NORETHINDRONE ACETATE - Generic Drug Details

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 Generics, Mylan Labs Ltd, Novast Labs, 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:	6,317
Formulation / Manufacturing:	see details
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
		1MG;0.01MG;75MG	TABLET;ORAL
		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

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Glenmark Generics	NORETHINDRONE ACETATE	norethindrone acetate	TABLET;ORAL	091090-001	Jul 21, 2010	AB	RX	No	No
Barr	NORETHINDRONE ACETATE	norethindrone acetate	TABLET;ORAL	075951-001	May 25, 2001	AB	RX	No	Yes
Mylan Labs Ltd	NORETHINDRONE ACETATE	norethindrone acetate	TABLET;ORAL	205278-001	Nov 10, 2016	AB	RX	No	No
Novast Labs	NORETHINDRONE ACETATE	norethindrone acetate	TABLET;ORAL	206490-001	Nov 5, 2018	AB	RX	No	No
Amneal Pharms	NORETHINDRONE ACETATE	norethindrone acetate	TABLET;ORAL	200275-001	Jul 30, 2012	AB	RX	No	No