Time limited offer for new users ▶ Get up to 3 months free

Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Express Scripts

Last Updated: March 23, 2023

Details for Patent: 8,436,051

✉ Email this page to a colleague

« Back to Dashboard

▶ Start for $1
Remove trial restrictions

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

International Family Members for US Patent 8,436,051

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Australia 2010339837 See Plans and Pricing
Canada 2690450 See Plans and Pricing
Canada 2784772 See Plans and Pricing
Chile 2012001636 See Plans and Pricing
China 102970971 See Plans and Pricing
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Harvard Business School

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.