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Last Updated: April 19, 2024

Phenytoin - Generic Drug Details

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What are the generic drug 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, Hospira, Marsam Pharms Llc, Smith And Nephew, Solopak, Warner Chilcott, and West-ward Pharms Int, 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. Eleven 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:	11
Raw Ingredient (Bulk) Api Vendors:	155
Clinical Trials:	127
Patent Applications:	6,781
Formulation / Manufacturing:	see details
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

See drug prices for phenytoin

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
Sohag University	Phase 2/Phase 3
Dr Cipto Mangunkusumo General Hospital	Phase 4
Wayne State University	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

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
Taro	PHENYTOIN	phenytoin	TABLET, CHEWABLE;ORAL	200565-001	Apr 17, 2014	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Am Regent	PHENYTOIN SODIUM	phenytoin sodium	INJECTABLE;INJECTION	040781-001	Dec 4, 2007		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Watson Labs	PHENYTEX	phenytoin sodium	CAPSULE;ORAL	088711-001	Dec 21, 1984		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Sun Pharm Inds (in)	EXTENDED PHENYTOIN SODIUM	phenytoin sodium	CAPSULE;ORAL	040621-001	Dec 11, 2006		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
>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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