Details for Patent: 8,217,083

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.

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 Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 8,217,083
Patent Claim Types: see list of patent claims	Formulation; Dosage form; Use;

Drugs Protected by US Patent 8,217,083

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

International Family Members for US Patent 8,217,083

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2010339837
Canada	2690450
Canada	2784772
Chile	2012001636
China	102970971
European Patent Office	2512443