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Last Updated: December 7, 2019

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Valproate sodium - Generic Drug Details

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

Valproate sodium is the generic ingredient in two branded drugs marketed by Abbvie, Athenex Inc, Fresenius Kabi Usa, and Hikma Farmaceutica, and is included in four NDAs. Additional information is available in the individual branded drug profile pages.

There are nine drug master file entries for valproate sodium. Two suppliers are listed for this compound.

Recent Clinical Trials for valproate sodium

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

SponsorPhase
Virginia Commonwealth UniversityPhase 1/Phase 2
Puma Biotechnology, Inc.Phase 1/Phase 2
Elizabeth ThielePhase 3

See all valproate sodium clinical trials

US Patents and Regulatory Information for valproate sodium

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Abbvie DEPACON valproate sodium INJECTABLE;INJECTION 020593-001 Dec 30, 1996 DISCN Yes No   Start Trial   Start Trial   Start Trial
Fresenius Kabi Usa VALPROATE SODIUM valproate sodium INJECTABLE;INJECTION 076539-001 Jun 26, 2003 AP RX No No   Start Trial   Start Trial   Start Trial
Athenex Inc VALPROATE SODIUM valproate sodium INJECTABLE;INJECTION 076295-001 Nov 14, 2002 AP RX No No   Start Trial   Start Trial   Start Trial
Hikma Farmaceutica VALPROATE SODIUM valproate sodium INJECTABLE;INJECTION 078523-001 Feb 17, 2010 AP RX No Yes   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:

Medtronic
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Colorcon
Moodys

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