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Last Updated: March 18, 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 patent protection?

Ethinyl estradiol; levonorgestrel is the generic ingredient in fifty-four 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-five 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
Wits Reproductive Health and HIV InstitutePhase 1
Merck Sharp & Dohme LLCPhase 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
Aurobindo Pharma AYUNA ethinyl estradiol; levonorgestrel TABLET;ORAL-28 206866-001 Sep 23, 2016 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Mylan Labs Ltd LEVONORGESTREL AND ETHINYL ESTRADIOL ethinyl estradiol; levonorgestrel TABLET;ORAL 200490-001 Apr 21, 2015 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Xiromed ALTAVERA ethinyl estradiol; levonorgestrel TABLET;ORAL-28 079102-001 Aug 3, 2010 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Mylan Labs Ltd LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL ethinyl estradiol; levonorgestrel TABLET;ORAL 206053-001 Oct 2, 2017 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Xiromed JAIMIESS ethinyl estradiol; levonorgestrel TABLET;ORAL 203770-001 Dec 27, 2017 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Watson Labs QUASENSE ethinyl estradiol; levonorgestrel TABLET;ORAL 077101-001 Sep 6, 2006 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
Denmark 1453521 ⤷  Try a Trial
Taiwan 200831107 Methods of hormonal treatment utilizing ascending-dose extended cycle regimens ⤷  Try a Trial
Hong Kong 1142798 具有原位密封的皮膚遞送裝置 (DERMAL DELIVERY DEVICE WITH IN SITU SEAL) ⤷  Try a Trial
Canada 2655959 CONTRACEPTIFS ORAUX POUR EVITER LES GROSSESSES ET DIMINUER LA SYMPTOMATOLOGIE PREMENSTRUELLE (ORAL CONTRACEPTIVES TO PREVENT PREGNANCY AND DIMINISH PREMENSTRUAL SYMPTOMATOLOGY) ⤷  Try a Trial
Israel 207561 ⤷  Try a Trial
New Zealand 585546 Methods of hormonal treatment utilizing contraceptive regimens with continuous estrogen administration ⤷  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 C201630040 Spain ⤷  Try a Trial PRODUCT NAME: ETINILESTRADIOL Y MEZCLA DE LEVONORGESTREL Y ETINILESTRADIOL; NATIONAL AUTHORISATION NUMBER: 80340; DATE OF AUTHORISATION: 20160122; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): 17/0017/15-S; DATE OF FIRST AUTHORISATION IN EEA: 20150211
1453521 C20160011 00192 Estonia ⤷  Try a Trial PRODUCT NAME: LEVONORGESTREEL JA ETUENUEUELOESTRADIOOL;REG NO/DATE: EE 894715 11.11.2015
1214076 SZ 49/2008 Austria ⤷  Try a Trial PRODUCT NAME: WIRKSTOFFKOMBINATION VON ETHINYLESTRADIOL UND DROSPIRENON
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
1380301 2009C/007 Belgium ⤷  Try a Trial PRODUCT NAME: DROSPIRENONE-ETHINYLESTRADIOL; AUTHORISATION NUMBER AND DATE: BE321386 20080811
1453521 2015C/042 Belgium ⤷  Try a Trial DETAILS ASSIGNMENT: CHANGE OF OWNER(S), CHANGEMENT DE NOM DU PROPRIETAIRE, NOM/ADRESSE
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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