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Last Updated: July 13, 2024

Phenytoin sodium - Generic Drug Details

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

Phenytoin sodium is the generic ingredient in seven branded drugs marketed by Viatris, Chartwell Molecular, Amneal Pharms Ny, Ani Pharms, Lupin Ltd, Mylan, Sun Pharm Inds, Sun Pharm Inds (in), Taro, 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 thirty-three NDAs. Additional information is available in the individual branded drug profile pages.

There are eighteen drug master file entries for phenytoin sodium. Twenty-four suppliers are listed for this compound.

Summary for phenytoin sodium
Drug Sales Revenue Trends for phenytoin sodium

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Recent Clinical Trials for phenytoin sodium

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

Shaheed Zulfiqar Ali Bhutto Medical UniversityN/A
Hospital Israelita Albert EinsteinPhase 4
Industria FarmacĂȘutica Health MedsPhase 4

See all phenytoin sodium clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for phenytoin sodium

US Patents and Regulatory Information for phenytoin sodium

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Parke Davis DILANTIN phenytoin sodium INJECTABLE;INJECTION 010151-001 Approved Prior to Jan 1, 1982 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
Watson Labs PHENYTOIN SODIUM phenytoin sodium INJECTABLE;INJECTION 085434-001 Approved Prior to Jan 1, 1982 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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