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Serving leading biopharmaceutical companies globally:

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Generated: December 16, 2017

DrugPatentWatch Database Preview

Details for Patent: 8,217,083

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Which drugs does patent 8,217,083 protect, and when does it expire?


Patent 8,217,083 protects CANASA and is included in one NDA. There has been one Paragraph IV challenge on Canasa.

This patent has thirteen patent family members in twelve countries.

Summary for Patent: 8,217,083

Title:Mesalamine suppository
Abstract: The present invention relates to a mesalamine rectal suppository designed to provide improved comfort of use. One embodiment of the invention is a mesalamine rectal suppository comprising mesalamine and one or more pharmaceutically acceptable excipients, wherein the drug load of the suppository ranges from 35% to 50%. Another embodiment of the invention is a mesalamine rectal suppository comprising from about 850 to about 1150 mg mesalamine and one or more pharmaceutically acceptable excipients, wherein the total weight of the suppository ranges from about 2250 to about 2700 mg. Another embodiment of the invention is a mesalamine rectal suppository comprising from about 400 to about 600 mg mesalamine and one or more pharmaceutically acceptable excipients, wherein the total weight of the suppository ranges from about 870 to about 1715 mg. Yet another embodiment of the invention is a mesalamine rectal suppository comprising mesalamine having a tap density ranging from about 600 to about 800 g/L (as measured by USP <616>) and a hard fat having an ascending melting point of 32 to 35.5.degree. C. Methods of preparing and methods of treatment with mesalamine suppositories are also provided. The invention further provides a method of determining a dissolution parameter (such as dissolution rate) of a mesalamine rectal suppository, such as a 1 g mesalamine suppository, by measuring its dissolution with USP Apparatus #2 at 40.degree. C. and a paddle rotation speed of 125 rpm in 0.2 M phosphate buffer at a pH of 7.5.
Inventor(s): Gauthier; Carl (Quebec, CA), Dumoulin; Yves (Quebec, CA), Powell; David (Loudon, TN)
Assignee: Aptalis Pharma Canada Inc. (Mont-Saint-Hilaire, Quebec, CA)
Application Number:12/476,185
Patent Claim Types:
see list of patent claims
Formulation; Dosage form; Use;

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
Forest Labs LlcCANASAmesalamineSUPPOSITORY;RECTAL021252-002Nov 5, 2004ABRXYesYes► Subscribe► SubscribeY► Subscribe
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Non-Orange Book Patents for Patent: 8,217,083

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
7,541,384Mesalamine suppository► Subscribe
8,436,051Mesalamine suppository► 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: 8,217,083

Country Document Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
World Intellectual Property Organization (WIPO)2011084638► Subscribe
Singapore181169► Subscribe
Russian Federation2012125186► Subscribe
Mexico2012006902► Subscribe
South Korea20120104604► Subscribe
Israel220397► Subscribe
European Patent Office2512443► Subscribe
China102970971► Subscribe
Japan2013514979► Subscribe
Canada2784772► 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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Serving leading biopharmaceutical companies globally:

Covington
Cipla
Deloitte
Harvard Business School
Merck
AstraZeneca
Moodys
Chubb
McKesson
Boehringer Ingelheim

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