NORETHINDRONE AND ETHINYL ESTRADIOL Drug Patent Profile

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Norethindrone And Ethinyl Estradiol is a drug marketed by Watson Labs, Watson Pharms Teva, Dr Reddys Labs Sa, Mylan Labs Ltd, Naari Pte Ltd, Watson Labs Teva, Xiromed, Teva Branded Pharm, Amneal Pharms, Barr, and Lupin Ltd. and is included in twenty-four NDAs.

The generic ingredient in NORETHINDRONE AND ETHINYL ESTRADIOL is ethinyl estradiol; norethindrone. There are twenty-six drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; norethindrone profile page.

US Patents:	0
Applicants:	11
NDAs:	24
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	7
Clinical Trials:	41
Patent Applications:	131
DailyMed Link:	NORETHINDRONE AND ETHINYL ESTRADIOL at DailyMed

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
University of Virginia	Early Phase 1
Celerion	Phase 1
Achillion, a wholly owned subsidiary of Alexion	Phase 1

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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
Watson Labs	NORETHINDRONE AND ETHINYL ESTRADIOL	ethinyl estradiol; norethindrone	TABLET;ORAL-21	078379-001	Feb 23, 2010		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Teva Branded Pharm	NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE	ethinyl estradiol; norethindrone	TABLET, CHEWABLE;ORAL	022573-001	Dec 22, 2010	AB	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Xiromed	NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE	ethinyl estradiol; norethindrone	TABLET;ORAL	202086-001	Apr 1, 2015	AB	RX	No	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Mylan Labs Ltd	NORETHINDRONE AND ETHINYL ESTRADIOL	ethinyl estradiol; norethindrone	TABLET;ORAL-28	200489-001	Oct 21, 2015		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Dr Reddys Labs Sa	NORETHINDRONE AND ETHINYL ESTRADIOL	ethinyl estradiol; norethindrone	TABLET;ORAL-28	070686-001	Jan 29, 1987		DISCN	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