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Generated: September 19, 2018

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Estradiol; norethindrone acetate - Generic Drug Details

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What are the generic drug sources for estradiol; norethindrone acetate and what is the scope of estradiol; norethindrone acetate freedom to operate?

Estradiol; norethindrone acetate is the generic ingredient in four branded drugs marketed by Noven Pharms Inc, Amneal Pharms Llc, Lupin Ltd, Accord Hlthcare, Barr, Breckenridge Pharm, Mylan Labs Ltd, and Teva Pharms Usa, and is included in eight NDAs. Additional information is available in the individual branded drug profile pages.

There are seventy-five drug master file entries for estradiol; norethindrone acetate. Eight suppliers are listed for this compound.

Pharmacology for estradiol; norethindrone acetate

US Patents and Regulatory Information for estradiol; norethindrone acetate

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Mylan Labs Ltd ESTRADIOL AND NORETHINDRONE ACETATE estradiol; norethindrone acetate TABLET;ORAL 207261-001 Feb 10, 2017 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Noven Pharms Inc COMBIPATCH estradiol; norethindrone acetate FILM, EXTENDED RELEASE;TRANSDERMAL 020870-002 Aug 7, 1998 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Mylan Labs Ltd ESTRADIOL AND NORETHINDRONE ACETATE estradiol; norethindrone acetate TABLET;ORAL 207261-002 Feb 10, 2017 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Lupin Ltd AMABELZ estradiol; norethindrone acetate TABLET;ORAL 203339-002 Jun 20, 2016 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Breckenridge Pharm ESTRADIOL AND NORETHINDRONE ACETATE estradiol; norethindrone acetate TABLET;ORAL 078324-001 Apr 17, 2008 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Accord Hlthcare ESTRADIOL AND NORETHINDRONE ACETATE estradiol; norethindrone acetate TABLET;ORAL 210233-001 Feb 28, 2018 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Expired US Patents for estradiol; norethindrone acetate

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Noven Pharms Inc COMBIPATCH estradiol; norethindrone acetate FILM, EXTENDED RELEASE;TRANSDERMAL 020870-001 Aug 7, 1998 ➤ Sign Up ➤ Sign Up
Noven Pharms Inc COMBIPATCH estradiol; norethindrone acetate FILM, EXTENDED RELEASE;TRANSDERMAL 020870-002 Aug 7, 1998 ➤ Sign Up ➤ Sign Up
Noven Pharms Inc COMBIPATCH estradiol; norethindrone acetate FILM, EXTENDED RELEASE;TRANSDERMAL 020870-001 Aug 7, 1998 ➤ Sign Up ➤ Sign Up
Noven Pharms Inc COMBIPATCH estradiol; norethindrone acetate FILM, EXTENDED RELEASE;TRANSDERMAL 020870-001 Aug 7, 1998 ➤ Sign Up ➤ Sign Up
Noven Pharms Inc COMBIPATCH estradiol; norethindrone acetate FILM, EXTENDED RELEASE;TRANSDERMAL 020870-002 Aug 7, 1998 ➤ Sign Up ➤ Sign Up
Amneal Pharms Llc ACTIVELLA estradiol; norethindrone acetate TABLET;ORAL 020907-001 Nov 18, 1998 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

QuintilesIMS
Chinese Patent Office
Accenture
Cerilliant
Argus Health
Colorcon
Deloitte
Chubb
US Department of Justice

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