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Last Updated: April 19, 2024

Ethinyl estradiol; levonorgestrel - Generic Drug Details

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What are the generic sources for ethinyl estradiol; levonorgestrel and what is the scope of patent protection?

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
Xiromed	JAIMIESS	ethinyl estradiol; levonorgestrel	TABLET;ORAL	203770-001	Dec 27, 2017	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Sun Pharm	CERINTA	ethinyl estradiol; levonorgestrel	TABLET;ORAL-28	202817-001	Jan 7, 2019		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Novast Labs	SETLAKIN	ethinyl estradiol; levonorgestrel	TABLET;ORAL	090716-001	Sep 15, 2014	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Lupin Ltd	KURVELO	ethinyl estradiol; levonorgestrel	TABLET;ORAL-28	091408-001	Oct 17, 2012	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Lupin Ltd	MINZOYA	ethinyl estradiol; levonorgestrel	TABLET;ORAL	217087-001	Feb 15, 2024	AB3	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Mylan Labs Ltd	LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL	ethinyl estradiol; levonorgestrel	TABLET;ORAL	200493-001	Jun 17, 2015	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Aurobindo Pharma	AYUNA	ethinyl estradiol; levonorgestrel	TABLET;ORAL-28	206866-001	Sep 23, 2016	AB	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
Argentina	051931	METODOS DE TRATAMIENTO HORMONAL QUE UTILIZAN REGIMENES DE CICLOS EXTENDIDOS CON DOSIS ASCENDENTES	⤷ Try a Trial
Canada	2655959	CONTRACEPTIFS ORAUX POUR EVITER LES GROSSESSES ET DIMINUER LA SYMPTOMATOLOGIE PREMENSTRUELLE (ORAL CONTRACEPTIVES TO PREVENT PREGNANCY AND DIMINISH PREMENSTRUAL SYMPTOMATOLOGY)	⤷ Try a Trial
Japan	2010508275		⤷ Try a Trial
Japan	2010533199		⤷ Try a Trial
Taiwan	200626161	Methods of hormonal treatment utilizing ascending-dose extended cycle regimens	⤷ Try a Trial
Spain	2581652		⤷ Try a Trial
Japan	5603235		⤷ 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	C20160011 00192	Estonia	⤷ Try a Trial	PRODUCT NAME: LEVONORGESTREEL JA ETUENUEUELOESTRADIOOL;REG NO/DATE: EE 894715 11.11.2015
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	39/2015	Austria	⤷ Try a Trial	PRODUCT NAME: ETHINYLESTRADIOL UND EINE KOMBINATION VON LEVONORGESTREL UND ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: 136021 20150224; FIRST REGISTRATION: SK 17/0017/15-S 20150211
0136011	2000C/027	Belgium	⤷ Try a Trial	PRODUCT NAME: ETHINYLESTRADIOLUM / NORETHISTERONI ACETAS; NAT. REGISTRATION NO/DATE: 19 IS 106 F3 20000911; FIRST REGISTRATION: NL RVG 23909 19991124
1453521	C201630040	Spain	⤷ Try a Trial	PRODUCT NAME: ETINILESTRADIOL Y MEZCLA DE LEVONORGESTREL Y ETINILESTRADIOL; NATIONAL AUTHORISATION NUMBER: 80340; DATE OF AUTHORISATION: 20160122; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): 17/0017/15-S; DATE OF FIRST AUTHORISATION IN EEA: 20150211
1214076	C01214076/01	Switzerland	⤷ Try a Trial	PRODUCT NAME: DROSPIRENONE + ETHINYLESTRADIOL; REGISTRATION NUMBER/DATE: SWISSMEDIC 57946 13.06.2008
1453521	93156	Luxembourg	⤷ Try a Trial	PRODUCT NAME: LEVONORGESTREL ET ETHINYLESTRADIOL; FIRST REGISTRATION DATE: 20150211
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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