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Last Updated: April 21, 2024

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-five 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, Dr Reddys Labs Sa, Aurobindo 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, Hetero Labs, Naari Pte Ltd, and Vintage Pharms Llc, and is included in seventy-six 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 eight patent family members in twenty-eight countries.

Twenty-six 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
ParexelPhase 1
University of WashingtonPhase 1
Wits Reproductive Health and HIV InstitutePhase 1

See all ethinyl estradiol; levonorgestrel clinical trials

Generic filers with tentative approvals for ETHINYL ESTRADIOL; LEVONORGESTREL
Applicant Application No. Strength Dosage Form
⤷  Try a Trial⤷  Try a Trial0.03MG,0.01MG; 0.15MG,N/ATABLET;ORAL
⤷  Try a Trial⤷  Try a 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 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
Teva Branded Pharm SEASONALE ethinyl estradiol; levonorgestrel TABLET;ORAL 021544-001 Sep 5, 2003 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Teva Branded Pharm QUARTETTE ethinyl estradiol; levonorgestrel TABLET;ORAL 204061-001 Mar 28, 2013 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Mylan Labs Ltd LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL ethinyl estradiol; levonorgestrel TABLET;ORAL 200493-001 Jun 17, 2015 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Naari Pte Ltd LEVONORGESTREL AND ETHINYL ESTRADIOL ethinyl estradiol; levonorgestrel TABLET;ORAL-28 207033-001 Oct 9, 2020 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Bayer Hlthcare LEVLITE ethinyl estradiol; levonorgestrel TABLET;ORAL-28 020860-002 Jul 13, 1998 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Amneal Pharms LEVONORGESTREL AND ETHINYL ESTRADIOL ethinyl estradiol; levonorgestrel TABLET;ORAL 203871-001 Nov 13, 2015 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a 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

International Patents for ethinyl estradiol; levonorgestrel

Country Patent Number Title Estimated Expiration
Japan 2010180236 ORAL CONTRACEPTIVE TO PREVENT PREGNANCY AND DIMINISH PREMENSTRUAL SYMPTOMATOLOGY ⤷  Try a Trial
Spain 2428118 ⤷  Try a Trial
Russian Federation 2006101214 СПОСОБЫ ГОРМОНАЛЬНОГО ЛЕЧЕНИЯ С ПРИМЕНЕНИЕМ КОНТРАЦЕПТИВНЫХ РЕЖИМОВ С НЕПРЕРЫВНЫМ ВВЕДЕНИЕМ ЭСТРОГЕНА ⤷  Try a Trial
Canada 2532089 PROCEDES DE TRAITEMENT HORMONAL UTILISANT DES POSOLOGIES CONTRACEPTIVES AVEC ADMINISTRATION CONTINUE D'OESTROGENES (METHODS OF HORMONAL TREATMENT UTILIZING CONTRACEPTIVE REGIMENS WITH CONTINUOUS ESTROGEN ADMINISTRATION) ⤷  Try a Trial
European Patent Office 1648382 PROCEDES DE TRAITEMENT HORMONAL UTILISANT DES POSOLOGIES CONTRACEPTIVES AVEC ADMINISTRATION CONTINUE D'OESTROGENES (METHODS OF HORMONAL TREATMENT UTILIZING CONTRACEPTIVE REGIMENS WITH CONTINUOUS ESTROGEN ADMINISTRATION) ⤷  Try a Trial
World Intellectual Property Organization (WIPO) 2004098517 ⤷  Try a Trial
>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 39/2015 Austria ⤷  Try a 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 CA 2009 00017 Denmark ⤷  Try a Trial PRODUCT NAME: ETHINYLESTRADIOL (SOM BETADEXCLATHRAT) OG DROSPIRENON; NAT. REG. NO/DATE: 42417 (DK) 20080619; FIRST REG. NO/DATE: NL 33842 20070629
1453521 2015C/042 Belgium ⤷  Try a Trial DETAILS ASSIGNMENT: CHANGE OF OWNER(S), CHANGEMENT DE NOM DU PROPRIETAIRE, NOM/ADRESSE
0771217 CA 2006 00038 Denmark ⤷  Try a Trial PRODUCT NAME: ETHINYLESTRADIOL (SOM BETA-CYCLODEXTRIN-CLATHRAT) OG DROSPIRENON; NAT. REG. NO/DATE: 38687 20060627; FIRST REG. NO/DATE: EU RVG 31781 20050804
1453521 C20160011 00192 Estonia ⤷  Try a Trial PRODUCT NAME: LEVONORGESTREEL JA ETUENUEUELOESTRADIOOL;REG NO/DATE: EE 894715 11.11.2015
0771217 07C0001 France ⤷  Try a 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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