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, Mylan Labs Ltd, 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. Eight suppliers are listed for this compound.

Summary for FOSPHENYTOIN SODIUM

International Patents:	51
US Patents:	5
Tradenames:	3
Applicants:	14
NDAs:	16
Drug Master File Entries:	8
Finished Product Suppliers / Packagers:	8
Raw Ingredient (Bulk) Api Vendors:	61
Clinical Trials:	3
Patent Applications:	1,312
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for FOSPHENYTOIN SODIUM
What excipients (inactive ingredients) are in FOSPHENYTOIN SODIUM?	FOSPHENYTOIN SODIUM excipients list
DailyMed Link:	FOSPHENYTOIN SODIUM at DailyMed

Recent Clinical Trials for FOSPHENYTOIN SODIUM

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

Sponsor	Phase
Nobelpharma	Phase 3
Shaheed Zulfiqar Ali Bhutto Medical University	N/A
Banaras Hindu University	Phase 2

See all FOSPHENYTOIN SODIUM clinical trials

Pharmacology for FOSPHENYTOIN SODIUM

Drug Class	Anti-epileptic Agent
Mechanism of Action	Cytochrome P450 1A2 Inducers Cytochrome P450 2B6 Inducers Cytochrome P450 2C19 Inducers Cytochrome P450 2C8 Inducers Cytochrome P450 2C9 Inducers Cytochrome P450 2D6 Inducers Cytochrome P450 3A Inducers
Physiological Effect	Decreased Central Nervous System Disorganized Electrical Activity

Anatomical Therapeutic Chemical (ATC) Classes for FOSPHENYTOIN SODIUM

N03AB	Hydantoin derivatives
N03A	ANTIEPILEPTICS
N03	ANTIEPILEPTICS
N	Nervous system

N03AB	Hydantoin derivatives
N03A	ANTIEPILEPTICS
N03	ANTIEPILEPTICS
N	Nervous system

US Patents and Regulatory Information for FOSPHENYTOIN SODIUM

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Glossary

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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
Hikma Farmaceutica	FOSPHENYTOIN SODIUM	fosphenytoin sodium	INJECTABLE;INJECTION	078765-001	Dec 2, 2009	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
Fresenius Kabi Usa	FOSPHENYTOIN SODIUM	fosphenytoin sodium	INJECTABLE;INJECTION	078052-001	Aug 6, 2007	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

Expired US Patents for FOSPHENYTOIN SODIUM

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

International Patents for FOSPHENYTOIN SODIUM

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Country	Patent Number	Title	Estimated Expiration
Japan	2018048350	アルキル化シクロデキストリン組成物ならびにその調製方法および使用方法 (ALKYLATED CYCLODEXTRIN COMPOSITION AS WELL AS PREPARATION METHOD AND USE METHOD THEREOF)	⤷ Sign Up
New Zealand	589290	SULFOALKYL ETHER CYCLODEXTRIN COMPOSITIONS	⤷ Sign Up
Mexico	2014010323	COMPOSICIONES DE CICLODEXTRINA ALQUILADA Y PROCESOS PARA PREPARAR Y UTILIZAR LAS MISMAS. (ALKYLATED CYCLODEXTRIN COMPOSITIONS AND PROCESSES FOR PREPARING AND USING THE SAME.)	⤷ Sign Up
Mexico	352459	COMPOSICIONES DE ETER-SULFOALQUILICO-CICLODEXTRINA. (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

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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	3/1999	Austria	⤷ Sign Up	PRODUCT NAME: FOSPHENYTOIN-NATRIUM; NAT. REGISTRATION NO/DATE: 1-22664 19980728; FIRST REGISTRATION: GB 00019/0157 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
0473687	C980045	Netherlands	⤷ Sign Up	PRODUCT NAME: FOSPHENYTOINUM-DI-NATRICUM; NATL REGISTRATION NO/DATE: RVG 22758 19980702; FIRST REGISTRATION: GB PL 00019/0157 19980204
0473687	99C0008	Belgium	⤷ Sign Up	PRODUCT NAME: FOSPHENYTOINUM DINATRICUM; REGISTRATION NO/DATE: 19 IS 102 F12 19980901; FIRST REGISTRATION: GB PL00019/1057 19980204
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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