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Last Updated: August 3, 2020

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EXTENDED PHENYTOIN SODIUM Drug Profile

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

Extended Phenytoin Sodium is a drug marketed by Amneal Pharms Ny, Ani Pharms Inc, Lupin Ltd, Mylan, Sun Pharm Inds, Sun Pharm Inds (in), Taro, Wockhardt, and Wockhardt Usa. and is included in ten NDAs.

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

US ANDA Litigation and Generic Entry Outlook for Extended Phenytoin Sodium

A generic version of EXTENDED 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 EXTENDED PHENYTOIN SODIUM
Drug Prices for EXTENDED PHENYTOIN SODIUM

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Recent Clinical Trials for EXTENDED PHENYTOIN SODIUM

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

See all EXTENDED PHENYTOIN SODIUM clinical trials

US Patents and Regulatory Information for EXTENDED PHENYTOIN SODIUM

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Amneal Pharms Ny EXTENDED PHENYTOIN SODIUM phenytoin sodium CAPSULE;ORAL 040765-001 Nov 12, 2008 AB RX No No   Start Trial   Start Trial   Start Trial
Sun Pharm Inds EXTENDED PHENYTOIN SODIUM phenytoin sodium CAPSULE;ORAL 040731-002 Jun 30, 2008 AB RX No No   Start Trial   Start Trial   Start Trial
Lupin Ltd EXTENDED PHENYTOIN SODIUM phenytoin sodium CAPSULE;ORAL 211633-001 Sep 30, 2019 DISCN No No   Start Trial   Start Trial   Start Trial
Sun Pharm Inds (in) EXTENDED PHENYTOIN SODIUM phenytoin sodium CAPSULE;ORAL 040621-001 Dec 11, 2006 DISCN No No   Start Trial   Start Trial   Start Trial
Ani Pharms Inc EXTENDED PHENYTOIN SODIUM phenytoin sodium CAPSULE;ORAL 040435-001 Jun 20, 2003 DISCN No No   Start Trial   Start Trial   Start Trial
Ani Pharms Inc EXTENDED PHENYTOIN SODIUM phenytoin sodium CAPSULE;ORAL 089441-001 Dec 18, 1986 DISCN No No   Start Trial   Start Trial   Start Trial
Sun Pharm Inds EXTENDED PHENYTOIN SODIUM phenytoin sodium CAPSULE;ORAL 040731-001 Jun 30, 2008 AB 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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