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Details for Generic Name: leuprolide acetate

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Leuprolide acetate is the generic ingredient in seven branded drugs marketed by Ortho Mcneil Janssen, Genzyme, Sandoz, Sun Pharma Global, Teva Pharms Usa, Abbvie Endocrine Inc, Tolmar Therap, and Abbvie Endocrine, and is included in sixteen NDAs. There are seventeen patents protecting this compound. Additional information is available in the individual branded drug profile pages.

This ingredient has three hundred and nineteen patent family members in forty-three countries.

There are nineteen drug master file entries for leuprolide acetate. Four suppliers are listed for this compound.

Summary for Generic Name: leuprolide acetate

Drug Master File Entries: see list19
Suppliers / Packaging: see list25
Therapeutic Class:Hormonal Agents, Suppressant (Pituitary)

Clinical Trials for: leuprolide acetate

Safety Extension Study Of Leuprolide Acetate (Lupron Depot) In The Treatment Of Central Precocious Puberty
Status: Completed Condition: Precocious; Leuprolide Acetate; Luteinizing Hormone (LH); Gonadotrophin-releasing Hormone Agonist (GnRHa); Tanner Staging; Depot Formulation; Suppression of LH; Central Precocious Puberty (CPP); Gonadotrophin-releasing Hormone (GnRH); Lupron; GnRH Analog; Pediatrics Central Precocious Puberty

A Study of Leuprolide 11.25 mg and 30 mg Administered Every 3 Months to Treat Central Precocious Puberty
Status: Completed Condition: Puberty, Precocious

A Study of Leuprolide to Treat Prostate Cancer
Status: Completed Condition: Prostate Cancer

Courtesy of
See more clinical trials for this drug
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Abbvie Endocrine Inc
leuprolide acetate
INJECTABLE;INJECTION020011-002Oct 26, 1995RXYes<disabled><disabled>
Ortho Mcneil Janssen
leuprolide acetate
IMPLANT;IMPLANTATION021088-001Mar 3, 2000DISCNNo6,124,261<disabled> <disabled>
Abbvie Endocrine Inc
leuprolide acetate
INJECTABLE;INJECTION020263-003Apr 16, 1993DISCNNo<disabled><disabled>
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International Patent Family for Ingredient: leuprolide acetate

Country Document Number Publication Date
Spain2263788Dec 16, 2006
China101239179Aug 13, 2008
Germany60211464Sep 07, 2006
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ISSN: 2162-2639

Preferred citation:

Friedman, Y. Location of pharmaceutical innovation: 2000–2009 Nature Reviews Drug Discovery 9, 835–836 (2010).

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