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Details for Generic Name: estradiol; norethindrone acetate

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Estradiol; norethindrone acetate is the generic ingredient in three branded drugs marketed by Noven Pharms Inc, Amneal Pharms Llc, Barr, Breckenridge Pharm, and Teva Pharms Usa, and is included in five NDAs. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

This ingredient has one hundred and fifty patent family members in twenty-eight countries.

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

Summary for Generic Name: estradiol; norethindrone acetate

Tradenames:3
Patents:1
Applicants:5
NDAs:5
Drug Master File Entries: see list74
Suppliers: see list4
Formulation / Manufacturing:see details

Pharmacology for Ingredient: estradiol; norethindrone acetate

Clinical Trials for: estradiol; norethindrone acetate

Estradiol/Norethindrone Acetate Tablets, 1/0.5 mg Under Fed Conditions
Status: Completed Condition: Healthy

Estradiol/Norethindrone Acetate Tablets, 1/0.5 mg Under Fasting Conditions
Status: Completed Condition: Healthy

Drug Interaction Study of an OCP (Norethindrone (ND) Acetate and Ethinyl Estradiol (EE))With a Combination of Daclatasvir (DCV) Asunaprevir (ASV) and BMS-791325
Status: Completed Condition: Hepatitis C

Drug Interaction Study of Isavuconazole and Oral Contraceptive Containing Ethinyl Estradiol and Norethindrone
Status: Completed Condition: Pharmacokinetics of Isavuconazole; Pharmacokinetics of Ethinyl Estradiol and Norethindrone; Healthy Volunteers

Norethindrone/Ethinyl Estradiol 0.4 mg/35 Mcg Chewable Tablets Under Fasting Conditions
Status: Completed Condition: Bioequivalence

Norethindrone/Ethinyl Estradiol 0.4 mg/35 Mcg Chewable Tablets Under Non-Fasted Conditions
Status: Completed Condition: Healthy

Courtesy of ClinicalTrials.org
See more clinical trials for this drug
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Breckenridge Pharm
ESTRADIOL AND NORETHINDRONE ACETATE
estradiol; norethindrone acetate
TABLET;ORAL078324-002Jun 9, 2011RXNo<disabled><disabled>
Teva Pharms Usa
ESTRADIOL AND NORETHINDRONE ACETATE
estradiol; norethindrone acetate
TABLET;ORAL200747-001Mar 8, 2012RXNo<disabled><disabled>
Noven Pharms Inc
COMBIPATCH
estradiol; norethindrone acetate
FILM, EXTENDED RELEASE;TRANSDERMAL020870-002Aug 7, 1998RXYes5,656,286<disabled><disabled>
Breckenridge Pharm
ESTRADIOL AND NORETHINDRONE ACETATE
estradiol; norethindrone acetate
TABLET;ORAL078324-001Apr 17, 2008RXNo<disabled><disabled>
Amneal Pharms Llc
ACTIVELLA
estradiol; norethindrone acetate
TABLET;ORAL020907-001Nov 18, 1998RXYes<disabled><disabled>
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International Patent Family for Ingredient: estradiol; norethindrone acetate

Country Document Number Publication Date
South Korea100391229Nov 01, 2003
JapanH06508820Oct 06, 1994
Denmark0591432Jan 06, 2003
Portugal92829Feb 29, 1996
South Africa9604735Dec 19, 1996
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ISSN: 2162-2639

Preferred citation:

Friedman, Y. Location of pharmaceutical innovation: 2000–2009 Nature Reviews Drug Discovery 9, 835–836 (2010).

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