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.
| 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 |
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. |
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 (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-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 |
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-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 |
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 |
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. |
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 |
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 |
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 |
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 |
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 |
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 |
ZOFRAN; ZOFRAN PRESERVATIVE FREE (INJECTABLE) ONDANSETRON HYDROCHLORIDE
Drug Classes: ANTIEMETICS; VERTIGO/MOTION SICKNESS/VOMITING
NDA Applicant: GLAXOSMITHKLINE NDA No.: 020007 Prod. No.: 001 RX (EQ 2MG BASE/ML); 003 RX (EQ 2MG BASE/ML)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 4753789 Method for treating nausea and vomiting Claim Types: Method of use | Dec 24, 2006 *PED | U-44: Relief of nausea and vomiting |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: D - New Dosing Schedule | Sep 25,2008 PED | D-97: Ped cancer pt population expanded to include pts 6 mos up to but not including 4 yrs and dosing instructions to admin 30 min before chemo with second and third doses 4 & 8 hours after first dose |
| Exclusivity Code: D - New Dosing Schedule | Sep 25,2008 PED | D-98: Dosing for ped surgical pts expanded to include pts 1 month up to but not including 2 years of age |
ZOFRAN IN PLASTIC CONTAINER (INJECTABLE) ONDANSETRON HYDROCHLORIDE
Drug Classes: ANTIEMETICS
NDA Applicant: GLAXOSMITHKLINE NDA No.: 020403 Prod. No.: 001 RX (EQ 0.64MG BASE/ML)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 4753789 Method for treating nausea and vomiting Claim Types: Method of use | Dec 24, 2006 *PED | U-44: Relief of nausea and vomiting |