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Last Updated: July 4, 2020

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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-one branded drugs marketed by Agile, Exeltis Usa Inc, 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 seventy NDAs. There are sixteen 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 sixty-one patent family members in thirty countries.

There are twenty-six drug master file entries for ethinyl estradiol; levonorgestrel. Nineteen 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
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
  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
Mylan Labs Ltd LEVONORGESTREL AND ETHINYL ESTRADIOL ethinyl estradiol; levonorgestrel TABLET;ORAL 200490-001 Apr 21, 2015 AB RX No No   Start Trial   Start Trial   Start Trial
Agile TWIRLA ethinyl estradiol; levonorgestrel SYSTEM;TRANSDERMAL 204017-001 Feb 14, 2020 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Amneal Pharms LEVONORGESTREL AND ETHINYL ESTRADIOL ethinyl estradiol; levonorgestrel TABLET;ORAL-28 201108-001 Feb 5, 2014 AB1 RX No No   Start Trial   Start Trial   Start Trial
Glenmark Generics ASHLYNA ethinyl estradiol; levonorgestrel TABLET;ORAL 203163-001 Feb 23, 2015 AB RX No No   Start Trial   Start Trial   Start Trial
Teva Branded Pharm SEASONALE ethinyl estradiol; levonorgestrel TABLET;ORAL 021544-001 Sep 5, 2003 AB RX Yes Yes   Start Trial   Start Trial   Start Trial
Teva Branded Pharm PREVEN EMERGENCY CONTRACEPTIVE KIT ethinyl estradiol; levonorgestrel TABLET;ORAL 020946-001 Sep 1, 1998 DISCN No 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
0398460 C300221 Netherlands   Start Trial PRODUCT NAME: DROSPIRENON EN ETHINYLESTRADIOL; REGISTRATION NO/DATE: RVG 23827 20000307
1453521 C20160011 00192 Estonia   Start Trial PRODUCT NAME: LEVONORGESTREEL JA ETUENUEUELOESTRADIOOL;REG NO/DATE: EE 894715 11.11.2015
1453521 132016000025143 Italy   Start Trial PRODUCT NAME: LEVONORGESTREL ED ETINILESTRADIOLO(SEASONIQUE); AUTHORISATION NUMBER(S) AND DATE(S): 17/0017/15-S, 20150211;042139016, 20150414
1453521 300814 Netherlands   Start Trial DETAILS ASSIGNMENT: CHANGE OF OWNER(S), CHANGE OF LEGAL ENTITY
1453521 93156 Luxembourg   Start Trial PRODUCT NAME: LEVONORGESTREL ET ETHINYLESTRADIOL; FIRST REGISTRATION DATE: 20150211
1380301 2009C/007 Belgium   Start Trial PRODUCT NAME: DROSPIRENONE-ETHINYLESTRADIOL; AUTHORISATION NUMBER AND DATE: BE321386 20080811
>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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