Norethindrone - Generic Drug Details

What are the generic drug sources for norethindrone and what is the scope of patent protection?

Norethindrone is the generic ingredient in thirteen branded drugs marketed by Parke Davis, Dr Reddys Labs Sa, Aurobindo Pharma, Glenmark Pharms Ltd, Lupin Ltd, Janssen Pharms, Teva Branded Pharm, Amneal Pharms, Naari Pte Ltd, Novast Labs, Xiromed, 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. Sixteen suppliers are listed for this compound. There are two tentative approvals for this compound.

Summary for norethindrone

US Patents:	0
Tradenames:	13
Applicants:	14
NDAs:	25
Drug Master File Entries:	26
Finished Product Suppliers / Packagers:	16
Raw Ingredient (Bulk) Api Vendors:	76
Clinical Trials:	85
Patent Applications:	6,351
Drug Prices:	Drug price trends for norethindrone
Drug Sales Revenues:	Drug sales revenues for norethindrone
What excipients (inactive ingredients) are in norethindrone?	norethindrone excipients list
DailyMed Link:	norethindrone at DailyMed

See drug prices for norethindrone

See drug sales revenues for norethindrone

Recent Clinical Trials for norethindrone

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 clinical trials

Generic filers with tentative approvals for NORETHINDRONE

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

Drug Class

Progestin

Medical Subject Heading (MeSH) Categories for norethindrone

Contraceptives, Oral, Synthetic

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
Glenmark Pharms Ltd	NORETHINDRONE	norethindrone	TABLET;ORAL-28	091209-001	Jul 22, 2010	AB2	RX	No	No
Xiromed	NORETHINDRONE	norethindrone	TABLET;ORAL-28	201483-001	Jun 24, 2013	AB1	RX	No	No
Duramed Res	AYGESTIN	norethindrone acetate	TABLET;ORAL	018405-001	Apr 21, 1982		DISCN	Yes	No
Dr Reddys Labs Sa	ERRIN	norethindrone	TABLET;ORAL-28	076225-001	Oct 21, 2002	AB2	RX	No	No
Xiromed	NORETHINDRONE	norethindrone	TABLET;ORAL-28	200980-001	Jun 12, 2013	AB2	RX	No	Yes