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, Meitheal, Rk Pharma, Sandoz, Sun Pharm, Abbvie Endocrine Inc, Tolmar, and Abbvie Endocrine, and is included in twenty-one NDAs. There are four 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.

Summary for leuprolide acetate

International Patents:	46
US Patents:	4
Tradenames:	9
Applicants:	12
NDAs:	21
Drug Master File Entries:	16
Finished Product Suppliers / Packagers:	10
Raw Ingredient (Bulk) Api Vendors:	57
Clinical Trials:	195
Patent Applications:	10,001
Formulation / Manufacturing:	see details
Drug Prices:	Drug price trends for leuprolide acetate
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for leuprolide acetate
What excipients (inactive ingredients) are in leuprolide acetate?	leuprolide acetate excipients list
DailyMed Link:	leuprolide acetate at DailyMed

See drug prices for leuprolide acetate

Recent Clinical Trials for leuprolide acetate

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Johns Hopkins Bloomberg School of Public Health	Phase 2
Takeda	Phase 4
Emory University	Phase 4

See all leuprolide acetate clinical trials

Pharmacology for leuprolide acetate

Drug Class	Gonadotropin Releasing Hormone Receptor Agonist
Mechanism of Action	Gonadotropin Releasing Hormone Receptor Agonists

Medical Subject Heading (MeSH) Categories for leuprolide acetate

Antineoplastic Agents, Hormonal
Fertility Agents, Female

US Patents and Regulatory Information for leuprolide acetate

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Glossary

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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	020708-001	Mar 7, 1997		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Abbvie Endocrine Inc	LUPRON DEPOT	leuprolide acetate	INJECTABLE;INJECTION	020517-001	Dec 22, 1995		RX	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Abbvie Endocrine Inc	LUPRON DEPOT-PED KIT	leuprolide acetate	POWDER;INTRAMUSCULAR	020263-008	Aug 15, 2011		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Eugia Pharma	LEUPROLIDE ACETATE	leuprolide acetate	INJECTABLE;INJECTION	212963-001	Jun 6, 2022	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	LUPANETA PACK	leuprolide acetate; norethindrone acetate	INJECTABLE, TABLET;INTRAMUSCULAR, ORAL	203696-002	Dec 14, 2012		DISCN	Yes	No	⤷ 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
>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

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Abbvie Endocrine Inc	LUPRON DEPOT	leuprolide acetate	INJECTABLE;INJECTION	020011-001	Oct 22, 1990	⤷ Sign Up	⤷ Sign Up
Abbvie Endocrine Inc	LUPRON DEPOT	leuprolide acetate	INJECTABLE;INJECTION	020517-003	Jun 17, 2011	⤷ Sign Up	⤷ Sign Up
Abbvie Endocrine Inc	LUPRON DEPOT	leuprolide acetate	INJECTABLE;INJECTION	020708-001	Mar 7, 1997	⤷ Sign Up	⤷ Sign Up
Tolmar	FENSOLVI KIT	leuprolide acetate	POWDER;SUBCUTANEOUS	213150-001	May 1, 2020	⤷ Sign Up	⤷ Sign Up
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	020263-006	Jan 21, 1994	⤷ Sign Up	⤷ Sign Up
Abbvie Endocrine Inc	LUPRON DEPOT-PED KIT	leuprolide acetate	POWDER;INTRAMUSCULAR	020263-004	Apr 16, 1993	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for leuprolide acetate

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Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2008075762		⤷ Sign Up
Taiwan	200833376	Sustained-release composition and method for producing the same	⤷ Sign Up
South Africa	200903644	Sustained-release composition and method for producing the same	⤷ Sign Up
Australia	2007335406	Sustained-release composition and method for producing the same	⤷ Sign Up
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)	⤷ Sign Up
China	116847900	用于混合注射器阀门组件的系统和方法 (Systems and methods for hybrid syringe valve assembly)	⤷ Sign Up
Norway	20092662		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

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