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FDA Orange Book · active-ingredient family

Acetaminophen; oxycodone hydrochloride

Acetaminophen; oxycodone hydrochloride is approved as 1 brand and 64 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:XARTEMIS XR · NDA 204031

1

Brand (NDA)

64

Generics (ANDA)

12

Listed patents

0

Exclusivity periods

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

ProductApplicantApplicationTEApproved
XARTEMIS XRRLDMALLINCKRODT INCNDA 204031—Mar 11, 2014

Generic (ANDA) products (64)

ProductApplicantApplicationTEApproved
OXYCODONE AND ACETAMINOPHENSANKALP LIFECAREANDA 201448—Aug 26, 2021
OXYCODONE AND ACETAMINOPHEN×4GRANULESANDA 211708AAOct 31, 2019
OXYCODONE AND ACETAMINOPHEN×3CHARTWELLANDA 207834—Aug 15, 2019
OXYCODONE AND ACETAMINOPHENABHAI LLCANDA 211499—Dec 31, 2018
OXYCODONE AND ACETAMINOPHENMIKARTANDA 202142—Nov 27, 2018
OXYCODONE AND ACETAMINOPHEN×3ELITE LABS INCANDA 209385AAJul 02, 2018
OXYCODONE AND ACETAMINOPHEN×3EPIC PHARMA LLCANDA 203864AAJul 02, 2018
OXYCODONE AND ACETAMINOPHEN×3WES PHARMA INCANDA 207510AAMar 21, 2018
OXYCODONE AND ACETAMINOPHEN×4ABHAI LLCANDA 210644AAFeb 09, 2018
OXYCODONE AND ACETAMINOPHEN×4NESHER PHARMSANDA 210079—Dec 28, 2017
OXYCODONE AND ACETAMINOPHEN×2LANNETT CO INCANDA 207333AASep 25, 2017
OXYCODONE AND ACETAMINOPHEN×4ASCENT PHARMS INCANDA 207419AAMar 22, 2017
OXYCODONE AND ACETAMINOPHEN×4NOVEL LABS INCANDA 204407AAFeb 24, 2017
OXYCODONE AND ACETAMINOPHENSANALUZANDA 207574—Dec 13, 2016
OXYCODONE AND ACETAMINOPHEN×3ALVOGENANDA 202677AAMar 08, 2016
OXYCODONE HYDROCHLORIDE AND ACETAMINOPHENPH HEALTHANDA 203573—Dec 18, 2014
OXYCODONE AND ACETAMINOPHEN×3RHODES PHARMSANDA 201278AAAug 28, 2014
OXYCODONE AND ACETAMINOPHEN×2AMNEAL PHARMS NYANDA 040778AAJun 27, 2014
OXYCODONE AND ACETAMINOPHEN×4SUN PHARM INDS INCANDA 090535—Dec 26, 2013
OXYCODONE AND ACETAMINOPHEN×4AUROLIFE PHARMA LLCANDA 201972AAJul 15, 2013
OXYCODONE AND ACETAMINOPHENPH HEALTHANDA 090733—Jul 11, 2013
OXYCODONE AND ACETAMINOPHEN×2PH HEALTHANDA 090734—Jul 11, 2013
OXYCODONE AND ACETAMINOPHEN×4ACTAVIS ELIZABETHANDA 201447AAApr 12, 2013
OXYCODONE AND ACETAMINOPHEN×2ACTAVIS ELIZABETHANDA 040800—Apr 03, 2012
OXYCODONE AND ACETAMINOPHEN×6DR REDDYS LABS SAANDA 090177—Oct 20, 2008
OXYCODONE AND ACETAMINOPHENAMNEAL PHARMSANDA 040777AANov 27, 2007
OXYCODONE AND ACETAMINOPHEN×2AMNEAL PHARMS NYANDA 040789—Nov 27, 2007
OXYCODONE AND ACETAMINOPHENSPECGX LLCANDA 040680—Sep 29, 2006
OXYCODONE AND ACETAMINOPHENMIKARTANDA 040679—May 16, 2006
OXYCODONE AND ACETAMINOPHENMIKARTANDA 040687—Apr 27, 2006
OXYCODONE AND ACETAMINOPHENMIKARTANDA 040698—Apr 27, 2006
OXYCODONE AND ACETAMINOPHENMIKARTANDA 040692—Apr 27, 2006
OXYCODONE AND ACETAMINOPHENMIKARTANDA 040676—Apr 19, 2006
OXYCODONE AND ACETAMINOPHEN×4MIKARTANDA 040608—Dec 30, 2005
OXYCODONE AND ACETAMINOPHEN×2MALLINCKRODTANDA 040550—Jun 30, 2004
OXYCODONE AND ACETAMINOPHEN×2SPECGX LLCANDA 040545AAJun 30, 2004
OXYCODONE AND ACETAMINOPHEN×2WATSON LABSANDA 040535—Sep 05, 2003
OXYCODONE AND ACETAMINOPHEN×2WATSON LABSANDA 040371—Dec 29, 2000
OXYCODONE AND ACETAMINOPHENBARRANDA 040304—Oct 02, 2000
OXYCODONE AND ACETAMINOPHENVINTAGE PHARMS LLCANDA 040303—Dec 30, 1999
PERCOCET×2VINTAGE PHARMS LLCANDA 040341—Jul 26, 1999
PERCOCET×4OZANTRIANDA 040330AAJun 25, 1999
OXYCODONE AND ACETAMINOPHENDURAMED PHARMS BARRANDA 040289—Mar 16, 1999
OXYCODONE AND ACETAMINOPHENACTAVIS ELIZABETHANDA 040203—Mar 15, 1999
OXYCODONE AND ACETAMINOPHENACTAVIS ELIZABETHANDA 040199—Dec 30, 1998
OXYCODONE AND ACETAMINOPHENMALLINCKRODTANDA 040257—Aug 04, 1998
OXYCODONE AND ACETAMINOPHENDURAMED PHARMS BARRANDA 040272—Jun 30, 1998
OXYCODONE AND ACETAMINOPHENMUTUAL PHARMANDA 040219—Jan 22, 1998
OXYCODONE AND ACETAMINOPHENWATSON LABSANDA 040234—Oct 30, 1997
OXYCODONE AND ACETAMINOPHENWATSON LABSANDA 040171—Oct 30, 1997
OXYCODONE AND ACETAMINOPHENVINTAGE PHARMSANDA 040106—Jul 30, 1996
OXYCODONE AND ACETAMINOPHENPH HEALTHANDA 040105—Jul 30, 1996
ROXILOXROXANEANDA 040061—Jul 03, 1995
OXYCODONE AND ACETAMINOPHENHALSEYANDA 089994—May 04, 1989
ROXICET 5/500ROXANEANDA 089775—Jan 12, 1989
ROXICETHIKMAANDA 089351—Dec 03, 1986
TYLOXJANSSEN PHARMSANDA 088790—Dec 12, 1984
TYLOX-325ORTHO MCNEIL PHARMANDA 088246—Nov 08, 1984
OXYCETSPECGX LLCANDA 087463AADec 07, 1983
OXYCODONE 2.5/APAP 500BRISTOL MYERS SQUIBBANDA 085910—Approved Prior to Jan 1, 1982
OXYCODONE 5/APAP 500BRISTOL MYERS SQUIBBANDA 085911—Approved Prior to Jan 1, 1982
OXYCODONE AND ACETAMINOPHENBARRANDA 087406—Approved Prior to Jan 1, 1982
PERCOCETRLDOZANTRIANDA 085106—Approved Prior to Jan 1, 1982
ROXICETRLDHIKMAANDA 087003—Approved Prior to Jan 1, 1982

Listed patents (12)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
7976870Jun 01, 2027in 1 yr
U-1498
8668929Mar 11, 2029in 2 yr 9 mo
U-1499
8372432Mar 11, 2029in 2 yr 9 mo
ProductU-1499
8394408Mar 11, 2029in 2 yr 9 mo
Product
8377453Nov 19, 2029in 3 yr 6 mo
ProductU-1499
8597681Dec 21, 2030in 4 yr 7 mo
Product
8980319Dec 21, 2030in 4 yr 7 mo
Product
8741885May 16, 2032in 6 yr
ProductU-1499
9468636May 16, 2032in 6 yr
U-1499
9050335May 16, 2032in 6 yr
Product
8992975May 16, 2032in 6 yr
Product
8658631May 16, 2032in 6 yr
Product

Acetaminophen; oxycodone hydrochloride — frequently asked questions

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

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