Last Updated: September 24, 2026

Details for Patent: 8,367,685


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Which drugs does patent 8,367,685 protect, and when does it expire?

Patent 8,367,685 protects OPSUMIT and is included in one NDA.

Protection for OPSUMIT has been extended six months for pediatric studies, as indicated by the *PED designation in the table below.

This patent has thirty-one patent family members in twenty-three countries.

Summary for Patent: 8,367,685
Title:Stable pharmaceutical compositions comprising a pyrimidine-sulfamide
Abstract:Stable pharmaceutical compositions include the compound of the below formula, or pharmaceutically acceptable salts, solvates, hydrates or morphological forms thereof:
Inventor(s):Charles Tokunbo Adesuyi, Lovelace Holman, Olivier Lambert, Bruce Hamilton Lithgow
Assignee: Actelion Pharmaceuticals Ltd
Application Number:US12/388,142
Patent Claim Types:
see list of patent claims
Use; Composition; Dosage form;

Drugs Protected by US Patent 8,367,685

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Actelion OPSUMIT macitentan TABLET;ORAL 204410-001 Oct 18, 2013 AB RX Yes Yes 8,367,685*PED ⤷  Start Trial Y ⤷  Start 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

Foreign Priority and PCT Information for Patent: 8,367,685

Foriegn Application Priority Data
Foreign Country Foreign Patent Number Foreign Patent Date
PCT/EP2005/009775Sep 15, 2005

International Family Members for US Patent 8,367,685

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Australia 2006290309 ⤷  Start Trial
Brazil PI0615898 ⤷  Start Trial
Canada 2621273 ⤷  Start Trial
China 101262847 ⤷  Start Trial
Cyprus 1113395 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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