Last Updated: November 14, 2026

PHENYTOIN - Generic Drug Details

Name: PHENYTOIN Generic Launch, Drug Patent, and Exclusivity Dataset
Creator: DrugPatentWatch
License: https://www.drugpatentwatch.com/terms.php

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What are the generic drug sources for phenytoin and what is the scope of patent protection?

Phenytoin is the generic ingredient in ten branded drugs marketed by Viatris, Actavis Mid Atlantic, Pai Holdings Pharm, Taro, Vistapharm Llc, Pharmacia, Epic Pharma Llc, Rising, Chartwell Molecular, Amneal Pharms Ny, Ani Pharms, Aurobindo Pharma, Lupin, Mankind Pharma, Mylan, Sun Pharm Inds, Sun Pharm Inds (in), Unichem, Wockhardt, Wockhardt Usa, Watson Labs, 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-three NDAs. Additional information is available in the individual branded drug profile pages.

Twelve suppliers are listed for this compound.

Summary for PHENYTOIN

US Patents:	0
Tradenames:	10
Applicants:	32
NDAs:	43
Finished Product Suppliers / Packagers:	12
Raw Ingredient (Bulk) Api Vendors:	124
Clinical Trials:	151
Patent Applications:	7,015
Drug Prices:	Drug price trends for PHENYTOIN
What excipients (inactive ingredients) are in PHENYTOIN?	PHENYTOIN excipients list
DailyMed Link:	PHENYTOIN at DailyMed

See drug prices for PHENYTOIN

See drug sales revenues for PHENYTOIN

Recent Clinical Trials for PHENYTOIN

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

Sponsor	Phase
West China Hospital	PHASE4
Guangdong 999 Brain Hospital	PHASE4
Nanfang Hospital, Southern Medical University	PHASE4

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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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
Watson Labs	PROMPT PHENYTOIN SODIUM	phenytoin sodium	CAPSULE;ORAL	080905-001	Approved Prior to Jan 1, 1982		DISCN	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Sun Pharm Inds	EXTENDED PHENYTOIN SODIUM	phenytoin sodium	CAPSULE;ORAL	040731-002	Jun 30, 2008		DISCN	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Viatris	DILANTIN-30	phenytoin	SUSPENSION;ORAL	008762-002	Approved Prior to Jan 1, 1982		DISCN	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Ani Pharms	EXTENDED PHENYTOIN SODIUM	phenytoin sodium	CAPSULE;ORAL	089441-001	Dec 18, 1986		DISCN	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Pharmeral	PHENYTOIN SODIUM	phenytoin sodium	CAPSULE;ORAL	085435-001	Approved Prior to Jan 1, 1982		DISCN	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Wockhardt	EXTENDED PHENYTOIN SODIUM	phenytoin sodium	CAPSULE;ORAL	040759-001	Dec 18, 2007		DISCN	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start 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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