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Serving leading biopharmaceutical companies globally:

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Harvard Business School
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Generated: December 12, 2017

DrugPatentWatch Database Preview

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 Abbvie, Dr Reddys Labs Ltd, Mylan, Zydus Pharms Usa Inc, Abbott, Actavis Labs Fl Inc, Anchen Pharms, Aurobindo Pharma Ltd, Lupin, Nu Pharm, Orchid Hlthcare, Prinston Inc, Sandoz, Sun Pharm Inds, Teva, Unichem Labs Ltd, Upsher-smith Labs, Wockhardt, Amneal Pharms, G And W Labs Inc, Impax Labs, and Reddys, 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 forty patent family members in twenty-seven countries.

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

Tentative approvals for DIVALPROEX SODIUM

Applicant Application No. Strength Dosage Form
u► SubscribeEQ 125MG VALPROIC ACIDTABLET, DELAYED RELEASE;ORAL
u► SubscribeEQ 500MG VALPROIC ACIDTABLET, DELAYED RELEASE;ORAL
u► SubscribeEQ 250MG VALPROIC ACIDTABLET, DELAYED RELEASE;ORAL
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Patent Submitted Product Substance Delist Req. Exclusivity Expiration
WockhardtDIVALPROEX SODIUMdivalproex sodiumTABLET, DELAYED RELEASE;ORAL077296-001Jul 31, 2008ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
AbbvieDEPAKOTEdivalproex sodiumTABLET, DELAYED RELEASE;ORAL018723-001Mar 10, 1983ABRXYesNo► Subscribe► Subscribe► Subscribe► Subscribe
MylanDIVALPROEX SODIUMdivalproex sodiumTABLET, DELAYED RELEASE;ORAL077254-002Jul 29, 2008DISCNNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Unichem Labs LtdDIVALPROEX SODIUMdivalproex sodiumTABLET, DELAYED RELEASE;ORAL079163-002Apr 5, 2011ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
MylanDIVALPROEX SODIUMdivalproex sodiumTABLET, EXTENDED RELEASE;ORAL077567-001Jan 29, 2009ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Zydus Pharms Usa IncDIVALPROEX SODIUMdivalproex sodiumTABLET, DELAYED RELEASE;ORAL077100-002Mar 5, 2009ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Prinston IncDIVALPROEX SODIUMdivalproex sodiumTABLET, DELAYED RELEASE;ORAL090210-002Nov 30, 2009ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Dr Reddys Labs LtdDIVALPROEX SODIUMdivalproex sodiumCAPSULE, DELAYED REL PELLETS;ORAL078979-001Jan 23, 2009ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
WockhardtDIVALPROEX SODIUMdivalproex sodiumTABLET, EXTENDED RELEASE;ORAL078705-002Feb 10, 2009ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
TevaDIVALPROEX SODIUMdivalproex sodiumTABLET, DELAYED RELEASE;ORAL076941-003Jul 29, 2008ABRXNoNo► Subscribe► 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
AbbvieDEPAKOTEdivalproex sodiumTABLET, DELAYED RELEASE;ORAL018723-002Mar 10, 1983► Subscribe► Subscribe
AbbvieDEPAKOTE ERdivalproex sodiumTABLET, EXTENDED RELEASE;ORAL021168-002May 31, 2002► Subscribe► Subscribe
AbbottDEPAKOTE CPdivalproex sodiumTABLET, DELAYED RELEASE;ORAL019794-002Jul 11, 1990► Subscribe► Subscribe
AbbvieDEPAKOTEdivalproex sodiumCAPSULE, DELAYED REL PELLETS;ORAL019680-001Sep 12, 1989► Subscribe► Subscribe
AbbvieDEPAKOTE ERdivalproex sodiumTABLET, EXTENDED RELEASE;ORAL021168-001Aug 4, 2000► Subscribe► Subscribe
AbbvieDEPAKOTEdivalproex sodiumTABLET, DELAYED RELEASE;ORAL018723-002Mar 10, 1983► Subscribe► Subscribe
AbbvieDEPAKOTE ERdivalproex sodiumTABLET, EXTENDED RELEASE;ORAL021168-002May 31, 2002► Subscribe► Subscribe
AbbottDEPAKOTE CPdivalproex sodiumTABLET, DELAYED RELEASE;ORAL019794-001Jul 11, 1990► Subscribe► Subscribe
AbbvieDEPAKOTEdivalproex sodiumTABLET, DELAYED RELEASE;ORAL018723-001Mar 10, 1983► Subscribe► Subscribe
AbbvieDEPAKOTEdivalproex sodiumTABLET, DELAYED RELEASE;ORAL018723-003Oct 26, 1984► Subscribe► Subscribe
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International Patent Family for Ingredient: divalproex sodium

Country Document Number Estimated Expiration
Bulgaria105665► Subscribe
Denmark1140034► Subscribe
World Intellectual Property Organization (WIPO)0037055► Subscribe
Israel143407► Subscribe
Austria254907► Subscribe
Turkey200402549► Subscribe
European Patent Office1219295► Subscribe
Austria275398► Subscribe
Spain2212667► Subscribe
Hungary0105463► 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 leading biopharmaceutical companies globally:

Cerilliant
Baxter
Julphar
Argus Health
US Department of Justice
Fish and Richardson
Queensland Health
Citi
AstraZeneca
Novartis

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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