ETHINYL ESTRADIOL; NORGESTIMATE - Generic Drug Details

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, Amneal Pharms, Glenmark Pharms Ltd, Glenmark Speclt, Lupin Ltd, Lupin Pharms, Mylan, Naari Pte Ltd, Watson Labs, Endo Operations, 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.

Twenty-two suppliers are listed for this compound.

Summary for ETHINYL ESTRADIOL; NORGESTIMATE

US Patents:	0
Tradenames:	19
Applicants:	17
NDAs:	34
Finished Product Suppliers / Packagers:	22
Clinical Trials:	29
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ETHINYL ESTRADIOL; NORGESTIMATE
DailyMed Link:	ETHINYL ESTRADIOL; NORGESTIMATE at DailyMed

Recent Clinical Trials for ETHINYL ESTRADIOL; NORGESTIMATE

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

Sponsor	Phase
Benha University	Phase 2/Phase 3
Amgen	Phase 1
Gilead Sciences	Phase 1

See all ETHINYL ESTRADIOL; NORGESTIMATE clinical trials

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

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; NORGESTIMATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Glenmark Speclt	NORGESTIMATE AND ETHINYL ESTRADIOL	ethinyl estradiol; norgestimate	TABLET;ORAL-28	204057-001	Feb 23, 2016	AB	RX	No	Yes
Xiromed	TRI-ESTARYLLA	ethinyl estradiol; norgestimate	TABLET;ORAL-28	090793-001	Jan 30, 2013	AB	RX	No	No
Barr Labs Inc	TRI LO SPRINTEC	ethinyl estradiol; norgestimate	TABLET;ORAL-28	076784-001	Jun 29, 2009	AB	RX	No	No
Barr	SPRINTEC	ethinyl estradiol; norgestimate	TABLET;ORAL-28	075804-001	Sep 25, 2002	AB	RX	No	Yes
Naari Pte Ltd	NORGESTIMATE AND ETHINYL ESTRADIOL	ethinyl estradiol; norgestimate	TABLET;ORAL-28	200384-001	Apr 7, 2015	AB	RX	No	No
Watson Labs	NORGESTIMATE AND ETHINYL ESTRADIOL	ethinyl estradiol; norgestimate	TABLET;ORAL-28	090479-001	Mar 9, 2011		DISCN	No	No
Aurobindo Pharma Ltd	MILI	ethinyl estradiol; norgestimate	TABLET;ORAL-28	205449-001	Jul 7, 2016	AB	RX	No	No

Expired US Patents for ETHINYL ESTRADIOL; NORGESTIMATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Janssen Pharms	ORTHO TRI-CYCLEN LO	ethinyl estradiol; norgestimate	TABLET;ORAL-28	021241-001	Aug 22, 2002
Janssen Pharms	ORTHO TRI-CYCLEN LO	ethinyl estradiol; norgestimate	TABLET;ORAL-28	021241-001	Aug 22, 2002
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-28	019697-001	Jul 3, 1992
Janssen Pharms	ORTHO TRI-CYCLEN	ethinyl estradiol; norgestimate	TABLET;ORAL-28	019697-001	Jul 3, 1992