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Last Updated: March 5, 2021

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Fosphenytoin sodium - Generic Drug Details

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What are the generic drug 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, Hikma Farmaceutica, Hospira, Mylan Labs Ltd, Sun Pharm, West-ward Pharms Int, Wockhardt, and Sedor Pharms Llc, and is included in fifteen NDAs. There are five patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Fosphenytoin sodium has forty-nine 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
Institute of Medical Sciences of the Banaras Hindu University (BHU),IndiaPhase 2
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
Sedor Pharms Llc SESQUIENT fosphenytoin sodium SOLUTION;INTRAVENOUS 210864-002 Nov 5, 2020 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Sedor Pharms Llc SESQUIENT fosphenytoin sodium SOLUTION;INTRAVENOUS 210864-001 Nov 5, 2020 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Fresenius Kabi Usa FOSPHENYTOIN SODIUM fosphenytoin sodium INJECTABLE;INJECTION 078052-001 Aug 6, 2007 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
Dr Reddys FOSPHENYTOIN SODIUM fosphenytoin sodium INJECTABLE;INJECTION 076886-001 Aug 6, 2007 DISCN No No   Start Trial   Start Trial   Start Trial
Am Regent FOSPHENYTOIN SODIUM fosphenytoin sodium INJECTABLE;INJECTION 090099-001 May 13, 2010 DISCN No No   Start Trial   Start Trial   Start Trial
Am Regent FOSPHENYTOIN SODIUM fosphenytoin sodium INJECTABLE;INJECTION 078277-001 Aug 6, 2007 DISCN 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

Expired US Patents for fosphenytoin sodium

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Parke Davis CEREBYX fosphenytoin sodium INJECTABLE;INJECTION 020450-001 Aug 5, 1996   Start Trial   Start Trial
Parke Davis CEREBYX fosphenytoin sodium INJECTABLE;INJECTION 020450-001 Aug 5, 1996   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for fosphenytoin sodium

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0473687 3/1999 Austria   Start Trial PRODUCT NAME: FOSPHENYTOIN-NATRIUM; NAT. REGISTRATION NO/DATE: 1-22664 19980728; FIRST REGISTRATION: GB 00019/0157 19980204
0473687 99C0008 Belgium   Start Trial PRODUCT NAME: FOSPHENYTOINUM DINATRICUM; REGISTRATION NO/DATE: 19 IS 102 F12 19980901; FIRST REGISTRATION: GB PL00019/1057 19980204
0473687 SPC/GB98/030 United Kingdom   Start Trial PRODUCT NAME: FOSPHENYTOIN SODIUM (3-HYDROXYMETHYL)-5,5-DIPHENYLHYDANTOIN DISODIUM PHOSPHATE ESTER); REGISTERED: UK 0019/0157 19980204
0473687 C980045 Netherlands   Start Trial PRODUCT NAME: FOSPHENYTOINUM-DI-NATRICUM; NATL REGISTRATION NO/DATE: RVG 22758 19980702; FIRST REGISTRATION: GB PL 00019/0157 19980204
0145340 99C0005 Belgium   Start Trial 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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