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Last Updated: December 8, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 018723

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NDA 018723 describes DEPAKOTE, which is a drug marketed by Abbvie and Abbott and is included in four NDAs. It is available from three suppliers. There are six patents protecting this drug and two Paragraph IV challenges. Additional details are available on the DEPAKOTE profile page.

The generic ingredient in DEPAKOTE is divalproex sodium. There are eighteen drug master file entries for this compound. Forty-one suppliers are listed for this compound. Additional details are available on the divalproex sodium profile page.
Summary for 018723
Tradename:DEPAKOTE
Applicant:Abbvie
Ingredient:divalproex sodium
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 018723
Suppliers and Packaging for NDA: 018723
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DEPAKOTE divalproex sodium TABLET, DELAYED RELEASE;ORAL 018723 NDA AbbVie Inc. 0074-6212 0074-6212-13 100 TABLET, DELAYED RELEASE in 1 BOTTLE (0074-6212-13)
DEPAKOTE divalproex sodium TABLET, DELAYED RELEASE;ORAL 018723 NDA AbbVie Inc. 0074-6214 0074-6214-13 100 TABLET, DELAYED RELEASE in 1 BOTTLE (0074-6214-13)
Paragraph IV (Patent) Challenges for 018723
Tradename Dosage Ingredient NDA Submissiondate
DEPAKOTE TABLET, DELAYED RELEASE;ORAL divalproex sodium 018723

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, DELAYED RELEASE;ORALStrengthEQ 250MG VALPROIC ACID
Approval Date:Mar 10, 1983TE:ABRLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, DELAYED RELEASE;ORALStrengthEQ 500MG VALPROIC ACID
Approval Date:Mar 10, 1983TE:ABRLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET, DELAYED RELEASE;ORALStrengthEQ 125MG VALPROIC ACID
Approval Date:Oct 26, 1984TE:ABRLD:Yes

Expired US Patents for NDA 018723

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Abbvie DEPAKOTE divalproex sodium TABLET, DELAYED RELEASE;ORAL 018723-003 Oct 26, 1984   Start Trial   Start Trial
Abbvie DEPAKOTE divalproex sodium TABLET, DELAYED RELEASE;ORAL 018723-002 Mar 10, 1983   Start Trial   Start Trial
Abbvie DEPAKOTE divalproex sodium TABLET, DELAYED RELEASE;ORAL 018723-001 Mar 10, 1983   Start Trial   Start Trial
Abbvie DEPAKOTE divalproex sodium TABLET, DELAYED RELEASE;ORAL 018723-002 Mar 10, 1983   Start Trial   Start Trial
Abbvie DEPAKOTE divalproex sodium TABLET, DELAYED RELEASE;ORAL 018723-001 Mar 10, 1983   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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