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FDA Orange Book · active-ingredient family

Clobetasol propionate

Clobetasol propionate is approved as 13 brand and 87 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:BYQLOVI · NDA 218158

13

Brand (NDA)

87

Generics (ANDA)

8

Listed patents

1

Exclusivity periods

Brand (NDA) products · aerosol, foam, cream, gel, lotion, ointment, shampoo, solution, spray, suspension/drops

ProductApplicantApplicationTEApproved
BYQLOVIRLDHARROW EYENDA 218158—Mar 04, 2024
IMPEKLORLDPHARMOBEDIENTNDA 213691—May 19, 2020
IMPOYZRLDPRIMUS PHARMSNDA 209483—Nov 28, 2017
OLUX ERLDPHARMOBEDIENTNDA 022013—Jan 12, 2007
CLOBEXRLDGALDERMA LABS LPNDA 021835ATOct 27, 2005
CLOBEXRLDGALDERMA LABSNDA 021644ABFeb 05, 2004
CLOBEXRLDGALDERMA LABS LPNDA 021535ABJul 24, 2003
OLUXRLDPHARMOBEDIENTNDA 021142—May 26, 2000
TEMOVATE ERLDFOUGERA PHARMSNDA 020340—Jun 17, 1994
TEMOVATERLDFOUGERA PHARMSNDA 020337—Apr 29, 1994
TEMOVATERLDFOUGERA PHARMSNDA 019966—Feb 22, 1990
TEMOVATERLDFOUGERA PHARMSNDA 019322—Dec 27, 1985
TEMOVATERLDFOUGERA PHARMSNDA 019323—Dec 27, 1985

Generic (ANDA) products (87)

ProductApplicantApplicationTEApproved
CLOBETASOL PROPIONATEXIROMEDANDA 210638AB1Nov 20, 2025
CLOBETASOL PROPIONATEMACLEODS PHARMS LTDANDA 214345—Dec 02, 2024
CLOBETASOL PROPIONATETAROANDA 208563—Mar 14, 2024
CLOBETASOL PROPIONATEMACLEODS PHARMS LTDANDA 215990ABDec 28, 2023
CLOBETASOL PROPIONATEALEMBICANDA 215838AB1Apr 21, 2022
CLOBETASOL PROPIONATEQUAGENANDA 211240ATFeb 17, 2022
CLOBETASOL PROPIONATEAMNEALANDA 214895ABJun 14, 2021
CLOBETASOL PROPIONATECHARTWELL RXANDA 211207—Mar 26, 2021
CLOBETASOL PROPIONATESUN PHARMA CANADAANDA 214867ABMar 25, 2021
CLOBETASOL PROPIONATEPRINSTON INCANDA 213139—Feb 08, 2021
CLOBETASOL PROPIONATEENCUBEANDA 212982AB1Aug 28, 2020
CLOBETASOL PROPIONATEALEMBICANDA 213290ABMay 18, 2020
CLOBETASOL PROPIONATEALEMBICANDA 213291AB1Jan 27, 2020
CLOBETASOL PROPIONATETORRENTANDA 211836AB1Dec 30, 2019
CLOBETASOL PROPIONATEENCUBEANDA 211295ABNov 15, 2019
CLOBETASOL PROPIONATETORRENTANDA 212926—Oct 25, 2019
CLOBETASOL PROPIONATEALEMBICANDA 212881ATOct 21, 2019
CLOBETASOL PROPIONATESAPTALIS PHARMSANDA 211494ATOct 02, 2019
CLOBETASOL PROPIONATEALEMBICANDA 211191ATOct 02, 2019
CLOBETASOL PROPIONATEZYDUS LIFESCIENCESANDA 205249ABSep 24, 2019
CLOBETASOL PROPIONATEGLENMARK PHARMS LTDANDA 211450AB2Sep 09, 2019
CLOBETASOL PROPIONATEALEMBICANDA 211800ABMar 04, 2019
CLOBETASOL PROPIONATEGLENMARK PHARMS LTDANDA 210809AB1Feb 15, 2019
CLOBETASOL PROPIONATEPAI HOLDINGS PHARMANDA 208589—Jan 23, 2019
CLOBETASOL PROPIONATERISINGANDA 211401AB1Jan 11, 2019
CLOBETASOL PROPIONATEAMNEALANDA 211256AB1Dec 26, 2018
CLOBETASOL PROPIONATEEPIC PHARMA LLCANDA 211348—Oct 26, 2018
CLOBETASOL PROPIONATEZYDUS PHARMSANDA 211074AB1Oct 15, 2018
CLOBETASOL PROPIONATETAROANDA 208779AB1Oct 04, 2018
CLOBETASOL PROPIONATEAMNEALANDA 210551—Aug 21, 2018
CLOBETASOL PROPIONATEXIROMEDANDA 210034AB1Jun 15, 2018
CLOBETASOL PROPIONATEGLENMARK SPECLTANDA 209095—May 10, 2018
CLOBETASOL PROPIONATENOVEL LABS INCANDA 208841ABMay 04, 2018
CLOBETASOL PROPIONATEGLENMARK PHARMS LTDANDA 210190—Apr 18, 2018
CLOBETASOL PROPIONATEPAI HOLDINGS PHARMANDA 209974—Apr 17, 2018
CLOBETASOL PROPIONATEXIROMEDANDA 209701ABApr 17, 2018
CLOBETASOL PROPIONATEAPOTEXANDA 210446—Apr 17, 2018
CLOBETASOL PROPIONATEGLENMARK SPECLTANDA 209004—Mar 26, 2018
CLOBETASOL PROPIONATELUPINANDA 208125—Mar 26, 2018
CLOBETASOL PROPIONATESUN PHARMA CANADAANDA 208842ATMar 26, 2018
CLOBETASOL PROPIONATELUPINANDA 210208AB1Jan 30, 2018
CLOBETASOL PROPIONATEZYDUS PHARMSANDA 210199ABOct 27, 2017
CLOBETASOL PROPIONATEHIKMAANDA 209871—Oct 27, 2017
CLOBETASOL PROPIONATEMACLEODS PHARMS LTDANDA 209361ATOct 25, 2017
CLOBETASOL PROPIONATELUPINANDA 209147ABSep 22, 2017
CLOBETASOL PROPIONATE (EMOLLIENT)BEACH PRODSANDA 209411AB2Aug 21, 2017
CLOBETASOL PROPIONATEINGENUS PHARMS LLCANDA 206805—Jul 31, 2017
CLOBETASOL PROPIONATESCIEGEN PHARMSANDA 207218—Apr 28, 2017
CLOBETASOL PROPIONATEGLENMARK SPECLTANDA 208933—Mar 20, 2017
CLOBETASOL PROPIONATEENCUBEANDA 208881—Mar 06, 2017
CLOBETASOL PROPIONATEZYDUS PHARMSANDA 206378ATFeb 16, 2017
CLOBETASOL PROPIONATEBEACH PRODSANDA 208667—Nov 29, 2016
CLOBETASOL PROPIONATENOVEL LABS INCANDA 206075ATNov 23, 2015
CLOBETASOL PROPIONATEPADAGIS ISRAELANDA 201402AB2Aug 14, 2012
CLOBETASOL PROPIONATEPADAGIS ISRAELANDA 090974ABAug 09, 2012
CLOBETASOL PROPIONATESUN PHARMA CANADAANDA 200302ABJul 02, 2012
CLOBETASOL PROPIONATEPADAGIS USANDA 090898—Jun 16, 2011
CLOBETASOL PROPIONATEACTAVIS MID ATLANTICANDA 078854—Jun 07, 2011
CLOBETASOL PROPIONATEACTAVIS MID ATLANTICANDA 078223ABDec 04, 2008
CLOBETASOL PROPIONATEPADAGIS ISRAELANDA 077763AB1Mar 10, 2008
CLOBETASOL PROPIONATEENCUBEANDA 076977ATAug 05, 2005
EMBELINEHIKMAANDA 076141—Apr 12, 2002
CLOBETASOL PROPIONATE (EMOLLIENT)ANI PHARMSANDA 075733—Aug 22, 2001
CLOBETASOL PROPIONATEAUROBINDO PHARMA USAANDA 075338AB1Feb 09, 2001
CLOBETASOL PROPIONATESUN PHARMA CANADAANDA 075363—Dec 29, 2000
CLOBETASOL PROPIONATE (EMOLLIENT)SUN PHARMA CANADAANDA 075633AB2May 17, 2000
CLOBETASOL PROPIONATEFOUGERA PHARMSANDA 075368ABFeb 15, 2000
CLOBETASOL PROPIONATESUN PHARMA CANADAANDA 075279ABMay 28, 1999
CLOBETASOL PROPIONATE (EMOLLIENT)FOUGERA PHARMSANDA 075430AB2May 26, 1999
CLOBETASOL PROPIONATEFOUGERA PHARMSANDA 075391ATFeb 08, 1999
EMBELINE EHIKMAANDA 075325—Dec 24, 1998
CLOBETASOL PROPIONATESUN PHARMA CANADAANDA 075224ATNov 16, 1998
CLOBETASOL PROPIONATEWOCKHARDT BIO AGANDA 075205—Nov 13, 1998
CLOBETASOL PROPIONATEAUROBINDO PHARMA USAANDA 075057ABAug 12, 1998
CLOBETASOL PROPIONATEPADAGIS USANDA 075027ABOct 31, 1997
CORMAXHIKMAANDA 074220—May 16, 1997
CLOBETASOL PROPIONATEFOUGERA PHARMS INCANDA 074392AB1Sep 30, 1996
CLOBETASOL PROPIONATESUN PHARMA CANADAANDA 074248ABJul 12, 1996
CLOBETASOL PROPIONATESUN PHARMA CANADAANDA 074249AB1Jul 08, 1996
CLOBETASOL PROPIONATEFOUGERA PHARMSANDA 074407ABFeb 23, 1996
CLOBETASOL PROPIONATECOSETTEANDA 074331—Dec 15, 1995
EMBELINEHIKMAANDA 074222—Dec 06, 1995
EMBELINEHIKMAANDA 074221—Mar 31, 1995
CLOBETASOL PROPIONATECOSETTEANDA 074139—Aug 03, 1994
CLOBETASOL PROPIONATEACTAVIS MID ATLANTICANDA 074128—Aug 03, 1994
CLOBETASOL PROPIONATETEVA PHARMS USAANDA 074087—Feb 16, 1994
CLOBETASOL PROPIONATECOSETTE PHARMS NCANDA 074089ABFeb 16, 1994

Marketing exclusivity (1)

  • NPNew product exclusivity (3 years)

    Mar 04, 2027

    in 9 mo

Listed patents (8)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
8460641Nov 05, 2028in 2 yr 5 mo
ProductU-1410
10064875Aug 31, 2030in 4 yr 3 mo
ProductU-88
9956231Aug 31, 2030in 4 yr 3 mo
ProductU-88
11179465Aug 31, 2030in 4 yr 3 mo
ProductU-1858
10588914Aug 31, 2030in 4 yr 3 mo
ProductU-2771
9855334Mar 11, 2035in 8 yr 10 mo
Product
11376262May 09, 2036in 10 yr
ProductU-19
10588913May 09, 2036in 10 yr
Product

Clobetasol propionate — frequently asked questions

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

Agent CTA Background

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