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FDA Orange Book · active-ingredient family

Metformin hydrochloride

Metformin hydrochloride is approved as 6 brand and 104 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:RIOMET ER · NDA 212595

6

Brand (NDA)

104

Generics (ANDA)

1

Listed patents

0

Exclusivity periods

Brand (NDA) products · for suspension, extended release, solution, tablet, tablet, extended release

ProductApplicantApplicationTEApproved
RIOMET ERRLDSUN PHARMNDA 212595—Aug 29, 2019
GLUMETZARLD×2SANTARUS INCNDA 021748—Jun 03, 2005
FORTAMETRLD×2ANDRX LABS LLCNDA 021574—Apr 27, 2004
RIOMETRLDRANBAXYNDA 021591—Sep 11, 2003
GLUCOPHAGE XRRLD×2EMD SERONO INCNDA 021202—Oct 13, 2000
GLUCOPHAGERLD×5EMD SERONO INCNDA 020357—Nov 05, 1998

Generic (ANDA) products (104)

ProductApplicantApplicationTEApproved
METFORMIN HYDROCHLORIDEBIONPHARMAANDA 219151ABApr 14, 2025
METFORMIN HYDROCHLORIDEANNORA PHARMAANDA 215008ABMar 13, 2025
METFORMIN HYDROCHLORIDE×2AUROBINDO PHARMAANDA 209694AB2Oct 18, 2024
METFORMIN HYDROCHLORIDE×2HARMAN FINOCHEMANDA 218673AB1Jul 05, 2024
METFORMIN HYDROCHLORIDEMACLEODS PHARMS LTDANDA 211163—Mar 13, 2024
METFORMIN HYDROCHLORIDE×2LAURUSANDA 217631AB1Oct 05, 2023
METFORMIN HYDROCHLORIDE×2SENORES PHARMSANDA 215629—Jun 20, 2023
METFORMIN HYDROCHLORIDE×2MICRO LABSANDA 212448AB3Jan 10, 2023
METFORMIN HYDROCHLORIDEVISTAPHARM LLCANDA 212677ABAug 19, 2022
METFORMIN HYDROCHLORIDE×2PRINSTON INCANDA 212681AB3Jun 09, 2022
METFORMIN HYDROCHLORIDE×2SCIEGEN PHARMSANDA 214629AB2Feb 22, 2022
METFORMIN HYDROCHLORIDE×2APOTEXANDA 213356—Dec 13, 2021
METFORMIN HYDROCHLORIDE×3HARMAN FINOCHEMANDA 213320ABDec 03, 2021
METFORMIN HYDROCHLORIDE×2TWI PHARMSANDA 213247—Sep 29, 2021
METFORMIN HYDROCHLORIDE×2UNICHEMANDA 213359AB1Aug 11, 2021
METFORMIN HYDROCHLORIDE×2UTOPIC PHARMSANDA 213394—Aug 03, 2021
METFORMIN HYDROCHLORIDE×2SCIEGEN PHARMSANDA 213334AB3Apr 16, 2021
METFORMIN HYDROCHLORIDE×2AJANTA PHARMA LTDANDA 213962AB3Mar 09, 2021
METFORMIN HYDROCHLORIDE×2GRANULESANDA 213344AB3Jan 12, 2021
METFORMIN HYDROCHLORIDE×2AJANTA PHARMA LTDANDA 213651AB2Apr 09, 2020
METFORMIN HYDROCHLORIDESAPTALIS PHARMSANDA 211309ABMar 03, 2020
METFORMIN HYDROCHLORIDE×2GLENMARK PHARMS LTDANDA 212969AB3Nov 25, 2019
METFORMIN HYDROCHLORIDE×2QINGDAO BAHEAL PHARMANDA 209993AB2Dec 27, 2018
METFORMIN HYDROCHLORIDE×2NOVAST LABSANDA 209674AB2Nov 02, 2018
METFORMIN HYDROCHLORIDE×2ALKEM LABS LTDANDA 206145AB1Oct 22, 2018
METFORMIN HYDROCHLORIDE×3SUNSHINEANDA 208999—Oct 12, 2018
METFORMIN HYDROCHLORIDE×2YICHANG HUMANWELLANDA 211052AB1Sep 24, 2018
METFORMIN HYDROCHLORIDE×2PRINSTON INCANDA 208880AB1Sep 10, 2018
METFORMIN HYDROCHLORIDE×3LAURUSANDA 209882ABAug 27, 2018
METFORMIN HYDROCHLORIDEALIGNSCIENCE PHARMAANDA 209303AB1Mar 19, 2018
METFORMIN HYDROCHLORIDE×2GRANULESANDA 209313AB1Mar 16, 2018
METFORMIN HYDROCHLORIDE×2MPP PHARMAANDA 203832AB2Dec 26, 2017
METFORMIN HYDROCHLORIDE×3AARXION ANDA HLDINGANDA 205330—Oct 31, 2017
METFORMIN HYDROCHLORIDE×2PLATINUMANDA 202306AB1Feb 23, 2017
METFORMIN HYDROCHLORIDE×2REGCON HOLDINGSANDA 207427AB1Dec 13, 2016
METFORMIN HYDROCHLORIDE×2MACLEODS PHARMS LTDANDA 206955AB1Dec 07, 2016
METFORMIN HYDROCHLORIDE×2ACTAVIS LABS FL INCANDA 203755AB3Aug 01, 2016
METFORMIN HYDROCHLORIDE×2SUN PHARMANDA 202917—Aug 01, 2016
METFORMIN HYDROCHLORIDE×3CSPC OUYIANDA 205096ABJul 11, 2016
METFORMIN HYDROCHLORIDE×2MARKSANS PHARMAANDA 090295AB1Apr 29, 2016
METFORMIN HYDROCHLORIDE×3ZYDUS HLTHCAREANDA 203686ABAug 28, 2014
METFORMIN HYDROCHLORIDE×5SCIEGEN PHARMSANDA 203769ABSep 11, 2013
METFORMIN HYDROCHLORIDE×2LUPINANDA 091664AB3Jul 19, 2013
METFORMIN HYDROCHLORIDE×2MYLAN PHARMS INCANDA 200690AB2Aug 01, 2012
METFORMIN HYDROCHLORIDE×2AUROBINDO PHARMA LTDANDA 079118AB1Jul 20, 2012
METFORMIN HYDROCHLORIDE×3MARKSANS PHARMAANDA 090888ABMar 12, 2012
METFORMIN HYDROCHLORIDEINVENTIAANDA 201991AB1Jan 18, 2012
METFORMIN HYDROCHLORIDE×3APOTEXANDA 090666—Dec 07, 2011
METFORMIN HYDROCHLORIDE×2LUPIN LTDANDA 090692AB2Jun 29, 2011
METFORMIN HYDROCHLORIDE×3ALKEMANDA 091184ABNov 01, 2010
METFORMIN HYDROCHLORIDE×3GRANULES INDIAANDA 090564ABApr 22, 2010
METFORMIN HYDROCHLORIDETORRENT PHARMS LTDANDA 079226—Feb 18, 2010
METFORMIN HYDROCHLORIDETORRENTANDA 090014—Dec 30, 2009
METFORMIN HYDROCHLORIDE×3INDICUS PHARMAANDA 079148—Nov 25, 2008
METFORMIN HYDROCHLORIDE×3GLENMARK PHARMS LTDANDA 078170—May 23, 2008
METFORMIN HYDROCHLORIDE×2CSPC OUYIANDA 078321AB1Apr 17, 2008
METFORMIN HYDROCHLORIDE×2AMNEAL PHARMS NYANDA 078596—Jan 03, 2008
METFORMIN HYDROCHLORIDE×3IPCA LABS LTDANDA 078422—Aug 06, 2007
METFORMIN HYDROCHLORIDE×3TORRENT PHARMSANDA 077711—Jan 24, 2007
METFORMIN HYDROCHLORIDE×3DR REDDYS LABS INCANDA 077787ABAug 23, 2006
METFORMIN HYDROCHLORIDE×3PROVIDENT PHARMANDA 077853—Jul 28, 2006
METFORMIN HYDROCHLORIDE×2NOSTRUM PHARMS LLCANDA 076756AB1Jul 26, 2006
METFORMIN HYDROCHLORIDE×3AMNEAL PHARMS NYANDA 077880—Jun 05, 2006
METFORMIN HYDROCHLORIDE×2SUN PHARM INDS (IN)ANDA 077336—Feb 09, 2006
METFORMIN HYDROCHLORIDESUN PHARM INDUSTRIESANDA 077124—Dec 21, 2005
METFORMIN HYDROCHLORIDEBARRANDA 076496—Nov 25, 2005
METFORMIN HYDROCHLORIDEIMPAX LABSANDA 076985—Sep 13, 2005
METFORMIN HYDROCHLORIDEPHARMOBEDIENTANDA 076650—Sep 13, 2005
METFORMIN HYDROCHLORIDEPHARMOBEDIENTANDA 077113—Sep 08, 2005
METFORMIN HYDROCHLORIDERANBAXY LABS LTDANDA 077211—Jun 29, 2005
METFORMIN HYDROCHLORIDEZYDUS LIFESCIENCESANDA 077078ABApr 21, 2005
METFORMIN HYDROCHLORIDEZYDUS LIFESCIENCESANDA 077060AB1Apr 20, 2005
METFORMIN HYDROCHLORIDE×3ZYDUS PHARMS USAANDA 077064ABApr 18, 2005
METFORMIN HYDROCHLORIDEACTAVIS ELIZABETHANDA 076878—Apr 13, 2005
METFORMIN HYDROCHLORIDEACTAVIS LABS FL INCANDA 076869ABApr 12, 2005
METFORMIN HYDROCHLORIDETEVAANDA 076864ABApr 12, 2005
METFORMIN HYDROCHLORIDE×3AUROBINDOANDA 077095ABJan 14, 2005
METFORMIN HYDROCHLORIDE×2APOTEXANDA 076706—Dec 14, 2004
METFORMIN HYDROCHLORIDESANDOZANDA 076223—Dec 14, 2004
METFORMIN HYDROCHLORIDESANDOZANDA 076873AB1Dec 14, 2004
METFORMIN HYDROCHLORIDEWATSON LABS INCANDA 076818—Dec 14, 2004
METFORMIN HYDROCHLORIDEBARRANDA 076863—Oct 14, 2004
METFORMIN HYDROCHLORIDEACTAVIS ELIZABETHANDA 076450—Oct 01, 2004
METFORMIN HYDROCHLORIDEIMPAX LABSANDA 076249—Jul 30, 2004
METFORMIN HYDROCHLORIDERANBAXY LABS LTDANDA 076413—Jun 18, 2004
METFORMIN HYDROCHLORIDETEVAANDA 076269AB1Jun 18, 2004
METFORMIN HYDROCHLORIDEACTAVIS LABS FL INCANDA 076172—Jun 16, 2004
METFORMIN HYDROCHLORIDEIVAX SUB TEVA PHARMSANDA 076545—Dec 01, 2003
METFORMIN HYDROCHLORIDE×3TEVAANDA 076328—Dec 16, 2002
METFORMIN HYDROCHLORIDE×3HERITAGE PHARMAANDA 075978—Nov 05, 2002
METFORMIN HYDROCHLORIDE×3APOTEXANDA 075984—Apr 23, 2002
METFORMIN HYDROCHLORIDE×3SUN PHARM INDUSTRIESANDA 076038—Feb 21, 2002
METFORMIN HYDROCHLORIDE×3PHARMOBEDIENTANDA 075969—Jan 29, 2002
METFORMIN HYDROCHLORIDE×3SUN PHARM INDS INCANDA 075967—Jan 29, 2002
METFORMIN HYDROCHLORIDE×3BARRANDA 075971—Jan 25, 2002
METFORMIN HYDROCHLORIDE×3EPIC PHARMA LLCANDA 075965ABJan 25, 2002
METFORMIN HYDROCHLORIDE×3MYLANANDA 075973ABJan 25, 2002
METFORMIN HYDROCHLORIDE×3SANDOZANDA 075985—Jan 25, 2002
METFORMIN HYDROCHLORIDE×3WATSON LABS FLORIDAANDA 075961—Jan 25, 2002
METFORMIN HYDROCHLORIDE×5CHARTWELLANDA 075972ABJan 24, 2002
METFORMIN HYDROCHLORIDE×5IVAX SUB TEVA PHARMSANDA 075975—Jan 24, 2002
METFORMIN HYDROCHLORIDE×3PHARMOBEDIENTANDA 075976—Jan 24, 2002
METFORMIN HYDROCHLORIDE×3SENORES PHARMSANDA 076033ABJan 24, 2002
METFORMIN HYDROCHLORIDE×3WATSON LABSANDA 075979—Jan 24, 2002

Listed patents (1)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
9962336May 01, 2035in 9 yr
Product

Metformin hydrochloride — frequently asked questions

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

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