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, Abbvie Endocrine Inc, Tolmar, Amneal, Eugia Pharma, Genzyme, Meitheal, Rk Pharma, Sandoz, Sun Pharm, UBI, and Abbvie Endocrine, and is included in twenty-two 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. Eleven suppliers are listed for this compound.

Summary for leuprolide acetate

International Patents:	46
US Patents:	4
Tradenames:	9
Applicants:	13
NDAs:	22
Drug Master File Entries:	16
Finished Product Suppliers / Packagers:	11
Raw Ingredient (Bulk) Api Vendors:	57
Clinical Trials:	196
Patent Applications:	10,001
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
NRG Oncology	Phase 2
Johns Hopkins Bloomberg School of Public Health	Phase 2
Takeda	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-PED KIT	leuprolide acetate	POWDER;INTRAMUSCULAR	020263-009	Apr 14, 2023		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Tolmar	ELIGARD KIT	leuprolide acetate	POWDER;SUBCUTANEOUS	021731-001	Dec 14, 2004		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y	Y		⤷ 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
Tolmar	FENSOLVI KIT	leuprolide acetate	POWDER;SUBCUTANEOUS	213150-001	May 1, 2020		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up		Y		⤷ 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	020011-001	Oct 22, 1990	⤷ Sign Up	⤷ Sign Up
Abbvie Endocrine Inc	LUPRON DEPOT-PED KIT	leuprolide acetate	POWDER;INTRAMUSCULAR	020263-007	Aug 15, 2011	⤷ Sign Up	⤷ Sign Up
Tolmar	ELIGARD KIT	leuprolide acetate	POWDER;SUBCUTANEOUS	021731-001	Dec 14, 2004	⤷ 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
Norway	20092662		⤷ Sign Up
Georgia, Republic of	P20125597	SUSTAINED-RELEASE COMPOSITION AND PRODUCTION METHOD THEREOF	⤷ Sign Up
Japan	5258844		⤷ Sign Up
Japan	2010513225		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

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