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.
|Applicant||Tradename||Generic Name||Dosage||NDA||Approval Date||Type||RLD||Patent No.||Patent Expiration||Product||Substance||Delist Req.||Exclusivity Expiration|
|INJECTABLE;SUBCUTANEOUS||021379||Jul 24, 2002||RX||Yes||6,773,714||<disabled>||Y||<disabled>|
|INJECTABLE;SUBCUTANEOUS||021488||Feb 13, 2003||RX||Yes||5,599,552||<disabled>||<disabled>|
Ortho Mcneil Janssen
|IMPLANT;IMPLANTATION||021088||Mar 3, 2000||DISCN||No||6,124,261||<disabled>||<disabled>|
Abbvie Endocrine Inc
|INJECTABLE;INJECTION||019010||Apr 9, 1985||DISCN||No||<disabled>||<disabled>|
leuprolide acetate; norethindrone acetate
|INJECTABLE, TABLET;INTRAMUSCULAR, ORAL||203696||Dec 14, 2012||RX||Yes||6,036,976||<disabled>||Y||<disabled>|
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