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Details for Patent: 8,436,051

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Patent 8,436,051 protects CANASA and is included in one NDA. There has been one Paragraph IV challenge on Canasa. There is one tentative approval for the compound protected by this patent. Additional details are available via the generic ingredient links below.

This patent has twelve patent family members in eleven countries.

Summary for Patent: 8,436,051

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%. 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. Yet another embodiment is a mesalamine rectal suppository comprising mesalamine particles and one or more pharmaceutically acceptable excipients, where the mesalamine particles have a surface area of from about 0.1 m.sup.2/g to about 2.8 m.sup.2/g (e.g., from about 0.1 m.sup.2/g to about 1.3 m.sup.2/g). 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), Moreau; Hugues (Luce, FR)
Assignee: Aptalis Pharma Canada Inc. (Mont-Saint-Hilaire, Quebec, CA)
Application Number:12/639,645
Patent Claim Types:
see list of patent claims
Formulation; Dosage form; Use;
Patent Metrics:
Source: PatentQuant.com
Field: Basic materials chemistry
Back Citations: 0th 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
Forest Labs Llc
CANASA
mesalamine
SUPPOSITORY;RECTAL021252-002Nov 5, 2004RXYes8,436,051► subscribeY
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Non-Orange Book Patents for Patent: 8,436,051

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

Country Document Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Australia2010339837► subscribe
Canada2690450► 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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