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Last Updated: August 15, 2022

Leuprolide acetate - Generic Drug Details


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What are the generic drug sources for leuprolide acetate and what is the scope of patent protection?

Leuprolide acetate is the generic ingredient in nine branded drugs marketed by Invagen Pharms, Ortho Mcneil Janssen, Eugia Pharma, Genzyme, Sandoz, Sun Pharm, Teva Pharms Usa, Vgyaan, Abbvie Endocrine Inc, Tolmar Therap, Tolmar, and Abbvie Endocrine, and is included in twenty 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 sixteen drug master file entries for leuprolide acetate. Seven suppliers are listed for this compound.

Drug Prices for leuprolide acetate

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Recent Clinical Trials for leuprolide acetate

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SponsorPhase
TakedaPhase 4
National Cancer Institute (NCI)Phase 4
Emory UniversityPhase 4

See all leuprolide acetate clinical trials

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
Abbvie Endocrine Inc LUPRON DEPOT-PED KIT leuprolide acetate POWDER;INTRAMUSCULAR 020263-007 Aug 15, 2011 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Tolmar Therap ELIGARD KIT leuprolide acetate POWDER;SUBCUTANEOUS 021488-001 Feb 13, 2003 RX Yes Yes See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Abbvie Endocrine Inc LUPRON DEPOT leuprolide acetate INJECTABLE;INJECTION 020517-003 Jun 17, 2011 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
>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 020517-001 Dec 22, 1995 See Plans and Pricing See Plans and Pricing
Abbvie Endocrine Inc LUPRON DEPOT leuprolide acetate INJECTABLE;INJECTION 019732-001 Jan 26, 1989 See Plans and Pricing See Plans and Pricing
Ortho Mcneil Janssen VIADUR leuprolide acetate IMPLANT;IMPLANTATION 021088-001 Mar 3, 2000 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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