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Last Updated: March 29, 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-five patent family members in twenty-eight countries.

There are sixteen drug master file entries for leuprolide acetate. Nine 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
Emory UniversityPhase 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 020708-001 Mar 7, 1997 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Abbvie Endocrine LUPANETA PACK leuprolide acetate; norethindrone acetate INJECTABLE, TABLET;INTRAMUSCULAR, ORAL 203696-001 Dec 14, 2012 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Abbvie Endocrine Inc LUPRON DEPOT-PED KIT leuprolide acetate POWDER;INTRAMUSCULAR 020263-002 Apr 16, 1993 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>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-PED KIT leuprolide acetate POWDER;INTRAMUSCULAR 020263-007 Aug 15, 2011 ⤷  Try a Trial ⤷  Try a Trial
Tolmar ELIGARD KIT leuprolide acetate POWDER;SUBCUTANEOUS 021343-001 Jan 23, 2002 ⤷  Try a Trial ⤷  Try a Trial
Tolmar ELIGARD KIT leuprolide acetate POWDER;SUBCUTANEOUS 021731-001 Dec 14, 2004 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for leuprolide acetate

Country Patent Number Title Estimated Expiration
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 ⤷  Try a Trial
Japan 2010513225 ⤷  Try a Trial
China 101563068 Sustained-release composition and method for producing the same ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

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