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FDA Orange Book · active-ingredient family

Ondansetron

Ondansetron is approved as 2 brand and 11 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:ZUPLENZ · NDA 022524

2

Brand (NDA)

11

Generics (ANDA)

2

Listed patents

0

Exclusivity periods

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

ProductApplicantApplicationTEApproved
ZUPLENZRLD×2AQUESTIVENDA 022524—Jul 02, 2010
ZOFRAN ODTRLD×2SANDOZNDA 020781—Jan 27, 1999

Generic (ANDA) products (11)

ProductApplicantApplicationTEApproved
ONDANSETRON×2IPCA LABS LTDANDA 209389ABOct 30, 2023
ONDANSETRON×2SUN PHARM INDS LTDANDA 078602—Feb 24, 2011
ONDANSETRON×2AUROBINDO PHARMAANDA 090469ABApr 12, 2010
ONDANSETRON×2SANDOZANDA 078050ABAug 13, 2007
ONDANSETRON×2SUN PHARM INDSANDA 077557ABAug 02, 2007
ONDANSETRON×2GLENMARK PHARMS LTDANDA 078152ABJun 27, 2007
ONDANSETRON×2BARRANDA 076693—Jun 25, 2007
ONDANSETRON×2NESHER PHARMSANDA 077717—Jun 25, 2007
ONDANSETRON×2PHARMOBEDIENTANDA 078139—Jun 25, 2007
ONDANSETRON×2TEVAANDA 076810—Jun 25, 2007
ONDANSETRON×4CHARTWELL MOLECULESANDA 077406ABDec 26, 2006

Listed patents (2)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
8580830Nov 23, 2029in 3 yr 6 mo
Product
9095577Jul 13, 2030in 4 yr 2 mo
Product

Ondansetron — frequently asked questions

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

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