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Last Updated: June 23, 2024

LEUPROLIDE ACETATE - Generic Drug Details


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What are the generic 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 four 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

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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
Rk Pharma LEUPROLIDE ACETATE leuprolide acetate INJECTABLE;INJECTION 213829-001 Aug 13, 2021 AP RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Abbvie Endocrine Inc LUPRON DEPOT leuprolide acetate INJECTABLE;INJECTION 020011-001 Oct 22, 1990 DISCN Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Tolmar ELIGARD KIT leuprolide acetate POWDER;SUBCUTANEOUS 021343-001 Jan 23, 2002 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Abbvie Endocrine Inc LUPRON DEPOT-PED KIT leuprolide acetate POWDER;INTRAMUSCULAR 020263-002 Apr 16, 1993 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-PED KIT leuprolide acetate POWDER;INTRAMUSCULAR 020263-006 Jan 21, 1994 ⤷  Sign Up ⤷  Sign Up
Ortho Mcneil Janssen VIADUR leuprolide acetate IMPLANT;IMPLANTATION 021088-001 Mar 3, 2000 ⤷  Sign Up ⤷  Sign Up
Abbvie Endocrine Inc LUPRON DEPOT leuprolide acetate INJECTABLE;INJECTION 020708-001 Mar 7, 1997 ⤷  Sign Up ⤷  Sign Up
Abbvie Endocrine Inc LUPRON DEPOT-PED KIT leuprolide acetate POWDER;INTRAMUSCULAR 020263-002 Apr 16, 1993 ⤷  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
Israel 303673 מערכות ושיטות לערבול מכלולי שסתומי מזרק (Systems and methods for mixing syringe valve assemblies) ⤷  Sign Up
World Intellectual Property Organization (WIPO) 2022137182 ⤷  Sign Up
Canada 2671670 COMPOSITION A LIBERATION PROLONGEE ET PROCEDE DE PRODUCTION CORRESPONDANT (SUSTAINED-RELEASE COMPOSITION AND METHOD FOR PRODUCING THE SAME) ⤷  Sign Up
Peru 20081842 COMPOSICION DE LIBERACION SOSTENIDA Y METODOS PARA PRODUCIRLAS ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

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