapy.

TECZEM (TABLET, EXTENDED RELEASE) DILTIAZEM MALATE; ENALAPRIL MALEATE
NDA Applicant: BIOVAIL      NDA No.: 020507  Prod. No.: 001 RX (EQ 180MG HCL;5MG)

Patents	Expiration	Patented Use
Pat. No. 4968507 Controlled porosity osmotic pump Claim Types: Device	Jul 25, 2006
Pat. No. 4880631 Controlled porosity osmotic pump Claim Types: Device; Formulation	Sep 24, 2007
Pat. No. 4983598 Pharmaceutical composition containing diltiazem and angiotensin-converting enzyme inhibitor Claim Types: Composition; Method of use	Jan 8, 2008

TIAMATE (TABLET, EXTENDED RELEASE) DILTIAZEM MALATE
NDA Applicant: MERCK      NDA No.: 020506  Prod. No.: 001 DISC (EQ 120MG HCL); 002 DISC (EQ 180MG HCL); 003 DISC (EQ 240MG HCL)

Patents	Expiration	Patented Use
Pat. No. 4968507 Controlled porosity osmotic pump Claim Types: Device	Jul 25, 2006
Pat. No. 4880631 Controlled porosity osmotic pump Claim Types: Device; Formulation	Sep 24, 2007

XALATAN (SOLUTION/DROPS) LATANOPROST
Drug Classes: GLAUCOMA
NDA Applicant: PHARMACIA AND UPJOHN      NDA No.: 020597  Prod. No.: 001 RX (0.005%)

Patents	Expiration	Patented Use
Pat. No. 4599353 [Extended 1116 days (3.1 years)] Use of eicosanoids and their derivatives for treatment of ocular hypertension and glaucoma Claim Types: Method of use; Composition	Jul 28, 2006	U-260: Reduction of intraocular pressure in patients with open angle glaucoma and ocular hypertension who are intolerant of other IOP lowering medications or insufficiently responsive to another iop lowering medication
Pat. No. 6429226 Prostaglandin derivatives for the treatment of glaucoma or ocular hypertension Claim Types: Composition; Method of use	Sep 6, 2009	U-260: Reduction of intraocular pressure in patients with open angle glaucoma and ocular hypertension who are intolerant of other IOP lowering medications or insufficiently responsive to another iop lowering medication
Pat. No. 5296504 Prostaglandin derivatives for the treatment of glaucoma or ocular hypertension Claim Types: Composition; Method of use	Mar 22, 2011	U-260: Reduction of intraocular pressure in patients with open angle glaucoma and ocular hypertension who are intolerant of other IOP lowering medications or insufficiently responsive to another iop lowering medication
Pat. No. 5422368 Prostaglandin derivatives for the treatment of glaucoma or ocular hypertension Claim Types: Composition; Method of use	Mar 22, 2011	U-260: Reduction of intraocular pressure in patients with open angle glaucoma and ocular hypertension who are intolerant of other IOP lowering medications or insufficiently responsive to another iop lowering medication

LOTREL (CAPSULE) AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE
Drug Classes: CALCIUM CHANNEL BLOCKERS; ACE INHIBITORS; ANTIHYPERTENSIVES
NDA Applicant: NOVARTIS      NDA No.: 020364  Prod. No.: 002 RX (EQ 2.5MG BASE;10MG); 003 RX (EQ 5MG BASE;10MG); 004 RX (EQ 5MG BASE;20MG); 005 RX (EQ 10MG BASE;20MG)

Patents	Expiration	Patented Use
Pat. No. 4572909 [Extended 1252 days (3.4 years)] 2-(Secondary aminoalkoxymethyl) dihydropyridine derivatives as anti-ischaemic and antihypertensive agents Claim Types: Compound; Composition; Method of use Comments: Amlodipine and its salts, generally.	Jul 31, 2006
Pat. No. 4879303 Pharmaceutically acceptable salts Claim Types: Compound;Composition; Formulation	Mar 25, 2007
Pat. No. 6162802 Synergistic combination therapy using benazepril and amlodipine for the treatment of cardiovascular disorders and compositions therefor Claim Types: Method of use; Formulation	Dec 19, 2017	U-367: Treatment of cardiovascular disorders

GLIADEL (IMPLANT) CARMUSTINE
Drug Classes: ANTINEOPLASTICS
NDA Applicant: MGI PHARMA INC      NDA No.: 020637  Prod. No.: 001 RX (7.7MG)

Patents	Expiration	Patented Use
Pat. No. 4757128 High molecular weight polyanhydride and preparation thereof Claim Types: Excipient; Process	Aug 1, 2006
Pat. No. 4789724 Preparation of anhydride copolymers Claim Types: Packaging or device material	Aug 1, 2006
Exclusivity	Expiration	Exclusivity Description
Exclusivity Code: I - New Indication	FEB 25,2006	I-382: For newly-diagnosed high grade malignant glioma patients as an adjunct to surgery and radiation
Exclusivity Code ODE: Orphan Drug	FEB 25,2010	For patients with malignant glioma undergoing primary surgical resection.

DEMADEX (TABLET) TORSEMIDE [GENERIC AB]
Drug Classes: DIURETICS
NDA Applicant: ROCHE      NDA No.: 020136  Prod. No.: 001 RX (5MG); 002 RX (10MG); 003 RX (20MG); 004 RX (100MG)

Patents	Expiration	Patented Use
Pat. No. RE34672 Pharmaceutical composition containing a stable modification of torasemide Claim Types: New polymorph, salt or hydrate; Method of use	Aug 11, 2006

DEMADEX (INJECTABLE) TORSEMIDE
Drug Classes: DIURETICS
NDA Applicant: ROCHE      NDA No.: 020137  Prod. No.: 002 RX (10MG/ML)

Patents	Expiration	Patented Use
Pat. No. RE34672 Pharmaceutical composition containing a stable modification of torasemide Claim Types: New polymorph, salt or hydrate; Method of use	Aug 11, 2006
Pat. No. 4861786 Composition for a stable vein compatible injectable solution of torasemide process for the preparation and method of use Claim Types: Formulation; Kit; Method of use	Jul 8, 2007

EFIDAC 24 CHLORPHENIRAMINE MALEATE (TABLET, EXTENDED RELEASE) CHLORPHENIRAMINE MALEATE
NDA Applicant: ALZA      NDA No.: 019746  Prod. No.: 002 DISC (16MG)

Patents	Expiration	Patented Use
Pat. No. 4857330 Chlorpheniramine therapy Claim Types: Device	Aug 15, 2006

ACEON (TABLET) PERINDOPRIL ERBUMINE
Drug Classes: ACE INHIBITORS
NDA Applicant: SOLVAY PHARMS      NDA No.: 020184  Prod. No.: 001 RX (2MG); 002 RX (4MG); 003 RX (8MG)

Patents	Expiration	Patented Use
Pat. No. 4508729 [Extended 1601 days (4.4 years)] Substituted iminodiacids, their preparation and pharmaceutical compositions containing them Claim Types: Compound; Composition; Method of use	Aug 21, 2006
Pat. No. 5162362 DS* DP* Octahydroindole-2-carboxylic acids Claim Types: Compound; Composition; Method of use	Nov 10, 2009	U-531: Treatment of patients with essential hypertension. May be used alone or given with other classes of antihypertensives, especially thiazide derivatives
Exclusivity	Expiration	Exclusivity Description
Exclusivity Code: I - New Indication	AUG 23,2008	I-468: Use in patients with stable coronary artery disease to reduce the risk of cardiovascular mortality or non-fatal myocardial infection

PULMICORT RESPULES (SUSPENSION) BUDESONIDE
Drug Classes: ADRENAL CORTICOSTEROIDS
NDA Applicant: ASTRAZENECA      NDA No.: 020929  Prod. No.: 001 RX (0.25MG/2ML); 002 RX (0.5MG/2ML)

Patents	Expiration	Patented Use
Pat. No. 4787536 Dosage package Claim Types: Device; Process	Aug 27, 2006 *PED
Pat. No. 6598603 Method for treating respiratory diseases Claim Types: Method of use; Kit	Jun 23, 2019 *PED	U-529: Once daily treatment of asthma with nebulized budesonide
Pat. No. 6899099 Method for treating a respiratory disease Claim Types: Kit; Method of use	Jun 23, 2019 *PED	U-751: Once daily dosing of budesonide via nebulizer for the treatment of asthma

PULMICORT RESPULES (SUSPENSION) BUDESONIDE
Drug Classes: ADRENAL CORTICOSTEROIDS
NDA Applicant: ASTRAZENECA      NDA No.: 020929  Prod. No.: 003 DISC (1MG/2ML)

Patents	Expiration	Patented Use
Pat. No. 4787536 Dosage package Claim Types: Device; Process	Aug 27, 2006 *PED
Pat. No. 6598603 Method for treating respiratory diseases Claim Types: Method of use; Kit	Jun 23, 2019 *PED	U-529: Once daily treatment of asthma with nebulized budesonide

CIPRO (INJECTABLE) CIPROFLOXACIN [GENERIC AP]
Drug Classes: ANTIBACTERIALS, MISCELLANEOUS; QUINOLONES/DERIVATIVES
NDA Applicant: BAYER PHARMS      NDA No.: 019847  Prod. No.: 001 RX (400MG/40ML (10MG/ML))

Patents	Expiration	Patented Use
Pat. No. 4808583 Solutions of lactic acid salts of piperazinylquinolone- and piperazinyl-azaquinolone-carboxylic acids Claim Types: Formulation	Aug 28, 2006 *PED
Exclusivity	Expiration	Exclusivity Description
Exclusivity Code: I - New Indication	Sep 25,2007 PED	I-421: Treatment of complicated urinary tract infections and pyelonephritis due to E.Coli for PED patients (1-17) not as first choice

CIPRO IN DEXTROSE 5% IN PLASTIC CONTAINER (INJECTABLE) CIPROFLOXACIN
Drug Classes: ANTIBACTERIALS, MISCELLANEOUS; QUINOLONES/DERIVATIVES
NDA Applicant: BAYER PHARMS      NDA No.: 019857  Prod. No.: 001 RX (200MG/100ML)

Patents	Expiration	Patented Use
Pat. No. 4808583 Solutions of lactic acid salts of piperazinylquinolone- and piperazinyl-azaquinolone-carboxylic acids Claim Types: Formulation	Aug 28, 2006 *PED
Pat. No. 4957922 Infusion solutions of 1-cyclopropyl-6-fluoro-1,4-di-hydro-4-oxo- 7-(1-piperazinyl)-quinoline-3-carboxylic acid Claim Types: Formulation	Mar 18, 2008 *PED
Exclusivity	Expiration	Exclusivity Description
Exclusivity Code: I - New Indication	Sep 25,2007 PED	I-421: Treatment of complicated urinary tract infections and pyelonephritis due to E.Coli for PED patients (1-17) not as first choice

CIPRO IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER (INJECTABLE) CIPROFLOXACIN
NDA Applicant: BAYER PHARMS      NDA No.: 019858  Prod. No.: 001 DISC (200MG/100ML)

Patents	Expiration	Patented Use
Pat. No. 4808583 Solutions of lactic acid salts of piperazinylquinolone- and piperazinyl-azaquinolone-carboxylic acids Claim Types: Formulation	Aug 28, 2006 *PED
Pat. No. 4957922 Infusion solutions of 1-cyclopropyl-6-fluoro-1,4-di-hydro-4-oxo- 7-(1-piperazinyl)-quinoline-3-carboxylic acid Claim Types: Formulation	Mar 18, 2008 *PED

OXYCONTIN (TABLET, EXTENDED RELEASE) OXYCODONE HYDROCHLORIDE [GENERIC AB]
Drug Classes: ANALGESICS, GENERAL; ANALGESICS-NARCOTIC
NDA Applicant: PURDUE PHARMA LP      NDA No.: 020553  Prod. No.: 001 RX (10MG); 002 RX (20MG); 003 RX (40MG); 004 RX (80MG) NDA No.: 020553  Prod. No.: 005 DISC (160MG)

Patents	Expiration	Patented Use
Pat. No. 4861598 Controlled release bases for pharmaceuticals Claim Types: Formulation	Aug 29, 2006
Pat. No. 4970075 Controlled release bases for pharmaceuticals Claim Types: Formulation	Aug 29, 2006
Pat. No. 5266331 Controlled release oxycodone compositions Claim Types: Formulation; Process	Oct 26, 2007
Pat. No. 5549912 Controlled release oxycodone compositions Claim Types: Formulation	Oct 26, 2007
Pat. No. 5656295 Controlled release oxycodone compositions Claim Types: Formulation; Method of use	Oct 26, 2007	U-443: Management of moderate to severe pain when a continuous, around-the-clock analgesic is needed for an extended period of time
Pat. No. 5508042 Controlled release oxycodone compositions Claim Types: Method of use	Apr 16, 2013	U-443: Management of moderate to severe pain when a continuous, around-the-clock analgesic is needed for an extended period of time

ACTIQ (SUGAR-FREE) (TROCHE/LOZENGE) FENTANYL CITRATE
Drug Classes: ANALGESICS-NARCOTIC
NDA Applicant: CEPHALON      NDA No.: 020747  Prod. No.: 001 RX (EQ 0.2MG BASE); 002 RX (EQ 0.4MG BASE); 003 RX (EQ 0.6MG BASE); 004 RX (EQ 0.8MG BASE); 005 RX (EQ 1.2MG BASE); 006 RX (EQ 1.6MG BASE)

Patents	Expiration	Patented Use
Pat. No. 4863737 Compositions and methods of manufacture of compressed powder medicaments Claim Types: Device; Process	Sep 5, 2006

K-DUR 20; K-DUR 10 (TABLET, EXTENDED RELEASE) POTASSIUM CHLORIDE [GENERIC AB]
Drug Classes: REPL/REGS OF ELECTROLYTES/WATER BALANCE
NDA Applicant: KEY PHARMS      NDA No.: 019439  Prod. No.: 001 RX (20MEQ); 002 RX (10MEQ)

Patents	Expiration	Patented Use
Pat. No. 4863743 Controlled release potassium chloride Claim Types: Formulation; Method of use	Sep 5, 2006	U-99: Method of providing potassium to a subject in need of potassium

PRANDIN (TABLET) REPAGLINIDE
Drug Classes: BLOOD GLUCOSE REGULATORS
NDA Applicant: NOVO NORDISK INC      NDA No.: 020741  Prod. No.: 001 RX (0.5MG); 002 RX (1MG); 003 RX (2MG)

Patents	Expiration	Patented Use
Pat. No. 5312924 Phenylacetic acid benzylamides Claim Types: Compound; Method of use	Sep 5, 2006	U-214: Use as a blood glucose-lowering agent
Pat. No. 6143769 Phenylacetic acid benzylamides Claim Types: Composition	Sep 5, 2006
Pat. No. RE37035 [Extended 921 days (2.5 years)] Phenylacetic acid benzylamides Claim Types: Compound; Composition	Mar 14, 2009
Pat. No. 6677358 DS* DP* NIDDM regimen Claim Types: Composition; Method of use; Kit	Jun 12, 2018	U-546: Use of repaglinide in combination with metformin to lower blood glucose

TIMOPTIC-XE (SOLUTION, GEL FORMING/DROPS) TIMOLOL MALEATE
Drug Classes: GLAUCOMA
NDA Applicant: MERCK      NDA No.: 020330  Prod. No.: 001 RX (EQ 0.25% BASE); 002 RX (EQ 0.5% BASE)

Patents	Expiration	Patented Use
Pat. No. 4861760 Ophthalmological composition of the type which undergoes liquid-gel phase transition Claim Types: Formulation	Sep 25, 2006

FASLODEX (INJECTABLE) FULVESTRANT
Drug Classes: ESTROGENS/PROGESTINS
NDA Applicant: ASTRAZENECA      NDA No.: 021344  Prod. No.: 001 RX (50MG/ML)

Patents	Expiration	Patented Use
Pat. No. 4659516 [Extension length not available] Steroid derivatives Claim Types: Compound; Method of use	Oct 1, 2006
Pat. No. 6774122 Formulation Claim Types: Method of use	Jan 9, 2021	U-596: Treatment of hormone receptor positive metastatic breast cancer in postmenopausal women with disease progression following antiestrogen therapy
Exclusivity	Expiration	Exclusivity Description
Exclusivity Code: NCE - New chemical entity	APR 25,2007

ALOCRIL (SOLUTION/DROPS) NEDOCROMIL SODIUM
Drug Classes: OPHTHALMICS-DECONGESTANTS/ANTIALLERGY AGENTS
NDA Applicant: ALLERGAN      NDA No.: 021009  Prod. No.: 001 RX (2%)

Patents	Expiration	Patented Use
Pat. No. 4474787 [Extended 5 years] 7,6 Dioxo-4H,6H-pyrano[3,2-g]quinoline dicarboxylic acids and anti-allergic use thereof Claim Types: Compound; Composition; Method of use	Oct 2, 2006	U-304: A method of treatment of a condition involving an antibody antigen reaction
Pat. No. RE38628 Pharmaceutical compositions Claim Types: Method of use	Aug 22, 2012	U-304: A method of treatment of a condition involving an antibody antigen reaction

TILADE (AEROSOL, METERED) NEDOCROMIL SODIUM
Drug Classes: ANTIASTHMATICS/BRONCODILATORS
NDA Applicant: KING PHARMS      NDA No.: 019660  Prod. No.: 001 RX (1.75MG/INH)

Patents	Expiration	Patented Use
Pat. No. 4474787 [Extended 5 years] 7,6 Dioxo-4H,6H-pyrano[3,2-g]quinoline dicarboxylic acids and anti-allergic use thereof Claim Types: Compound; Composition; Method of use	Oct 2, 2006

PATANOL (SOLUTION/DROPS) OLOPATADINE HYDROCHLORIDE
Drug Classes: OPHTHALMICS-DECONGESTANTS/ANTIALLERGY AGENTS
NDA Applicant: ALCON      NDA No.: 020688  Prod. No.: 001 RX (EQ 0.1% BASE)

Patents	Expiration	Patented Use
Pat. No. 4871865 Tricyclic aromatic compounds Claim Types: Compound	Oct 3, 2006
Pat. No. 4923892 Tricyclic aromatic compounds Claim Types: Composition; Method of use	May 8, 2007	U-174: Use as an antihistamine agent
Pat. No. 5116863 [Extended 571 days* (1.6 years)] Dibenz[b,e]oxepin derivative and pharmaceutical compositions thereof Claim Types: Compound; Composition	Dec 18, 2010
Pat. No. 5641805 Topical ophthalmic formulations for treating allergic eye diseases Claim Types: Method of use	Jun 6, 2015	U-184: Treating allergic eye diseases in humans

PULMICORT (POWDER, METERED) BUDESONIDE
Drug Classes: CORTICOSTEROIDS-INHALATION/NASAL
NDA Applicant: ASTRAZENECA      NDA No.: 020441  Prod. No.: 002 RX (0.16MG/INH) NDA No.: 020441  Prod. No.: 003 DISC (0.32MG/INH)

Patents	Expiration	Patented Use
Pat. No. 4668218 Indicating means for a dosage dispensing device Claim Types: Device	Oct 11, 2006 *PED
Pat. No. 4907583 Device in powder inhalators Claim Types: Device	Sep 13, 2007 *PED

AMBIEN (TABLET) ZOLPIDEM TARTRATE
Drug Classes: SEDATIVES/HYPNOTICS
NDA Applicant: SANOFI AVENTIS US      NDA No.: 019908  Prod. No.: 001 RX (5MG); 002 RX (10MG)

Patents	Expiration	Patented Use
Pat. No. 4382938 [Extended 5 years] Imidazo[1,2-a] pyridine derivatives and their application as pharmaceuticals Claim Types: Compound; Method of use	Oct 21, 2006	U-74: Method of providing hypnotic effect

AMBIEN CR (TABLET, EXTENDED RELEASE) ZOLPIDEM TARTRATE
NDA Applicant: SANOFI AVENTIS US      NDA No.: 021774  Prod. No.: 001 RX (12.5MG); 002 RX (6.25MG)

Patents	Expiration	Patented Use
Pat. No. 4382938 DS* [Extended 5 years] Imidazo[1,2-a] pyridine derivatives and their application as pharmaceuticals Claim Types: Compound; Method of use	Oct 21, 2006	U-682: Non-benzodiazepine hypnotic agent indicated for treatment of insomnia, characterized by difficulties with sleep onset and/or sleep maintenance
Pat. No. 6514531 DP* Controlled-release dosage forms comprising zolpidem or a salt thereof Claim Types: Formulation	Dec 1, 2019
Exclusivity	Expiration	Exclusivity Description
Exclusivity Code: NDF - New dosage form	SEP 02,2008

HIVID (TABLET) ZALCITABINE
Drug Classes: ANTIVIRALS
NDA Applicant: ROCHE      NDA No.: 020199  Prod. No.: 001 RX (0.375MG); 002 RX (0.75MG)

Patents	Expiration	Patented Use
Pat. No. 4879277 Antiviral compositions and methods Claim Types: Method of use	Nov 7, 2006	U-65: Method of treatment of a patient infected with HIV
Pat. No. 5028595 Method for preventing AIDS in a subject or treating a subject infected with the AIDS virus Claim Types: Method of use	Jul 2, 2008	U-65: Method of treatment of a patient infected with HIV

ANDRODERM (FILM, EXTENDED RELEASE) TESTOSTERONE
Drug Classes: ANDROGENS/ANABOLIC STEROIDS
NDA Applicant: WATSON LABS      NDA No.: 020489  Prod. No.: 001 RX (2.5MG/24HR); 002 RX (5MG/24HR)

Patents	Expiration	Patented Use
Pat. No. 4863970 Penetration enhancement with binary system of oleic acid, oleins, and oleyl alcohol with lower alcohols Claim Types: Formulation	Nov 14, 2006
Pat. No. 4849224 Device for administering an active agent to the skin or mucosa Claim Types: Device	Nov 12, 2007
Pat. No. 4983395 Device for administering an active agent to the skin or mucosa Claim Types: Device	Nov 12, 2007
Pat. No. 4855294 Method for reducing skin irritation associated with drug/penetration enhancer compositions Claim Types: Formulation; Method of use	Sep 6, 2008
Pat. No. 5152997 Method and device for transdermally administering testosterone across nonscrotal skin at therapeutically effective levels Claim Types: Device; Method of use	Dec 11, 2010	U-490: Testosterone replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone
Pat. No. 5164190 Subsaturated transdermal drug delivery device exhibiting enhanced drug flux Claim Types: Device; Method of administration	Dec 11, 2010

CARDENE (INJECTABLE) NICARDIPINE HYDROCHLORIDE
Drug Classes: ANTIHYPERTENSIVES
NDA Applicant: PDL BIOPHARMA INC      NDA No.: 019734  Prod. No.: 001 RX (2.5MG/ML)

Patents	Expiration	Patented Use
Pat. No. 4880823 Injection of nicardinpine hydrochloride and process for the production thereof Claim Types: Formulation	Nov 14, 2006
Pat. No. 5164405 Nicardipine pharmaceutical composition for parenteral administration Claim Types: Composition; Process	Nov 17, 2009

PROHANCE (INJECTABLE) GADOTERIDOL
Drug Classes: DIAGNOSTICS, RADIOPAQUE & NONRADIOACTIVE
NDA Applicant: BRACCO      NDA No.: 020131  Prod. No.: 001 RX (279.3MG/ML)

Patents	Expiration	Patented Use
Pat. No. 4885363 1-substituted-1,4,7-triscarboxymethyl-1,4,7,10-tetraazacyclododecane and analogs Claim Types: Compound; Composition	Dec 5, 2006
Pat. No. 5474756 Method for imaging mammalian tissue using 1-substituted-1,4,7-tricarboxymethyl- 1,4,7,10-tetraazacyclododecane and analogs Claim Types: Diagnostic or surgical method	Dec 12, 2012	U-480: Contrast agent for MRI
Pat. No. 6143274 Method for imaging and radiopharmaceutical therapy using 1-substituted-4,7,10-tricarboxymethyl- 1,4,7,10-tetraazacyclododecane and analogs Claim Types: Diagnostic or surgical method; Method of use	Dec 12, 2012	U-480: Contrast agent for MRI
Pat. No. 5846519 Method for imaging mammalian tissue using 1-substituted-1,4,7-tricarboxymethyl- 1,4,7,10-tetraazacyclododecane and analogs Claim Types: Formulation	Dec 8, 2015

PROHANCE MULTIPACK (INJECTABLE) GADOTERIDOL
Drug Classes: DIAGNOSTICS, RADIOPAQUE & NONRADIOACTIVE
NDA Applicant: BRACCO      NDA No.: 021489  Prod. No.: 001 RX (279.3MG/ML)

Patents	Expiration	Patented Use
Pat. No. 4885363 1-substituted-1,4,7-triscarboxymethyl-1,4,7,10-tetraazacyclododecane and analogs Claim Types: Compound; Composition	Dec 5, 2006
Pat. No. 5474756 Method for imaging mammalian tissue using 1-substituted-1,4,7-tricarboxymethyl- 1,4,7,10-tetraazacyclododecane and analogs Claim Types: Diagnostic or surgical method	Dec 12, 2012	U-536: Contrast agent for magnetic resonace imaging
Pat. No. 6143274 Method for imaging and radiopharmaceutical therapy using 1-substituted-4,7,10-tricarboxymethyl- 1,4,7,10-tetraazacyclododecane and analogs Claim Types: Diagnostic or surgical method; Method of use	Dec 12, 2012	U-536: Contrast agent for magnetic resonace imaging
Pat. No. 5846519 Method for imaging mammalian tissue using 1-substituted-1,4,7-tricarboxymethyl- 1,4,7,10-tetraazacyclododecane and analogs Claim Types: Formulation	Dec 8, 2015

DILACOR XR (CAPSULE, EXTENDED RELEASE) DILTIAZEM HYDROCHLORIDE [GENERIC AB2]
Drug Classes: CALCIUM CHANNEL BLOCKERS; ANTIHYPERTENSIVES
NDA Applicant: WATSON LABS      NDA No.: 020092  Prod. No.: 001 RX (120MG); 002 RX (180MG); 003 RX (240MG)

Patents	Expiration	Patented Use
Pat. No. 4839177 System for the controlled-rate release of active substances Claim Types: Device; Process	Dec 9, 2006
Pat. No. 5422123 Tablets with controlled-rate release of active substances Claim Types: Formulation; Process	Jun 6, 2012

EXTRANEAL (SOLUTION) ICODEXTRIN
Drug Classes: REPL/REGS OF ELECTROLYTES/WATER BALANCE
NDA Applicant: BAXTER HLTHCARE      NDA No.: 021321  Prod. No.: 001 RX (7.5GM/100ML)

Patents	Expiration	Patented Use
Pat. No. 4886789 Peritoneal dialysis and compositions for use therein Claim Types: Method of use	Dec 12, 2006	U-495: Peritoneal dialysis solution
Pat. No. 6077836 Peritoneal dialysis and compositions for use therein Claim Types: Formulation	Jun 20, 2017	U-495: Peritoneal dialysis solution
Pat. No. 6248726 Method of peritoneal dialysis using glucose polymer solutions Claim Types: Method of use	Jun 19, 2018	U-495: Peritoneal dialysis solution
Exclusivity	Expiration	Exclusivity Description
Exclusivity Code: I - New Indication	DEC 17,2007	I-445: To improve (compared to 4.25% dextrose) long-dwell ultrafiltration and clearance of creatinine and urea nitrogen in patients with high average or greater transport characteristics, as defined using the peritoneal equilibration test (PET)
Exclusivity Code: NCE - New chemical entity	DEC 20,2007
Exclusivity Code ODE: Orphan Drug	DEC 20,2009	Treatment of those patients having end stage renal disease and requiring peritoneal dialysis treatment.