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FDA Orange Book · active-ingredient family

Ethinyl estradiol; levonorgestrel

Ethinyl estradiol; levonorgestrel is approved as 15 brand and 61 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:TYBLUME · NDA 209405

15

Brand (NDA)

61

Generics (ANDA)

6

Listed patents

0

Exclusivity periods

Brand (NDA) products · system, tablet

ProductApplicantApplicationTEApproved
TYBLUMERLDEXELTIS USA INCNDA 209405—Mar 30, 2020
TWIRLARLDAGILENDA 204017—Feb 14, 2020
BALCOLTRARLDAVION PHARMSNDA 208612AB3Jan 09, 2018
QUARTETTERLDTEVA BRANDED PHARMNDA 204061ABMar 28, 2013
LYBRELRLDWYETH PHARMS INCNDA 021864—May 22, 2007
SEASONIQUERLDTEVA BRANDED PHARMNDA 021840ABMay 25, 2006
SEASONALERLDTEVA BRANDED PHARMNDA 021544ABSep 05, 2003
LEVLITERLD×2BAYER HLTHCARENDA 020860—Jul 13, 1998
ALESSERLD×2CADENCE HEALTHNDA 020683—Mar 27, 1997
TRIPHASIL-21RLDWYETH PHARMSNDA 019192—Nov 01, 1984
TRIPHASIL-28RLDWYETH PHARMS INCNDA 019190—Nov 01, 1984
NORDETTE-28RLDTEVA BRANDED PHARMNDA 018782—Jul 21, 1982
LOSEASONIQUETEVA BRANDED PHARMNDA 022262ABOct 24, 2008
PREVEN EMERGENCY CONTRACEPTIVE KITTEVA BRANDED PHARMNDA 020946—Sep 01, 1998
NORDETTE-21TEVA BRANDED PHARMNDA 018668—May 10, 1982

Generic (ANDA) products (61)

ProductApplicantApplicationTEApproved
MINZOYALUPINANDA 217087AB3Feb 15, 2024
LEVONORGESTREL AND ETHINYL ESTRADIOL AND FERROUS FUMARATEXIROMEDANDA 214640AB3Aug 16, 2023
LEVONORGESTREL AND ETHINYL ESTRADIOLHETERO LABSANDA 212298AB1Feb 13, 2023
DOLISHALENOVAST LABSANDA 091692ABOct 22, 2020
LEVONORGESTREL AND ETHINYL ESTRADIOLNAARI PTEANDA 207033ABOct 09, 2020
LEVONORGESTREL AND ETHINYL ESTRADIOLNAARI PTEANDA 207065AB1Aug 17, 2020
SYLEVIASUN PHARMANDA 202988—Feb 06, 2019
CERINTASUN PHARMANDA 202817—Jan 07, 2019
ICLEVIAAUROBINDO PHARMA LTDANDA 206850ABJun 29, 2018
LEVONORGESTREL AND ETHINYL ESTRADIOLXIROMEDANDA 202970—Mar 23, 2018
JAIMIESSXIROMEDANDA 203770ABDec 27, 2017
LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOLXIROMEDANDA 205131ABDec 14, 2017
LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOLXIROMEDANDA 206053ABOct 02, 2017
LO SIMPESSEAUROBINDO PHARMAANDA 206852ABApr 28, 2017
SIMPESSEAUROBINDO PHARMAANDA 206851ABApr 07, 2017
AFIRMELLEAUROBINDO PHARMAANDA 206886AB1Nov 14, 2016
AYUNAAUROBINDO PHARMAANDA 206866ABSep 23, 2016
FAYOSIMLUPINANDA 205943—Mar 29, 2016
LEVONORGESTREL AND ETHINYL ESTRADIOLNAARI PTEANDA 203872ABDec 22, 2015
ELIFEMMEXIROMEDANDA 202507—Dec 04, 2015
LEVONORGESTREL AND ETHINYL ESTRADIOLLUPINANDA 200248ABNov 19, 2015
LEVONORGESTREL AND ETHINYL ESTRADIOLNAARI PTEANDA 203871ABNov 13, 2015
LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOLXIROMEDANDA 200493ABJun 17, 2015
LEVONORGESTREL AND ETHINYL ESTRADIOLGLENMARK PHARMS LTDANDA 203164ABJun 12, 2015
LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOLXIROMEDANDA 200492ABMay 27, 2015
VIENVAXIROMEDANDA 201088AB1May 21, 2015
LEVONORGESTREL AND ETHINYL ESTRADIOLXIROMEDANDA 200490ABApr 21, 2015
LEVONORGESTREL AND ETHINYL ESTRADIOLGLENMARK PHARMS LTDANDA 202791ABApr 09, 2015
ASHLYNAGLENMARK PHARMS LTDANDA 203163ABFeb 23, 2015
LEVONORGESTREL AND ETHINYL ESTRADIOLAMNEAL PHARMSANDA 201095—Dec 08, 2014
LEVONORGESTREL AND ETHINYL ESTRADIOLXIROMEDANDA 202247—Dec 08, 2014
SETLAKINNOVAST LABSANDA 090716ABSep 15, 2014
LEVONORGESTREL AND ETHINYL ESTRADIOLAMNEAL PHARMSANDA 201108—Feb 05, 2014
LEVONORGESTREL AND ETHINYL ESTRADIOLXIROMEDANDA 200245AB1Oct 09, 2013
DAYSEELUPIN LTDANDA 091467ABApr 10, 2013
LEVONORGESTREL AND ETHINYL ESTRADIOLLUPIN LTDANDA 091425AB1Jan 18, 2013
LEVONORGESTREL AND ETHINYL ESTRADIOLXIROMEDANDA 091663ABDec 21, 2012
LEVONORGESTREL AND ETHINYL ESTRADIOLLUPIN LTDANDA 091440ABOct 23, 2012
KURVELOLUPIN LTDANDA 091408ABOct 17, 2012
FALMINANOVAST LABS LTDANDA 090721AB1Mar 28, 2012
MARLISSAGLENMARK PHARMS LTDANDA 091452ABFeb 29, 2012
MYZILRAPH HEALTHANDA 077502—Nov 23, 2011
LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOLLUPIN LTDANDA 091674ABOct 26, 2011
LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOLDR REDDYS LABS SAANDA 200407—Oct 25, 2011
LEVONORGESTREL AND ETHINYL ESTRADIOLWATSON LABSANDA 079218ABJun 06, 2011
LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOLDR REDDYS LABS SAANDA 078834ABMay 31, 2011
ORSYTHIAPH HEALTHANDA 077099—May 11, 2011
LEVONESTNOVAST LABS LTDANDA 090719ABDec 29, 2010
INTROVALEXIROMEDANDA 079064ABSep 27, 2010
ALTAVERAXIROMEDANDA 079102ABAug 03, 2010
QUASENSEWATSON LABSANDA 077101ABSep 06, 2006
LEVONORGESTREL AND ETHINYL ESTRADIOLDR REDDYS LABS SAANDA 077681AB2May 31, 2006
LEVONORGESTREL AND ETHINYL ESTRADIOLDR REDDYS LABS SAANDA 076625AB1Nov 18, 2004
LEVONORGESTREL AND ETHINYL ESTRADIOL×2BARRANDA 075862—Apr 29, 2003
PORTIA-21×2BARRANDA 075866—May 23, 2002
LESSINA-21×2BARRANDA 075803—Mar 20, 2002
ENPRESSE-21×2DURAMED PHARMS BARRANDA 075809—Jul 16, 2001
AVIANE-21×2DURAMED PHARMS BARRANDA 075796—Apr 30, 2001
TRIVORA-21×2DR REDDYS LABS SAANDA 074538—Dec 18, 1997
LEVORA 0.15/30-21WATSON LABSANDA 073592—Dec 13, 1993
LEVORA 0.15/30-28DR REDDYS LABS SAANDA 073594ABDec 13, 1993

Listed patents (6)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
7838042Jun 01, 2027in 1 yr
SubstanceU-3251
8747888Jul 10, 2028in 2 yr 1 mo
Product
9050348Jul 10, 2028in 2 yr 1 mo
Product
8246978Aug 26, 2028in 2 yr 3 mo
Product
7855190Dec 05, 2028in 2 yr 6 mo
U-1
8415332Mar 11, 2029in 2 yr 9 mo
Product

Ethinyl estradiol; levonorgestrel — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

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