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Last Updated: November 4, 2024

FOSPHENYTOIN SODIUM Drug Patent Profile


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

Fosphenytoin Sodium is a drug marketed by Am Regent, Amneal, Apotex Inc, Dr Reddys, Fresenius Kabi Usa, Gland Pharma Ltd, Hikma, Hikma Farmaceutica, Hospira, Norvium Bioscience, Sun Pharm, and Wockhardt. and is included in fourteen NDAs.

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

DrugPatentWatch® Litigation and Generic Entry Outlook for Fosphenytoin Sodium

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

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Drug patent expirations by year for FOSPHENYTOIN SODIUM
Recent Clinical Trials for FOSPHENYTOIN SODIUM

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
NobelpharmaPhase 3
Shaheed Zulfiqar Ali Bhutto Medical UniversityN/A
Institute of Medical Sciences of the Banaras Hindu University (BHU),IndiaPhase 2

See all FOSPHENYTOIN SODIUM clinical trials

US Patents and Regulatory Information for FOSPHENYTOIN SODIUM

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 ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Gland Pharma Ltd FOSPHENYTOIN SODIUM fosphenytoin sodium INJECTABLE;INJECTION 214926-001 Oct 13, 2023 AP RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Apotex Inc FOSPHENYTOIN SODIUM fosphenytoin sodium INJECTABLE;INJECTION 078126-001 Aug 6, 2007 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>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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