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FDA Orange Book · active-ingredient family

Rizatriptan benzoate

Rizatriptan benzoate is approved as 3 brand and 25 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:RIZAFILM · NDA 205394

3

Brand (NDA)

25

Generics (ANDA)

1

Listed patents

0

Exclusivity periods

Brand (NDA) products · film, tablet, tablet, orally disintegrating

ProductApplicantApplicationTEApproved
RIZAFILMRLD×2GENSCONDA 205394Feb 26, 2026
MAXALT-MLTRLD×2ORGANONNDA 020865Jun 29, 1998
MAXALTRLD×2ORGANON LLCNDA 020864Jun 29, 1998

Generic (ANDA) products (25)

ProductApplicantApplicationTEApproved
RIZATRIPTAN BENZOATE×2UNICHEMANDA 207835Mar 07, 2017
RIZATRIPTAN BENZOATE×2UNICHEMANDA 207836Mar 07, 2017
RIZATRIPTAN BENZOATE×2PANACEAANDA 204722ABJan 11, 2017
RIZATRIPTAN BENZOATE×2ALKEM LABS LTDANDA 203269ABFeb 18, 2016
RIZATRIPTAN BENZOATE×2JUBILANT GENERICSANDA 203334Oct 16, 2015
RIZATRIPTAN BENZOATE×2JUBILANT GENERICSANDA 203252Dec 31, 2014
RIZATRIPTAN BENZOATE×2MACLEODS PHARMS LTDANDA 203146ABSep 19, 2014
RIZATRIPTAN BENZOATE×2MACLEODS PHARMS LTDANDA 203147ABFeb 11, 2014
RIZATRIPTAN BENZOATE×2AVET LIFESCIENCESANDA 204090Nov 26, 2013
RIZATRIPTAN BENZOATE×2APOTEX INCANDA 202477Jul 01, 2013
RIZATRIPTAN BENZOATE×2AUROBINDO PHARMA LTDANDA 203062ABJul 01, 2013
RIZATRIPTAN BENZOATE×2CHARTWELL RXANDA 078739Jul 01, 2013
RIZATRIPTAN BENZOATE×2GLENMARK PHARMS LTDANDA 201914Jul 01, 2013
RIZATRIPTAN BENZOATE×2NATCO PHARMA LTDANDA 203478Jul 01, 2013
RIZATRIPTAN BENZOATE×2INVAGEN PHARMSANDA 204339Jul 01, 2013
RIZATRIPTAN BENZOATE×2CHARTWELL RXANDA 077526ABMar 26, 2013
RIZATRIPTAN BENZOATE×2PHARMOBEDIENTANDA 078173Dec 31, 2012
RIZATRIPTAN BENZOATE×2APOTEX INCANDA 202244Dec 31, 2012
RIZATRIPTAN BENZOATE×2AUROBINDO PHARMA LTDANDA 202490ABDec 31, 2012
RIZATRIPTAN BENZOATE×2CREEKWOOD PHARMSANDA 202047ABDec 31, 2012
RIZATRIPTAN BENZOATE×2GLENMARK PHARMS LTDANDA 201967Dec 31, 2012
RIZATRIPTAN BENZOATE×2NATCO PHARMA LTDANDA 200482Dec 31, 2012
RIZATRIPTAN BENZOATE×2PHARMOBEDIENTANDA 201993Dec 31, 2012
RIZATRIPTAN BENZOATE×2SANDOZANDA 079230Dec 31, 2012
RIZATRIPTAN BENZOATE×2TEVA PHARMSANDA 077263ABDec 31, 2012

Listed patents (1)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
9301948Jul 30, 2034in 8 yr 3 mo
SubstanceProduct

Rizatriptan benzoate — 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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