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Generated: October 24, 2017

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Estradiol; norethindrone acetate - Generic Drug Details

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What are the generic 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 Amneal Pharms Llc, Breckenridge Pharm, Lupin Ltd, Teva Pharms Usa, Mylan Labs Ltd, Noven Pharms Inc, and Barr, and is included in seven 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.

Summary for Generic Name: estradiol; norethindrone acetate

US Patents:0
Tradenames:4
Applicants:7
NDAs:7
Drug Master File Entries: see list75
Suppliers / Packagers: see list8
Clinical Trials: see list1,538
Drug Prices:see low prices
DailyMed Link:estradiol; norethindrone acetate at DailyMed

Pharmacology for Ingredient: 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;ORAL207261-001Feb 10, 2017ABRXNoNo► Subscribe► Subscribe► Subscribe
Mylan Labs Ltd
ESTRADIOL AND NORETHINDRONE ACETATE
estradiol; norethindrone acetate
TABLET;ORAL207261-002Feb 10, 2017ABRXNoNo► Subscribe► Subscribe► Subscribe
Amneal Pharms Llc
ACTIVELLA
estradiol; norethindrone acetate
TABLET;ORAL020907-002Dec 28, 2006ABRXYesNo► Subscribe► Subscribe► Subscribe
Noven Pharms Inc
COMBIPATCH
estradiol; norethindrone acetate
FILM, EXTENDED RELEASE;TRANSDERMAL020870-002Aug 7, 1998RXYesYes► Subscribe► Subscribe► Subscribe
Breckenridge Pharm
ESTRADIOL AND NORETHINDRONE ACETATE
estradiol; norethindrone acetate
TABLET;ORAL078324-001Apr 17, 2008ABRXNoNo► Subscribe► Subscribe► Subscribe
Noven Pharms Inc
COMBIPATCH
estradiol; norethindrone acetate
FILM, EXTENDED RELEASE;TRANSDERMAL020870-001Aug 7, 1998RXYesNo► Subscribe► Subscribe► Subscribe
Teva Pharms Usa
ESTRADIOL AND NORETHINDRONE ACETATE
estradiol; norethindrone acetate
TABLET;ORAL200747-001Mar 8, 2012ABRXNoNo► Subscribe► Subscribe► Subscribe
Barr
ESTRADIOL AND NORETHINDRONE ACETATE
estradiol; norethindrone acetate
TABLET;ORAL079193-001May 11, 2010ABRXNoNo► Subscribe► Subscribe► Subscribe
Breckenridge Pharm
ESTRADIOL AND NORETHINDRONE ACETATE
estradiol; norethindrone acetate
TABLET;ORAL078324-002Jun 9, 2011ABRXNoNo► Subscribe► Subscribe► Subscribe
Lupin Ltd
AMABELZ
estradiol; norethindrone acetate
TABLET;ORAL203339-001Jun 20, 2016ABRXNoNo► Subscribe► Subscribe► Subscribe
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Expired Orange Book Patents for Generic Ingredient: estradiol; norethindrone acetate

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Amneal Pharms Llc
ACTIVELLA
estradiol; norethindrone acetate
TABLET;ORAL020907-001Nov 18, 1998► Subscribe► Subscribe
Noven Pharms Inc
COMBIPATCH
estradiol; norethindrone acetate
FILM, EXTENDED RELEASE;TRANSDERMAL020870-002Aug 7, 1998► Subscribe► Subscribe
Noven Pharms Inc
COMBIPATCH
estradiol; norethindrone acetate
FILM, EXTENDED RELEASE;TRANSDERMAL020870-001Aug 7, 1998► Subscribe► Subscribe
Noven Pharms Inc
COMBIPATCH
estradiol; norethindrone acetate
FILM, EXTENDED RELEASE;TRANSDERMAL020870-001Aug 7, 1998► Subscribe► Subscribe
Noven Pharms Inc
COMBIPATCH
estradiol; norethindrone acetate
FILM, EXTENDED RELEASE;TRANSDERMAL020870-002Aug 7, 1998► Subscribe► Subscribe
Noven Pharms Inc
COMBIPATCH
estradiol; norethindrone acetate
FILM, EXTENDED RELEASE;TRANSDERMAL020870-002Aug 7, 1998► Subscribe► Subscribe
Noven Pharms Inc
COMBIPATCH
estradiol; norethindrone acetate
FILM, EXTENDED RELEASE;TRANSDERMAL020870-001Aug 7, 1998► Subscribe► Subscribe
Noven Pharms Inc
COMBIPATCH
estradiol; norethindrone acetate
FILM, EXTENDED RELEASE;TRANSDERMAL020870-001Aug 7, 1998► Subscribe► Subscribe
Noven Pharms Inc
COMBIPATCH
estradiol; norethindrone acetate
FILM, EXTENDED RELEASE;TRANSDERMAL020870-002Aug 7, 1998► Subscribe► Subscribe
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

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Serving leading biopharmaceutical companies globally:

Federal Trade Commission
Queensland Health
Daiichi Sankyo
Teva
Boehringer Ingelheim
Citi
Accenture
Johnson and Johnson
Cantor Fitzgerald
Healthtrust

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