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FDA Orange Book · active-ingredient family

Fosphenytoin sodium

Fosphenytoin sodium is approved as 2 brand and 14 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:SESQUIENT · NDA 210864

2

Brand (NDA)

14

Generics (ANDA)

5

Listed patents

0

Exclusivity periods

Brand (NDA) products · injectable, solution

ProductApplicantApplicationTEApproved
SESQUIENTRLD×2LUPINNDA 210864—Nov 05, 2020
CEREBYXRLDPARKE DAVISNDA 020450APAug 05, 1996

Generic (ANDA) products (14)

ProductApplicantApplicationTEApproved
FOSPHENYTOIN SODIUMGLANDANDA 214926APOct 13, 2023
FOSPHENYTOIN SODIUMPHARMOBEDIENTANDA 078736—Jun 08, 2010
FOSPHENYTOIN SODIUMAM REGENTANDA 090099—May 13, 2010
FOSPHENYTOIN SODIUMHIKMA FARMACEUTICAANDA 078765APDec 02, 2009
FOSPHENYTOIN SODIUMAMNEALANDA 078476—Mar 18, 2008
FOSPHENYTOIN SODIUMSUN PHARMANDA 078417APMar 18, 2008
FOSPHENYTOIN SODIUMAM REGENTANDA 078277—Aug 06, 2007
FOSPHENYTOIN SODIUMAPOTEX INCANDA 078126—Aug 06, 2007
FOSPHENYTOIN SODIUMDR REDDYSANDA 076886—Aug 06, 2007
FOSPHENYTOIN SODIUMFRESENIUS KABI USAANDA 078052APAug 06, 2007
FOSPHENYTOIN SODIUMHIKMAANDA 077481APAug 06, 2007
FOSPHENYTOIN SODIUMHIKMAANDA 077989APAug 06, 2007
FOSPHENYTOIN SODIUMHOSPIRAANDA 078158—Aug 06, 2007
FOSPHENYTOIN SODIUMWOCKHARDT BIO AGANDA 078137APAug 06, 2007

Listed patents (5)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
8410077Mar 13, 2029in 2 yr 9 mo
Product
9200088Mar 13, 2029in 2 yr 9 mo
Product
9750822Mar 13, 2029in 2 yr 9 mo
Product
7635773Mar 13, 2029in 2 yr 9 mo
Product
9493582Feb 27, 2033in 6 yr 10 mo
Product

Fosphenytoin sodium — 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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