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Last Updated: August 8, 2020

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NORETHINDRONE - Generic Drug Details

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

Norethindrone is the generic ingredient in twelve branded drugs marketed by Parke Davis, Mayne Pharma, Glenmark Generics, Aurobindo Pharma Ltd, Lupin Ltd, Janssen Pharms, Teva Branded Pharm, Accord Hlthcare, Amneal Pharms, Mylan Labs Ltd, Novast Labs, Duramed Res, and Barr, and is included in twenty-four NDAs. Additional information is available in the individual branded drug profile pages.

There are twenty-six drug master file entries for norethindrone. Twelve suppliers are listed for this compound. There are two tentative approvals for this compound.


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Drug Sales Revenue Trends for NORETHINDRONE

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Recent Clinical Trials for NORETHINDRONE

Identify potential brand extensions & 505(b)(2) entrants

University of VirginiaN/A
Ironwood Pharmaceuticals, Inc.Phase 1
Eisai Inc.Phase 1

See all NORETHINDRONE clinical trials

Generic filers with tentative approvals for NORETHINDRONE
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial1MG;0.01MG;75MGTABLET;ORAL
  Start Trial  Start Trial75MGTABLET;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for NORETHINDRONE
Drug ClassProgestin
Medical Subject Heading (MeSH) Categories for NORETHINDRONE

US Patents and Regulatory Information for NORETHINDRONE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Lupin Ltd NORETHINDRONE norethindrone TABLET;ORAL-28 091325-001 Sep 19, 2011 AB1 RX No No   Start Trial   Start Trial   Start Trial
Novast Labs NORETHINDRONE norethindrone TABLET;ORAL-28 200961-001 Sep 13, 2013 AB2 RX No No   Start Trial   Start Trial   Start Trial
Amneal Pharms NORETHINDRONE norethindrone TABLET;ORAL-28 202260-001 Aug 1, 2013 AB1 RX No No   Start Trial   Start Trial   Start Trial
Lupin Ltd JENCYCLA norethindrone TABLET;ORAL-28 091323-001 Mar 28, 2013 AB2 RX No No   Start Trial   Start Trial   Start Trial
Parke Davis NORLUTIN norethindrone TABLET;ORAL 010895-002 Approved Prior to Jan 1, 1982 DISCN No No   Start Trial   Start Trial   Start Trial
Mylan Labs Ltd NORETHINDRONE ACETATE norethindrone acetate TABLET;ORAL 205278-001 Nov 10, 2016 AB RX No No   Start Trial   Start Trial   Start Trial
Glenmark Generics NORETHINDRONE norethindrone TABLET;ORAL-28 091209-001 Jul 22, 2010 AB2 RX No No   Start Trial   Start Trial   Start Trial
>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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Serving leading biopharmaceutical companies globally:

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