NORETHINDRONE Drug Patent Profile

When do Norethindrone patents expire, and when can generic versions of Norethindrone launch?

Norethindrone is a drug marketed by Amneal Pharms, Glenmark Generics, Lupin Ltd, Mylan Labs Ltd, Naari Pte Ltd, Novast Labs, Aurobindo Pharma Ltd, Barr, Barr Labs Inc, Glenmark Pharms Ltd, Dr Reddys Labs Sa, Mylan, Apotex, Xiromed, Watson Labs, Watson Pharms Teva, Watson Labs Teva, and Apil. and is included in sixty-three NDAs.

The generic ingredient in NORETHINDRONE is mestranol; norethindrone. There are eleven drug master file entries for this compound. Additional details are available on the mestranol; norethindrone profile page.

Summary for NORETHINDRONE

US Patents:	0
Applicants:	18
NDAs:	63
Finished Product Suppliers / Packagers:	7
Raw Ingredient (Bulk) Api Vendors:	76
Clinical Trials:	85
Patent Applications:	3,769
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for NORETHINDRONE
Drug Sales Revenues:	Drug sales revenues for NORETHINDRONE
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
Myovant Sciences GmbH	Phase 4
University of Chicago	Phase 4

See all NORETHINDRONE clinical trials

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
Watson Pharms Teva	NORETHINDRONE AND ETHINYL ESTRADIOL	ethinyl estradiol; norethindrone	TABLET;ORAL-21	070685-001	Jan 29, 1987		DISCN	No	No
Amneal Pharms	NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE	ethinyl estradiol; norethindrone acetate	TABLET;ORAL	207514-001	Sep 11, 2017		DISCN	No	No
Watson Labs	NORETHINDRONE AND ETHINYL ESTRADIOL	ethinyl estradiol; norethindrone	TABLET;ORAL-28	078323-001	Feb 4, 2010	AB	RX	No	No
Lupin Ltd	NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE	ethinyl estradiol; norethindrone	TABLET;ORAL	091332-001	Mar 23, 2016	AB	RX	No	No
Mylan Labs Ltd	NORETHINDRONE AND ETHINYL ESTRADIOL	ethinyl estradiol; norethindrone	TABLET;ORAL-28	200488-001	Oct 21, 2015		DISCN	No	No
Watson Labs	NORETHINDRONE AND ETHINYL ESTRADIOL	ethinyl estradiol; norethindrone	TABLET;ORAL-28	076393-001	Feb 4, 2010		DISCN	No	No
Watson Labs	NORETHINDRONE AND ETHINYL ESTRADIOL (7/14)	ethinyl estradiol; norethindrone	TABLET;ORAL-28	071042-001	Sep 24, 1991		DISCN	No	No