Details for Patent: 10,946,015

Which drugs does patent 10,946,015 protect, and when does it expire?

Patent 10,946,015 protects OPSUMIT and OPSYNVI and is included in two NDAs.

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: 10,946,015

Title:	Stable pharmaceutical compositions comprising a pyrimidine-sulfamide
Abstract:	The invention relates to stable pharmaceutical compositions comprising the compound of the below formula, or pharmaceutically acceptable salts, solvates, hydrates or morphological forms thereof.
Inventor(s):	Charles Tokunbo Adesuyi, Bruce Hamilton Lithgow, Olivier Lambert, Lovelace Holman
Assignee:	Actelion Pharmaceuticals Ltd
Application Number:	US15/900,586
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 10,946,015
Patent Claim Types: see list of patent claims	Use; Composition; Dosage form;

Drugs Protected by US Patent 10,946,015

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					Y
Actelion	OPSYNVI	macitentan; tadalafil	TABLET;ORAL	218490-001	Mar 22, 2024		RX	Yes	No					Y
Actelion	OPSYNVI	macitentan; tadalafil	TABLET;ORAL	218490-002	Mar 22, 2024		RX	Yes	Yes					Y

Foreign Priority and PCT Information for Patent: 10,946,015

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
	PCT/EP2005/009775	Sep 12, 2005

International Family Members for US Patent 10,946,015

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2006290309
Brazil	PI0615898
Canada	2621273