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FDA Orange Book · active-ingredient family

Minocycline hydrochloride

Minocycline hydrochloride is approved as 12 brand and 28 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:EMROSI · NDA 219015

12

Brand (NDA)

28

Generics (ANDA)

28

Listed patents

1

Exclusivity periods

Brand (NDA) products · aerosol, foam, capsule, capsule, extended release, injectable, powder, extended release, suspension, tablet, tablet, extended release

ProductApplicantApplicationTEApproved
EMROSIRLDJOURNEYNDA 219015—Nov 01, 2024
ZILXIRLDJOURNEYNDA 213690—May 28, 2020
AMZEEQRLDJOURNEYNDA 212379—Oct 18, 2019
SOLODYNRLD×8BAUSCHNDA 050808—May 08, 2006
ARESTINRLDORAPHARMANDA 050781—Feb 16, 2001
MINOCINRLD×3BAUSCHNDA 050649ABMay 31, 1990
MINOCYCLINE HYDROCHLORIDERLD×2TRIAX PHARMSNDA 050451—Aug 10, 1982
MINOCINRLDREMPEXNDA 050444—Approved Prior to Jan 1, 1982
MINOLIRA×2EPI HLTHNDA 209269—May 08, 2017
XIMINO×5JOURNEYNDA 201922—Jul 11, 2012
MINOCIN×2TRIAX PHARMSNDA 050315—Approved Prior to Jan 1, 1982
MINOCINBAUSCHNDA 050445—Approved Prior to Jan 1, 1982

Generic (ANDA) products (28)

ProductApplicantApplicationTEApproved
MINOCYCLINE HYDROCHLORIDE×3REGCON HOLDINGSANDA 215466ABMay 27, 2022
MINOCYCLINE HYDROCHLORIDE×3AUROBINDO PHARMA LTDANDA 213662ABMay 01, 2020
MINOCYCLINE HYDROCHLORIDE×3RISINGANDA 203443—Aug 21, 2019
MINOCYCLINE HYDROCHLORIDE×2RISINGANDA 201467—Jul 30, 2019
MINOCYCLINE HYDROCHLORIDE×8ZYDUS PHARMSANDA 203553—Nov 16, 2017
MINOCYCLINE HYDROCHLORIDE×8ALKEM LABS LTDANDA 204453ABSep 28, 2016
MINOCYCLINE HYDROCHLORIDE×3SUN PHARM INDUSTRIESANDA 090217—Jan 29, 2016
MINOCYCLINE HYDROCHLORIDE×7SUN PHARMANDA 204394—Dec 30, 2015
MINOCYCLINE HYDROCHLORIDE×7SUN PHARM INDS LTDANDA 091118—Sep 25, 2014
MINOCYCLINE HYDROCHLORIDE×3SUN PHARM INDS INCANDA 090867—May 13, 2013
MINOCYCLINE HYDROCHLORIDE×8AUROBINDO PHARMA LTDANDA 202261ABNov 19, 2012
MINOCYCLINE HYDROCHLORIDE×4LUPINANDA 091424ABNov 30, 2011
MINOCYCLINE HYDROCHLORIDE×3PHARMOBEDIENTANDA 090911—Jul 20, 2010
MINOCYCLINE HYDROCHLORIDE×3SANDOZANDA 090422ABAug 13, 2009
MINOCYCLINE HYDROCHLORIDE×7BARR LABS INCANDA 065485—Mar 17, 2009
MINOCYCLINE HYDROCHLORIDE×3IMPAX LABS INCANDA 090024—Feb 03, 2009
MINOCYCLINE HYDROCHLORIDE×3AUROBINDO PHARMAANDA 065470ABMar 11, 2008
MINOCYCLINE HYDROCHLORIDE×3CHARTWELL RXANDA 065436ABDec 26, 2007
MINOCYCLINE HYDROCHLORIDE×3TORRENTANDA 065156ABJan 06, 2004
MINOCYCLINE HYDROCHLORIDE×2ZYDUSANDA 063009ABAug 12, 2003
MINOCYCLINE HYDROCHLORIDE×3STRIDES PHARMA INTLANDA 065131ABApr 16, 2003
MINOCYCLINE HYDROCHLORIDE×3TORRENTANDA 065062ABNov 30, 2000
MINOCYCLINE HYDROCHLORIDE×2WATSON LABSANDA 063065ABJun 10, 1999
MINOCYCLINE HYDROCHLORIDE×3IMPAX LABSANDA 065005ABMar 23, 1999
MINOCYCLINE HYDROCHLORIDEZYDUSANDA 063011ABMar 02, 1992
MINOCYCLINE HYDROCHLORIDEWATSON LABS TEVAANDA 063181ABDec 30, 1991
DYNACIN×3ALVOGENANDA 063067—Aug 14, 1990
MINOCINLEDERLEANDA 062139—Approved Prior to Jan 1, 1982

Marketing exclusivity (1)

  • NPNew product exclusivity (3 years)

    Nov 01, 2027

    in 1 yr 5 mo

Listed patents (28)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
7919483Mar 07, 2027in 9 mo
U-124
7541347Apr 02, 2027in 10 mo
U-917
7544373Apr 02, 2027in 10 mo
Product
10137200Oct 01, 2030in 4 yr 4 mo
U-2647
8865139Oct 01, 2030in 4 yr 4 mo
ProductU-2647
9675700Oct 01, 2030in 4 yr 4 mo
ProductU-2647
8992896Oct 01, 2030in 4 yr 4 mo
ProductU-2647
10086080Oct 01, 2030in 4 yr 4 mo
U-2647
10213512Oct 01, 2030in 4 yr 4 mo
ProductU-2647
10517882Oct 01, 2030in 4 yr 4 mo
U-2647
10821187Oct 01, 2030in 4 yr 4 mo
U-2647
8945516Oct 01, 2030in 4 yr 4 mo
Product
10265404Oct 01, 2030in 4 yr 4 mo
Product
10322186Oct 01, 2030in 4 yr 4 mo
U-1631
10946101Oct 01, 2030in 4 yr 4 mo
U-1631
12138311Oct 01, 2030in 4 yr 4 mo
U-1631
9084802May 12, 2031in 5 yr
U-282
9278105May 12, 2031in 5 yr
U-282
12161656May 12, 2031in 5 yr
Product
9192615Nov 17, 2031in 5 yr 6 mo
Product
11944634Oct 16, 2032in 6 yr 5 mo
Product
11103517Apr 07, 2036in 9 yr 11 mo
Product
10398641Sep 08, 2037in 11 yr 5 mo
U-2647
10849847Sep 08, 2037in 11 yr 5 mo
U-2647
11364212Jan 07, 2039in 12 yr 9 mo
U-4043
11191740Jan 07, 2039in 12 yr 9 mo
U-4043
10905664Jan 07, 2039in 12 yr 9 mo
U-4043
12594252Jan 07, 2039in 12 yr 9 mo
U-4043

Minocycline hydrochloride — 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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