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FDA Orange Book · active-ingredient family

Morphine sulfate

Morphine sulfate is approved as 17 brand and 58 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:ARYMO ER · NDA 208603

17

Brand (NDA)

58

Generics (ANDA)

7

Listed patents

0

Exclusivity periods

Brand (NDA) products · capsule, extended release, injectable, injectable, liposomal, solution, tablet, tablet, extended release

ProductApplicantApplicationTEApproved
ARYMO ERRLD×3ZYLANDA 208603—Jan 09, 2017
MORPHABOND ERRLD×4OHEMO LIFENDA 206544—Oct 02, 2015
MORPHINE SULFATERLD×5FRESENIUS KABI USANDA 204223—Oct 30, 2013
MORPHINE SULFATERLD×6HOSPIRA INCNDA 202515APNov 14, 2011
MORPHINE SULFATERLD×3HIKMANDA 022195AAMar 17, 2008
MORPHINE SULFATERLD×2HIKMANDA 022207ABMar 17, 2008
KADIANRLD×12ALLERGANNDA 020616—Apr 20, 2007
MORPHINE SULFATERLD×2ICU MEDICAL INCNDA 019916—Oct 30, 1992
MORPHINE SULFATE (AUTOINJECTOR)RLDMERIDIAN MEDCL TECHNNDA 019999—Jul 12, 1990
MS CONTINRLD×5KNOA PHARMANDA 019516ABSep 12, 1989
DURAMORPH PFRLD×4HIKMANDA 018565APSep 18, 1984
MORPHINE SULFATECHARTWELL MOLECULARNDA 201517—Jun 23, 2011
DEPODUR×3PACIRA PHARMS INCNDA 021671—May 18, 2004
AVINZA×6KING PHARMS LLCNDA 021260—Mar 20, 2002
MORPHINE SULFATE×2SPECGX LLCNDA 020631—Jul 03, 1996
ORAMORPH SR×4XANODYNE PHARMS INCNDA 019977—Nov 23, 1994
MORPHINE SULFATEICU MEDICAL INCNDA 019917—Oct 30, 1992

Generic (ANDA) products (58)

ProductApplicantApplicationTEApproved
MORPHINE SULFATE×2PHARM ASSOCANDA 206573AASep 12, 2023
MORPHINE SULFATE×2SPECGX LLCANDA 215194ABAug 21, 2023
MORPHINE SULFATE×5HIKMAANDA 211452APJan 12, 2023
MORPHINE SULFATE×2INGENUS PHARMS NJANDA 215584—Feb 07, 2022
MORPHINE SULFATE×2DR REDDYS LABS SAANDA 207270—Jan 12, 2022
MORPHINE SULFATE×6ANDA REPOSITORYANDA 203158—Aug 04, 2021
MORPHINE SULFATEINTL MEDICATION SYSANDA 202861—Apr 29, 2021
MORPHINE SULFATE×3WINDER LABS LLCANDA 211454AAFeb 12, 2021
MORPHINE SULFATE×2ALKEM LABS LTDANDA 212451ABDec 03, 2020
MORPHINE SULFATE×2UPSHER SMITH LABSANDA 210610ABJul 22, 2019
MITIGO×2PIRAMAL CRITICALANDA 204393APJul 16, 2018
MORPHINE SULFATE×3ANI PHARMSANDA 205509—Apr 17, 2018
MORPHINE SULFATEHIKMAANDA 208809—Jul 06, 2017
MORPHINE SULFATE×2RHODES PHARMSANDA 206308—Jun 22, 2017
MORPHINE SULFATE×4DR REDDYS LABS SAANDA 205386—Oct 28, 2016
MORPHINE SULFATE×5SUN PHARM INDUSTRIESANDA 205634—Aug 25, 2016
MORPHINE SULFATERHODES PHARMSANDA 206420—Jul 12, 2016
MORPHINE SULFATE×5EPIC PHARMA LLCANDA 091357—Jun 23, 2016
MORPHINE SULFATETRIS PHARMA INCANDA 203519—May 18, 2016
MORPHINE SULFATE×7IMPAX LABS INCANDA 200411—Apr 12, 2016
MORPHINE SULFATE×5NOVEL LABS INCANDA 203602—Dec 16, 2015
MORPHINE SULFATECHARTWELL MOLECULARANDA 202309—Nov 25, 2015
MORPHINE SULFATECHARTWELL MOLECULARANDA 202310—Oct 30, 2015
MORPHINE SULFATE×3HIKMAANDA 205758APMay 21, 2015
MORPHINE SULFATE×2TRIS PHARMA INCANDA 203518—May 12, 2015
MORPHINE SULFATE×5ACTAVIS ELIZABETHANDA 203849ABApr 06, 2015
MORPHINE SULFATE×8TEVA PHARMS USAANDA 202718—Dec 29, 2014
MORPHINE SULFATE×3SANKALP LIFECAREANDA 201011—Feb 05, 2014
MORPHINE SULFATE×7UPSHER SMITH LABSANDA 202104—Jun 03, 2013
MORPHINE SULFATE×6ACTAVIS ELIZABETHANDA 079040—Jan 16, 2013
MORPHINE SULFATEPADAGIS USANDA 201574—Aug 06, 2012
MORPHINE SULFATE×5SUN PHARM INDS LTDANDA 078761ABMay 11, 2012
MORPHINE SULFATE×2VISTAPHARMANDA 201947—Jan 05, 2012
MORPHINE SULFATE×6STRIDES PHARMA INTLANDA 200812—Nov 10, 2011
MORPHINE SULFATE×5RISINGANDA 200824—Oct 18, 2011
MORPHINE SULFATESPECGX LLCANDA 202348AAJul 15, 2011
MORPHINE SULFATE×2NESHER PHARMSANDA 077855—Sep 27, 2007
MORPHINE SULFATE×2NESHER PHARMSANDA 076720—Dec 23, 2005
MORPHINE SULFATENESHER PHARMSANDA 076733—May 19, 2004
MORPHINE SULFATE×3SPECGX LLCANDA 076412ABJul 31, 2003
MORPHINE SULFATE×2SPECGX LLCANDA 076438ABJul 03, 2003
MORPHINE SULFATEWATSON LABSANDA 075656—Jan 30, 2001
MORPHINE SULFATEDAVA PHARMS INCANDA 075407ABJan 28, 2000
MORPHINE SULFATE×5STRIDES PHARMA INTLANDA 075295—Oct 28, 1998
MORPHINE SULFATE×3RHODES PHARMSANDA 074862ABJul 07, 1998
MORPHINE SULFATE×2RHODES PHARMSANDA 074769ABJul 02, 1998
MORPHINE SULFATEHOSPIRAANDA 073509APSep 30, 1992
MORPHINE SULFATEHOSPIRAANDA 073510APSep 30, 1992
MORPHINE SULFATEWATSON LABSANDA 073373—Sep 30, 1991
MORPHINE SULFATEWATSON LABSANDA 073375—Sep 30, 1991
MORPHINE SULFATEWATSON LABSANDA 073374—Sep 30, 1991
MORPHINE SULFATEWATSON LABSANDA 073376—Sep 30, 1991
MORPHINE SULFATEHOSPIRAANDA 071849—May 11, 1988
MORPHINE SULFATEHOSPIRAANDA 071850—May 11, 1988
ASTRAMORPH PFFRESENIUS KABI USAANDA 071050—Oct 07, 1986
ASTRAMORPH PFFRESENIUS KABI USAANDA 071051—Oct 07, 1986
ASTRAMORPH PFFRESENIUS KABI USAANDA 071052—Oct 07, 1986
ASTRAMORPH PFFRESENIUS KABI USAANDA 071053—Oct 07, 1986

Listed patents (7)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
10314788Aug 12, 2028in 2 yr 2 mo
Product
7955619Aug 12, 2028in 2 yr 2 mo
Product
9549899Jul 01, 2033in 7 yr 2 mo
ProductU-1556
9044402Jul 01, 2033in 7 yr 2 mo
ProductU-1556
9192608Mar 12, 2034in 7 yr 10 mo
U-43
9248229Mar 12, 2034in 7 yr 10 mo
Product
9072781Mar 12, 2034in 7 yr 10 mo
Product

Morphine sulfate — frequently asked questions

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

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