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Last Updated: December 8, 2022

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, Celltrion, Invatech, Lupin, Mylan, Orbion Pharms, Prinston Inc, Sun Pharm Inds, Teva, Unichem Labs Ltd, Upsher Smith Labs, Amneal Pharms, Amta, Cosette, Impax Labs, Lupin Ltd, Reddys, Unichem, and Wockhardt, and is included in thirty-nine NDAs. Additional information is available in the individual branded drug profile pages.

There are eighteen drug master file entries for divalproex sodium. Forty-three 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
NuventraPhase 1
Emalex Biosciences Inc.Phase 1
Syneos HealthPhase 1

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Generic filers with tentative approvals for DIVALPROEX SODIUM
Applicant Application No. Strength Dosage Form
See Plans and PricingSee Plans and PricingEQ 500MG VALPROIC ACIDTABLET, DELAYED RELEASE;ORAL
See Plans and PricingSee Plans and PricingEQ 250MG VALPROIC ACIDTABLET, DELAYED RELEASE;ORAL
See Plans and PricingSee Plans and PricingEQ 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 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
Invatech DIVALPROEX SODIUM divalproex sodium TABLET, DELAYED RELEASE;ORAL 078290-003 Jul 29, 2008 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Mylan DIVALPROEX SODIUM divalproex sodium TABLET, DELAYED RELEASE;ORAL 090062-002 Mar 17, 2009 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Zydus Pharms Usa Inc DIVALPROEX SODIUM divalproex sodium TABLET, DELAYED RELEASE;ORAL 077100-003 Mar 5, 2009 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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 See Plans and Pricing See Plans and Pricing
Abbvie DEPAKOTE ER divalproex sodium TABLET, EXTENDED RELEASE;ORAL 021168-001 Aug 4, 2000 See Plans and Pricing See Plans and Pricing
Abbvie DEPAKOTE ER divalproex sodium TABLET, EXTENDED RELEASE;ORAL 021168-001 Aug 4, 2000 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.