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Last Updated: January 20, 2020

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Details for Patent: 8,580,302

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Which drugs does patent 8,580,302 protect, and when does it expire?

Patent 8,580,302 protects ASACOL HD and is included in one NDA.

This patent has twenty patent family members in seventeen countries.

Summary for Patent: 8,580,302
Title:Pharmaceutical dosage form with multiple coatings for reduced impact of coating fractures
Abstract: The present invention relates to a pharmaceutical composition in a solid unit dosage form for oral administration in a human or lower animal comprising: a. a safe and effective amount of a therapeutically active agent; b. an inner coating layer selected from the group consisting of poly(methacrylic acid, methyl methacrylate) 1:2, poly(methacrylic acid, methyl methacrylate) 1:1, and mixtures thereof; and c. an outer coating layer comprising an enteric polymer or film coating material; wherein the inner coating layer is not the same as the outer coating layer; wherein if the inner coating layer is poly(methacrylic acid, methyl methacrylate) 1:1 then the outer coating layer is not poly(methacrylic acid, methyl methacrylate) 1:2 or is not a mixture of poly(methacrylic acid, methyl methacrylate) 1:1 and poly(methacrylic acid, methyl methacrylate) 1:2; and wherein the inner coating layer and the outer coating layer do not contain any therapeutically active agent. This invention further relates to a method of maintaining the desired site of delivery of a therapeutic agent in the gastrointestinal tract by administering the above compositions to a human or lower animal.
Inventor(s): Dittmar; Gregory Paul (Norwich, NY), Amante; Joseph Michael (Norwich, NY), Cronk; Tony Ryan (Mishawaka, IN), Newby; Daniel Gary (South New Berlin, NY)
Assignee: Warner Chilcott Company, LLC (Fajardo, PR)
Application Number:11/070,995
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 8,580,302
Patent Claim Types:
see list of patent claims
Composition; Compound; Dosage form; Use; Delivery;

Drugs Protected by US Patent 8,580,302

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Apil ASACOL HD mesalamine TABLET, DELAYED RELEASE;ORAL 021830-001 May 29, 2008 AB RX Yes Yes   Start Trial   Start Trial Y   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 8,580,302

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Austria 389389   Start Trial
Australia 2002226955   Start Trial
Brazil 0117180   Start Trial
Brazil PI0117180   Start Trial
Canada 2359812   Start Trial
China 1314390   Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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Serving leading biopharmaceutical companies globally:

Colorcon
Mallinckrodt
Johnson and Johnson
Harvard Business School
Express Scripts
AstraZeneca

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