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Last Updated: January 30, 2023

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 Invagen Pharms, Ortho Mcneil Janssen, Amneal, Eugia Pharma, Genzyme, Sandoz, Sun Pharm, Teva Pharms Usa, Vgyaan, Abbvie Endocrine Inc, Tolmar Therap, Tolmar, and Abbvie Endocrine, and is included in twenty-one 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. Ten 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
Johns Hopkins Bloomberg School of Public HealthPhase 2
TakedaPhase 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 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
Tolmar Therap ELIGARD KIT leuprolide acetate POWDER;SUBCUTANEOUS 021343-001 Jan 23, 2002 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Abbvie Endocrine Inc LUPRON DEPOT leuprolide acetate INJECTABLE;INJECTION 019732-001 Jan 26, 1989 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Abbvie Endocrine LUPANETA PACK leuprolide acetate; norethindrone acetate INJECTABLE, TABLET;INTRAMUSCULAR, ORAL 203696-001 Dec 14, 2012 DISCN Yes No 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
>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

International Patents for leuprolide acetate

Country Patent Number Title Estimated Expiration
Poland 204903 See Plans and Pricing
Ukraine 97125 КОМПОЗИЦИЯ ПРОДОЛЖИТЕЛЬНОГО ВЫСВОБОЖДЕНИЯ И СПОСОБ ЕЕ ПОЛУЧЕНИЯ;КОМПОЗИЦІЯ ТРИВАЛОГО ВИВІЛЬНЕННЯ І СПОСІБ ЇЇ ОДЕРЖАННЯ (SUSTAINED-RELEASE COMPOSITION AND METHOD FOR PRODUCING THE SAME) See Plans and Pricing
Argentina 064381 COMPOSICION DE LIBERACION SOSTENIDA Y METODOS PARA PRODUCIRLA See Plans and Pricing
Czech Republic 306327 Kompozice s regulovaným uvolňováním a způsob její výroby (Controlled release composition and process for preparing thereof) See Plans and Pricing
China 100536922 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.