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Last Updated: November 24, 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 patent protection?

Ethinyl estradiol; levonorgestrel is the generic ingredient in fifty-two branded drugs marketed by Agile, 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, 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-one 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
Barr LESSINA-28 ethinyl estradiol; levonorgestrel TABLET;ORAL-28 075803-002 Mar 20, 2002 AB2 RX No No   Start Trial   Start Trial   Start Trial
Teva Branded Pharm LOSEASONIQUE ethinyl estradiol; levonorgestrel TABLET;ORAL 022262-001 Oct 24, 2008 AB RX No No   Start Trial   Start Trial   Start Trial
Barr PORTIA-21 ethinyl estradiol; levonorgestrel TABLET;ORAL-21 075866-001 May 23, 2002 DISCN No No   Start Trial   Start Trial   Start Trial
Lupin Ltd FAYOSIM ethinyl estradiol; levonorgestrel TABLET;ORAL 205943-001 Mar 29, 2016 DISCN No No   Start Trial   Start Trial   Start Trial
Naari Pte Ltd LEVONORGESTREL AND ETHINYL ESTRADIOL ethinyl estradiol; levonorgestrel TABLET;ORAL-28 207065-001 Aug 17, 2020 AB RX No No   Start Trial   Start Trial   Start Trial
Glenmark Generics MARLISSA ethinyl estradiol; levonorgestrel TABLET;ORAL-28 091452-001 Feb 29, 2012 AB RX No No   Start Trial   Start Trial   Start Trial
Lupin Ltd LEVONORGESTREL AND ETHINYL ESTRADIOL ethinyl estradiol; levonorgestrel TABLET;ORAL-28 091425-001 Jan 18, 2013 AB1 RX 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
1214076 SZ 49/2008 Austria   Start Trial PRODUCT NAME: WIRKSTOFFKOMBINATION VON ETHINYLESTRADIOL UND DROSPIRENON
1453521 39/2015 Austria   Start Trial PRODUCT NAME: ETHINYLESTRADIOL UND EINE KOMBINATION VON LEVONORGESTREL UND ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: 136021 20150224; FIRST REGISTRATION: SK 17/0017/15-S 20150211
1380301 2009C/007 Belgium   Start Trial PRODUCT NAME: DROSPIRENONE-ETHINYLESTRADIOL; AUTHORISATION NUMBER AND DATE: BE321386 20080811
1453521 15C0050 France   Start Trial PRODUCT NAME: ETHINYLESTRADIOL ET MELANGE DE LEVONORGESTREL ET ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: NL 42237 20150320; FIRST REGISTRATION: SK - 17/0017/15-S 20150129
0136011 2000C/027 Belgium   Start Trial PRODUCT NAME: ETHINYLESTRADIOLUM / NORETHISTERONI ACETAS; NAT. REGISTRATION NO/DATE: 19 IS 106 F3 20000911; FIRST REGISTRATION: NL RVG 23909 19991124
1453521 C20160011 00192 Estonia   Start Trial PRODUCT NAME: LEVONORGESTREEL JA ETUENUEUELOESTRADIOOL;REG NO/DATE: EE 894715 11.11.2015
0771217 07C0001 France   Start Trial PRODUCT NAME: ETHINYLESTRADIOL BETADEX CLATHRATE; NAT. REGISTRATION NO/DATE: NL 32343 20060710; FIRST REGISTRATION: NL - RVG 31781 20050804
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

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