Norethindrone acetate - Generic Drug Details

✉ Email this page to a colleague

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

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

There are nine drug master file entries for norethindrone acetate. Seven suppliers are listed for this compound. There are two tentative approvals for this compound.

Summary for norethindrone acetate

US Patents:	0
Tradenames:	3
Applicants:	8
NDAs:	8
Drug Master File Entries:	9
Finished Product Suppliers / Packagers:	7
Raw Ingredient (Bulk) Api Vendors:	62
Clinical Trials:	49
Patent Applications:	6,358
Drug Prices:	Drug price trends for norethindrone acetate
What excipients (inactive ingredients) are in norethindrone acetate?	norethindrone acetate excipients list
DailyMed Link:	norethindrone acetate at DailyMed

See drug prices for norethindrone acetate

Recent Clinical Trials for norethindrone acetate

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

Sponsor	Phase
Bio Genuine (Shanghai) Biotech Co., Ltd.	Phase 3
University of Chicago	Phase 4
Myovant Sciences GmbH	Phase 4

See all norethindrone acetate clinical trials

Generic filers with tentative approvals for NORETHINDRONE ACETATE

Applicant	Application No.	Strength	Dosage Form
⤷ Sign Up	⤷ Sign Up	1MG;0.01MG;75MG	TABLET;ORAL
⤷ Sign Up	⤷ Sign Up	75MG	TABLET;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 acetate

Drug Class	Progestin

US Patents and Regulatory Information for norethindrone acetate

+ Get email alerts for changes to this table

Glossary

Subscribe to access the full database, or Sign Up
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Glenmark Pharms Ltd	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		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Barr	NORETHINDRONE ACETATE	norethindrone acetate	TABLET;ORAL	075951-001	May 25, 2001	AB	RX	No	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

Make Better Decisions: Try a trial or see plans & pricing

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 verification 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.