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Last Updated: November 2, 2024

Fosphenytoin sodium - Generic Drug Details


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What are the generic drug sources for fosphenytoin sodium and what is the scope of freedom to operate?

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
Banaras Hindu UniversityPhase 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
Sun Pharm FOSPHENYTOIN SODIUM fosphenytoin sodium INJECTABLE;INJECTION 078417-001 Mar 18, 2008 AP RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Lupin SESQUIENT fosphenytoin sodium SOLUTION;INTRAVENOUS 210864-001 Nov 5, 2020 DISCN Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Lupin SESQUIENT fosphenytoin sodium SOLUTION;INTRAVENOUS 210864-002 Nov 5, 2020 DISCN Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  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
South Korea 20150004797 ALKYLATED CYCLODEXTRIN COMPOSITIONS AND PROCESSES FOR PREPARING AND USING THE SAME ⤷  Sign Up
Russian Federation 2014136206 КОМПОЗИЦИИ АЛКИЛИРОВАННОГО ЦИКЛОДЕКСТРИНА И СПОСОБЫ ИХ ПОЛУЧЕНИЯ И ПРИМЕНЕНИЯ ⤷  Sign Up
European Patent Office 2268269 COMPOSITIONS DE CYCLODEXTRINE À GROUPEMENTS ÉTHER SULFOALKYLIQUE (SULFOALKYL ETHER CYCLODEXTRIN COMPOSITIONS) ⤷  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
0145340 99C0005 Belgium ⤷  Sign Up PRODUCT NAME: FOSPHENYTOIN DISODIUM; NAT. REGISTRATION NO/DATE: NL 23 613 19980806; FIRST REGISTRATION: GB - PL 000 19/0157 19980204
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.