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Last Updated: May 8, 2021

DrugPatentWatch Database Preview

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 fourteen 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 fifty-six patent family members in thirty countries.

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

Recent Clinical Trials for ETHINYL ESTRADIOL; LEVONORGESTREL

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

SponsorPhase
Society of Family PlanningPhase 4
Oregon Health and Science UniversityPhase 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
  Get Started for $10  Get Started for $100.03MG,0.01MG; 0.15MG,N/ATABLET;ORAL
  Get Started for $10  Get Started for $100.02MG,0.15MG;0.025MG,0.15MG;0.03MG,0.15MG;0.01MG,N/ATABLET;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
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
Naari Pte Ltd LEVONORGESTREL AND ETHINYL ESTRADIOL ethinyl estradiol; levonorgestrel TABLET;ORAL-28 207033-001 Oct 9, 2020 AB RX No No   Get Started for $10   Get Started for $10   Get Started for $10
Xiromed LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL ethinyl estradiol; levonorgestrel TABLET;ORAL 205131-001 Dec 14, 2017 AB RX No No   Get Started for $10   Get Started for $10   Get Started for $10
Cadence Health ALESSE ethinyl estradiol; levonorgestrel TABLET;ORAL-28 020683-002 Mar 27, 1997 DISCN Yes No   Get Started for $10   Get Started for $10   Get Started for $10
>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
Agile TWIRLA ethinyl estradiol; levonorgestrel SYSTEM;TRANSDERMAL 204017-001 Feb 14, 2020   Get Started for $10   Get Started for $10
Teva Branded Pharm SEASONALE ethinyl estradiol; levonorgestrel TABLET;ORAL 021544-001 Sep 5, 2003   Get Started for $10   Get Started for $10
Agile TWIRLA ethinyl estradiol; levonorgestrel SYSTEM;TRANSDERMAL 204017-001 Feb 14, 2020   Get Started for $10   Get Started for $10
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for ETHINYL ESTRADIOL; LEVONORGESTREL

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1453521 C 2015 029 Romania   Get Started for $10 PRODUCT NAME: LEVONORGESTREL SI ETINILESTRADIOL; NATIONAL AUTHORISATION NUMBER: RO 7793/2015/001; DATE OF NATIONAL AUTHORISATION: 20150612; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): SK. 17/0017/15-S; DATE OF FIRST AUTHORISATION IN EEA: 20150129
0771217 CA 2006 00038 Denmark   Get Started for $10 PRODUCT NAME: ETHINYLESTRADIOL (SOM BETA-CYCLODEXTRIN-CLATHRAT) OG DROSPIRENON; NAT. REG. NO/DATE: 38687 20060627; FIRST REG. NO/DATE: EU RVG 31781 20050804
1453521 15C0050 France   Get Started for $10 PRODUCT NAME: ETHINYLESTRADIOL ET MELANGE DE LEVONORGESTREL ET ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: NL 42237 20150320; FIRST REGISTRATION: SK - 17/0017/15-S 20150129
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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