Get our Free Patent Expiration Newsletter

Serving leading biopharmaceutical companies globally:

Dow
Boehringer Ingelheim
Express Scripts
McKesson
Colorcon
Mallinckrodt

Last Updated: January 19, 2020

DrugPatentWatch Database Preview

Ethinyl estradiol; levonorgestrel - Generic Drug Details

Join the DrugPatentWatch Referral Program
Get access to a free drug patent landscape report or a free one-month subscription

« Back to Dashboard

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

Ethinyl estradiol; levonorgestrel is the generic ingredient in fifty branded drugs marketed by Glenmark Generics, Avion Pharms, Lupin Ltd, Aurobindo Pharma Ltd, Xiromed, Amneal Pharms, Glenmark Pharms Ltd, Mylan Labs Ltd, Watson Labs, Mayne Pharma, Teva Branded Pharm, Wyeth Pharms Inc, Novast Labs, Sun Pharm, Cadence Health, Duramed Pharms Barr, Barr, Bayer Hlthcare, Wyeth Pharms, Novast Labs Ltd, and Vintage Pharms Llc, and is included in sixty-eight 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 three patent family members in twenty-six countries.

There are twenty-six drug master file entries for ethinyl estradiol; levonorgestrel. Twenty suppliers are listed for this compound. There are two tentative approvals 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
Assembly BiosciencesPhase 1
University of Sao PauloPhase 4

See all ethinyl estradiol; levonorgestrel clinical trials

Recent Litigation for ethinyl estradiol; levonorgestrel

Identify potential future generic entrants

District Court Litigation
Case NameDate
Teva Women's Health, Inc. v. Famy Care Ltd.2014-12-05
Teva Women's Health, Inc. v. Famy Care Ltd.2014-07-02
TEVA WOMEN'S HEALTH, INC. v. MYLAN PHARMACEUTICALS, INC.2010-03-09

See all ethinyl estradiol; levonorgestrel litigation

Generic filers with tentative approvals for ETHINYL ESTRADIOL; LEVONORGESTREL
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial0.03MG,0.01MG; 0.15MG,N/ATABLET;ORAL
  Start Trial  Start Trial0.02MG,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
Teva Branded Pharm NORDETTE-28 ethinyl estradiol; levonorgestrel TABLET;ORAL-28 018782-001 Jul 21, 1982 DISCN Yes No   Start Trial   Start Trial   Start Trial
Novast Labs Ltd FALMINA ethinyl estradiol; levonorgestrel TABLET;ORAL-28 090721-001 Mar 28, 2012 AB1 RX No No   Start Trial   Start Trial   Start Trial
Aurobindo Pharma Ltd LO SIMPESSE ethinyl estradiol; levonorgestrel TABLET;ORAL 206852-001 Apr 28, 2017 AB RX No No   Start Trial   Start Trial   Start Trial
Teva Branded Pharm SEASONIQUE ethinyl estradiol; levonorgestrel TABLET;ORAL 021840-001 May 25, 2006 AB RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Wyeth Pharms Inc LYBREL ethinyl estradiol; levonorgestrel TABLET;ORAL 021864-001 May 22, 2007 DISCN Yes No   Start Trial   Start Trial   Start 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

Supplementary Protection Certificates for ethinyl estradiol; levonorgestrel

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1214076 SZ 49/2008 Austria   Start Trial PRODUCT NAME: WIRKSTOFFKOMBINATION VON ETHINYLESTRADIOL UND DROSPIRENON
1380301 CA 2009 00017 Denmark   Start Trial PRODUCT NAME: ETHINYLESTRADIOL (SOM BETADEXCLATHRAT) OG DROSPIRENON; NAT. REG. NO/DATE: 42417 (DK) 20080619; FIRST REG. NO/DATE: NL 33842 20070629
0398460 C300221 Netherlands   Start Trial PRODUCT NAME: DROSPIRENON EN ETHINYLESTRADIOL; REGISTRATION NO/DATE: RVG 23827 20000307
0771217 CA 2006 00038 Denmark   Start Trial PRODUCT NAME: ETHINYLESTRADIOL (SOM BETA-CYCLODEXTRIN-CLATHRAT) OG DROSPIRENON; NAT. REG. NO/DATE: 38687 20060627; FIRST REG. NO/DATE: EU RVG 31781 20050804
1214076 49/2008 Austria   Start Trial PRODUCT NAME: WIRKSTOFFKOMBINATION VON ETHINYLESTRADIOL UND DROSPIRENON; REGISTRATION NO/DATE: 1-27586 20080612
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Moodys
AstraZeneca
Mallinckrodt
Express Scripts
Baxter
Johnson and Johnson

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.