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Last Updated: September 29, 2020

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PHENYTOIN SODIUM Drug Profile

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Which patents cover Phenytoin Sodium, and what generic alternatives are available?

Phenytoin Sodium is a drug marketed by Aurobindo Pharma Ltd, Pharmeral, Watson Labs, 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 sixteen NDAs.

The generic ingredient in PHENYTOIN SODIUM is phenytoin sodium. There are twenty-one drug master file entries for this compound. Twenty-six suppliers are listed for this compound. Additional details are available on the phenytoin sodium profile page.

US ANDA Litigation and Generic Entry Outlook for Phenytoin Sodium

A generic version of PHENYTOIN SODIUM was approved as phenytoin sodium by WEST-WARD PHARMS INT on December 31st, 1969.

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Drug patent expirations by year for PHENYTOIN SODIUM
Drug Sales Revenue Trends for PHENYTOIN SODIUM

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Recent Clinical Trials for PHENYTOIN SODIUM

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SponsorPhase
Weill Medical College of Cornell UniversityPhase 4
Eisai Inc.Phase 4
Laboratorios Grossman, S.A.Phase 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
Aurobindo Pharma Ltd PHENYTOIN SODIUM phenytoin sodium CAPSULE;ORAL 204309-001 Jun 10, 2015 AB RX No No   Start Trial   Start Trial   Start Trial
Hospira PHENYTOIN SODIUM phenytoin sodium INJECTABLE;INJECTION 089521-001 Mar 17, 1987 DISCN No No   Start Trial   Start Trial   Start Trial
Acella PHENYTOIN SODIUM phenytoin sodium INJECTABLE;INJECTION 040573-001 Sep 13, 2006 AP RX 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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