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Last Updated: August 3, 2020

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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 Parke-davis, Lannett, Amneal Pharms Ny, Ani Pharms Inc, Lupin Ltd, Mylan, Sun Pharm Inds, Sun Pharm Inds (in), Taro, Wockhardt, Wockhardt Usa, Watson Labs, Aurobindo Pharma Ltd, 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-two NDAs. Additional information is available in the individual branded drug profile pages.

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

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

SponsorPhase
Weill Medical College of Cornell UniversityPhase 4
Eisai Inc.Phase 4
Instituto Nacional de Salud Publica, MexicoPhase 3

See all phenytoin sodium clinical trials

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
Watson Labs PHENYTOIN SODIUM phenytoin sodium INJECTABLE;INJECTION 085434-001 Approved Prior to Jan 1, 1982 DISCN No No   Start Trial   Start Trial   Start Trial
Smith And Nephew PHENYTOIN SODIUM phenytoin sodium INJECTABLE;INJECTION 088521-001 Dec 18, 1984 DISCN No No   Start Trial   Start Trial   Start Trial
Mylan PHENYTEK phenytoin sodium CAPSULE;ORAL 040298-002 Dec 6, 2001 AB RX No No   Start Trial   Start Trial   Start Trial
Warner Chilcott PHENYTOIN SODIUM phenytoin sodium INJECTABLE;INJECTION 089900-001 Mar 30, 1990 DISCN No No   Start Trial   Start Trial   Start Trial
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
Hospira PHENYTOIN SODIUM phenytoin sodium INJECTABLE;INJECTION 089744-001 Dec 18, 1987 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
>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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Serving leading biopharmaceutical companies globally:

McKinsey
Express Scripts
Merck
Medtronic
AstraZeneca
Johnson and Johnson

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