Ethinyl estradiol; norgestrel - Generic Drug Details

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

Ethinyl estradiol; norgestrel is the generic ingredient in twelve branded drugs marketed by Duramed Pharms Barr, Cadence Health, Dr Reddys Labs Sa, Watson Labs, Wyeth Pharms, Novast Labs Ltd, Mylan Labs Ltd, and Lupin Ltd, and is included in eleven NDAs. Additional information is available in the individual branded drug profile pages.

Nine suppliers are listed for this compound.

Summary for ethinyl estradiol; norgestrel

US Patents:	0
Tradenames:	12
Applicants:	8
NDAs:	11
Finished Product Suppliers / Packagers:	9
Clinical Trials:	5
DailyMed Link:	ethinyl estradiol; norgestrel at DailyMed

Recent Clinical Trials for ethinyl estradiol; norgestrel

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Sponsor	Phase
Amgen	Phase 1
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.	Phase 1
National Cancer Institute (NCI)	Phase 2

See all ethinyl estradiol; norgestrel clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for ethinyl estradiol; norgestrel

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; norgestrel

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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
Mylan Labs Ltd	NORGESTREL AND ETHINYL ESTRADIOL	ethinyl estradiol; norgestrel	TABLET;ORAL-28	201828-001	Jun 21, 2016		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Dr Reddys Labs Sa	LOW-OGESTREL-28	ethinyl estradiol; norgestrel	TABLET;ORAL-28	075288-002	Jul 28, 1999	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Duramed Pharms Barr	CRYSELLE	ethinyl estradiol; norgestrel	TABLET;ORAL-28	075840-002	Nov 30, 2001	AB	RX	No	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

Expired US Patents for ethinyl estradiol; norgestrel

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Wyeth Pharms	OVRAL-28	ethinyl estradiol; norgestrel	TABLET;ORAL-28	016806-001	Approved Prior to Jan 1, 1982	⤷ Sign Up	⤷ Sign Up
Cadence Health	LO/OVRAL	ethinyl estradiol; norgestrel	TABLET;ORAL-21	017612-001	Approved Prior to Jan 1, 1982	⤷ Sign Up	⤷ Sign Up
Wyeth Pharms	OVRAL	ethinyl estradiol; norgestrel	TABLET;ORAL-21	016672-001	Approved Prior to Jan 1, 1982	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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