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Last Updated: May 24, 2024

LEUPROLIDE ACETATE - Generic Drug Details


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What are the generic drug sources for leuprolide acetate and what is the scope of freedom to operate?

Leuprolide acetate is the generic ingredient in nine branded drugs marketed by Invagen Pharms, Ortho Mcneil Janssen, Amneal, Eugia Pharma, Genzyme, Meitheal, Rk Pharma, Sandoz, Sun Pharm, Abbvie Endocrine Inc, Tolmar, and Abbvie Endocrine, and is included in twenty-one NDAs. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Leuprolide acetate has forty-six patent family members in twenty-eight countries.

There are sixteen drug master file entries for leuprolide acetate. Ten suppliers are listed for this compound.

Drug Prices for LEUPROLIDE ACETATE

See drug prices for LEUPROLIDE ACETATE

Recent Clinical Trials for LEUPROLIDE ACETATE

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Johns Hopkins Bloomberg School of Public HealthPhase 2
TakedaPhase 4
National Cancer Institute (NCI)Phase 4

See all LEUPROLIDE ACETATE clinical trials

Pharmacology for LEUPROLIDE ACETATE
Medical Subject Heading (MeSH) Categories for LEUPROLIDE ACETATE

US Patents and Regulatory Information for LEUPROLIDE ACETATE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Abbvie Endocrine Inc LUPRON DEPOT leuprolide acetate INJECTABLE;INJECTION 019732-001 Jan 26, 1989 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Genzyme LEUPROLIDE ACETATE leuprolide acetate INJECTABLE;INJECTION 075721-001 Nov 29, 2001 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Tolmar ELIGARD KIT leuprolide acetate POWDER;SUBCUTANEOUS 021379-001 Jul 24, 2002 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y Y ⤷  Sign Up
Tolmar ELIGARD KIT leuprolide acetate POWDER;SUBCUTANEOUS 021343-001 Jan 23, 2002 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y Y ⤷  Sign Up
Abbvie Endocrine Inc LUPRON DEPOT leuprolide acetate INJECTABLE;INJECTION 020517-001 Dec 22, 1995 RX Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Amneal LEUPROLIDE ACETATE leuprolide acetate INJECTABLE;INJECTION 215336-001 Oct 28, 2022 AP RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Abbvie Endocrine Inc LUPRON DEPOT leuprolide acetate INJECTABLE;INJECTION 020517-002 May 30, 1997 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for LEUPROLIDE ACETATE

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Abbvie Endocrine Inc LUPRON DEPOT leuprolide acetate INJECTABLE;INJECTION 020517-001 Dec 22, 1995 ⤷  Sign Up ⤷  Sign Up
Abbvie Endocrine Inc LUPRON DEPOT-PED KIT leuprolide acetate POWDER;INTRAMUSCULAR 020263-008 Aug 15, 2011 ⤷  Sign Up ⤷  Sign Up
Tolmar ELIGARD KIT leuprolide acetate POWDER;SUBCUTANEOUS 021379-001 Jul 24, 2002 ⤷  Sign Up ⤷  Sign Up
Abbvie Endocrine Inc LUPRON DEPOT-PED KIT leuprolide acetate POWDER;INTRAMUSCULAR 020263-007 Aug 15, 2011 ⤷  Sign Up ⤷  Sign Up
Abbvie Endocrine Inc LUPRON DEPOT-PED KIT leuprolide acetate POWDER;INTRAMUSCULAR 020263-007 Aug 15, 2011 ⤷  Sign Up ⤷  Sign Up
Abbvie Endocrine Inc LUPRON DEPOT-PED KIT leuprolide acetate POWDER;INTRAMUSCULAR 020263-006 Jan 21, 1994 ⤷  Sign Up ⤷  Sign Up
Abbvie Endocrine Inc LUPRON DEPOT leuprolide acetate INJECTABLE;INJECTION 019732-001 Jan 26, 1989 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for LEUPROLIDE ACETATE

Country Patent Number Title Estimated Expiration
Australia 2007335406 Sustained-release composition and method for producing the same ⤷  Sign Up
Colombia 2023009588 Métodos y sistemas para conjuntos de válvulas de jeringa mezcladoras ⤷  Sign Up
South Korea 20090094272 SUSTAINED-RELEASE COMPOSITION AND METHOD FOR PRODUCING THE SAME ⤷  Sign Up
New Zealand 577281 SUSTAINED-RELEASE COMPOSITION AND METHOD FOR PRODUCING THE SAME ⤷  Sign Up
European Patent Office 2094246 COMPOSITION À LIBÉRATION PROLONGÉE ET PROCÉDÉ DE PRODUCTION CORRESPONDANT (SUSTAINED-RELEASE COMPOSITION AND METHOD FOR PRODUCING THE SAME) ⤷  Sign Up
Brazil PI0720582 COMPOSIÇÃO DE LIBERAÇÃO PROLONGADA, PROCESSO PARA A PREPARAÇÃO DA MESMA, COMPOSIÇÃO FARMACÊUTICA, AGENTE PROFILÁTICO OU TERAPÊUTICO PARA O CÂNCER DA PRÓSTATA, AGENTE PROFILÁTICO PARA A RECORRÊNCIA PÓS-OPERATÓRIA DE CÃNCER DE MAMA PRÉ-MENOPAUSA, E, USO DA COMPOSIÇÃO DE LIBERAÇÃO PROLONGADA ⤷  Sign Up
Canada 3205655 SYSTEMES ET PROCEDES DE COMBINAISON D'ENSEMBLES VALVE DE SERINGUE (SYSTEMS AND METHODS FOR MIXING SYRINGE VALVE ASSEMBLIES) ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

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