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Last Updated: May 26, 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, Mylan, Teva Pharms Usa, Zydus Pharms Usa Inc, Abbott, Actavis Labs Fl Inc, Anchen Pharms, Apotex, Aurobindo Pharma Ltd, Celltrion, Invatech, Lupin, 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-two suppliers are listed 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
Emalex Biosciences Inc.Phase 1
Syneos HealthPhase 1
NuventraPhase 1

See all divalproex sodium clinical trials

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 078290-002 Jul 29, 2008 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Aurobindo Pharma Ltd DIVALPROEX SODIUM divalproex sodium TABLET, DELAYED RELEASE;ORAL 090554-002 Apr 21, 2011 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
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 CAPSULE, DELAYED REL PELLETS;ORAL 090407-001 Mar 28, 2011 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Celltrion DIVALPROEX SODIUM divalproex sodium TABLET, DELAYED RELEASE;ORAL 077296-002 Jul 31, 2008 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 divalproex sodium TABLET, DELAYED RELEASE;ORAL 018723-002 Mar 10, 1983 See Plans and Pricing See Plans and Pricing
Abbvie DEPAKOTE divalproex sodium TABLET, DELAYED RELEASE;ORAL 018723-003 Oct 26, 1984 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 divalproex sodium CAPSULE, DELAYED REL PELLETS;ORAL 019680-001 Sep 12, 1989 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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