Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

Serving leading biopharmaceutical companies globally:

Colorcon
Dow
Express Scripts
Mallinckrodt
Federal Trade Commission
Boehringer Ingelheim
Argus Health
Healthtrust
Deloitte
Fish and Richardson

Generated: February 25, 2018

DrugPatentWatch Database Preview

Norethindrone acetate - Generic Drug Details

« Back to Dashboard

What are the generic drug sources for norethindrone acetate and what is the scope of norethindrone acetate patent protection?

Norethindrone acetate
is the generic ingredient in three branded drugs marketed by Duramed Res, Amneal Pharms, Aurobindo Pharma Ltd, Barr, Glenmark Generics, Mylan Labs Ltd, and Parke Davis, and is included in seven NDAs. Additional information is available in the individual branded drug profile pages.

There are twenty-six drug master file entries for norethindrone acetate. Nine suppliers are listed for this compound. There are three tentative approvals for this compound.
Pharmacology for norethindrone acetate
Ingredient-typeProgesterone Congeners
Drug ClassProgestin
Tentative approvals for NORETHINDRONE ACETATE
Applicant Application No. Strength Dosage Form
➤ Sign Up➤ Sign Up1MG;0.01MG;75MGTABLET;ORAL
➤ Sign Up➤ Sign Up1MG;0.02MGTABLET;ORAL
➤ Sign Up➤ Sign Up75MGTABLET;ORAL

US Patents and Regulatory Information for 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 NORETHINDRONE ACETATE norethindrone acetate TABLET;ORAL 205278-001 Nov 10, 2016 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Aurobindo Pharma Ltd NORETHINDRONE ACETATE norethindrone acetate TABLET;ORAL 204236-001 Jan 8, 2016 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Barr NORETHINDRONE ACETATE norethindrone acetate TABLET;ORAL 075951-001 May 25, 2001 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Amneal Pharms NORETHINDRONE ACETATE norethindrone acetate TABLET;ORAL 200275-001 Jul 30, 2012 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Parke Davis NORLUTATE norethindrone acetate TABLET;ORAL 012184-002 Approved Prior to Jan 1, 1982 DISCN No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Glenmark Generics NORETHINDRONE ACETATE norethindrone acetate TABLET;ORAL 091090-001 Jul 21, 2010 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Duramed Res AYGESTIN norethindrone acetate TABLET;ORAL 018405-001 Apr 21, 1982 AB RX Yes Yes ➤ 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

This preview shows a limited data set. Subscribe for full access, or try a Free Trial

For more information try a trial or see the plans and pricing

Serving hundreds of leading biopharmaceutical companies globally:

Fuji
Cantor Fitzgerald
AstraZeneca
Medtronic
Citi
Baxter
Chubb
Accenture
Farmers Insurance

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

botpot