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Last Updated: October 25, 2021

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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 Gp-pharm Sa, Ortho Mcneil Janssen, Genzyme, Sandoz, Sun Pharm, Teva Pharms Usa, Vgyaan, Abbvie Endocrine Inc, Tolmar Therap, Tolmar, and Abbvie Endocrine, and is included in nineteen NDAs. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Leuprolide acetate has one hundred and sixty-nine patent family members in forty-two countries.

There are twenty-two drug master file entries for leuprolide acetate. Five 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
Bharat Serums and Vaccines LimitedPhase 3
Johns Hopkins UniversityPhase 1
National Institute of Allergy and Infectious Diseases (NIAID)Phase 1

See all leuprolide acetate clinical trials

Medical Subject Heading (MeSH) Categories for leuprolide acetate
Paragraph IV (Patent) Challenges for LEUPROLIDE ACETATE
Tradename Dosage Ingredient NDA Submissiondate
LUPRON DEPOT INJECTABLE;INJECTION leuprolide acetate 019732

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
Tolmar Therap ELIGARD KIT leuprolide acetate POWDER;SUBCUTANEOUS 021379-001 Jul 24, 2002 RX Yes Yes ⤷  Try it Free ⤷  Try it Free Y Y ⤷  Try it Free
Sandoz LEUPROLIDE ACETATE leuprolide acetate INJECTABLE;INJECTION 074728-001 Aug 4, 1998 AP RX No Yes ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Abbvie Endocrine Inc LUPRON DEPOT leuprolide acetate INJECTABLE;INJECTION 020517-003 Jun 17, 2011 RX Yes Yes ⤷  Try it Free ⤷  Try it Free Y ⤷  Try it Free
Genzyme LEUPROLIDE ACETATE leuprolide acetate INJECTABLE;INJECTION 075721-001 Nov 29, 2001 DISCN No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Sun Pharm LEUPROLIDE ACETATE leuprolide acetate INJECTABLE;INJECTION 078885-001 Mar 9, 2009 AP RX No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Abbvie Endocrine Inc LUPRON DEPOT-PED KIT leuprolide acetate POWDER;INTRAMUSCULAR 020263-006 Jan 21, 1994 RX Yes Yes ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Tolmar Therap ELIGARD KIT leuprolide acetate POWDER;SUBCUTANEOUS 021731-001 Dec 14, 2004 RX Yes Yes ⤷  Try it Free ⤷  Try it Free Y Y ⤷  Try it Free
>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

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Medtronic
Express Scripts
AstraZeneca
Baxter
Harvard Business School
Boehringer Ingelheim

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