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Last Updated: December 5, 2020

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LEUPROLIDE ACETATE Drug Profile

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When do Leuprolide Acetate patents expire, and what generic alternatives are available?

Leuprolide Acetate is a drug marketed by Genzyme, Sandoz, Sun Pharm, and Teva Pharms Usa. and is included in four NDAs.

The generic ingredient in LEUPROLIDE ACETATE is leuprolide acetate. There are twenty-two drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the leuprolide acetate profile page.

US ANDA Litigation and Generic Entry Outlook for Leuprolide Acetate

A generic version of LEUPROLIDE ACETATE was approved as leuprolide acetate by SANDOZ on August 4th, 1998.

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Drug patent expirations by year for LEUPROLIDE ACETATE
Drug Prices for LEUPROLIDE ACETATE

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Recent Clinical Trials for LEUPROLIDE ACETATE

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

SponsorPhase
ECOG-ACRIN Cancer Research GroupPhase 3
Alliance for Clinical Trials in OncologyPhase 3
Colorado Center for Reproductive MedicineEarly 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
Genzyme LEUPROLIDE ACETATE leuprolide acetate INJECTABLE;INJECTION 075721-001 Nov 29, 2001 DISCN No No   Start Trial   Start Trial   Start Trial
Teva Pharms Usa LEUPROLIDE ACETATE leuprolide acetate INJECTABLE;INJECTION 075471-001 Oct 25, 2000 AP RX No No   Start Trial   Start Trial   Start Trial
Sandoz LEUPROLIDE ACETATE leuprolide acetate INJECTABLE;INJECTION 074728-001 Aug 4, 1998 AP RX No Yes   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Express Scripts
Colorcon
Medtronic
Johnson and Johnson
Merck

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