Assyro AI

FDA Orange Book · active-ingredient family

Risperidone

Risperidone is approved as 8 brand and 48 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:RISVAN · NDA 214835

8

Brand (NDA)

48

Generics (ANDA)

35

Listed patents

12

Exclusivity periods

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

ProductApplicantApplicationTEApproved
RISVANRLD×2LABS FARMS ROVI SANDA 214835—Mar 29, 2024
UZEDYRLD×7TEVANDA 213586—Apr 28, 2023
RYKINDORLD×4SHANDONG LUYENDA 212849—Jan 13, 2023
PERSERIS KITRLD×2INDIVIORNDA 210655—Jul 27, 2018
RISPERDAL CONSTARLD×4JANSSEN PHARMSNDA 021346ABApr 12, 2007
RISPERDALRLD×5JANSSEN PHARMSNDA 021444—Apr 02, 2003
RISPERDALRLD×7JANSSEN PHARMSNDA 020272ABMay 10, 1999
RISPERDALRLDJANSSEN PHARMSNDA 020588AAJun 10, 1996

Generic (ANDA) products (48)

ProductApplicantApplicationTEApproved
RISPERIDONE×4AMNEALANDA 218586ABSep 02, 2025
RISPERIDONE×3NANOMIANDA 211220ABSep 02, 2025
RISPERIDONE×6IPCA LABS LTDANDA 205104ABJun 26, 2024
RISPERIDONE×4TEVA PHARMS USA INCANDA 214068ABDec 05, 2023
RISPERIDONECHARTWELL MOLECULARANDA 202386AAJan 12, 2015
RISPERIDONE×6SUN PHARM INDS INCANDA 078036—Mar 10, 2014
RISPERIDONE×5SUN PHARM INDS LTDANDA 078464—Apr 08, 2013
RISPERIDONE×6NATCO PHARMA USAANDA 091537—Feb 12, 2013
RISPERIDONETRIS PHARMA INCANDA 079059AADec 12, 2012
RISPERIDONE×3CHARTWELL RXANDA 076908—Mar 12, 2012
RISPERIDONE×6PRINSTON INCANDA 077493ABNov 29, 2011
RISPERIDONE×5JUBILANT GENERICSANDA 090839ABNov 04, 2011
RISPERIDONE×6AJANTA PHARMA LTDANDA 201003ABAug 24, 2011
RISPERIDONEAMNEAL PHARMSANDA 091384AAMay 25, 2011
RISPERIDONE×6CHARTWELL MOLECULARANDA 077543ABMay 18, 2011
RISPERIDONE×5ACTAVIS LABS FL INCANDA 076996—Apr 19, 2011
RISPERIDONESUN PHARMA CANADAANDA 090347—Feb 07, 2011
RISPERIDONELANNETT CO INCANDA 079158—Dec 03, 2010
RISPERIDONE×3SUN PHARM INDS LTDANDA 077542ABAug 06, 2010
RISPERIDONE×2SUN PHARM INDS LTDANDA 078474ABAug 06, 2010
RISPERIDONEPRECISION DOSEANDA 076797—Jun 28, 2010
RISPERIDONE×6RATIOPHARMANDA 077784—Jun 08, 2010
RISPERIDONE×5SANDOZANDA 078116ABDec 22, 2009
RISPERIDONE×6SYNTHON PHARMSANDA 078187—Oct 22, 2009
RISPERIDONE×6SANDOZANDA 078528ABOct 16, 2009
RISPERIDONEWOCKHARDT BIO AGANDA 078744—Oct 08, 2009
RISPERIDONEAUROBINDO PHARMA LTDANDA 078452AASep 04, 2009
RISPERIDONEAPOZEAL PHARMSANDA 078909AAJul 29, 2009
RISPERIDONEHIKMAANDA 076904—Jul 29, 2009
RISPERIDONEPHARM ASSOCANDA 077719—Jul 29, 2009
RISPERIDONE×6AMNEALANDA 078071ABJun 17, 2009
RISPERIDONE×6WEST WARD PHARMSANDA 078740—May 29, 2009
RISPERIDONE×2ZYDUS PHARMS USAANDA 078516ABMay 01, 2009
RISPERIDONE×6PH HEALTHANDA 077494—Apr 30, 2009
RISPERIDONE×6JUBILANT CADISTAANDA 078828ABMar 23, 2009
RISPERIDONE×5SENORES PHARMSANDA 077328ABFeb 24, 2009
RISPERIDONEANI PHARMSANDA 076440AAJan 30, 2009
RISPERIDONE×6RENATAANDA 078707ABDec 29, 2008
RISPERIDONE×6WATSON LABSANDA 077860—Dec 05, 2008
RISPERIDONE×6TORRENT PHARMSANDA 079088ABOct 30, 2008
RISPERIDONE×6DR REDDYS LABS LTDANDA 076879ABOct 24, 2008
RISPERIDONE×6HERITAGE PHARMA AVETANDA 077769—Oct 16, 2008
RISPERIDONE×6ZYDUS PHARMS USA INCANDA 078040ABOct 16, 2008
RISPERIDONE×6NOVITIUM PHARMAANDA 078871ABOct 09, 2008
RISPERIDONE×6RISINGANDA 078269ABOct 08, 2008
RISPERIDONE×6APOTEX INCANDA 077953—Sep 15, 2008
RISPERIDONE×6NATCO PHARMA USAANDA 076288—Sep 15, 2008
RISPERIDONE×6HERITAGE PHARMA AVETANDA 076228—Jun 30, 2008

Marketing exclusivity (12)

  • NPNew product exclusivity (3 years)

    Mar 29, 2027

    in 9 mo

  • NPNew product exclusivity (3 years)

    Mar 29, 2027

    in 9 mo

  • CGTFDA marketing exclusivity

    May 12, 2026

    1 mo ago

  • CGTFDA marketing exclusivity

    May 09, 2026

    1 mo ago

  • CGTFDA marketing exclusivity

    May 09, 2026

    1 mo ago

  • NPNew product exclusivity (3 years)

    Apr 28, 2026

    2 mo ago

  • NPNew product exclusivity (3 years)

    Apr 28, 2026

    2 mo ago

  • NPNew product exclusivity (3 years)

    Apr 28, 2026

    2 mo ago

  • NPNew product exclusivity (3 years)

    Apr 28, 2026

    2 mo ago

  • NPNew product exclusivity (3 years)

    Apr 28, 2026

    2 mo ago

  • NPNew product exclusivity (3 years)

    Apr 28, 2026

    2 mo ago

  • NPNew product exclusivity (3 years)

    Apr 28, 2026

    2 mo ago

Listed patents (35)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
10406160Jun 26, 2026in 7 d
ProductU-2608
10058554Sep 26, 2026in 3 mo
U-2363
9597402Sep 26, 2026in 3 mo
Product
11110093Nov 05, 2026in 5 mo
ProductU-3135
8221778Nov 12, 2027in 1 yr 5 mo
ProductU-601
8741327Nov 12, 2027in 1 yr 5 mo
ProductU-543
9186413Feb 13, 2028in 1 yr 8 mo
U-543
10376590Feb 13, 2028in 1 yr 8 mo
U-2608
11712475Feb 13, 2028in 1 yr 8 mo
U-3135
11013809Feb 13, 2028in 1 yr 8 mo
ProductU-3135
10010612Feb 13, 2028in 1 yr 8 mo
Product
9180197Feb 13, 2028in 1 yr 8 mo
Product
11752092May 31, 2031in 5 yr
U-3941
11241377May 31, 2031in 5 yr
U-3939
11173110May 31, 2031in 5 yr
U-3941
11007139May 31, 2031in 5 yr
U-3942
10195138May 31, 2031in 5 yr
U-3943
10182982May 31, 2031in 5 yr
U-3943
11759416May 31, 2031in 5 yr
U-3939
11752094May 31, 2031in 5 yr
U-3942
10085936May 31, 2031in 5 yr
Product
10881605May 31, 2031in 5 yr
Product
10058504May 31, 2031in 5 yr
Product
10463607May 31, 2031in 5 yr
Product
11752093May 31, 2031in 5 yr
Product
10335366May 31, 2031in 5 yr
Product
10406161Apr 10, 2032in 5 yr 11 mo
ProductU-3513
10098882Apr 10, 2032in 5 yr 11 mo
ProductU-3513
9532991Apr 10, 2032in 5 yr 11 mo
ProductU-3513
9446135Apr 10, 2032in 5 yr 11 mo
ProductU-3513
11110094Apr 10, 2032in 5 yr 11 mo
Product
9023897Apr 05, 2033in 6 yr 11 mo
Product
12128132Sep 11, 2040in 14 yr 5 mo
ProductU-601
12383493Sep 11, 2040in 14 yr 5 mo
ProductU-601
12329851Mar 17, 2042in 16 yr
U-4214

Risperidone — frequently asked questions

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

Agent CTA Background

Your Next Submission Could Take 6+ Fewer Weeks and Cost $250K Less.

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