Last Updated: June 22, 2026

FOSPHENYTOIN Drug Patent Profile


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Which patents cover Fosphenytoin, and when can generic versions of Fosphenytoin launch?

Fosphenytoin is a drug marketed by Am Regent, Amneal, Apotex Inc, Dr Reddys, Fresenius Kabi Usa, Gland, Hikma, Hikma Farmaceutica, Hospira, Pharmobedient, Sun Pharm, and Wockhardt Bio Ag. and is included in fourteen NDAs.

The generic ingredient in FOSPHENYTOIN is fosphenytoin sodium. There are eight drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the fosphenytoin sodium profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Fosphenytoin

A generic version of FOSPHENYTOIN was approved as fosphenytoin sodium by FRESENIUS KABI USA on August 6th, 2007.

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Summary for FOSPHENYTOIN
US Patents:0
Applicants:12
NDAs:14
Drug Prices: Drug price information for FOSPHENYTOIN
DailyMed Link:FOSPHENYTOIN at DailyMed

US Patents and Regulatory Information for FOSPHENYTOIN

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Am Regent FOSPHENYTOIN SODIUM fosphenytoin sodium INJECTABLE;INJECTION 078277-001 Aug 6, 2007 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Gland FOSPHENYTOIN SODIUM fosphenytoin sodium INJECTABLE;INJECTION 214926-001 Oct 13, 2023 AP RX No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Apotex Inc FOSPHENYTOIN SODIUM fosphenytoin sodium INJECTABLE;INJECTION 078126-001 Aug 6, 2007 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Pharmobedient FOSPHENYTOIN SODIUM fosphenytoin sodium INJECTABLE;INJECTION 078736-001 Jun 8, 2010 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Hikma FOSPHENYTOIN SODIUM fosphenytoin sodium INJECTABLE;INJECTION 077481-001 Aug 6, 2007 AP RX No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Wockhardt Bio Ag FOSPHENYTOIN SODIUM fosphenytoin sodium INJECTABLE;INJECTION 078137-001 Aug 6, 2007 AP RX No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration
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