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Details for Patent: 6,419,953

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Patent 6,419,953 protects DEPAKOTE ER and is included in one NDA. There have been two Paragraph IV challenges on Depakote ER.

Protection for DEPAKOTE ER has been extended six months for pediatric studies, as indicated by the *PED designation in the table below.

This patent has thirty-six patent family members in twenty-six countries.

Summary for Patent: 6,419,953

Title: Controlled release formulation of divalproex sodium
Abstract:The present invention pertains to a hydrophilic matrix tablet suitable for the once-a-day administration of valproate compounds such as divalproex sodium. The tablet comprises from about 50 weight percent to about 55 weight percent of an active ingredient selected from the group consisting of valproic acid, a pharmaceutically acceptable salt or ester of valproic acid, divalproex sodium, and valpromide; from about 20 weight percent to about 40 weight percent hydroxypropyl methylcellulose; from about 5 weight percent to about 15 weight percent lactose, from about 4 weight percent to about 6 weight percent microcrystalline cellulose, and from about 1 weight percent to about 5 weight percent of silicon dioxide; all weight percentages based upon the total weight of the tablet dosage form. Other aspects of the invention relate to the use of this formulation in the treatment of epilepsy and to methods for manufacturing this dosage form.
Inventor(s): Qiu; Yihong (Gurnee, IL), Poska; Paul Richard (Mundelein, IL), Cheskin; Howard S. (Glencoe, IL), Bollinger; J. Daniel (Libertyville, IL), Engh; Robert K. (Kenosha, WI)
Assignee: Abbott Laboratories (Abbott Park, IL)
Application Number:09/216,650
Patent Claim Types:
see list of patent claims
Compound; Dosage form; Formulation; Composition; Use;
Patent Metrics:
Source: PatentQuant.com
Field: Pharmaceuticals
Back Citations: 19th percentile
Forward Citations: 0th percentile

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use
Abbvie
DEPAKOTE ER
divalproex sodium
TABLET, EXTENDED RELEASE;ORAL021168-001Aug 4, 2000RXYes6,419,953*PED► subscribeY
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Non-Orange Book Patents for Patent: 6,419,953

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
6,720,004 Controlled release formulation of divalproex sodium► subscribe
6,511,678 Controlled release formulation of divalproex sodium► subscribe
6,528,090 Controlled release formulation of divalproex sodium► subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Patent: 6,419,953

Country Document Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Argentina021443► subscribe
Austria254907► subscribe
Austria275398► 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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