DrugPatentWatch Database Preview

Ethinyl estradiol; levonorgestrel - Generic Drug Details

« Back to Dashboard

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

Ethinyl estradiol; levonorgestrel is the generic ingredient in fifty-one branded drugs marketed by Agile, Exeltis Usa Inc, Glenmark Generics, Avion Pharms, Lupin Ltd, Aurobindo Pharma Ltd, Xiromed, Amneal Pharms, Glenmark Pharms Ltd, Mylan Labs Ltd, Watson Labs, Mayne Pharma, Teva Branded Pharm, Wyeth Pharms Inc, Novast Labs, Sun Pharm, Cadence Health, Duramed Pharms Barr, Barr, Bayer Hlthcare, Wyeth Pharms, Novast Labs Ltd, and Vintage Pharms Llc, and is included in seventy NDAs. There are sixteen patents protecting this compound and five Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Ethinyl estradiol; levonorgestrel has one hundred and sixty-one patent family members in thirty countries.

There are twenty-six drug master file entries for ethinyl estradiol; levonorgestrel. Nineteen suppliers are listed for this compound. There are two tentative approvals for this compound.

Summary for ethinyl estradiol; levonorgestrel

International Patents:	161
US Patents:	16
Tradenames:	51
Applicants:	23
NDAs:	70
Drug Master File Entries:	26
Suppliers / Packagers:	19
Clinical Trials:	56
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ethinyl estradiol; levonorgestrel
DailyMed Link:	ethinyl estradiol; levonorgestrel at DailyMed

Recent Clinical Trials for ethinyl estradiol; levonorgestrel

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

Sponsor	Phase
Society of Family Planning	Phase 4
Oregon Health and Science University	Phase 4
Laboratorios Andromaco S.A.	Phase 1

See all ethinyl estradiol; levonorgestrel clinical trials

Generic filers with tentative approvals for ETHINYL ESTRADIOL; LEVONORGESTREL

Applicant	Application No.	Strength	Dosage Form
		0.03MG,0.01MG; 0.15MG,N/A	TABLET;ORAL
		0.02MG,0.15MG;0.025MG,0.15MG;0.03MG,0.15MG;0.01MG,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; levonorgestrel

Drug Class	Progestin Progestin-containing Intrauterine Device Estrogen
Mechanism of Action	Estrogen Receptor Agonists
Physiological Effect	Inhibit Ovum Fertilization

Paragraph IV (Patent) Challenges for ETHINYL ESTRADIOL; LEVONORGESTREL

Tradename	Dosage	Ingredient	NDA	Submissiondate
QUARTETTE	TABLET;ORAL	ethinyl estradiol; levonorgestrel	204061	2013-07-10
LOSEASONIQUE	TABLET;ORAL	ethinyl estradiol; levonorgestrel	022262	2009-11-16
SEASONIQUE	TABLET;ORAL	ethinyl estradiol; levonorgestrel	021840	2008-01-22
LYBREL	TABLET;ORAL	ethinyl estradiol; levonorgestrel	021864	2007-10-05
SEASONALE	TABLET;ORAL	ethinyl estradiol; levonorgestrel	021544	2004-03-29

US Patents and Regulatory Information for ethinyl estradiol; levonorgestrel

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	LEVONORGESTREL AND ETHINYL ESTRADIOL	ethinyl estradiol; levonorgestrel	TABLET;ORAL	200490-001	Apr 21, 2015	AB	RX	No	No
Agile	TWIRLA	ethinyl estradiol; levonorgestrel	SYSTEM;TRANSDERMAL	204017-001	Feb 14, 2020		RX	Yes	Yes			Y
Amneal Pharms	LEVONORGESTREL AND ETHINYL ESTRADIOL	ethinyl estradiol; levonorgestrel	TABLET;ORAL-28	201108-001	Feb 5, 2014	AB1	RX	No	No
Glenmark Generics	ASHLYNA	ethinyl estradiol; levonorgestrel	TABLET;ORAL	203163-001	Feb 23, 2015	AB	RX	No	No
Teva Branded Pharm	SEASONALE	ethinyl estradiol; levonorgestrel	TABLET;ORAL	021544-001	Sep 5, 2003	AB	RX	Yes	Yes
Teva Branded Pharm	PREVEN EMERGENCY CONTRACEPTIVE KIT	ethinyl estradiol; levonorgestrel	TABLET;ORAL	020946-001	Sep 1, 1998		DISCN	No	No

Expired US Patents for ethinyl estradiol; levonorgestrel

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Wyeth Pharms Inc	TRIPHASIL-28	ethinyl estradiol; levonorgestrel	TABLET;ORAL-28	019190-001	Nov 1, 1984
Teva Branded Pharm	NORDETTE-21	ethinyl estradiol; levonorgestrel	TABLET;ORAL-21	018668-001	May 10, 1982
Teva Branded Pharm	NORDETTE-21	ethinyl estradiol; levonorgestrel	TABLET;ORAL-21	018668-001	May 10, 1982
Wyeth Pharms Inc	LYBREL	ethinyl estradiol; levonorgestrel	TABLET;ORAL	021864-001	May 22, 2007
Wyeth Pharms	TRIPHASIL-21	ethinyl estradiol; levonorgestrel	TABLET;ORAL-21	019192-001	Nov 1, 1984
Teva Branded Pharm	NORDETTE-21	ethinyl estradiol; levonorgestrel	TABLET;ORAL-21	018668-001	May 10, 1982

International Patents for ethinyl estradiol; levonorgestrel

Country	Patent Number	Estimated Expiration
Austria	453374
Russian Federation	2351339
Canada	2253289
South Africa	200203525
China	1264428
Japan	2006525358

Supplementary Protection Certificates for ethinyl estradiol; levonorgestrel

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0398460	C300221	Netherlands		PRODUCT NAME: DROSPIRENON EN ETHINYLESTRADIOL; REGISTRATION NO/DATE: RVG 23827 20000307
1453521	C20160011 00192	Estonia		PRODUCT NAME: LEVONORGESTREEL JA ETUENUEUELOESTRADIOOL;REG NO/DATE: EE 894715 11.11.2015
1453521	132016000025143	Italy		PRODUCT NAME: LEVONORGESTREL ED ETINILESTRADIOLO(SEASONIQUE); AUTHORISATION NUMBER(S) AND DATE(S): 17/0017/15-S, 20150211;042139016, 20150414
1453521	300814	Netherlands		DETAILS ASSIGNMENT: CHANGE OF OWNER(S), CHANGE OF LEGAL ENTITY
1453521	93156	Luxembourg		PRODUCT NAME: LEVONORGESTREL ET ETHINYLESTRADIOL; FIRST REGISTRATION DATE: 20150211
1380301	2009C/007	Belgium		PRODUCT NAME: DROSPIRENONE-ETHINYLESTRADIOL; AUTHORISATION NUMBER AND DATE: BE321386 20080811