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Last Updated: May 26, 2022

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
Recent Clinical Trials for ethinyl estradiol; levonorgestrel

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

SponsorPhase
Laboratorios Andromaco S.A.Phase 1
Society of Family PlanningPhase 4
Oregon Health and Science UniversityPhase 4

See all ethinyl estradiol; levonorgestrel clinical trials

Pharmacology 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

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

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

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

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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Serving leading biopharmaceutical companies globally:

Dow
Boehringer Ingelheim
Moodys
Johnson and Johnson
Medtronic
Colorcon

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