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 freedom to operate?

Ethinyl estradiol; levonorgestrel is the generic ingredient in fifty-three 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, Mayne 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, Naari Pte Ltd, and Vintage Pharms Llc, and is included in seventy-three NDAs. There are ten 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 nine patent family members in twenty-seven countries.

Twenty-two suppliers are listed for this compound.

Summary for ethinyl estradiol; levonorgestrel

International Patents:	109
US Patents:	10
Tradenames:	53
Applicants:	24
NDAs:	73
Finished Product Suppliers / Packagers:	22
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
Laboratorios Andromaco S.A.	Phase 1
Society of Family Planning	Phase 4
Oregon Health and Science University	Phase 4

See all ethinyl estradiol; levonorgestrel clinical trials

Pharmacology for ethinyl estradiol; levonorgestrel

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

Anatomical Therapeutic Chemical (ATC) Classes for ethinyl estradiol; levonorgestrel

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
Aurobindo Pharma Ltd	LO SIMPESSE	ethinyl estradiol; levonorgestrel	TABLET;ORAL	206852-001	Apr 28, 2017	AB	RX	No	No	See Plans and Pricing	See Plans and Pricing				See Plans and Pricing
Mylan Labs Ltd	LEVONORGESTREL AND ETHINYL ESTRADIOL	ethinyl estradiol; levonorgestrel	TABLET;ORAL	200490-001	Apr 21, 2015	AB	RX	No	No	See Plans and Pricing	See Plans and Pricing				See Plans and Pricing
Xiromed	LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL	ethinyl estradiol; levonorgestrel	TABLET;ORAL	205131-001	Dec 14, 2017	AB	RX	No	No	See Plans and Pricing	See Plans and Pricing				See Plans and Pricing
>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
Teva Branded Pharm	NORDETTE-28	ethinyl estradiol; levonorgestrel	TABLET;ORAL-28	018782-001	Jul 21, 1982	See Plans and Pricing	See Plans and Pricing
Teva Branded Pharm	PREVEN EMERGENCY CONTRACEPTIVE KIT	ethinyl estradiol; levonorgestrel	TABLET;ORAL	020946-001	Sep 1, 1998	See Plans and Pricing	See Plans and Pricing
Agile	TWIRLA	ethinyl estradiol; levonorgestrel	SYSTEM;TRANSDERMAL	204017-001	Feb 14, 2020	See Plans and Pricing	See Plans and Pricing
>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
European Patent Office	2392333	Procédé de traitement hormonal utilisant des régimes de cycle étendu à dose croissante (Methods of hormonal treatment utilizing ascending-dose extended cycle regimens)	See Plans and Pricing
Hungary	0402651		See Plans and Pricing
World Intellectual Property Organization (WIPO)	2008127303		See Plans and Pricing
>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	2015C/042	Belgium	See Plans and Pricing	DETAILS ASSIGNMENT: CHANGE OF OWNER(S), CHANGEMENT DE NOM DU PROPRIETAIRE, NOM/ADRESSE
1380301	CA 2009 00017	Denmark	See Plans and Pricing	PRODUCT NAME: ETHINYLESTRADIOL (SOM BETADEXCLATHRAT) OG DROSPIRENON; NAT. REG. NO/DATE: 42417 (DK) 20080619; FIRST REG. NO/DATE: NL 33842 20070629
1453521	C201630040	Spain	See Plans and Pricing	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
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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