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Last Updated: March 28, 2024

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 thirteen branded drugs marketed by Parke Davis, Dr Reddys Labs Sa, Aurobindo Pharma, Glenmark Generics, Lupin Ltd, Janssen Pharms, Teva Branded Pharm, Amneal Pharms, Mylan Labs Ltd, Naari Pte Ltd, Novast Labs, Duramed Res, Aurobindo Pharma Ltd, and Barr, and is included in twenty-five NDAs. Additional information is available in the individual branded drug profile pages.

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

Drug Prices for norethindrone

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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

SponsorPhase
Bio Genuine (Shanghai) Biotech Co., Ltd.Phase 3
Myovant Sciences GmbHPhase 4
University of ChicagoPhase 4

See all norethindrone clinical trials

Generic filers with tentative approvals for NORETHINDRONE
Applicant Application No. Strength Dosage Form
⤷  Try a Trial⤷  Try a Trial1MG;0.01MG;75MGTABLET;ORAL
⤷  Try a Trial⤷  Try a 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
Aurobindo Pharma Ltd NORETHINDRONE ACETATE norethindrone acetate TABLET;ORAL 204236-001 Jan 8, 2016 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Mylan Labs Ltd NORETHINDRONE ACETATE norethindrone acetate TABLET;ORAL 205278-001 Nov 10, 2016 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Aurobindo Pharma INCASSIA norethindrone TABLET;ORAL-28 207304-001 Sep 23, 2016 AB1 RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Barr NORETHINDRONE ACETATE norethindrone acetate TABLET;ORAL 075951-001 May 25, 2001 AB RX No Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Aurobindo Pharma EMZAHH norethindrone TABLET;ORAL-28 216796-001 Jan 6, 2023 AB2 RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Dr Reddys Labs Sa CAMILA norethindrone TABLET;ORAL-28 076177-001 Oct 21, 2002 AB1 RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Glenmark Generics HEATHER norethindrone TABLET;ORAL-28 090454-001 Apr 23, 2010 AB1 RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a 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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