Assyro AI

FDA Orange Book · active-ingredient family

Ibuprofen

Ibuprofen is approved as 22 brand and 186 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:CALDOLOR · NDA 022348

22

Brand (NDA)

186

Generics (ANDA)

10

Listed patents

3

Exclusivity periods

Brand (NDA) products · capsule, solution, suspension, suspension/drops, tablet, tablet, chewable

ProductApplicantApplicationTEApproved
CALDOLORRLD×3CUMBERLAND PHARMSNDA 022348—Jun 11, 2009
MIDOL LIQUID GELSRLDBIONPHARMANDA 021472—Oct 18, 2002
INFANT'S ADVILRLD×2HALEON US HOLDINGSNDA 020812—Jan 12, 2000
CHILDREN'S MOTRINRLD×2KENVUE BRANDSNDA 020601—Nov 15, 1996
CHILDREN'S MOTRINRLDKENVUE BRANDSNDA 020603—Jun 10, 1996
CHILDREN'S MOTRINRLDKENVUE BRANDSNDA 020516—Jun 16, 1995
ADVIL LIQUI-GELSRLD×2HALEON US HOLDINGSNDA 020402—Apr 20, 1995
MOTRIN IBRLD×4KENVUE BRANDSNDA 019012—Dec 17, 1990
MOTRINRLDMCNEIL CONSUMERNDA 019842—Sep 19, 1989
ADVILRLDHALEON US HOLDINGSNDA 018989—May 18, 1984
MOTRINRLD×4MCNEIL CONSUMERNDA 017463—Approved Prior to Jan 1, 1982
CHILDREN'S ELIXSUREMOBERG PHARMA NORTHNDA 021604—Jan 07, 2004
CHILDREN'S ADVIL×2HALEON US HOLDINGSNDA 020944—Dec 18, 1998
JUNIOR STRENGTH ADVILHALEON US HOLDINGSNDA 020267—Dec 13, 1996
CHILDREN'S ADVIL×2HALEON US HOLDINGSNDA 020589—Jun 27, 1996
JUNIOR STRENGTH MOTRINKENVUE BRANDSNDA 020602—Jun 10, 1996
MOTRINMCNEILNDA 020476—May 25, 1995
MOTRIN×2MCNEIL PEDNDA 020135—Nov 16, 1994
MOTRINMCNEIL PEDNDA 020418—Nov 16, 1994
IBUABBOTTNDA 019784—Dec 18, 1989
CHILDREN'S ADVILHALEON US HOLDINGSNDA 019833—Sep 19, 1989
IBU×2BASFNDA 018197—Approved Prior to Jan 1, 1982

Generic (ANDA) products (186)

ProductApplicantApplicationTEApproved
IBUPROFENRUBICON RESEARCHANDA 220239—Mar 05, 2026
IBUPROFENPAI HOLDINGS PHARMANDA 214789—Nov 08, 2024
IBUPROFEN×4SHANDONG XINHUAANDA 202413—Jul 05, 2024
IBUPROFENAUROBINDO PHARMA LTDANDA 213506—Apr 08, 2024
IBUPROFENPATHEON SOFTGELSANDA 217236—Feb 13, 2024
IBUPROFENAUROBINDO PHARMA LTDANDA 215777—Sep 14, 2023
IBUPROFENSUN PHARMA CANADAANDA 217261—Aug 08, 2023
IBUPROFENSTRIDES PHARMAANDA 214071—Jun 09, 2022
IBUPROFENSTRIDES PHARMAANDA 215311ABMay 27, 2022
IBUPROFEN×3YICHANG HUMANWELLANDA 215318ABMar 30, 2022
IBUPROFEN×3ALKEM LABS LTDANDA 214699ABSep 13, 2021
IBUPROFENSTRIDES PHARMAANDA 211666—Feb 22, 2021
IBUPROFENYICHANG HUMANWELLANDA 214003—Oct 19, 2020
IBUPROFEN×3AUROBINDO PHARMA LTDANDA 213794ABMay 08, 2020
IBUPROFENULTRATAB LABS INCANDA 209076—Jan 06, 2020
IBUPROFENANNORA PHARMAANDA 210602—Nov 23, 2018
IBUPROFENGUARDIAN DRUGANDA 210755—Sep 26, 2018
IBUPROFEN×3SUNSHINEANDA 204062—Sep 10, 2018
IBUPROFENGUARDIAN DRUGANDA 210149—Aug 17, 2018
IBUPROFENAUROBINDO PHARMA LTDANDA 207753—Jun 29, 2018
IBUPROFENSTRIDES PHARMAANDA 206989—Jun 29, 2018
IBUPROFENAUROBINDO PHARMA LTDANDA 209179—Apr 17, 2018
IBUPROFENONESOURCE SPECIALTYANDA 204469—Mar 28, 2018
IBUPROFENAUROBINDO PHARMA LTDANDA 209178ABFeb 16, 2018
IBUPROFENASCENT PHARMS INCANDA 206999—Dec 21, 2017
IBUPROFENAUROBINDO PHARMAANDA 208865—Nov 08, 2017
IBUPROFENSUN PHARMA CANADAANDA 209207—Jun 27, 2017
IBUPROFENSUN PHARMA CANADAANDA 209204ABJun 23, 2017
IBUPROFENSTRIDES PHARMAANDA 207052—May 30, 2017
IBUPROFEN×2SHANDONG XINHUAANDA 207095—May 05, 2017
IBUPROFENPAI HOLDINGS PHARMANDA 205647—Nov 03, 2016
IBUPROFENGRANULESANDA 202312—Oct 07, 2016
IBUPROFENSOFGEN PHARMSANDA 203599—Sep 07, 2016
IBUPROFENHUMANWELL PURACAPANDA 206568—Jun 21, 2016
IBUPROFEN×3GRANULESANDA 091625ABSep 15, 2015
IBUPROFENAMNEAL PHARMSANDA 079233—Mar 18, 2014
IBUPROFENAMNEAL PHARMSANDA 202300—Dec 23, 2011
IBUPROFENARISEANDA 200457—Aug 18, 2011
IBUPROFENSTRIDES PHARMAANDA 091355—Apr 04, 2011
IBUPROFENSTRIDES PHARMAANDA 079129—Mar 28, 2011
IBUPROFENMARKSANS PHARMAANDA 091237—Feb 08, 2011
IBUPROFENMARKSANS PHARMAANDA 091239—Feb 01, 2011
IBUPROFEN×3MARKSANS PHARMAANDA 090796ABDec 21, 2010
IBUPROFENGRANULES INDIAANDA 079174—Dec 10, 2010
IBUPROFENTRIS PHARMA INCANDA 079058—Aug 31, 2009
IBUPROFENP AND L DEV LLCANDA 077338—Jul 10, 2009
IBUPROFENMARKSANS PHARMAANDA 079205—Jun 26, 2009
IBUPROFENBIONPHARMAANDA 078682—Mar 24, 2009
IBUPROFEN×3STRIDES PHARMAANDA 078329ABFeb 05, 2009
IBUPROFEN×3NORTHSTAR HLTHCAREANDA 078132—Sep 10, 2007
IBUPROFEN×3AMNEAL PHARMS NYANDA 078558ABJun 18, 2007
IBUPROFEN×3L PERRIGO COANDA 077114—Jul 18, 2005
IBUPROFENPERRIGO R AND DANDA 077349—Jun 21, 2005
IBUPROFENPADAGIS USANDA 076925ABSep 23, 2004
IBUPROFENLNKANDA 076741—Jun 17, 2004
IBUPROFEN×2PERRIGOANDA 076359—Jan 16, 2004
IBUPROFENAVEMA PHARMAANDA 076460—Nov 26, 2003
IBUPROFENPERRIGOANDA 075995—Mar 14, 2002
IBUPROFENDR REDDYSANDA 075661—Dec 12, 2001
IBUPROFENDR REDDYS LABS INCANDA 076117—Nov 20, 2001
IBUPROFEN×3DR REDDYSANDA 075682ABNov 14, 2001
IBUPROFEN×3DR REDDYS LABS INCANDA 076112ABOct 31, 2001
IBUPROFENP AND LANDA 074916—Apr 30, 1999
JUNIOR STRENGTH IBUPROFENL PERRIGO COANDA 075367—Apr 22, 1999
IBUPROFENLNKANDA 075010—Mar 01, 1999
IBUPROFENLNKANDA 075139—Mar 01, 1999
CHILDREN'S IBUPROFENPERRIGOANDA 074937—Dec 22, 1998
IBUPROFENL PERRIGO COANDA 075217—Dec 16, 1998
IBUPROFENCONTRACT PHARMACALANDA 074931—Jul 20, 1998
IBUPROFENCONTRACT PHARMACALANDA 074782—Jul 06, 1998
IBUPROFENACTAVIS MID ATLANTICANDA 074978ABMar 25, 1998
IBUPROFENSANDOZANDA 074525—Dec 15, 1995
IBUPROFENSANDOZANDA 074533—Dec 15, 1995
IBUPROFENMCNEILANDA 073019—Mar 30, 1994
IBUPROFENCONTRACT PHARMACALANDA 073691—Feb 25, 1994
IBUPROFENTEVAANDA 073343—Jun 30, 1992
IBUPROFENTEVAANDA 073344—Jun 30, 1992
IBUPROFENTEVAANDA 073345—Jun 30, 1992
IBUPROFENTEVAANDA 073141—May 29, 1992
IBUPROFENANI PHARMSANDA 072901—Dec 19, 1991
IBUPROFENANI PHARMSANDA 072903—Dec 19, 1991
IBUPROFENPH HEALTHANDA 072249—Jan 10, 1989
IBU-TABALRAANDA 071058—Aug 11, 1988
IBU-TABALRAANDA 071059—Aug 11, 1988
IBU-TABALRAANDA 071965—Aug 11, 1988
IBU-TAB 200ALRAANDA 071057—Aug 11, 1988
IBUPROFENADAPTISANDA 072299—Jul 01, 1988
IBUPROFENAMNEAL PHARMS NYANDA 072199—May 23, 1988
IBUPROFENPHARMOBEDIENTANDA 071870—May 05, 1988
IBUPROFENIVAX SUB TEVA PHARMSANDA 072040—Apr 29, 1988
IBUPROFENWATSON LABSANDA 071905—Mar 08, 1988
IBUPROFENSANDOZANDA 071807—Feb 25, 1988
NUPRINBRISTOL MYERSANDA 072035—Feb 16, 1988
NUPRINBRISTOL MYERSANDA 072036—Feb 16, 1988
IBUPROFENHALSEYANDA 072137—Feb 05, 1988
IBUPROFENPH HEALTHANDA 071639—Feb 02, 1988
IBUPROFENPH HEALTHANDA 071644—Feb 01, 1988
IBUPROFENPUREPAC PHARMANDA 071964—Feb 01, 1988
IBUPROFENRISINGANDA 071938—Jan 14, 1988
IBUPROFENSANDOZANDA 072064—Jan 14, 1988
IBUPROFENSANDOZANDA 072065—Jan 14, 1988
IBUPROFENSANDOZANDA 072169—Dec 11, 1987
CAP-PROFENPERRIGOANDA 072097—Dec 08, 1987
IBUPROFENPERRIGOANDA 072096—Dec 08, 1987
IBUPROFENPERRIGOANDA 072098—Dec 08, 1987
TAB-PROFENPERRIGOANDA 072095—Dec 08, 1987
IBUPROFENPHARMOBEDIENTANDA 071999—Dec 03, 1987
IBUPROFENPH HEALTHANDA 072004—Nov 18, 1987
IBUPROFENIVAX SUB TEVA PHARMSANDA 071154—Oct 27, 1987
IBUPROFENAMNEAL PHARMS NYANDA 071935ABOct 13, 1987
IBUPROFENWATSON LABSANDA 071911—Oct 13, 1987
IBUPROFENMERRO PHARMANDA 070985—Oct 02, 1987
IBUPROFENHALSEYANDA 071027—Sep 29, 1987
IBUPROFENCONTRACT PHARMACALANDA 071735—Sep 10, 1987
IBUPROFENWATSON LABSANDA 071765—Sep 04, 1987
MIDOLBAYERANDA 070626—Sep 02, 1987
MIDOLBAYERANDA 071002—Sep 02, 1987
MIDOLBAYERANDA 070591—Sep 02, 1987
MIDOLBAYERANDA 071001—Sep 02, 1987
IBUPRINPLIVAANDA 071773—Jul 16, 1987
IBUPROFENWATSON LABSANDA 071547—Jul 02, 1987
IBUPROFENPLIVAANDA 071666—Jun 18, 1987
IBUPROFENPLIVAANDA 071667—Jun 18, 1987
IBUPROFENPLIVAANDA 071668—Jun 18, 1987
ACHES-N-PAINLEDERLEANDA 071065—May 28, 1987
IBUPROFENIVAX SUB TEVA PHARMSANDA 071769—May 08, 1987
IBUPROFENSTRIDES PHARMA INTLANDA 071575—May 08, 1987
IBUPROFENPH HEALTHANDA 071229—Apr 01, 1987
IBUPROFENHALSEYANDA 071028—Mar 23, 1987
IBUPROFENHALSEYANDA 071029—Mar 23, 1987
IBUPROFENHALSEYANDA 071030—Mar 23, 1987
IBUPROFENSUN PHARM INDUSTRIESANDA 071448—Feb 18, 1987
IBUPROFENAMNEAL PHARMS NYANDA 071333—Feb 17, 1987
IBUPROFENPUREPAC PHARMANDA 071664—Feb 03, 1987
IBUPROFENANI PHARMSANDA 071144—Jan 20, 1987
IBUPROFENWATSON LABSANDA 071338—Dec 01, 1986
IBUPROHMOHM LABSANDA 071214—Dec 01, 1986
IBUPROFENAMNEAL PHARMS NYANDA 071334ABNov 25, 1986
IBUPROFENAMNEAL PHARMS NYANDA 071335ABNov 25, 1986
IBUPROFENPH HEALTHANDA 071230—Oct 22, 1986
IBUPROFENPH HEALTHANDA 071231—Oct 22, 1986
IBUPROFENPH HEALTHANDA 071232—Oct 22, 1986
IBUPROFEN×2ADAPTISANDA 071265—Oct 15, 1986
IBUPROFEN×3CONTRACT PHARMACALANDA 071268ABOct 15, 1986
IBUPROFENLEINERANDA 071266—Oct 15, 1986
IBUPROFENPUREPAC PHARMANDA 071122—Oct 03, 1986
IBUPROFENSUN PHARM INDUSTRIESANDA 071462—Oct 02, 1986
IBUPROFENSUN PHARM INDUSTRIESANDA 070908—Sep 26, 1986
IBUPROFENSTRIDES PHARMA INTLANDA 070481—Sep 24, 1986
IBUPROFENIVAX SUB TEVA PHARMSANDA 071145—Sep 23, 1986
IBUPROFENIVAX SUB TEVA PHARMSANDA 071146—Sep 23, 1986
IBUPROFENLEDERLEANDA 070629—Sep 19, 1986
IBUPROFENLEDERLEANDA 070630—Sep 19, 1986
IBUPROFENP AND L DEV LLCANDA 070733—Sep 19, 1986
IBUPROFENPUREPAC PHARMANDA 071123—Sep 19, 1986
IBUPROFENPUREPAC PHARMANDA 071124—Sep 19, 1986
IBUPROFENPUREPAC PHARMANDA 071125—Sep 19, 1986
IBUPROFENABBOTTANDA 071264—Jul 25, 1986
IBUPROFENSTRIDES PHARMA INTLANDA 070986—Jul 25, 1986
IBUBASFANDA 070745—Jul 23, 1986
IBUPROFENOHMANDA 071163—Jul 15, 1986
MEDIPRENMCNEILANDA 071215—Jun 26, 1986
IBUPROFENJ AND J CONSUMER INCANDA 070081—Jun 16, 1986
IBUPROFENMCNEILANDA 070476—Jun 16, 1986
IBUPROFEN×3RISINGANDA 070736—Jun 12, 1986
IBUPROFENSUPERPHARMANDA 070709—Apr 25, 1986
IBUPROFENWATSON LABSANDA 070435—Mar 05, 1986
MEDIPRENMCNEILANDA 070475—Feb 06, 1986
IBUPROFENOHM LABSANDA 070818—Dec 26, 1985
IBUPROFENSUN PHARM INDUSTRIESANDA 070493—Dec 24, 1985
IBUPROFENPHARMOBEDIENTANDA 070045—Sep 24, 1985
IBUPROFENPHARMOBEDIENTANDA 070057—Sep 24, 1985
IBUPROFENWATSON LABSANDA 070038—Sep 06, 1985
IBUPROFENWATSON LABSANDA 070041—Sep 06, 1985
IBUPROHMOHM LABSANDA 070469—Aug 29, 1985
IBUPROFENWATSON LABSANDA 070436—Aug 21, 1985
IBUPROFENWATSON LABSANDA 070437—Aug 21, 1985
IBUPROFENPAR PHARMANDA 070328—Aug 06, 1985
IBUPROFENSTRIDES PHARMA INTLANDA 070329—Aug 06, 1985
IBUPROFENSTRIDES PHARMA INTLANDA 070330—Aug 06, 1985
IBUPROFENSUN PHARM INDUSTRIESANDA 070079—Jul 24, 1985
IBUPROFENSUN PHARM INDUSTRIESANDA 070080—Jul 24, 1985
IBUPROFENABBOTTANDA 070556—Jun 14, 1985
IBUBASFANDA 070099—Mar 29, 1985
IBUBASFANDA 070083—Feb 22, 1985
IBUBASFANDA 070088—Feb 08, 1985

Marketing exclusivity (3)

  • NPPNew patient population exclusivity (3 years)

    May 11, 2026

    1 mo ago

  • NPPNew patient population exclusivity (3 years)

    May 11, 2026

    1 mo ago

  • NPPNew patient population exclusivity (3 years)

    May 11, 2026

    1 mo ago

Listed patents (10)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
9114068Sep 30, 2029in 3 yr 4 mo
U-1735
8735452Sep 30, 2029in 3 yr 4 mo
U-981
9649284Sep 30, 2029in 3 yr 4 mo
U-2018
8871810Sep 30, 2029in 3 yr 4 mo
U-981
9295639Sep 30, 2029in 3 yr 4 mo
U-1756
9138404Sep 30, 2029in 3 yr 4 mo
U-1756
9012508Sep 14, 2030in 4 yr 4 mo
U-981
11806400Mar 16, 2032in 5 yr 10 mo
U-3746
9072661Mar 16, 2032in 5 yr 10 mo
U-2264
9072710Mar 16, 2032in 5 yr 10 mo
U-2266

Ibuprofen — 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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