NORETHINDRONE - Generic Drug Details

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

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.

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	norethindrone	TABLET;ORAL-28	091209-001	Jul 22, 2010	AB2	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Xiromed	NORETHINDRONE	norethindrone	TABLET;ORAL-28	201483-001	Jun 24, 2013	AB1	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
Dr Reddys Labs Sa	ERRIN	norethindrone	TABLET;ORAL-28	076225-001	Oct 21, 2002	AB2	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Xiromed	NORETHINDRONE	norethindrone	TABLET;ORAL-28	200980-001	Jun 12, 2013	AB2	RX	No	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Naari Pte Ltd	NORETHINDRONE	norethindrone	TABLET;ORAL-28	206807-001	Dec 13, 2016	AB1	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Teva Branded Pharm	NOR-QD	norethindrone	TABLET;ORAL-28	017060-001	Approved Prior to Jan 1, 1982	AB1	RX	Yes	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

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