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FDA Orange Book · active-ingredient family

Ethinyl estradiol; norethindrone acetate

Ethinyl estradiol; norethindrone acetate is approved as 15 brand and 59 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:FEMLYV · NDA 218718

15

Brand (NDA)

59

Generics (ANDA)

2

Listed patents

1

Exclusivity periods

Brand (NDA) products · capsule, tablet, tablet, chewable, tablet, tablet, orally disintegrating

ProductApplicantApplicationTEApproved
FEMLYVRLDMILLICENT PRNDA 218718—Jul 22, 2024
LO MINASTRIN FERLDAPILNDA 204654—Jul 24, 2013
MINASTRIN 24 FERLDAPILNDA 203667—May 08, 2013
TAYTULLARLDAPILNDA 204426ABApr 19, 2013
LO LOESTRIN FERLDAPILNDA 022501—Oct 21, 2010
LOESTRIN 24 FERLDTEVA BRANDED PHARMNDA 021871—Feb 17, 2006
FEMHRTRLD×2APILNDA 021065—Jan 14, 2005
ESTROSTEP 21RLD×2APILNDA 020130—Oct 09, 1996
LOESTRIN 21 1.5/30RLDTEVA BRANDED PHARMNDA 017875—Approved Prior to Jan 1, 1982
LOESTRIN 21 1/20RLDTEVA BRANDED PHARMNDA 017876—Approved Prior to Jan 1, 1982
LOESTRIN FE 1.5/30RLDTEVA BRANDED PHARMNDA 017355—Approved Prior to Jan 1, 1982
LOESTRIN FE 1/20RLDTEVA BRANDED PHARMNDA 017354—Approved Prior to Jan 1, 1982
NORLESTRIN 21 1/50PARKE DAVISNDA 016749—Approved Prior to Jan 1, 1982
NORLESTRIN 21 2.5/50PARKE DAVISNDA 016852—Approved Prior to Jan 1, 1982
NORLESTRIN 28 1/50PARKE DAVISNDA 016723—Approved Prior to Jan 1, 1982

Generic (ANDA) products (59)

ProductApplicantApplicationTEApproved
OSHIHAUROBINDO PHARMAANDA 216558—Dec 06, 2023
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATEGLENMARK PHARMS LTDANDA 213418ABJul 27, 2022
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATEDR REDDYS LABS SAANDA 213901—Apr 28, 2022
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATEAMNEAL PHARMSANDA 214292—Jul 20, 2021
MERZEEWILSHIRE PHARMS INCANDA 212706ABDec 18, 2020
GEMMILYXIROMEDANDA 213317ABNov 09, 2020
CHABELINA FENOVAST LABSANDA 202962ABApr 15, 2020
FINZALATEVA PHARMS USA INCANDA 210087ABApr 07, 2020
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATEXIROMEDANDA 209609ABJul 16, 2018
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOLXIROMEDANDA 205069ABJun 22, 2018
HAILEY 1.5/30GLENMARK SPECLTANDA 209297ABJun 05, 2018
HAILEY FE 1.5/30GLENMARK SPECLTANDA 209031ABJun 05, 2018
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATEAPOTEXANDA 208639—Mar 21, 2018
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATEGLENMARK PHARMS LTDANDA 210369ABDec 26, 2017
HAILEY FE 1/20GLENMARK PHARMS LTDANDA 206597ABNov 21, 2017
HAILEY 24 FEGLENMARK PHARMS LTDANDA 204847ABNov 17, 2017
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATEXIROMEDANDA 206120—Sep 12, 2017
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATEAMNEAL PHARMSANDA 207514—Sep 11, 2017
AUROVELA 1.5/30AUROBINDO PHARMAANDA 207581ABJun 26, 2017
AUROVELA 1/20AUROBINDO PHARMAANDA 207506ABJun 16, 2017
AUROVELA FE 1/20AUROBINDO PHARMAANDA 207505ABJun 16, 2017
AUROVELA 24 FEAUROBINDO PHARMAANDA 207504ABJun 15, 2017
AUROVELA FE 1.5/30AUROBINDO PHARMAANDA 207580ABJun 15, 2017
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOLXIROMEDANDA 207260—Feb 02, 2017
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOLXIROMEDANDA 207259—Dec 27, 2016
LERIBANE×2NOVAST LABSANDA 203435ABJun 03, 2016
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL AND FERROUS FUMARATEXIROMEDANDA 205049—May 31, 2016
MIBELAS 24 FELUPINANDA 206287ABMay 24, 2016
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOLGLENMARK PHARMS LTDANDA 206969ABJan 20, 2016
FYAVOLV×2LUPINANDA 204213ABDec 10, 2015
BLISOVI FE 1.5/30LUPINANDA 201585ABNov 18, 2015
BLISOVI FE 1/20LUPINANDA 201584ABNov 18, 2015
BLISOVI 24 FELUPINANDA 091398ABOct 28, 2015
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL×2GLENMARK PHARMS LTDANDA 203038ABApr 02, 2015
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOLXIROMEDANDA 202741ABFeb 20, 2015
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOLXIROMEDANDA 202770ABFeb 19, 2015
LARIN 24 FENOVAST LABSANDA 202994ABFeb 18, 2015
GILDESS 24 FEPH HEALTHANDA 090293—Dec 01, 2014
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATEBARR LABSANDA 090938ABDec 01, 2014
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATEXIROMEDANDA 202742—Oct 30, 2014
LARIN 1.5/30NOVAST LABSANDA 202996ABMar 20, 2014
LARIN 1/20NOVAST LABSANDA 202995ABDec 04, 2013
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOLXIROMEDANDA 202772ABNov 14, 2013
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOLXIROMEDANDA 202771ABNov 06, 2013
LARIN FE 1/20NOVAST LABSANDA 091454ABAug 26, 2013
LARIN FE 1.5/30NOVAST LABSANDA 091453ABAug 23, 2013
GILDESS 1.5/30×2PH HEALTHANDA 077075—Jul 24, 2012
GILDESS 1/20×2PH HEALTHANDA 077077—Jul 24, 2012
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOLDR REDDYS LABS SAANDA 076629—Mar 18, 2010
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOLBARR LABS INCANDA 076221ABNov 06, 2009
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATEAMNEAL PHARMSANDA 078267—Sep 01, 2009
TRI-LEGEST 21BARRANDA 076405—Oct 26, 2007
TRI-LEGEST FEBARRANDA 076105ABOct 26, 2007
JUNEL FE 1.5/30BARRANDA 076064ABSep 18, 2003
JUNEL FE 1/20BARRANDA 076081ABSep 18, 2003
MICROGESTIN 1.5/30×2DR REDDYS LABS SAANDA 075548—Jul 30, 2003
MICROGESTIN 1/20×2DR REDDYS LABS SAANDA 075647—Jul 30, 2003
JUNEL 1.5/30BARRANDA 076381ABMay 30, 2003
JUNEL 1/20BARR LABSANDA 076380ABMay 30, 2003

Marketing exclusivity (1)

  • NPNew product exclusivity (3 years)

    Jul 22, 2027

    in 1 yr 1 mo

Listed patents (2)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
7704984Feb 02, 2029in 2 yr 8 mo
U-1
12178824Jun 24, 2041in 15 yr 3 mo
Product

Ethinyl estradiol; norethindrone acetate — frequently asked questions

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

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