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Last Updated: November 12, 2019

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Details for Patent: 6,528,091

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Which drugs does patent 6,528,091 protect, and when does it expire?

Patent 6,528,091 protects DEPAKOTE ER and is included in one NDA.

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 forty patent family members in twenty-seven countries.

Summary for Patent: 6,528,091
Title: Controlled release formulation of divalproex sodium
Abstract:A controlled release tablet formulation which permits once daily dosing in the treatment of epilepsy 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 silicon dioxide having an average particle size ranging between about 1 micron and about 10 microns; all weight percentages based upon the total weight of the tablet dosage form. Also disclosed are pre-tableting granular formulations, methods of making the granular formulations and tablets, and a method of treating epilepsy employing the controlled release tablet formulations of the invention.
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:10/143,559
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 6,528,091
Patent Claim Types:
see list of patent claims
Use; Dosage form;

Drugs Protected by US Patent 6,528,091

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Abbvie DEPAKOTE ER divalproex sodium TABLET, EXTENDED RELEASE;ORAL 021168-001 Aug 4, 2000 AB RX Yes Yes   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. >Patented / Exclusive Use >Submissiondate

International Family Members for US Patent 6,528,091

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Argentina 021443   Start Trial
Austria 254907   Start Trial
Austria 275398   Start Trial
Australia 2002239260   Start Trial
Australia 2478900   Start Trial
Bulgaria 105665   Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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Serving leading biopharmaceutical companies globally:

Express Scripts
Boehringer Ingelheim

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