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Last Updated: November 21, 2024

FOSPHENYTOIN SODIUM - Generic Drug Details


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What are the generic sources for fosphenytoin sodium and what is the scope of patent protection?

Fosphenytoin sodium is the generic ingredient in three branded drugs marketed by Parke Davis, Am Regent, Amneal, Apotex Inc, Dr Reddys, Fresenius Kabi Usa, Gland Pharma Ltd, Hikma, Hikma Farmaceutica, Hospira, Norvium Bioscience, Sun Pharm, Wockhardt, and Lupin, and is included in sixteen NDAs. There are five patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Fosphenytoin sodium has fifty-one patent family members in fourteen countries.

There are eight drug master file entries for fosphenytoin sodium. Seven suppliers are listed for this compound.

Summary 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
Hikma FOSPHENYTOIN SODIUM fosphenytoin sodium INJECTABLE;INJECTION 077989-001 Aug 6, 2007 AP RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Hikma FOSPHENYTOIN SODIUM fosphenytoin sodium INJECTABLE;INJECTION 077481-001 Aug 6, 2007 AP RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Dr Reddys FOSPHENYTOIN SODIUM fosphenytoin sodium INJECTABLE;INJECTION 076886-001 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

International Patents for FOSPHENYTOIN SODIUM

Country Patent Number Title Estimated Expiration
Russian Federation 2014136206 КОМПОЗИЦИИ АЛКИЛИРОВАННОГО ЦИКЛОДЕКСТРИНА И СПОСОБЫ ИХ ПОЛУЧЕНИЯ И ПРИМЕНЕНИЯ ⤷  Sign Up
China 105288650 Sulfoalkyl ether cyclodextrin compositions ⤷  Sign Up
Russian Federation 2747757 КОМПОЗИЦИИ АЛКИЛИРОВАННОГО ЦИКЛОДЕКСТРИНА И СПОСОБЫ ИХ ПОЛУЧЕНИЯ И ПРИМЕНЕНИЯ (COMPOSITIONS OF ALKYLATED CYCLODEXTRIN AND METHODS OF THEIR PREPARATION AND APPLICATION) ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for FOSPHENYTOIN SODIUM

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0473687 SPC/GB98/030 United Kingdom ⤷  Sign Up PRODUCT NAME: FOSPHENYTOIN SODIUM (3-HYDROXYMETHYL)-5,5-DIPHENYLHYDANTOIN DISODIUM PHOSPHATE ESTER); REGISTERED: UK 0019/0157 19980204
0473687 99C0008 Belgium ⤷  Sign Up PRODUCT NAME: FOSPHENYTOINUM DINATRICUM; REGISTRATION NO/DATE: 19 IS 102 F12 19980901; FIRST REGISTRATION: GB PL00019/1057 19980204
0473687 C980045 Netherlands ⤷  Sign Up PRODUCT NAME: FOSPHENYTOINUM-DI-NATRICUM; NATL REGISTRATION NO/DATE: RVG 22758 19980702; FIRST REGISTRATION: GB PL 00019/0157 19980204
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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