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 eighteen branded drugs marketed by Lupin Ltd, Teva Branded Pharm, Xiromed, 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, Endo Operations, Novast Labs Ltd, Mylan Labs Ltd, Warner Chilcott Llc, Wilshire Pharms Inc, Millicent Pr, Teva Pharms Usa Inc, Novast Labs, Lupin, Barr Labs Inc, Apotex, Glenmark Speclt, and Parke Davis, and is included in one hundred and fifty 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:	118
Applicants:	32
NDAs:	150
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

Anatomical Therapeutic Chemical (ATC) Classes for ETHINYL ESTRADIOL; NORETHINDRONE

G03CA	Natural and semisynthetic estrogens, plain
G03C	ESTROGENS
G03	SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM
G	Genito-urinary system and sex hormones

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
Barr	JUNEL 1.5/30	ethinyl estradiol; norethindrone acetate	TABLET;ORAL-21	076381-001	May 30, 2003	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Barr	JUNEL FE 1/20	ethinyl estradiol; norethindrone acetate	TABLET;ORAL-28	076081-001	Sep 18, 2003	AB	RX	No	No	⤷ 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
Novast Labs Ltd	PHILITH	ethinyl estradiol; norethindrone	TABLET;ORAL-28	090947-001	Dec 22, 2011	AB	RX	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
Dr Reddys Labs Sa	TRI-NORINYL 28-DAY	ethinyl estradiol; norethindrone	TABLET;ORAL-28	018977-002	Apr 13, 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
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 7/7/7-21	ethinyl estradiol; norethindrone	TABLET;ORAL-21	018985-001	Apr 4, 1984	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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