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Generated: September 16, 2019

DrugPatentWatch Database Preview

Details for Patent: 8,436,051

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Which drugs does patent 8,436,051 protect, and when does it expire?

Patent 8,436,051 protects CANASA and is included in one NDA.

This patent has thirteen patent family members in twelve 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 Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 8,436,051
Patent Claim Types:
see list of patent claims
Formulation; Dosage form; Use;

Drugs Protected by US Patent 8,436,051

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Allergan Sales Llc CANASA mesalamine SUPPOSITORY;RECTAL 021252-002 Nov 5, 2004 AB RX Yes Yes   Try a Free Trial   Try a Free Trial Y   Try a Free 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

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International Family Members for US Patent 8,436,051

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Australia 2010339837   Try a Free Trial
Canada 2690450   Try a Free Trial
Canada 2784772   Try a Free Trial
China 102970971   Try a Free Trial
European Patent Office 2512443   Try a Free Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

UBS
US Department of Justice
Colorcon
Mallinckrodt
Chinese Patent Office
Chubb

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