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Last Updated: November 24, 2024

PHENYTOIN - Generic Drug Details

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What are the generic sources for phenytoin and what is the scope of freedom to operate?

Phenytoin is the generic ingredient in ten branded drugs marketed by Viatris, Actavis Mid Atlantic, Pai Holdings Pharm, Taro, Vistapharm, Pharmacia, Epic Pharma Llc, Rising, Chartwell Molecular, Amneal Pharms Ny, Ani Pharms, Lupin Ltd, Mylan, Sun Pharm Inds, Sun Pharm Inds (in), Unichem, Wockhardt, Wockhardt Usa, Watson Labs, Aurobindo Pharma, Pharmeral, Parke Davis, Acella, Am Regent, Fresenius Kabi Usa, Hikma, Hospira, Marsam Pharms Llc, Smith And Nephew, Solopak, and Warner Chilcott, and is included in forty-two NDAs. Additional information is available in the individual branded drug profile pages.

There are twenty-one drug master file entries for phenytoin. Fourteen suppliers are listed for this compound.

Summary for PHENYTOIN

US Patents:	0
Tradenames:	10
Applicants:	31
NDAs:	42
Drug Master File Entries:	21
Finished Product Suppliers / Packagers:	14
Raw Ingredient (Bulk) Api Vendors:	155
Clinical Trials:	129
Patent Applications:	5,975
Drug Prices:	Drug price trends for PHENYTOIN
Drug Sales Revenues:	Drug sales revenues for PHENYTOIN
What excipients (inactive ingredients) are in PHENYTOIN?	PHENYTOIN excipients list
DailyMed Link:	PHENYTOIN at DailyMed

Drug Prices for PHENYTOIN

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Drug Sales Revenue Trends for PHENYTOIN

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Recent Clinical Trials for PHENYTOIN

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

Sponsor	Phase
Takeda	Phase 1
Sohag University	Phase 2/Phase 3
Dr Cipto Mangunkusumo General Hospital	Phase 4

See all PHENYTOIN clinical trials

Pharmacology for PHENYTOIN

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

Medical Subject Heading (MeSH) Categories for PHENYTOIN

Anticonvulsants
Cytochrome P-450 CYP1A2 Inducers
Voltage-Gated Sodium Channel Blockers

Anatomical Therapeutic Chemical (ATC) Classes for PHENYTOIN

N03AB	Hydantoin derivatives
N03A	ANTIEPILEPTICS
N03	ANTIEPILEPTICS
N	Nervous system

US Patents and Regulatory Information for PHENYTOIN

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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
Watson Labs	PHENYTOIN SODIUM	phenytoin sodium	CAPSULE;ORAL	085894-001	Approved Prior to Jan 1, 1982		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Viatris	DILANTIN	phenytoin sodium	CAPSULE;ORAL	084349-002	Approved Prior to Jan 1, 1982	AB	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Sun Pharm Inds (in)	EXTENDED PHENYTOIN SODIUM	phenytoin sodium	CAPSULE;ORAL	040621-001	Dec 11, 2006		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Hikma	PHENYTOIN SODIUM	phenytoin sodium	INJECTABLE;INJECTION	084307-001	Approved Prior to Jan 1, 1982	AP	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Viatris	DILANTIN	phenytoin sodium	CAPSULE;ORAL	084349-001	Approved Prior to Jan 1, 1982		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Chartwell Molecular	DIPHENYLAN SODIUM	phenytoin sodium	CAPSULE;ORAL	080857-002	Approved Prior to Jan 1, 1982		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Warner Chilcott	PHENYTOIN SODIUM	phenytoin sodium	INJECTABLE;INJECTION	089900-001	Mar 30, 1990		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

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