ethinyl estradiol; norgestimate - Profile

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

Ethinyl estradiol; norgestimate is the generic ingredient in nineteen branded drugs marketed by Janssen Pharms, Xiromed, Aurobindo Pharma Ltd, Novast Labs Ltd, Glenmark Pharms Ltd, Glenmark Speclt, Lupin, Lupin Pharms, Mylan, Naari Pte, Watson Labs, Ph Health, Barr, Barr Labs Inc, Novast Labs, and Aurobindo Pharma, and is included in thirty-four NDAs. Additional information is available in the individual branded drug profile pages.

Summary for ethinyl estradiol; norgestimate

US Patents:	0
Tradenames:	19
Applicants:	16
NDAs:	34
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ethinyl estradiol; norgestimate

US Patents and Regulatory Information for ethinyl estradiol; norgestimate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Janssen Pharms	ORTHO CYCLEN-21	ethinyl estradiol; norgestimate	TABLET;ORAL-21	019653-001	Dec 29, 1989		DISCN	No	No
Janssen Pharms	ORTHO TRI-CYCLEN	ethinyl estradiol; norgestimate	TABLET;ORAL-21	019697-002	Jul 3, 1992		DISCN	No	No
Xiromed	ESTARYLLA	ethinyl estradiol; norgestimate	TABLET;ORAL-28	090794-001	Jan 30, 2013	AB	RX	No	No
Aurobindo Pharma Ltd	MILI	ethinyl estradiol; norgestimate	TABLET;ORAL-28	205449-001	Jul 7, 2016	AB	RX	No	No
Novast Labs Ltd	MONO-LINYAH	ethinyl estradiol; norgestimate	TABLET;ORAL-28	090523-001	May 23, 2012	AB	RX	No	No
Glenmark Pharms Ltd	NORGESTIMATE AND ETHINYL ESTRADIOL	ethinyl estradiol; norgestimate	TABLET;ORAL-28	200494-001	Jun 17, 2011	AB	RX	No	Yes

Expired US Patents for ethinyl estradiol; norgestimate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Janssen Pharms	ORTHO TRI-CYCLEN	ethinyl estradiol; norgestimate	TABLET;ORAL-21	019697-002	Jul 3, 1992
Janssen Pharms	ORTHO TRI-CYCLEN	ethinyl estradiol; norgestimate	TABLET;ORAL-28	019697-001	Jul 3, 1992
Janssen Pharms	ORTHO TRI-CYCLEN	ethinyl estradiol; norgestimate	TABLET;ORAL-21	019697-002	Jul 3, 1992
Janssen Pharms	ORTHO TRI-CYCLEN	ethinyl estradiol; norgestimate	TABLET;ORAL-21	019697-002	Jul 3, 1992
Janssen Pharms	ORTHO TRI-CYCLEN	ethinyl estradiol; norgestimate	TABLET;ORAL-21	019697-002	Jul 3, 1992
Janssen Pharms	ORTHO TRI-CYCLEN	ethinyl estradiol; norgestimate	TABLET;ORAL-21	019697-002	Jul 3, 1992