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Last Updated: April 16, 2024

Ethinyl estradiol; levonorgestrel - Generic Drug Details

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

Ethinyl estradiol; levonorgestrel is the generic ingredient in fifty-five branded drugs marketed by Agile, Glenmark Generics, Avion Pharms, Lupin Ltd, Novast Labs, Aurobindo Pharma Ltd, Xiromed, Amneal Pharms, Glenmark Pharms Ltd, Mylan Labs Ltd, Watson Labs, Dr Reddys Labs Sa, Aurobindo Pharma, Teva Branded Pharm, Wyeth Pharms Inc, Sun Pharm, Exeltis Usa Inc, Cadence Health, Duramed Pharms Barr, Barr, Bayer Hlthcare, Wyeth Pharms, Novast Labs Ltd, Hetero Labs, Naari Pte Ltd, and Vintage Pharms Llc, and is included in seventy-six NDAs. There are eight 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 eight patent family members in twenty-eight countries.

Twenty-six suppliers are listed for this compound. There are two tentative approvals for this compound.

Summary for ethinyl estradiol; levonorgestrel

International Patents:	108
US Patents:	8
Tradenames:	55
Applicants:	26
NDAs:	76
Finished Product Suppliers / Packagers:	26
Clinical Trials:	58
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
Parexel	Phase 1
Merck Sharp & Dohme LLC	Phase 1
University of Washington	Phase 1

See all ethinyl estradiol; levonorgestrel clinical trials

Generic filers with tentative approvals for ETHINYL ESTRADIOL; LEVONORGESTREL

Applicant	Application No.	Strength	Dosage Form
⤷ Try a Trial	⤷ Try a Trial	0.03MG,0.01MG; 0.15MG,N/A	TABLET;ORAL
⤷ Try a Trial	⤷ Try a Trial	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	Estrogen Progestin Progestin-containing Intrauterine System Progestin-containing Intrauterine Device
Mechanism of Action	Estrogen Receptor Agonists
Physiological Effect	Inhibit Ovum Fertilization

Paragraph IV (Patent) Challenges for ETHINYL ESTRADIOL; LEVONORGESTREL

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
BALCOLTRA	Tablets	ethinyl estradiol; levonorgestrel	0.1 mg/0.02 mg	208612	1	2020-07-14
QUARTETTE	Tablets	ethinyl estradiol; levonorgestrel	0.15 mg/0.02 mg, 0.15 mg/0.025 mg, 0.15 mg/0.03 mg and 0.01 mg	204061	1	2013-07-10
LOSEASONIQUE	Tablets	ethinyl estradiol; levonorgestrel	0.1 mg/0.02 mg and 0.01 mg	022262	1	2009-11-16
SEASONIQUE	Tablets	ethinyl estradiol; levonorgestrel	0.15 mg/0.03 mg/0.01 mg	021840		2008-01-22
LYBREL	Tablets	ethinyl estradiol; levonorgestrel	0.09 mg/0.02 mg	021864	1	2007-10-05
SEASONALE	Tablets	ethinyl estradiol; levonorgestrel	0.15 mg/0.03 mg	021544		2004-03-29

US Patents and Regulatory Information for ethinyl estradiol; levonorgestrel

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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
Duramed Pharms Barr	ENPRESSE-28	ethinyl estradiol; levonorgestrel	TABLET;ORAL-28	075809-002	Jul 16, 2001	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Barr	LESSINA-28	ethinyl estradiol; levonorgestrel	TABLET;ORAL-28	075803-002	Mar 20, 2002	AB2	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Barr	LESSINA-21	ethinyl estradiol; levonorgestrel	TABLET;ORAL-21	075803-001	Mar 20, 2002		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Xiromed	ELIFEMME	ethinyl estradiol; levonorgestrel	TABLET;ORAL-28	202507-001	Dec 4, 2015		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Dr Reddys Labs Sa	LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL	ethinyl estradiol; levonorgestrel	TABLET;ORAL	200407-001	Oct 25, 2011		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Amneal Pharms	LEVONORGESTREL AND ETHINYL ESTRADIOL	ethinyl estradiol; levonorgestrel	TABLET;ORAL	203872-001	Dec 22, 2015	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Xiromed	LEVONORGESTREL AND ETHINYL ESTRADIOL AND FERROUS FUMARATE	ethinyl estradiol; levonorgestrel	TABLET;ORAL	214640-001	Aug 16, 2023	AB3	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
>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; levonorgestrel

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Agile	TWIRLA	ethinyl estradiol; levonorgestrel	SYSTEM;TRANSDERMAL	204017-001	Feb 14, 2020	⤷ Try a Trial	⤷ Try a Trial
Agile	TWIRLA	ethinyl estradiol; levonorgestrel	SYSTEM;TRANSDERMAL	204017-001	Feb 14, 2020	⤷ Try a Trial	⤷ Try a Trial
Teva Branded Pharm	LOSEASONIQUE	ethinyl estradiol; levonorgestrel	TABLET;ORAL	022262-001	Oct 24, 2008	⤷ Try a Trial	⤷ Try a Trial
Agile	TWIRLA	ethinyl estradiol; levonorgestrel	SYSTEM;TRANSDERMAL	204017-001	Feb 14, 2020	⤷ Try a Trial	⤷ Try a Trial
Wyeth Pharms Inc	LYBREL	ethinyl estradiol; levonorgestrel	TABLET;ORAL	021864-001	May 22, 2007	⤷ Try a Trial	⤷ Try a Trial
Teva Branded Pharm	NORDETTE-28	ethinyl estradiol; levonorgestrel	TABLET;ORAL-28	018782-001	Jul 21, 1982	⤷ Try a Trial	⤷ Try a Trial
Teva Branded Pharm	NORDETTE-21	ethinyl estradiol; levonorgestrel	TABLET;ORAL-21	018668-001	May 10, 1982	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for ethinyl estradiol; levonorgestrel

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Country	Patent Number	Title	Estimated Expiration
Canada	2524474	METHODES DE TRAITEMENT HORMONAL FAISANT APPEL A DES SCHEMAS CONTRACEPTIFS A CYCLE PROLONGE (METHODS OF HORMONAL TREATMENT UTILIZING EXTENDED CYCLE CONTRACEPTIVE REGIMENS)	⤷ Try a Trial
European Patent Office	2079461	PROCÉDÉS DE TRAITEMENT HORMONAL UTILISANT DES SCHÉMAS POSOLOGIQUES CYCLIQUES PROLONGÉS À DOSES CROISSANTES (METHODS OF HORMONAL TREATMENT UTILIZING ASCENDING-DOSE EXTENDED CYCLE REGIMENS)	⤷ Try a Trial
Portugal	1453521		⤷ Try a Trial
Australia	2010201022	Methods of hormonal treatment utilizing contraceptive regimens with continuous estrogen administration	⤷ Try a Trial
China	100581550		⤷ Try a Trial
Japan	2010508275		⤷ Try a Trial
European Patent Office	2167002	DISPOSITIF D'ADMINISTRATION DERMIQUE AVEC UN JOINT IN SITU (DERMAL DELIVERY DEVICE WITH IN SITU SEAL)	⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for ethinyl estradiol; levonorgestrel

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1453521	132016000025143	Italy	⤷ Try a Trial	PRODUCT NAME: LEVONORGESTREL ED ETINILESTRADIOLO(SEASONIQUE); AUTHORISATION NUMBER(S) AND DATE(S): 17/0017/15-S, 20150211;042139016, 20150414
1214076	SZ 49/2008	Austria	⤷ Try a Trial	PRODUCT NAME: WIRKSTOFFKOMBINATION VON ETHINYLESTRADIOL UND DROSPIRENON
0398460	C300221	Netherlands	⤷ Try a Trial	PRODUCT NAME: DROSPIRENON EN ETHINYLESTRADIOL; REGISTRATION NO/DATE: RVG 23827 20000307
1380301	CA 2009 00017	Denmark	⤷ Try a Trial	PRODUCT NAME: ETHINYLESTRADIOL (SOM BETADEXCLATHRAT) OG DROSPIRENON; NAT. REG. NO/DATE: 42417 (DK) 20080619; FIRST REG. NO/DATE: NL 33842 20070629
1453521	300814	Netherlands	⤷ Try a Trial	PRODUCT NAME: LEVONORGESTREL EN ETHINYLESTRADIOL; NATIONAL REGISTRATION NO/DATE: RVG 117453 20151211; FIRST REGISTRATION: SK 17/0017/15-S 20150211
1453521	122015000093	Germany	⤷ Try a Trial	PRODUCT NAME: LEVONORGESTREL UND ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: 87675.00.00 20150720; FIRST REGISTRATION: SLOWAKEI 17/0017/15-S 20150129
1453521	CA 2016 00016	Denmark	⤷ Try a Trial	PRODUCT NAME: LEVONORGESTREL OG ETHINYLOESTRADIOL; NAT. REG. NO/DATE: 56336 20151105; FIRST REG. NO/DATE: SK 17/0017/15-S 20150211
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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