NORETHINDRONE ACETATE - Generic Drug Details

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What are the generic 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.

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

Sponsor

Phase

Bio Genuine (Shanghai) Biotech Co., Ltd.

Phase 3

Myovant Sciences GmbH

Phase 4

University of Chicago

Phase 4

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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
Aurobindo Pharma Ltd	NORETHINDRONE ACETATE	norethindrone acetate	TABLET;ORAL	204236-001	Jan 8, 2016		DISCN	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
Novast Labs	NORETHINDRONE ACETATE	norethindrone acetate	TABLET;ORAL	206490-001	Nov 5, 2018	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Xiromed	NORETHINDRONE ACETATE	norethindrone acetate	TABLET;ORAL	205278-001	Nov 10, 2016	AB	RX	No	No	⤷ 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

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