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Serving 500+ biopharmaceutical companies globally:

US Department of Justice
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AstraZeneca
Merck
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UBS
QuintilesIMS
Farmers Insurance
Teva
Dow

Generated: August 21, 2017

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Divalproex sodium - Generic Drug Details

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

Divalproex sodium
is the generic ingredient in four branded drugs marketed by Zydus Pharms Usa Inc, G And W Labs Inc, Wockhardt, Mylan, Prinston Inc, Anchen Pharms, Nu Pharm, Aurobindo Pharma Ltd, Abbvie, Amneal Pharms, Teva, Orchid Hlthcare, Dr Reddys Labs Ltd, Unichem Labs Ltd, Reddys, Actavis Labs Fl Inc, Upsher-smith Labs, Lupin, Sandoz, Impax Labs, Abbott, and Sun Pharm Inds, and is included in thirty-four NDAs. There are six patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Divalproex sodium has thirty-seven patent family members in twenty-seven countries.

There are seventeen drug master file entries for divalproex sodium. Fifty-one suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for Generic Name: divalproex sodium

Tradenames:4
Patents:6
Applicants:22
NDAs:34
Drug Master File Entries: see list17
Suppliers / Packagers: see list51
Bulk Api Vendors: see list35
Clinical Trials: see list2,424
Therapeutic Class:Bipolar Agents
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:divalproex sodium at DailyMed

Pharmacology for Ingredient: divalproex sodium

Tentative approvals for DIVALPROEX SODIUM

Applicant Application No. Strength Dosage Form
► Subscribe► SubscribeEQ 125MG VALPROIC ACIDTABLET, DELAYED RELEASE;ORAL
► Subscribe► SubscribeEQ 500MG VALPROIC ACIDTABLET, DELAYED RELEASE;ORAL
► Subscribe► SubscribeEQ 250MG VALPROIC ACIDTABLET, DELAYED RELEASE;ORAL
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Abbvie
DEPAKOTE ER
divalproex sodium
TABLET, EXTENDED RELEASE;ORAL021168-001Aug 4, 2000ABRXYesYes► Subscribe► SubscribeY► Subscribe
Mylan
DIVALPROEX SODIUM
divalproex sodium
TABLET, EXTENDED RELEASE;ORAL077567-001Jan 29, 2009ABRXNoNo► Subscribe► Subscribe► Subscribe
Nu Pharm
DIVALPROEX SODIUM
divalproex sodium
TABLET, DELAYED RELEASE;ORAL077615-003Jul 29, 2008ABRXNoNo► Subscribe► Subscribe► Subscribe
Mylan
DIVALPROEX SODIUM
divalproex sodium
TABLET, DELAYED RELEASE;ORAL077254-001Jul 29, 2008DISCNNoNo► Subscribe► Subscribe► Subscribe
Abbvie
DEPAKOTE
divalproex sodium
TABLET, DELAYED RELEASE;ORAL018723-002Mar 10, 1983ABRXYesYes► Subscribe► Subscribe► Subscribe
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Expired Orange Book Patents for Generic Ingredient: divalproex sodium

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Abbvie
DEPAKOTE ER
divalproex sodium
TABLET, EXTENDED RELEASE;ORAL021168-002May 31, 2002► Subscribe► Subscribe
Abbvie
DEPAKOTE ER
divalproex sodium
TABLET, EXTENDED RELEASE;ORAL021168-002May 31, 2002► Subscribe► Subscribe
Abbvie
DEPAKOTE
divalproex sodium
TABLET, DELAYED RELEASE;ORAL018723-003Oct 26, 1984► Subscribe► Subscribe
Abbvie
DEPAKOTE ER
divalproex sodium
TABLET, EXTENDED RELEASE;ORAL021168-001Aug 4, 2000► Subscribe► Subscribe
Abbott
DEPAKOTE CP
divalproex sodium
TABLET, DELAYED RELEASE;ORAL019794-002Jul 11, 1990► Subscribe► Subscribe
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International Patent Family for Ingredient: divalproex sodium

Country Document Number Estimated Expiration
World Intellectual Property Organization (WIPO)02051402► Subscribe
Canada2341805► Subscribe
South Korea20010101295► Subscribe
Turkey200402549► Subscribe
Spain2228762► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Serving 500+ biopharmaceutical companies globally:

Queensland Health
Accenture
Mallinckrodt
Teva
Farmers Insurance
Express Scripts
McKesson
US Department of Justice
Fuji
Chinese Patent Office

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 verifification 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.

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