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Last Updated: May 23, 2024

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, Amneal, Eugia Pharma, Genzyme, Meitheal, Rk Pharma, Sandoz, Sun Pharm, Abbvie Endocrine Inc, 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 forty-six patent family members in twenty-eight 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

Pharmacology for leuprolide acetate
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 020263-005 Jan 21, 1994 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Abbvie Endocrine Inc LUPRON DEPOT-PED KIT leuprolide acetate POWDER;INTRAMUSCULAR 020263-006 Jan 21, 1994 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Sandoz LEUPROLIDE ACETATE leuprolide acetate INJECTABLE;INJECTION 074728-001 Aug 4, 1998 AP RX No Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Meitheal LEUPROLIDE ACETATE leuprolide acetate INJECTABLE;INJECTION 075471-001 Oct 25, 2000 AP RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Abbvie Endocrine Inc LUPRON DEPOT leuprolide acetate INJECTABLE;INJECTION 020011-001 Oct 22, 1990 DISCN Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Abbvie Endocrine Inc LUPRON DEPOT leuprolide acetate INJECTABLE;INJECTION 020708-001 Mar 7, 1997 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>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 ⤷  Sign Up ⤷  Sign Up
Abbvie Endocrine Inc LUPRON DEPOT-PED KIT leuprolide acetate POWDER;INTRAMUSCULAR 020263-008 Aug 15, 2011 ⤷  Sign Up ⤷  Sign Up
Tolmar ELIGARD KIT leuprolide acetate POWDER;SUBCUTANEOUS 021379-001 Jul 24, 2002 ⤷  Sign Up ⤷  Sign Up
Abbvie Endocrine Inc LUPRON DEPOT-PED KIT leuprolide acetate POWDER;INTRAMUSCULAR 020263-007 Aug 15, 2011 ⤷  Sign Up ⤷  Sign Up
Abbvie Endocrine Inc LUPRON DEPOT-PED KIT leuprolide acetate POWDER;INTRAMUSCULAR 020263-007 Aug 15, 2011 ⤷  Sign Up ⤷  Sign Up
Abbvie Endocrine Inc LUPRON DEPOT-PED KIT leuprolide acetate POWDER;INTRAMUSCULAR 020263-006 Jan 21, 1994 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for leuprolide acetate

Country Patent Number Title Estimated Expiration
Taiwan I481424 ⤷  Sign Up
Costa Rica 10867 COMPOSICION DE LIBERACION SOSTENIDA Y METODOS PARA PRODUCIRLA ⤷  Sign Up
Japan 2024500885 混合シリンジ弁アセンブリのためのシステムおよび方法 ⤷  Sign Up
Norway 347209 ⤷  Sign Up
European Patent Office 4135830 SYSTÈMES ET PROCÉDÉS DE COMBINAISON D'ENSEMBLES VALVE DE SERINGUE (SYSTEMS AND METHODS FOR MIXING SYRINGE VALVE ASSEMBLIES) ⤷  Sign Up
Taiwan 200833376 Sustained-release composition and method for producing the same ⤷  Sign Up
>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.