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Last Updated: December 7, 2022

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, Atlantide, Dr Reddys, Fresenius Kabi Usa, Hikma, Hikma Farmaceutica, Hospira, Mylan Labs Ltd, Sun Pharm, and Lupin, 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 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.

Recent Clinical Trials for fosphenytoin sodium

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

SponsorPhase
NobelpharmaPhase 3
Banaras Hindu UniversityPhase 2
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
Lupin SESQUIENT fosphenytoin sodium SOLUTION;INTRAVENOUS 210864-002 Nov 5, 2020 DISCN Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Hospira FOSPHENYTOIN SODIUM fosphenytoin sodium INJECTABLE;INJECTION 078158-001 Aug 6, 2007 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Hikma FOSPHENYTOIN SODIUM fosphenytoin sodium INJECTABLE;INJECTION 077481-001 Aug 6, 2007 AP RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Hikma FOSPHENYTOIN SODIUM fosphenytoin sodium INJECTABLE;INJECTION 077989-001 Aug 6, 2007 AP RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Dr Reddys FOSPHENYTOIN SODIUM fosphenytoin sodium INJECTABLE;INJECTION 076886-001 Aug 6, 2007 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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 See Plans and Pricing See Plans and Pricing
Parke Davis CEREBYX fosphenytoin sodium INJECTABLE;INJECTION 020450-001 Aug 5, 1996 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for fosphenytoin sodium

Country Patent Number Title Estimated Expiration
European Patent Office 2748205 COMPOSITIONS DE CYCLODEXTRINE ALKYLÉE ET PROCÉDÉS POUR LEUR PRÉPARATION ET LEUR UTILISATION (ALKYLATED CYCLODEXTRIN COMPOSITIONS AND PROCESSES FOR PREPARING AND USING THE SAME) See Plans and Pricing
Japan 4923144 See Plans and Pricing
Israel 243654 תכשירי סולפואלקיל אתר ציקלודקסטרין (Sulfoalkyl ether cyclodextrin compositions) See Plans and Pricing
Eurasian Patent Organization 031355 КОМПОЗИЦИИ НА ОСНОВЕ СУЛЬФОАЛКИЛЬНЫХ ЭФИРОВ ЦИКЛОДЕКСТРИНА И СПОСОБЫ ИХ ПОЛУЧЕНИЯ (SULFOALKYL ETHER CYCLODEXTRIN COMPOSITIONS AND PROCESSES FOR PREPARATION THEREOF) See Plans and Pricing
China 101959508 Sulfoalkyl ether cyclodextrin compositions See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for fosphenytoin sodium

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0145340 99C0005 Belgium See Plans and Pricing PRODUCT NAME: FOSPHENYTOIN DISODIUM; NAT. REGISTRATION NO/DATE: NL 23 613 19980806; FIRST REGISTRATION: GB - PL 000 19/0157 19980204
0473687 3/1999 Austria See Plans and Pricing PRODUCT NAME: FOSPHENYTOIN-NATRIUM; NAT. REGISTRATION NO/DATE: 1-22664 19980728; FIRST REGISTRATION: GB 00019/0157 19980204
0473687 99C0008 Belgium See Plans and Pricing PRODUCT NAME: FOSPHENYTOINUM DINATRICUM; REGISTRATION NO/DATE: 19 IS 102 F12 19980901; FIRST REGISTRATION: GB PL00019/1057 19980204
0473687 SPC/GB98/030 United Kingdom See Plans and Pricing PRODUCT NAME: FOSPHENYTOIN SODIUM (3-HYDROXYMETHYL)-5,5-DIPHENYLHYDANTOIN DISODIUM PHOSPHATE ESTER); REGISTERED: UK 0019/0157 19980204
0473687 C980045 Netherlands See Plans and Pricing 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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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.