Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Serving leading biopharmaceutical companies globally:

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AstraZeneca

Last Updated: October 19, 2019

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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 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, Apotex Inc, Aurobindo Pharma Ltd, Celltrion, Lupin, Orchid Hlthcare, Prinston Inc, Sandoz, Sun Pharm Inds, Teva, Unichem Labs Ltd, Upsher Smith Labs, Acp Nimble, Amneal Pharms, Impax Labs, Reddys, and Wockhardt, 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 eighteen drug master file entries for divalproex sodium. Forty-two 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
Puma Biotechnology, Inc.Phase 1/Phase 2
Virginia Commonwealth UniversityPhase 1/Phase 2
Mayo ClinicPhase 4

See all divalproex sodium clinical trials

Recent Litigation for divalproex sodium

Identify potential future generic entrants

District Court Litigation
Case NameDate
Abbott Laboratories v. Teva Pharmaceuticals USA, Inc.2008-02-29
NU-PHARM INC. v. FOOD AND DRUG ADMINISTRATION2008-01-14
Sanofi-Aventis v. Apotex Inc.2007-12-06

See all divalproex sodium litigation

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

Synonyms for divalproex sodium
133299-66-8
644VL95AO6
76584-70-8
99-66-1 (Parent)
A838751
AB01568255_01
AB2000231
Abbott 50711
Abbott-50711
AC1Q1V4Q
AC1Q1VPW
AKOS015895200
AN-6581
API0002433
AS-17254
C-19234
C16H31NaO4
CC-27204
CHEBI:4667
CHEMBL2105613
D00304
Delepsine
Depakote
Depakote (TN)
Depakote CP
Depakote ER
Depakote Sprinkle
Depakote;Epival
Divalproate
divalproex
Divalproex sodium (USP)
Divalproex sodium [USAN:USP]
Divalproex sodium [USAN]
Divalproex sodium salt
DTXSID70227388
Epilex
Epival
FT-0625375
HMS3651C17
I06-0339
LS-101863
MolPort-006-167-562
MSRILKIQRXUYCT-UHFFFAOYSA-M
Natrium hydrogen bis(2-propylvalerat)
Pentanoic acid, 2-propyl-, sodium salt (2:1)
pentanoic acid, 2-propyl-, sodium salt(2:1)
potassium valproic acid dipropylacetate
s1703
SCHEMBL40996
Semisodium Valproate
Sodium 2-propylpentanoate 2-propylpentanoic acid
sodium 2-propylpentanoate--2-propylpentanoic acid (1:1)
Sodium divalproate
Sodium hydrogen bis(2-propylpentanoate)
Sodium hydrogen bis(2-propylvalerate)
Sodium hydrogen bis(2-propylvalerate), oligomer
Sodium hydrogen divalproate
sodium valproic acid valproate
sodium; 2-propylpentanoate; 2-propylpentanoic acid
Sprinkle
SW219169-1
U058
UNII-644VL95AO6
Valcote
Valdisoval
Valparin
Valproate semisodique
Valproate semisodique [French]
Valproate semisodium
Valproate semisodium (INN)
Valproate semisodium [INN]
Valproato semisodico
Valproato semisodico [Spanish]
Valproatum seminatricum
Valproatum seminatricum [Latin]
Valproic acid semisodium salt (2:1)

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
Celltrion DIVALPROEX SODIUM divalproex sodium TABLET, DELAYED RELEASE;ORAL 077296-003 Jul 31, 2008 AB RX No No   Start Trial   Start Trial   Start Trial
Mylan DIVALPROEX SODIUM divalproex sodium TABLET, DELAYED RELEASE;ORAL 077254-003 Jul 29, 2008 DISCN No No   Start Trial   Start Trial   Start Trial
Celltrion DIVALPROEX SODIUM divalproex sodium TABLET, DELAYED RELEASE;ORAL 077296-001 Jul 31, 2008 AB RX No No   Start Trial   Start Trial   Start Trial
Lupin DIVALPROEX SODIUM divalproex sodium TABLET, DELAYED RELEASE;ORAL 078790-003 Jul 29, 2008 AB RX No No   Start Trial   Start Trial   Start Trial
Mylan DIVALPROEX SODIUM divalproex sodium CAPSULE, DELAYED REL PELLETS;ORAL 090407-001 Mar 28, 2011 AB RX No No   Start Trial   Start Trial   Start Trial
Unichem Labs Ltd DIVALPROEX SODIUM divalproex sodium TABLET, DELAYED RELEASE;ORAL 079163-001 Apr 5, 2011 AB RX No No   Start Trial   Start Trial   Start 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 ER divalproex sodium TABLET, EXTENDED RELEASE;ORAL 021168-001 Aug 4, 2000   Start Trial   Start Trial
Abbvie DEPAKOTE divalproex sodium TABLET, DELAYED RELEASE;ORAL 018723-001 Mar 10, 1983   Start Trial   Start Trial
Abbvie DEPAKOTE ER divalproex sodium TABLET, EXTENDED RELEASE;ORAL 021168-002 May 31, 2002   Start Trial   Start Trial
Abbvie DEPAKOTE ER divalproex sodium TABLET, EXTENDED RELEASE;ORAL 021168-002 May 31, 2002   Start Trial   Start Trial
Abbvie DEPAKOTE ER divalproex sodium TABLET, EXTENDED RELEASE;ORAL 021168-002 May 31, 2002   Start Trial   Start Trial
Abbvie DEPAKOTE ER divalproex sodium TABLET, EXTENDED RELEASE;ORAL 021168-002 May 31, 2002   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

McKinsey
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Dow
Express Scripts
McKesson
AstraZeneca

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