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
Ortho Mcneil Janssen	VIADUR	leuprolide acetate	IMPLANT;IMPLANTATION	021088-001	Mar 3, 2000		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Tolmar	ELIGARD KIT	leuprolide acetate	POWDER;SUBCUTANEOUS	021488-001	Feb 13, 2003		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up		Y		⤷ Sign Up
Tolmar	ELIGARD KIT	leuprolide acetate	POWDER;SUBCUTANEOUS	021488-001	Feb 13, 2003		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y	Y		⤷ 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-PED KIT	leuprolide acetate	POWDER;INTRAMUSCULAR	020263-003	Apr 16, 1993		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Rk Pharma	LEUPROLIDE ACETATE	leuprolide acetate	INJECTABLE;INJECTION	213829-001	Aug 13, 2021	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	020708-001	Mar 7, 1997	⤷ Sign Up	⤷ Sign Up
Tolmar	ELIGARD KIT	leuprolide acetate	POWDER;SUBCUTANEOUS	021731-001	Dec 14, 2004	⤷ Sign Up	⤷ Sign Up
Abbvie Endocrine Inc	LUPRON DEPOT	leuprolide acetate	INJECTABLE;INJECTION	020708-001	Mar 7, 1997	⤷ Sign Up	⤷ Sign Up
Tolmar	ELIGARD KIT	leuprolide acetate	POWDER;SUBCUTANEOUS	021731-001	Dec 14, 2004	⤷ 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	leuprolide acetate	INJECTABLE;INJECTION	019010-001	Apr 9, 1985	⤷ 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
Malaysia	148370	SUSTAINED-RELEASE COMPOSITION AND METHOD FOR PRODUCING THE SAME	⤷ Sign Up
Australia	2021405417	SYSTEMS AND METHODS FOR MIXING SYRINGE VALVE ASSEMBLIES	⤷ Sign Up
Colombia	6180498	UNA COMPOSICION DE LIBERACION SOSTENIDA QUE COMPRENDE UN PEPTIDO FISIOLOGICAMENTE ACTIVO SOLUBLE EN AGUA DISPERSADO UNIFORMEMENTE EN UNA MICROCAPSULA	⤷ 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
South Korea	20090094272	SUSTAINED-RELEASE COMPOSITION AND METHOD FOR PRODUCING THE SAME	⤷ Sign Up
World Intellectual Property Organization (WIPO)	2022137182		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

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