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Last Updated: August 5, 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, Abbvie Endocrine Inc, Tolmar Therap, Tolmar, and Abbvie Endocrine, and is included in eighteen 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. Four 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
National Institute of Allergy and Infectious Diseases (NIAID)Phase 1
Johns Hopkins UniversityPhase 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 FENSOLVI KIT leuprolide acetate POWDER;SUBCUTANEOUS 213150-001 May 1, 2020 RX Yes Yes ⤷  Try it Free ⤷  Try it Free Y Y ⤷  Try it Free
Abbvie Endocrine LUPANETA PACK leuprolide acetate; norethindrone acetate INJECTABLE, TABLET;INTRAMUSCULAR, ORAL 203696-001 Dec 14, 2012 RX Yes No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Abbvie Endocrine Inc LUPRON DEPOT-PED KIT leuprolide acetate POWDER;INTRAMUSCULAR 020263-003 Apr 16, 1993 DISCN Yes No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Teva Pharms Usa LEUPROLIDE ACETATE leuprolide acetate INJECTABLE;INJECTION 075471-001 Oct 25, 2000 AP RX No No ⤷  Try it Free ⤷  Try it Free ⤷  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

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Tolmar Therap ELIGARD KIT leuprolide acetate POWDER;SUBCUTANEOUS 021731-001 Dec 14, 2004 ⤷  Try it Free ⤷  Try it Free
Abbvie Endocrine Inc LUPRON DEPOT-PED KIT leuprolide acetate POWDER;INTRAMUSCULAR 020263-006 Jan 21, 1994 ⤷  Try it Free ⤷  Try it Free
Abbvie Endocrine Inc LUPRON DEPOT leuprolide acetate INJECTABLE;INJECTION 020011-001 Oct 22, 1990 ⤷  Try it Free ⤷  Try it Free
Abbvie Endocrine Inc LUPRON DEPOT-PED KIT leuprolide acetate POWDER;INTRAMUSCULAR 020263-004 Apr 16, 1993 ⤷  Try it Free ⤷  Try it Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Boehringer Ingelheim
McKinsey
McKesson
Merck
Medtronic

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