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Last Updated: February 26, 2021

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Divalproex sodium - Generic Drug Details

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What are the generic sources for divalproex sodium and what is the scope of freedom to operate?

Divalproex sodium is the generic ingredient in four branded drugs marketed by Abbvie, Ajanta Pharma Ltd, Dr Reddys Labs Ltd, Mylan, Teva Pharms Usa, Zydus Pharms Usa Inc, Abbott, Actavis Labs Fl Inc, Anchen Pharms, Apotex, Aurobindo Pharma Ltd, Celltrion, Invatech, Lupin, Orchid Hlthcare, Prinston Inc, Sun Pharm Inds, Teva, Unichem Labs Ltd, Upsher Smith Labs, Amneal Pharms, Cosette, Impax Labs, Lupin Ltd, Reddys, and Wockhardt, and is included in thirty-seven NDAs. Additional information is available in the individual branded drug profile pages.

There are eighteen drug master file entries for divalproex sodium. Forty suppliers are listed for this compound. There is one tentative approval for this compound.

Drug Prices for divalproex sodium

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Drug Sales Revenue Trends for divalproex sodium

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Recent Clinical Trials for divalproex sodium

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SponsorPhase
Universidad Autonoma de San Luis PotosíPhase 3
Puma Biotechnology, Inc.Phase 1/Phase 2
Virginia Commonwealth UniversityPhase 1/Phase 2

See all divalproex sodium clinical trials

Generic filers with tentative approvals for DIVALPROEX SODIUM
Applicant Application No. Strength Dosage Form
  Start Trial  Start TrialEQ 500MG VALPROIC ACIDTABLET, DELAYED RELEASE;ORAL
  Start Trial  Start TrialEQ 250MG VALPROIC ACIDTABLET, DELAYED RELEASE;ORAL
  Start Trial  Start TrialEQ 125MG VALPROIC ACIDTABLET, DELAYED RELEASE;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Paragraph IV (Patent) Challenges for DIVALPROEX SODIUM
Tradename Dosage Ingredient NDA Submissiondate
DEPAKOTE ER TABLET, EXTENDED RELEASE;ORAL divalproex sodium 021168 2005-02-08
DEPAKOTE ER TABLET, EXTENDED RELEASE;ORAL divalproex sodium 021168 2004-05-03
DEPAKOTE TABLET, DELAYED RELEASE;ORAL divalproex sodium 018723

US Patents and Regulatory Information for divalproex sodium

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Orchid Hlthcare DIVALPROEX SODIUM divalproex sodium TABLET, DELAYED RELEASE;ORAL 078853-003 Nov 25, 2008 AB RX No No   Start Trial   Start Trial   Start Trial
Aurobindo Pharma Ltd DIVALPROEX SODIUM divalproex sodium TABLET, EXTENDED RELEASE;ORAL 202419-001 Jun 2, 2014 AB RX No No   Start Trial   Start Trial   Start Trial
Sun Pharm Inds DIVALPROEX SODIUM divalproex sodium TABLET, DELAYED RELEASE;ORAL 078597-001 Jul 29, 2008 AB RX No No   Start Trial   Start Trial   Start Trial
Mylan DIVALPROEX SODIUM divalproex sodium CAPSULE, DELAYED REL PELLETS;ORAL 090407-001 Mar 28, 2011 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

Expired US Patents for divalproex sodium

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Abbvie DEPAKOTE ER divalproex sodium TABLET, EXTENDED RELEASE;ORAL 021168-001 Aug 4, 2000   Start Trial   Start Trial
Abbvie DEPAKOTE ER divalproex sodium TABLET, EXTENDED RELEASE;ORAL 021168-002 May 31, 2002   Start Trial   Start Trial
Abbvie DEPAKOTE ER divalproex sodium TABLET, EXTENDED RELEASE;ORAL 021168-002 May 31, 2002   Start Trial   Start Trial
Abbvie DEPAKOTE divalproex sodium CAPSULE, DELAYED REL PELLETS;ORAL 019680-001 Sep 12, 1989   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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