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Last Updated: April 27, 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 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 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. Nine suppliers are listed for this compound.

Summary for LEUPROLIDE ACETATE

International Patents:	46
US Patents:	3
Tradenames:	9
Applicants:	12
NDAs:	21
Drug Master File Entries:	16
Finished Product Suppliers / Packagers:	9
Raw Ingredient (Bulk) Api Vendors:	57
Clinical Trials:	194
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
National Cancer Institute (NCI)	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	020011-002	Oct 26, 1995		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Abbvie Endocrine	LUPANETA PACK	leuprolide acetate; norethindrone acetate	INJECTABLE, TABLET;INTRAMUSCULAR, ORAL	203696-001	Dec 14, 2012		DISCN	Yes	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Abbvie Endocrine Inc	LUPRON DEPOT-PED KIT	leuprolide acetate	POWDER;INTRAMUSCULAR	020263-007	Aug 15, 2011		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Rk Pharma	LEUPROLIDE ACETATE	leuprolide acetate	INJECTABLE;INJECTION	213829-001	Aug 13, 2021	AP	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Abbvie Endocrine Inc	LUPRON DEPOT-PED KIT	leuprolide acetate	POWDER;INTRAMUSCULAR	020263-002	Apr 16, 1993		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Abbvie Endocrine Inc	LUPRON DEPOT-PED KIT	leuprolide acetate	POWDER;INTRAMUSCULAR	020263-008	Aug 15, 2011		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
>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-PED KIT	leuprolide acetate	POWDER;INTRAMUSCULAR	020263-003	Apr 16, 1993	⤷ Try a Trial	⤷ Try a Trial
Abbvie Endocrine Inc	LUPRON DEPOT-PED KIT	leuprolide acetate	POWDER;INTRAMUSCULAR	020263-004	Apr 16, 1993	⤷ Try a Trial	⤷ Try a Trial
Abbvie Endocrine Inc	LUPRON DEPOT	leuprolide acetate	INJECTABLE;INJECTION	020517-001	Dec 22, 1995	⤷ Try a Trial	⤷ Try a Trial
Abbvie Endocrine Inc	LUPRON DEPOT	leuprolide acetate	INJECTABLE;INJECTION	020708-001	Mar 7, 1997	⤷ Try a Trial	⤷ Try a Trial
Abbvie Endocrine Inc	LUPRON DEPOT	leuprolide acetate	INJECTABLE;INJECTION	020517-003	Jun 17, 2011	⤷ Try a Trial	⤷ Try a Trial
Abbvie Endocrine Inc	LUPRON DEPOT	leuprolide acetate	INJECTABLE;INJECTION	020517-002	May 30, 1997	⤷ Try a Trial	⤷ Try a Trial
>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
Argentina	064381	COMPOSICION DE LIBERACION SOSTENIDA Y METODOS PARA PRODUCIRLA	⤷ Try a Trial
Japan	2010222371	SUSTAINED-RELEASE COMPOSITION AND METHOD FOR PRODUCING THE SAME	⤷ Try a Trial
Norway	20092662		⤷ Try a Trial
Colombia	6180498	UNA COMPOSICION DE LIBERACION SOSTENIDA QUE COMPRENDE UN PEPTIDO FISIOLOGICAMENTE ACTIVO SOLUBLE EN AGUA DISPERSADO UNIFORMEMENTE EN UNA MICROCAPSULA	⤷ Try a Trial
Israel	303673	מערכות ושיטות לערבול מכלולי שסתומי מזרק (Systems and methods for mixing syringe valve assemblies)	⤷ Try a Trial
Chile	2007003658	COMPOSICION DE LIBERACION SOSTENIDA QUE COMPRENDE UN PEPTIDO; PROCEDIMIENTO PARA PREPARAR DICHA COMPOSICION; AGENTE PROFILACTICO O TERAPEUTICO PARA CANCER DE PROSTATA, HIPERPLASIA PROSTATICA, ENDOMETRIOSIS, FIBROIDE UTERINO, FIBROMA UTERINO, PUBERTAD	⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

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