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Last Updated: March 18, 2024

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, Rising, Teva Pharms Usa, Zydus Pharms Usa Inc, Abbott, Actavis Labs Fl Inc, Anchen Pharms, Apotex, Aurobindo Pharma Ltd, Chartwell Rx, Invatech, Lupin, Mylan, Orbion Pharms, Prinston Inc, Sun Pharm Inds, Teva, Unichem Labs Ltd, Upsher Smith Labs, Amneal Pharms, Amta, Annora Pharma, Cosette, Impax Labs, Lupin Ltd, Reddys, Unichem, and Wockhardt, and is included in forty 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

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

SponsorPhase
NuventraPhase 1
Emalex Biosciences Inc.Phase 1
Syneos HealthPhase 1

See all divalproex sodium clinical trials

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

Pharmacology for divalproex sodium
Paragraph IV (Patent) Challenges for DIVALPROEX SODIUM
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
DEPAKOTE ER Extended-release Tablets divalproex sodium 500 mg 021168 2005-02-08
DEPAKOTE ER Extended-release Tablets divalproex sodium 250 mg 021168 2004-05-03

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
Zydus Pharms Usa Inc DIVALPROEX SODIUM divalproex sodium TABLET, DELAYED RELEASE;ORAL 077100-001 Mar 5, 2009 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Aurobindo Pharma Ltd DIVALPROEX SODIUM divalproex sodium TABLET, DELAYED RELEASE;ORAL 090554-001 Apr 21, 2011 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Upsher Smith Labs DIVALPROEX SODIUM divalproex sodium TABLET, DELAYED RELEASE;ORAL 078182-002 Jul 29, 2008 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Chartwell Rx DIVALPROEX SODIUM divalproex sodium TABLET, DELAYED RELEASE;ORAL 077296-003 Jul 31, 2008 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Abbott DEPAKOTE CP divalproex sodium TABLET, DELAYED RELEASE;ORAL 019794-002 Jul 11, 1990 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a 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 divalproex sodium TABLET, DELAYED RELEASE;ORAL 018723-002 Mar 10, 1983 ⤷  Try a Trial ⤷  Try a Trial
Abbvie DEPAKOTE ER divalproex sodium TABLET, EXTENDED RELEASE;ORAL 021168-001 Aug 4, 2000 ⤷  Try a Trial ⤷  Try a Trial
Abbvie DEPAKOTE ER divalproex sodium TABLET, EXTENDED RELEASE;ORAL 021168-001 Aug 4, 2000 ⤷  Try a Trial ⤷  Try a Trial
Abbvie DEPAKOTE divalproex sodium CAPSULE, DELAYED REL PELLETS;ORAL 019680-001 Sep 12, 1989 ⤷  Try a Trial ⤷  Try a Trial
Abbvie DEPAKOTE ER divalproex sodium TABLET, EXTENDED RELEASE;ORAL 021168-002 May 31, 2002 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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