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FDA Orange Book · active-ingredient family

Doxycycline hyclate

Doxycycline hyclate is approved as 11 brand and 99 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:LYMEPAK · NDA 209844

11

Brand (NDA)

99

Generics (ANDA)

4

Listed patents

0

Exclusivity periods

Brand (NDA) products · capsule, capsule, coated pellets, capsule, delayed release, injectable, system, extended release, tablet, tablet, delayed release

ProductApplicantApplicationTEApproved
LYMEPAKRLDCHARTWELL PHARMANDA 209844—Jun 15, 2018
ACTICLATE CAPRLDCHARTWELL RXNDA 208253—Apr 26, 2016
DORYXRLD×8MAYNE PHARMANDA 050795—Dec 19, 2014
ACTICLATERLD×2CHARTWELL RXNDA 205931ABJul 25, 2014
DORYXRLD×2MAYNE PHARMANDA 050582—Aug 13, 2001
PERIOSTATRLDGALDERMA LABS LPNDA 050783—Feb 02, 2001
PERIOSTATRLDCOLLAGENEXNDA 050744—Sep 30, 1998
ATRIDOXRLDDEN-MATNDA 050751—Sep 03, 1998
VIBRAMYCINRLD×2PFIZERNDA 050007—Approved Prior to Jan 1, 1982
VIBRAMYCINRLD×2PFIZERNDA 050442—Approved Prior to Jan 1, 1982
VIBRA-TABSRLDPFIZERNDA 050533—Approved Prior to Jan 1, 1982

Generic (ANDA) products (99)

ProductApplicantApplicationTEApproved
DOXYCYCLINE HYCLATEAVET LIFESCIENCESANDA 203276—Feb 19, 2026
DOXYCYCLINE HYCLATEMACLEODS PHARMS LTDANDA 211137ABDec 09, 2025
DOXYCYCLINE HYCLATE×2STRIDES PHARMA INTLANDA 062538ABNov 24, 2025
DOXYCYCLINE HYCLATEMACLEODS PHARMS LTDANDA 211418ABNov 19, 2025
DOXYCYCLINE HYCLATESTERISCIENCEANDA 217972APNov 06, 2025
DOXYCYCLINE HYCLATEASPIROANDA 218888APAug 05, 2025
DOXYCYCLINE HYCLATEDR REDDYSANDA 218753APJul 01, 2025
DOXYCYCLINE HYCLATEPRECISION DOSE INCANDA 217078APFeb 21, 2025
DOXYCYCLINE HYCLATEAMNEALANDA 217487—Dec 04, 2024
DOXYCYCLINE HYCLATEKINDOSANDA 218053APOct 28, 2024
DOXYCYCLINE HYCLATEHERITAGEANDA 217854APJul 23, 2024
DOXYCYCLINE HYCLATE×2SLATE RUN PHARMAANDA 217685APJun 21, 2024
DOXYCYCLINE HYCLATEPHARMOBEDIENTANDA 209560—Apr 15, 2024
DOXYCYCLINE HYCLATE×2TORRENTANDA 214356—Apr 15, 2024
DOXYCYCLINE HYCLATELUPINANDA 217794APMar 14, 2024
DOXYCYCLINE HYCLATE×8LUPINANDA 208741—Aug 11, 2023
DOXYCYCLINE HYCLATEGLANDANDA 215583APApr 12, 2023
DOXYCYCLINE HYCLATEPH HEALTHANDA 216690APDec 07, 2022
DOXYCYCLINE HYCLATEAMNEALANDA 216599—Oct 24, 2022
DOXYCYCLINE HYCLATEPRAXGENANDA 212487—Mar 30, 2022
DOXYCYCLINE HYCLATE×4ALEMBICANDA 213075ABJan 03, 2022
DOXYCYCLINE HYCLATE×2NESHER PHARMSANDA 208263—Nov 22, 2021
DOXYCYCLINE HYCLATE×2ALEMBICANDA 210536ABSep 14, 2021
DOXYCYCLINE HYCLATE×2CHARTWELLANDA 062505ABJul 27, 2021
DOXYCYCLINE HYCLATEORYZAANDA 213475—Mar 10, 2021
DOXYCYCLINE HYCLATE×2EPIC PHARMA LLCANDA 214207ABDec 16, 2020
DOXYCYCLINE HYCLATE×2BIONPHARMAANDA 209393—Dec 10, 2020
DOXYCYCLINE HYCLATE×2RISINGANDA 209987—Oct 05, 2020
DOXYCYCLINE HYCLATE×2ALEMBICANDA 211744ABJun 30, 2020
DOXYCYCLINE HYCLATE×2AJANTA PHARMA LTDANDA 211584ABJun 01, 2020
DOXYCYCLINE HYCLATE×2ZHEJIANG YONGTAIANDA 212610—Mar 31, 2020
DOXYCYCLINE HYCLATEACELLAANDA 210664ABMar 16, 2020
DOXYCYCLINE HYCLATEALEMBICANDA 210537ABMar 03, 2020
DOXYCYCLINE HYCLATECHANGZHOU PHARMANDA 211343ABOct 09, 2019
DOXYCYCLINE HYCLATECHANGZHOU PHARMANDA 209402ABOct 07, 2019
DOXYCYCLINE HYCLATE×2APOTEXANDA 209243—Apr 15, 2019
DOXYCYCLINE HYCLATE×3PRINSTON INCANDA 207494ABFeb 19, 2019
DOXYCYCLINE HYCLATE×3ZYDUS PHARMSANDA 206772—Dec 21, 2018
DOXYCYCLINE HYCLATEAVET LIFESCIENCESANDA 209969—Nov 09, 2018
DOXYCYCLINE HYCLATE×2AJANTA PHARMA LTDANDA 211012—Sep 24, 2018
DOXYCYCLINE HYCLATE×2ALEMBICANDA 210527ABJun 13, 2018
DOXYCYCLINE HYCLATE×2ZYDUS LIFESCIENCESANDA 207774ABMay 31, 2018
DOXYCYCLINE HYCLATE×4ACTAVIS ELIZABETHANDA 090134ABMay 22, 2018
DOXYCYCLINE HYCLATEZYDUS LIFESCIENCESANDA 207773ABOct 30, 2017
DOXYCYCLINE HYCLATE×2AMNEAL PHARMS COANDA 209372—Oct 06, 2017
DOXYCYCLINE×2ZYDUS PHARMSANDA 207757APSep 28, 2017
DOXYCYCLINE HYCLATE×2LUPINANDA 208818ABSep 27, 2017
DOXYCYCLINE HYCLATENOVEL LABS INCANDA 207558ABSep 06, 2017
DOXYCYCLINE HYCLATE×2DR REDDYS LABS SAANDA 208765ABJun 14, 2017
DOXYCYCLINE HYCLATEAMNEAL PHARMSANDA 207289ABJun 27, 2016
DOXYCYCLINE HYCLATE×5RISINGANDA 090431—May 23, 2016
DOXYCYCLINE HYCLATE×4HERITAGEANDA 200856ABApr 30, 2013
DOXYCYCLINEMYLAN LABS LTDANDA 091406APAug 21, 2012
DOXYCYCLINE HYCLATEAUROBINDO PHARMA USAANDA 091052—Feb 08, 2012
DOXYCYCLINE HYCLATE×2IMPAX LABS INCANDA 090505—Dec 28, 2010
DOXYCYCLINE HYCLATEPHARMOBEDIENTANDA 065287ABFeb 28, 2006
DOXYCYCLINE HYCLATE×2BAUSCHANDA 065281—Dec 21, 2005
DOXYCYCLINE HYCLATECHARTWELL MOLECULARANDA 065277ABNov 10, 2005
DOXYCYCLINE HYCLATEHIKMA INTL PHARMSANDA 065103—May 13, 2005
DOXYCYCLINE HYCLATEEPIC PHARMA LLCANDA 065182ABMay 13, 2005
DOXYCYCLINE HYCLATEHERITAGE PHARMAANDA 065163—May 13, 2005
DOXYCYCLINE HYCLATESUN PHARM INDUSTRIESANDA 065134ABMay 13, 2005
DOXYCYCLINE HYCLATEHIKMA INTL PHARMSANDA 065095ABJul 02, 2003
DOXYCYCLINE HYCLATEPLIVAANDA 063187—Jun 30, 1992
DOXYCYCLINE HYCLATE×2WEST-WARD PHARMS INTANDA 062992APFeb 16, 1989
DOXYCYCLINE HYCLATE×2INTERPHARMANDA 062763—Sep 02, 1988
DOXYCYCLINE HYCLATEINTERPHARMANDA 062764—Sep 02, 1988
DOXYCYCLINE×2HIKMAANDA 062569—Mar 09, 1988
DOXYCYCLINE HYCLATE×2PVT FORMANDA 062631—Jul 24, 1986
DOXYCYCLINE HYCLATE×2SUN PHARM INDUSTRIESANDA 062676ABJul 10, 1986
DOXYCYCLINE HYCLATESUN PHARM INDUSTRIESANDA 062677ABJul 10, 1986
DOXYCYCLINE HYCLATE×2WARNER CHILCOTTANDA 062594—Dec 05, 1985
DORYXWARNER CHILCOTTANDA 062653—Oct 30, 1985
DOXYCYCLINE HYCLATEWARNER CHILCOTTANDA 062593—Aug 28, 1985
DOXYCYCLINE HYCLATE×2HALSEYANDA 062119—May 24, 1985
DOXY-LEMMONTEVAANDA 062581—Mar 15, 1985
DOXYCYCLINE HYCLATESUPERPHARMANDA 062494—Feb 20, 1985
DOXYCYCLINE HYCLATE×2HIKMA INTL PHARMSANDA 062396ABNov 07, 1984
DOXYCYCLINE HYCLATE×2SUPERPHARMANDA 062469—Oct 31, 1984
DOXYCYCLINE HYCLATEPAR PHARMANDA 062434—Oct 19, 1984
DOXYCYCLINE HYCLATE×2CHARTWELLANDA 062500ABSep 11, 1984
DOXY-LEMMON×2TEVAANDA 062497—Aug 23, 1984
DOXYCYCLINE HYCLATE×2RANBAXYANDA 062479—Dec 23, 1983
DOXYCYCLINE HYCLATEPAR PHARMANDA 062442—Dec 22, 1983
DOXY 100×2FRESENIUS KABI USAANDA 062475APDec 09, 1983
DOXYCYCLINE HYCLATE×2HEATHERANDA 062463—Dec 07, 1983
DOXYCYCLINE×2HIKMAANDA 062450—Oct 27, 1983
DOXYCYCLINE HYCLATE×2EPIC PHARMA LLCANDA 062269ABOct 05, 1983
DOXYCYCLINE HYCLATEHEATHERANDA 062462—May 11, 1983
DOXYCYCLINE HYCLATE×2WATSON LABSANDA 062392—Mar 31, 1983
DOXYCYCLINE HYCLATEMYLANANDA 062432—Feb 15, 1983
DOXYCYCLINE HYCLATEACTAVIS LABS FL INCANDA 062421ABFeb 02, 1983
DOXYCYCLINE HYCLATE×2MUTUAL PHARMANDA 062418—Jan 28, 1983
DOXYCYCLINE HYCLATE×2ACTAVIS LABS FL INCANDA 062031ABOct 13, 1982
DOXYCYCLINE HYCLATEMUTUAL PHARMANDA 062391—Sep 30, 1982
DOXYCYCLINE HYCLATE×2STRIDES PHARMAANDA 062337ABMar 29, 1982
DOXYCYCLINE HYCLATE×2WATSON LABSANDA 061717—Approved Prior to Jan 1, 1982
DOXYCYCLINE HYCLATE×2WATSON LABSANDA 062142—Approved Prior to Jan 1, 1982
DOXYCHEL HYCLATERACHELLEANDA 061953—Approved Prior to Jan 1, 1982

Listed patents (4)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
8715724Feb 03, 2028in 1 yr 8 mo
Product
9295652Oct 23, 2034in 8 yr 6 mo
ProductU-918
9511031Oct 23, 2034in 8 yr 6 mo
Product
9446057Dec 23, 2034in 8 yr 8 mo
ProductU-918

Doxycycline hyclate — frequently asked questions

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

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