Patent Expiration View
Products whose first patent expiration is in 2006

Patents whose numbers are in italics have been extended under 35 USC 156. All expiration dates include applicable Sec. 156 and pediatric (PED) extensions.

Products tagged as GENERIC have had a generic equivalent approved for at least one strength of the product.


FINACEA (GEL) AZELAIC ACID
Drug Classes: ACNE PRODUCTS
NDA Applicant: INTENDIS      NDA No.:
021470  Prod. No.: 001 RX (15%)
PatentsExpirationPatented Use
Pat. No. 4713394 Treatment of nonacne inflammatory and infectious dermatoses and hair loss
Claim Types: Method of use
Jan 17, 2006U-492: Method for the treatment of skin, suffering from a condition selected from a group consisting of non-acne inflammatory dermatoses comprising applying to affected area a therapeutically effective amt azelaic acid
Pat. No. 6534070 Composition with azelaic acid
Claim Types: Formulation; Method of use
Nov 18, 2018 

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)
PatentsExpirationPatented 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)
PatentsExpirationPatented 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 
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entityAPR 04,2008 

NICOTROL (INHALANT) NICOTINE
Drug Classes: CNS, MISCELLANEOUS
NDA Applicant: PHARMACIA AND UPJOHN      NDA No.:
020714  Prod. No.: 001 RX (4MG/CARTRIDGE)
PatentsExpirationPatented 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)
PatentsExpirationPatented 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, 2006U-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)
PatentsExpirationPatented 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, 2006U-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)
PatentsExpirationPatented 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)
PatentsExpirationPatented 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)
PatentsExpirationPatented 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))
PatentsExpirationPatented Use
Pat. No. 4820738 1,4-bis(substituted-amino)-5,8-dihydroxy-anthraquinones and leuco bases thereof
Claim Types: Method of use
Apr 11, 2006U-98: A method of inducing regression of leukemia cell growth in a mammal
ExclusivityExpirationExclusivity Description
Exclusivity Code ODE: Orphan DrugOCT 13,2007Treatment of progressive-relapsing multiple sclerosis.
Exclusivity Code ODE: Orphan DrugOCT 13,2007Treatment 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))
PatentsExpirationPatented 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 
ExclusivityExpirationExclusivity Description
Exclusivity Code ODE: Orphan DrugOCT 13,2007Treatment of progressive-relapsing multiple sclerosis.
Exclusivity Code ODE: Orphan DrugOCT 13,2007Treatment 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)
PatentsExpirationPatented 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 *PEDU-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
ExclusivityExpirationExclusivity Description
Exclusivity Code: I - New IndicationApr 29,2006 PEDI-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)
PatentsExpirationPatented 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 *PEDU-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)
PatentsExpirationPatented Use
Pat. No. 4724233 Therapeutical application of phosphonylmethoxyalkyl adenines
Claim Types: Method of use
Apr 21, 2006U-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, 2014U-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, 2018U-470: Therapy in chronic hepatitis B virus infection
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entitySEP 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)
PatentsExpirationPatented 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)
PatentsExpirationPatented 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)
PatentsExpirationPatented 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)
PatentsExpirationPatented 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)
PatentsExpirationPatented 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)
PatentsExpirationPatented 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)
PatentsExpirationPatented 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)
PatentsExpirationPatented 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)
PatentsExpirationPatented 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)
PatentsExpirationPatented 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, 2006U-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 
ExclusivityExpirationExclusivity Description
Exclusivity Code: D - New Dosing ScheduleMAR 12,2006D-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)
PatentsExpirationPatented 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 
ExclusivityExpirationExclusivity Description
Exclusivity Code: D - New Dosing ScheduleMAR 12,2006D-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 ScheduleJUN 04,2006D-81: New lower starting dose for the prevention of postmenopausal osteoporosis
Exclusivity Code: NP - New productMAR 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)
PatentsExpirationPatented 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 
ExclusivityExpirationExclusivity Description
Exclusivity Code: D - New Dosing ScheduleJUN 04,2006D-81: New lower starting dose for the prevention of postmenopausal osteoporosis
Exclusivity Code: NS - New strengthJUN 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)
PatentsExpirationPatented 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, 2006U-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)
PatentsExpirationPatented Use
Pat. No. 4827945 Biologically degradable superparamagnetic materials for use in clinical applications
Claim Types: Diagnostic or surgical method; Method of use
May 9, 2006U-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, 2007U-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)
PatentsExpirationPatented Use
Pat. No. 4827945 Biologically degradable superparamagnetic materials for use in clinical applications
Claim Types: Diagnostic or surgical method; Method of use
May 9, 2006U-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, 2006U-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)
PatentsExpirationPatented Use
Pat. No. 4883812 [Extended 1347 days (3.7 years)]
Treatment of hypertension using prostacyclin
Claim Types: Method of use
May 12, 2006U-185: Method of treating hypertension
ExclusivityExpirationExclusivity Description
Exclusivity Code ODE: Orphan DrugAPR 14,2007Treatment 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)
PatentsExpirationPatented 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, 2006U-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)
PatentsExpirationPatented Use
Pat. No. 4694007 Use of trimetrexate as antiparasitic agent
Claim Types: Method of use
May 20, 2006U-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)
PatentsExpirationPatented 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)
PatentsExpirationPatented 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%)
PatentsExpirationPatented 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%)
PatentsExpirationPatented 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, 2008U-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, 2013U-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)
PatentsExpirationPatented 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 
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entityAUG 29,2006 

MACROBID (CAPSULE) NITROFURANTOIN; NITROFURANTOIN, MACROCRYSTALLINE [GENERIC AB]
Drug Classes: