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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 twenty-one patents protecting this compound. Additional information is available in the individual branded drug profile pages.

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

Summary for Generic Name: leuprolide acetate

Tradenames:7
Patents:21
Applicants:8
NDAs:16
Drug Master File Entries: see list18
Suppliers: see list3
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 ClinicalTrials.org
See more clinical trials for this drug
Glossary
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Tolmar Therap
ELIGARD
leuprolide acetate
INJECTABLE;SUBCUTANEOUS021379Jul 24, 2002RXYes6,773,714<disabled>Y<disabled>
Tolmar Therap
ELIGARD
leuprolide acetate
INJECTABLE;SUBCUTANEOUS021488Feb 13, 2003RXYes5,599,552<disabled><disabled>
Ortho Mcneil Janssen
VIADUR
leuprolide acetate
IMPLANT;IMPLANTATION021088Mar 3, 2000DISCNNo6,124,261<disabled><disabled>
Abbvie Endocrine Inc
LUPRON
leuprolide acetate
INJECTABLE;INJECTION019010Apr 9, 1985DISCNNo<disabled><disabled>
Abbvie Endocrine
LUPANETA PACK
leuprolide acetate; norethindrone acetate
INJECTABLE, TABLET;INTRAMUSCULAR, ORAL203696Dec 14, 2012RXYes6,036,976<disabled>Y<disabled>
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