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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 fourteen patent family members in forty-three countries.

There are eighteen drug master file entries for leuprolide acetate. Three suppliers are listed for this compound.

Summary for Generic Name: leuprolide acetate

Drug Master File Entries: see list18
Suppliers / Packaging: see list24
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;INJECTION020517-003Jun 17, 2011RXNo6,036,976<disabled>Y<disabled>
Ortho Mcneil Janssen
leuprolide acetate
IMPLANT;IMPLANTATION021088-001Mar 3, 2000DISCNNo6,156,331<disabled><disabled>
leuprolide acetate
INJECTABLE;INJECTION075721-001Nov 29, 2001DISCNNo<disabled><disabled>
Tolmar Therap
leuprolide acetate
INJECTABLE;SUBCUTANEOUS021379-001Jul 24, 2002RXYes6,565,874<disabled>Y<disabled>
Abbvie Endocrine Inc
leuprolide acetate
INJECTABLE;INJECTION020263-008Aug 15, 2011RXYes<disabled><disabled>
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International Patent Family for Ingredient: leuprolide acetate

Country Document Number Publication Date
Germany60211464Sep 07, 2006
Russian Federation2189221Sep 20, 2002
European Patent Office1330293Jul 30, 2003
Poland330927Jun 07, 1999
Czech Republic20031124Dec 17, 2003
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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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