Fosphenytoin sodium - Generic Drug Details

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

International Patents:	51
US Patents:	5
Tradenames:	3
Applicants:	14
NDAs:	16
Drug Master File Entries:	8
Finished Product Suppliers / Packagers:	7
Raw Ingredient (Bulk) Api Vendors:	61
Clinical Trials:	3
Patent Applications:	1,312
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
Institute of Medical Sciences of the Banaras Hindu University (BHU),India	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

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			Y
Norvium Bioscience	FOSPHENYTOIN SODIUM	fosphenytoin sodium	INJECTABLE;INJECTION	078736-001	Jun 8, 2010		DISCN	No	No
Sun Pharm	FOSPHENYTOIN SODIUM	fosphenytoin sodium	INJECTABLE;INJECTION	078417-001	Mar 18, 2008	AP	RX	No	No
Fresenius Kabi Usa	FOSPHENYTOIN SODIUM	fosphenytoin sodium	INJECTABLE;INJECTION	078052-001	Aug 6, 2007	AP	RX	No	No
Lupin	SESQUIENT	fosphenytoin sodium	SOLUTION;INTRAVENOUS	210864-001	Nov 5, 2020		DISCN	Yes	No			Y

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
Parke Davis	CEREBYX	fosphenytoin sodium	INJECTABLE;INJECTION	020450-001	Aug 5, 1996

International Patents for fosphenytoin sodium

Country	Patent Number	Title	Estimated Expiration
South Korea	20200106100	알킬화된 시클로덱스트린 조성물 및 이의 제조 및 사용 방법 (Alkylated Cyclodextrin Compositions and Processes for Preparing and using the same)
Japan	2018052991	スルホアルキルエーテルシクロデキストリン組成物 (SULFOALKYL ETHER CYCLODEXTRIN COMPOSITIONS)
Eurasian Patent Organization	201000828	СОСТАВЫ НА ОСНОВЕ СУЛЬФОАЛКИЛЬНЫХ ЭФИРОВ ЦИКЛОДЕКСТРИНА
European Patent Office	2268269	COMPOSITIONS DE CYCLODEXTRINE À GROUPEMENTS ÉTHER SULFOALKYLIQUE (SULFOALKYL ETHER CYCLODEXTRIN COMPOSITIONS)
China	110066351	烷基化环糊精组合物及其制备和使用方法 (Alkylated cyclodextrin compositions and processes for preparing and using the same)

Supplementary Protection Certificates for fosphenytoin sodium

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0145340	99C0005	Belgium		PRODUCT NAME: FOSPHENYTOIN DISODIUM; NAT. REGISTRATION NO/DATE: NL 23 613 19980806; FIRST REGISTRATION: GB - PL 000 19/0157 19980204
0473687	3/1999	Austria		PRODUCT NAME: FOSPHENYTOIN-NATRIUM; NAT. REGISTRATION NO/DATE: 1-22664 19980728; FIRST REGISTRATION: GB 00019/0157 19980204
0473687	C980045	Netherlands		PRODUCT NAME: FOSPHENYTOINUM-DI-NATRICUM; NATL REGISTRATION NO/DATE: RVG 22758 19980702; FIRST REGISTRATION: GB PL 00019/0157 19980204
0473687	99C0008	Belgium		PRODUCT NAME: FOSPHENYTOINUM DINATRICUM; REGISTRATION NO/DATE: 19 IS 102 F12 19980901; FIRST REGISTRATION: GB PL00019/1057 19980204
0473687	SPC/GB98/030	United Kingdom		PRODUCT NAME: FOSPHENYTOIN SODIUM (3-HYDROXYMETHYL)-5,5-DIPHENYLHYDANTOIN DISODIUM PHOSPHATE ESTER); REGISTERED: UK 0019/0157 19980204