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Last Updated: July 18, 2024

PHENYTOIN - Generic Drug Details


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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, 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. Fourteen suppliers are listed for this compound.

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

SponsorPhase
TakedaPhase 1
Sohag UniversityPhase 2/Phase 3
Dr Cipto Mangunkusumo General HospitalPhase 4

See all PHENYTOIN clinical trials

Medical Subject Heading (MeSH) Categories for PHENYTOIN
Anatomical Therapeutic Chemical (ATC) Classes for PHENYTOIN

US Patents and Regulatory Information for PHENYTOIN

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Ani Pharms EXTENDED PHENYTOIN SODIUM phenytoin sodium CAPSULE;ORAL 040435-001 Jun 20, 2003 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Watson Labs PHENYTEX phenytoin sodium CAPSULE;ORAL 088711-001 Dec 21, 1984 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Mylan EXTENDED PHENYTOIN SODIUM phenytoin sodium CAPSULE;ORAL 040298-001 Dec 28, 1998 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Epic Pharma Llc PHENYTOIN phenytoin TABLET, CHEWABLE;ORAL 040884-001 Nov 28, 2014 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Hospira PHENYTOIN SODIUM phenytoin sodium INJECTABLE;INJECTION 089521-001 Mar 17, 1987 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Hospira PHENYTOIN SODIUM phenytoin sodium INJECTABLE;INJECTION 089744-001 Dec 18, 1987 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Marsam Pharms Llc PHENYTOIN SODIUM phenytoin sodium INJECTABLE;INJECTION 089779-001 Nov 27, 1992 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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