Estradiol is the generic ingredient in thirty-seven branded drugs marketed by Warner Chilcott Us, Watson Labs, Bayer Hlthcare, Women First Hlthcare, Novartis, Mylan Technologies, Ortho Mcneil Pharm, Parke Davis, Noven, Meda Pharms, Ascend Theraps Us, Vertical Pharms Llc, Pharmacia And Upjohn, Elan Pharma Intl Ltd, Bristol Myers Squibb, Barr Labs Inc, Heritage Pharms Inc, Lannett Holdings Inc, Mylan, Usl Pharma, Duramed Pharms Barr, Novo Nordisk Inc, Warner Ireland, Warner Chilcott Llc, Medicis, Par Sterile Products, Luitpold, Sandoz, Watson Labs Inc, Savage Labs, Amneal Pharms Llc, Barr, Breckenridge Pharm, Teva Pharms Usa, and Teva Womens, and is included in fifty-four NDAs. There are twenty-two patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.
There are seventy-three drug master file entries for estradiol. Fifteen suppliers are listed for this compound.
|Drug Master File Entries: see list||73|
|Suppliers: see list||15|
|Therapeutic Class:||Hormonal Agents, Stimulant/Replacement/Modifying (Sex Hormones/Modifiers)|
|Applicant||Tradename||Generic Name||Dosage||NDA||Approval Date||Type||RLD||Patent No.||Patent Expiration||Product||Substance||Delist Req.||Exclusivity Expiration|
|FILM, EXTENDED RELEASE;TRANSDERMAL||019081||Sep 10, 1986||RX||Yes||<disabled>||<disabled>|
estradiol; norethindrone acetate
|FILM, EXTENDED RELEASE;TRANSDERMAL||020870||Aug 7, 1998||RX||No||6,024,976||<disabled>||<disabled>|
|FILM, EXTENDED RELEASE;TRANSDERMAL||203752||Oct 29, 2012||RX||No||6,024,976||<disabled>||Y||Y||<disabled>|
|TABLET;ORAL||040297||Apr 17, 2002||RX||No||<disabled>||<disabled>|
Novo Nordisk Inc
|TABLET;VAGINAL||020908||Mar 26, 1999||DISCN||No||<disabled>||<disabled>|
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