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Last Updated: June 2, 2024

ETHINYL ESTRADIOL; NORETHINDRONE - Generic Drug Details

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

Ethinyl estradiol; norethindrone is the generic ingredient in one hundred and seventeen branded drugs marketed by Lupin Ltd, Mylan Labs Ltd, Teva Branded Pharm, Apil, Aurobindo Pharma, Amneal Pharms, Barr, Naari Pte Ltd, Allergan, Ortho Mcneil Pharm, LPI, Watson Pharms Teva, Watson Labs, Watson Labs Teva, Ortho Mcneil Janssen, Janssen Pharms, Warner Chilcott, Dr Reddys Labs Sa, Glenmark Pharms Ltd, Vintage Pharms, Vintage Pharms Llc, Novast Labs Ltd, Warner Chilcott Llc, Xiromed, Slayback Pharma Llc, Teva Pharms Usa Inc, Novast Labs, Lupin, Barr Labs Inc, Apotex, Glenmark Pharms, Parke Davis, and Mylan, and is included in one hundred and forty-nine NDAs. There is one patent protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Fourteen suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for ETHINYL ESTRADIOL; NORETHINDRONE

US Patents:	1
Tradenames:	117
Applicants:	33
NDAs:	149
Finished Product Suppliers / Packagers:	14
Raw Ingredient (Bulk) Api Vendors:	7
Clinical Trials:	41
Patent Applications:	359
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ETHINYL ESTRADIOL; NORETHINDRONE
DailyMed Link:	ETHINYL ESTRADIOL; NORETHINDRONE at DailyMed

Recent Clinical Trials for ETHINYL ESTRADIOL; NORETHINDRONE

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

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

See all ETHINYL ESTRADIOL; NORETHINDRONE clinical trials

Generic filers with tentative approvals for ETHINYL ESTRADIOL; NORETHINDRONE

Applicant	Application No.	Strength	Dosage Form
⤷ Sign Up	⤷ Sign Up	0.01MG,0.01MG;1MG,N/A	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 ETHINYL ESTRADIOL; NORETHINDRONE

Drug Class	Estrogen Progestin
Mechanism of Action	Estrogen Receptor Agonists

US Patents and Regulatory Information for ETHINYL ESTRADIOL; NORETHINDRONE

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Glossary

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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
Novast Labs	LARIN FE 1.5/30	ethinyl estradiol; norethindrone acetate	TABLET;ORAL-28	091453-001	Aug 23, 2013	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Janssen Pharms	ORTHO-NOVUM 7/7/7-21	ethinyl estradiol; norethindrone	TABLET;ORAL-21	018985-001	Apr 4, 1984		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Glenmark Pharms Ltd	ALYACEN 7/7/7	ethinyl estradiol; norethindrone	TABLET;ORAL-28	091636-001	Jan 19, 2012	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Vintage Pharms Llc	CYCLAFEM 1/35	ethinyl estradiol; norethindrone	TABLET;ORAL-28	076337-001	Nov 12, 2010		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Aurobindo Pharma	AUROVELA 1.5/30	ethinyl estradiol; norethindrone acetate	TABLET;ORAL-21	207581-001	Jun 26, 2017	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Novast Labs	CHABELINA FE	ethinyl estradiol; norethindrone acetate	TABLET;ORAL-28	202962-001	Apr 15, 2020	AB	RX	No	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Barr	BALZIVA-21	ethinyl estradiol; norethindrone	TABLET;ORAL-21	076198-001	Apr 22, 2004		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

Expired US Patents for ETHINYL ESTRADIOL; NORETHINDRONE

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Janssen Pharms	ORTHO-NOVUM 7/7/7-28	ethinyl estradiol; norethindrone	TABLET;ORAL-28	018985-002	Apr 4, 1984	⤷ Sign Up	⤷ Sign Up
Apil	FEMCON FE	ethinyl estradiol; norethindrone	TABLET;ORAL	021490-001	Nov 14, 2003	⤷ 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	⤷ Sign Up	⤷ Sign Up
Janssen Pharms	ORTHO-NOVUM 7/7/7-28	ethinyl estradiol; norethindrone	TABLET;ORAL-28	018985-002	Apr 4, 1984	⤷ Sign Up	⤷ Sign Up
Janssen Pharms	ORTHO-NOVUM 7/7/7-21	ethinyl estradiol; norethindrone	TABLET;ORAL-21	018985-001	Apr 4, 1984	⤷ Sign Up	⤷ Sign Up
Janssen Pharms	ORTHO-NOVUM 7/7/7-28	ethinyl estradiol; norethindrone	TABLET;ORAL-28	018985-002	Apr 4, 1984	⤷ Sign Up	⤷ Sign Up
Janssen Pharms	ORTHO-NOVUM 7/7/7-28	ethinyl estradiol; norethindrone	TABLET;ORAL-28	018985-002	Apr 4, 1984	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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