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Serving hundreds of leading biopharmaceutical companies globally:

Johnson and Johnson
Covington
Julphar
Boehringer Ingelheim
Federal Trade Commission
Medtronic
Chinese Patent Office
Moodys
Argus Health

Generated: April 24, 2018

DrugPatentWatch Database Preview

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

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Non-Orange Book US Patents Family Members for Patent 8,580,302

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
6,893,662 Pharmaceutical dosage form with multiple coatings for reduced impact of coating fractures ➤ Sign Up
9,089,492 Pharmaceutical dosage form with multiple coatings for reduced impact of coating fractures ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

Chinese Patent Office
Queensland Health
Healthtrust
Teva
US Department of Justice
Merck
Harvard Business School
Julphar
Farmers Insurance

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