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Last Updated: August 11, 2020

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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 eight patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Leuprolide acetate has one hundred and ninety-five 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

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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
Abbvie Endocrine Inc LUPRON DEPOT leuprolide acetate INJECTABLE;INJECTION 020517-002 May 30, 1997 RX Yes Yes   Start Trial   Start Trial   Start Trial
Abbvie Endocrine Inc LUPRON DEPOT leuprolide acetate INJECTABLE;INJECTION 020011-002 Oct 26, 1995 RX Yes Yes   Start Trial   Start Trial   Start Trial
Tolmar Therap ELIGARD KIT leuprolide acetate POWDER;SUBCUTANEOUS 021488-001 Feb 13, 2003 RX Yes Yes   Start Trial   Start Trial Y Y   Start Trial
Abbvie Endocrine LUPANETA PACK leuprolide acetate; norethindrone acetate INJECTABLE, TABLET;INTRAMUSCULAR, ORAL 203696-002 Dec 14, 2012 RX Yes Yes   Start Trial   Start Trial   Start Trial
Tolmar Therap ELIGARD KIT leuprolide acetate POWDER;SUBCUTANEOUS 021379-001 Jul 24, 2002 RX Yes Yes   Start Trial   Start Trial Y Y   Start Trial
Abbvie Endocrine LUPANETA PACK leuprolide acetate; norethindrone acetate INJECTABLE, TABLET;INTRAMUSCULAR, ORAL 203696-001 Dec 14, 2012 RX Yes No   Start Trial   Start Trial   Start Trial
Abbvie Endocrine Inc LUPRON DEPOT-PED KIT leuprolide acetate POWDER;INTRAMUSCULAR 020263-004 Apr 16, 1993 DISCN Yes No   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

Expired US Patents for LEUPROLIDE ACETATE

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Abbvie Endocrine Inc LUPRON DEPOT leuprolide acetate INJECTABLE;INJECTION 020708-001 Mar 7, 1997   Start Trial   Start Trial
Abbvie Endocrine Inc LUPRON DEPOT leuprolide acetate INJECTABLE;INJECTION 020011-001 Oct 22, 1990   Start Trial   Start Trial
Ortho Mcneil Janssen VIADUR leuprolide acetate IMPLANT;IMPLANTATION 021088-001 Mar 3, 2000   Start Trial   Start Trial
Tolmar Therap ELIGARD KIT leuprolide acetate POWDER;SUBCUTANEOUS 021488-001 Feb 13, 2003   Start Trial   Start Trial
Abbvie Endocrine Inc LUPRON DEPOT-PED KIT leuprolide acetate POWDER;INTRAMUSCULAR 020263-003 Apr 16, 1993   Start Trial   Start Trial
Abbvie Endocrine Inc LUPRON DEPOT-PED KIT leuprolide acetate POWDER;INTRAMUSCULAR 020263-005 Jan 21, 1994   Start Trial   Start Trial
Abbvie Endocrine Inc LUPRON DEPOT leuprolide acetate INJECTABLE;INJECTION 019732-001 Jan 26, 1989   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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