Condensed Patent Expiration List
Products whose first patent expiration is in 2006

The Condensed List contains products that have at least one patent with compound, composition or "new polymorph, salt or hydrate" claims.

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.


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 

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 

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 

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 

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 

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 

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 

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 

PROSCAR (TABLET) FINASTERIDE [GENERIC AB]
NDA Applicant: MERCK      NDA No.:
020180  Prod. No.: 001 RX (5MG)
PatentsExpirationPatented 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, 2006U-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, 2011U-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, 2018U-280: Treating precipitated acute urinary retention with finasteride

PROPECIA (TABLET) FINASTERIDE [GENERIC AB]
Drug Classes: ANDROGENS/ANABOLIC STEROIDS
NDA Applicant: MERCK      NDA No.:
020788  Prod. No.: 001 RX (1MG)
PatentsExpirationPatented 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, 2013U-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, 2013U-259: Treatment of androgenic alopecia by oral administration of drug substance

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)
PatentsExpirationPatented Use
Pat. No. 4444784 [Extended 1704 days (4.7 years)]
Antihypercholesterolemic compounds
Claim Types: Compound; Composition; Method of use
Jun 23, 2006 *PEDU-59: Method of treating hypercholesterolemia
Pat. No. RE36481 HMG-CoA reductase inhibitors
Claim Types: Compound; Composition; Method of use
Jan 10, 2008 *PEDU-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 *PEDU-300: Indicated for the reduction of elevated total and LDL cholesterol levels in patients with primary hypercholesterolemia
ExclusivityExpirationExclusivity Description
Exclusivity Code: I - New IndicationApr 18,2006 PEDI-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 IndicationAPR 16,2006I-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

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)
PatentsExpirationPatented 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, 2006U-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 (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**)
PatentsExpirationPatented 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 *PEDU-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, 2009U-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, 2009U-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 *PEDU-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 
ExclusivityExpirationExclusivity Description
Exclusivity Code: I - New IndicationFEB 07,2006I-261: Treatment of social anxiety disorder

ZOLOFT (CONCENTRATE) SERTRALINE HYDROCHLORIDE [GENERIC AB]
Drug Classes: ANTIDEPRESSANTS
NDA Applicant: PFIZER      NDA No.:
020990  Prod. No.: 001 RX (EQ 20MG BASE/ML)
PatentsExpirationPatented 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 *PEDU-286: Depression
Pat. No. 5744501 Method for treating late luteal phase dysphoric disorder
Claim Types: Method of use
Jan 6, 2009U-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, 2009U-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 *PEDU-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 
ExclusivityExpirationExclusivity Description
Exclusivity Code: I - New IndicationFEB 07,2006I-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)
PatentsExpirationPatented Use
Pat. No. 4845077 Method of inducing ovulation
Claim Types: Method of use
Jul 4, 2006U-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)
PatentsExpirationPatented 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, 2011U-658: Treatment of advanced hormone-dependent breast cancer
ExclusivityExpirationExclusivity Description
Exclusivity Code: I - New IndicationOCT 05,2008I-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 DrugOCT 21,2006Treatment 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)
PatentsExpirationPatented 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 

XALATAN (SOLUTION/DROPS) LATANOPROST
Drug Classes: GLAUCOMA
NDA Applicant: PHARMACIA AND UPJOHN      NDA No.:
020597  Prod. No.: 001 RX (0.005%)
PatentsExpirationPatented 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, 2006U-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, 2009U-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, 2011U-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, 2011U-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)
PatentsExpirationPatented 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, 2017U-367: Treatment of cardiovascular disorders

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)
PatentsExpirationPatented 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)
PatentsExpirationPatented 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 

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)
PatentsExpirationPatented 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, 2009U-531: Treatment of patients with essential hypertension. May be used alone or given with other classes of antihypertensives, especially thiazide derivatives
ExclusivityExpirationExclusivity Description
Exclusivity Code: I - New IndicationAUG 23,2008I-468: Use in patients with stable coronary artery disease to reduce the risk of cardiovascular mortality or non-fatal myocardial infection

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)
PatentsExpirationPatented Use
Pat. No. 5312924 Phenylacetic acid benzylamides
Claim Types: Compound; Method of use
Sep 5, 2006U-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, 2018U-546: Use of repaglinide in combination with metformin to lower blood glucose

FASLODEX (INJECTABLE) FULVESTRANT
Drug Classes: ESTROGENS/PROGESTINS
NDA Applicant: ASTRAZENECA      NDA No.:
021344  Prod. No.: 001 RX (50MG/ML)
PatentsExpirationPatented 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, 2021U-596: Treatment of hormone receptor positive metastatic breast cancer in postmenopausal women with disease progression following antiestrogen therapy
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entityAPR 25,2007 

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

ALOCRIL (SOLUTION/DROPS) NEDOCROMIL SODIUM
Drug Classes: OPHTHALMICS-DECONGESTANTS/ANTIALLERGY AGENTS
NDA Applicant: ALLERGAN      NDA No.:
021009  Prod. No.: 001 RX (2%)
PatentsExpirationPatented 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, 2006U-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, 2012U-304: A method of treatment of a condition involving an antibody antigen reaction

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)
PatentsExpirationPatented 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, 2007U-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, 2015U-184: Treating allergic eye diseases in humans

AMBIEN (TABLET) ZOLPIDEM TARTRATE
Drug Classes: SEDATIVES/HYPNOTICS
NDA Applicant: SANOFI AVENTIS US      NDA No.:
019908  Prod. No.: 001 RX (5MG); 002 RX (10MG)
PatentsExpirationPatented 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, 2006U-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)
PatentsExpirationPatented 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, 2006U-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 
ExclusivityExpirationExclusivity Description
Exclusivity Code: NDF - New dosage formSEP 02,2008 

CARDENE (INJECTABLE) NICARDIPINE HYDROCHLORIDE
Drug Classes: ANTIHYPERTENSIVES
NDA Applicant: PDL BIOPHARMA INC      NDA No.:
019734  Prod. No.: 001 RX (2.5MG/ML)
PatentsExpirationPatented 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)
PatentsExpirationPatented 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, 2012U-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, 2012U-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)
PatentsExpirationPatented 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, 2012U-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, 2012U-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 

PAXIL CR (TABLET, EXTENDED RELEASE) PAROXETINE HYDROCHLORIDE
Drug Classes: ANTIDEPRESSANTS
NDA Applicant: GLAXOSMITHKLINE      NDA No.:
020936  Prod. No.: 001 RX (EQ 12.5MG BASE); 002 RX (EQ 25MG BASE); 003 RX (EQ 37.5MG BASE)
PatentsExpirationPatented Use
Pat. No. 4839177 System for the controlled-rate release of active substances
Claim Types: Device; Process
Dec 13, 2006 *PED 
Pat. No. 4721723 [Extended 67 days* (0.2 years)]
Anti-depressant crystalline paroxetine hydrochloride hemihydrate
Claim Types: New polymorph, salt or hydrate; Composition; Process; Method of use
Jun 29, 2007 *PED 
Pat. No. 5789449 Treatment of symptoms associated with premenstrual disorders
Claim Types: Method of use
Jul 6, 2009 *PEDU-286: Depression
Pat. No. 5422123 Tablets with controlled-rate release of active substances
Claim Types: Formulation; Process
Dec 6, 2012 *PED 
Pat. No. 5872132 Form of paroxetine hydrochloride anhydrate
Claim Types: New polymorph, salt or hydrate; Composition
Nov 19, 2015 *PED 
Pat. No. 5900423 Form of paroxetine hydrochloride anhydrate
Claim Types: New polymorph, salt or hydrate
Nov 19, 2015 *PED 
Pat. No. 6133289 Paroxetine hydrochloride form A or C
Claim Types: Method of using new polymorph, salt or hydrate
Nov 19, 2015 *PEDU-286: Depression
Pat. No. 6548084 Controlled release compositions
Claim Types: Method of improving a treatment; Formulation; Process
Jan 19, 2017 *PED 
Pat. No. 6121291 Paroxetine in the treatment of depression associated with withdrawal from heroin abuse and post-traumatic stress disorder
Claim Types: Method of use
Sep 17, 2017 *PEDU-286: Depression
ExclusivityExpirationExclusivity Description
Exclusivity Code: D - New Dosing ScheduleJAN 27,2007D-91: Alternate intermittent dosing regimen
Exclusivity Code: I - New IndicationAUG 28,2006I-405: Treatment of Premenstrual Dysphoric Disorder (PMDD) using an intermittent dosing regimen

LAMISIL (CREAM) TERBINAFINE HYDROCHLORIDE
Drug Classes: DERMATOLOGICS
NDA Applicant: NOVARTIS      NDA No.:
020192  Prod. No.: 001 DISC (1%)
PatentsExpirationPatented Use
Pat. No. 4755534 [Extended 543 days (1.5 years)]
Propenylamines, pharmaceutical compositions containing them and their use as pharmaceuticals
Claim Types: Compound; Composition; Method of use
Dec 30, 2006U-73: Method of treating diseases or infections caused by mycetes

LAMISIL (TABLET) TERBINAFINE HYDROCHLORIDE
Drug Classes: ANTIFUNGALS
NDA Applicant: NOVARTIS      NDA No.:
020539  Prod. No.: 001 RX (EQ 250MG BASE)
PatentsExpirationPatented Use
Pat. No. 4755534 [Extended 543 days (1.5 years)]
Propenylamines, pharmaceutical compositions containing them and their use as pharmaceuticals
Claim Types: Compound; Composition; Method of use
Dec 30, 2006U-73: Method of treating diseases or infections caused by mycetes

LAMISIL (SOLUTION) TERBINAFINE HYDROCHLORIDE
Drug Classes: ANTIFUNGALS; TOPICAL ANTI-INFECTIVES
NDA Applicant: NOVARTIS      NDA No.:
020749  Prod. No.: 001 RX (1%)
PatentsExpirationPatented Use
Pat. No. 4755534 [Extended 543 days (1.5 years)]
Propenylamines, pharmaceutical compositions containing them and their use as pharmaceuticals
Claim Types: Compound; Composition; Method of use
Dec 30, 2006 
Pat. No. 6121314 Pharmaceutical composition
Claim Types: Formulation; Method of use; Process
May 18, 2012U-502: Pityriasis Versicolor

LAMISIL (GEL) TERBINAFINE
NDA Applicant: NOVARTIS      NDA No.:
020846  Prod. No.: 001 RX (1%)
PatentsExpirationPatented Use
Pat. No. 4755534 [Extended 543 days (1.5 years)]
Propenylamines, pharmaceutical compositions containing them and their use as pharmaceuticals
Claim Types: Compound; Composition; Method of use
Dec 30, 2006U-445: Use as an antimycotic agent
Pat. No. 5856355 DP* Pharmaceutical composition
Claim Types: Formulation; Process; Method of use
May 18, 2012U-502: Pityriasis Versicolor
Pat. No. 5856355 DP* Pharmaceutical composition
Claim Types: Formulation; Process; Method of use
May 18, 2012U-504: Tinea Pedis, Tinea Cruris, Tinea Corporis
Pat. No. 5856355 DP* Pharmaceutical composition
Claim Types: Formulation; Process; Method of use
May 18, 2012U-540: Treatment of fungal infections
Pat. No. 6005001 DP* Pharmaceutical composition
Claim Types: Composition; Process; Method of use
May 18, 2012U-502: Pityriasis Versicolor
Pat. No. 6005001 DP* Pharmaceutical composition
Claim Types: Composition; Process; Method of use
May 18, 2012U-504: Tinea Pedis, Tinea Cruris, Tinea Corporis
Pat. No. 6005001 DP* Pharmaceutical composition
Claim Types: Composition; Process; Method of use
May 18, 2012U-540: Treatment of fungal infections
Pat. No. 6121314 DP* Pharmaceutical composition
Claim Types: Formulation; Method of use; Process
May 18, 2012U-502: Pityriasis Versicolor
Pat. No. 6121314 DP* Pharmaceutical composition
Claim Types: Formulation; Method of use; Process
May 18, 2012U-504: Tinea Pedis, Tinea Cruris, Tinea Corporis
Pat. No. 6121314 DP* Pharmaceutical composition
Claim Types: Formulation; Method of use; Process
May 18, 2012U-540: Treatment of fungal infections
Pat. No. 5681849 DP* Pharmaceutical composition for topical applications
Claim Types: Formulation; Method of use
Oct 28, 2014 

LAMISIL (CREAM) TERBINAFINE HYDROCHLORIDE
NDA Applicant: NOVARTIS      NDA No.:
020980  Prod. No.: 001 OTC (1%)
PatentsExpirationPatented Use
Pat. No. 4755534 [Extended 543 days (1.5 years)]
Propenylamines, pharmaceutical compositions containing them and their use as pharmaceuticals
Claim Types: Compound; Composition; Method of use
Dec 30, 2006U-73: Method of treating diseases or infections caused by mycetes

LAMISIL AT (SOLUTION; SPRAY) TERBINAFINE HYDROCHLORIDE
NDA Applicant: NOVARTIS      NDA No.:
021124  Prod. No.: 001 OTC (1%); 002 OTC (1%)
PatentsExpirationPatented Use
Pat. No. 4755534 [Extended 543 days (1.5 years)]
Propenylamines, pharmaceutical compositions containing them and their use as pharmaceuticals
Claim Types: Compound; Composition; Method of use
Dec 30, 2006U-73: Method of treating diseases or infections caused by mycetes
Pat. No. 6121314 Pharmaceutical composition
Claim Types: Formulation; Method of use; Process
May 18, 2012U-504: Tinea Pedis, Tinea Cruris, Tinea Corporis
Pat. No. 5681849 Pharmaceutical composition for topical applications
Claim Types: Formulation; Method of use
Oct 28, 2014 


DS*=Drug Substance; DP*=Drug Product - patent submitted for the product after Aug. 18, 2003.
* Extension limited by the 14-year cap of 35 USC 156(c)(3)
Last edited: 26 September 2006
© 2001-2006 Food and Drug Law Institute, All rights reserved worldwide