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Details for Patent: 6,528,090

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Patent 6,528,090 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: 6,528,090

Title: Controlled release formulation of divalproex sodium
Abstract:A new oral polymeric controlled release formulation suitable for the once-a-day administration of valproate compounds, such as divalproex sodium, has been discovered. This formulation exhibits significant advantages over the sustained release valproate formulations of the prior art. This formulation minimizes the variation between peak and trough plasma levels of valproate over a 24 hour dosing period. This formulation follows a zero-order release pattern thus producing essentially flat plasma levels of valproate, once steady-state levels have been achieved. This results in a significantly lower incidence of side effects for patients consuming such a formulation.
Inventor(s): Qiu; Yihong (Gumee, IL), Bollinger; J. Daniel (Libertyville, IL), Cheskin; Howard S. (Glencoe, IL), Dutta; Sandeep (Waukegan, IL), Engh; Kevin R. (Kenosha, WI), Poska; Richard P. (Mundelein, IL)
Assignee: Abbott Laboratories (Abbott Park, IL)
Application Number:09/748,566
Patent Claim Types:
see list of patent claims
Formulation; Compound; Dosage form; Composition;
Patent Metrics:
Source: PatentQuant.com
Field: Pharmaceuticals
Back Citations: 22nd 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;ORAL021168-002May 31, 2002RXNo6,528,090*PED► subscribeY
Abbvie
DEPAKOTE ER
divalproex sodium
TABLET, EXTENDED RELEASE;ORAL021168-001Aug 4, 2000RXYes6,528,090*PED► subscribeY
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Non-Orange Book Patents for Patent: 6,528,090

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
6,419,953 Controlled release formulation of divalproex sodium► subscribe
6,511,678 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: 6,528,090

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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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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