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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 seventeen 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)
Formulation / Manufacturing:see details

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;INJECTION020263-006Jan 21, 1994RXYes6,036,976<disabled> <disabled>
Tolmar Therap
leuprolide acetate
INJECTABLE;SUBCUTANEOUS021343-001Jan 23, 2002RXYes6,626,870<disabled>Y <disabled>
Abbvie Endocrine Inc
leuprolide acetate
INJECTABLE;INJECTION020517-002May 30, 1997RXYes6,036,976<disabled> <disabled>
Abbvie Endocrine Inc
leuprolide acetate
INJECTABLE;INJECTION020263-005Jan 21, 1994RXYes<disabled><disabled>
Tolmar Therap
leuprolide acetate
INJECTABLE;SUBCUTANEOUS021731-001Dec 14, 2004RXYes6,626,870<disabled>Y <disabled>
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International Patent Family for Ingredient: leuprolide acetate

Country Document Number Publication Date
Taiwan466121Dec 01, 2001
Denmark2158900Feb 18, 2013
Spain2404559May 28, 2013
Argentina034641Mar 03, 2004
Denmark1126822May 10, 2004
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Preferred citation:

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

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