Actelion Company Profile

What is the competitive landscape for ACTELION, and when can generic versions of ACTELION drugs launch?

ACTELION has nine approved drugs.

There are fifteen US patents protecting ACTELION drugs.

There are two hundred and fifty patent family members on ACTELION drugs in thirty-nine countries and thirty-four supplementary protection certificates in seventeen countries.

Summary for Actelion

International Patents:	250
US Patents:	15
Tradenames:	7
Ingredients:	7
NDAs:	9
PTAB Cases with Actelion as petitioner:	See PTAB cases with Actelion as petitioner

Drugs and US Patents for Actelion

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Actelion	VELETRI	epoprostenol sodium	INJECTABLE;INJECTION	022260-001	Jun 27, 2008	AP2	RX	Yes	Yes	8,318,802		Y
Actelion	OPSYNVI	macitentan; tadalafil	TABLET;ORAL	218490-001	Mar 22, 2024		RX	Yes	No
Actelion	UPTRAVI	selexipag	TABLET;ORAL	207947-006	Dec 21, 2015		RX	Yes	No	9,173,881
Actelion	UPTRAVI	selexipag	TABLET;ORAL	207947-006	Dec 21, 2015		RX	Yes	No	7,205,302		Y	Y
Actelion	UPTRAVI	selexipag	TABLET;ORAL	207947-001	Dec 21, 2015	AB	RX	Yes	No	8,791,122		Y	Y
Actelion	VENTAVIS	iloprost	SOLUTION;INHALATION	021779-001	Dec 29, 2004		DISCN	No	No

Expired US Patents for Actelion

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Actelion	ZAVESCA	miglustat	CAPSULE;ORAL	021348-001	Jul 31, 2003	5,472,969
Actelion	TRACLEER	bosentan	TABLET;ORAL	021290-001	Nov 20, 2001	5,292,740
Actelion	TRACLEER	bosentan	TABLET;ORAL	021290-002	Nov 20, 2001	5,292,740
Actelion	ZAVESCA	miglustat	CAPSULE;ORAL	021348-001	Jul 31, 2003	5,525,616

Paragraph IV (Patent) Challenges for ACTELION drugs

Drugname	Dosage	Strength	Tradename	Submissiondate
	Tablets	10 mg		2017-10-18
	for Oral Suspension	32 mg		2019-02-08

International Patents for Actelion Drugs

Country	Patent Number	Estimated Expiration
Norway	2018015
Hungary	E036071
Mexico	2011013471
Canada	3005169
Poland	2059246
Russian Federation	2735547

Supplementary Protection Certificates for Actelion Drugs

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1345920	1490025-2	Sweden		PRODUCT NAME: MACITENTAN; REG. NO/DATE: EU/1/13/893 20131220
1345920	2014C/019	Belgium		PRODUCT NAME: MACITENTAN ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; AUTHORISATION NUMBER AND DATE: EU/1/13/893 20131227
1345920	2014/018	Ireland		PRODUCT NAME: MACITENTAN, THE STEREOISOMERS AND THE PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF.; REGISTRATION NO/DATE: EU/1/13/893 20131220
0526708	0290017-3	Sweden		PRODUCT NAME: BOSENTAN ELLER ETT SALT DAERAV; NAT. REGISTZRATION NO/DATE: EU/1/02/220/001 20020515; FIRST REGISTRATION: CH 55841 01 20020228
1345920	C01345920/01	Switzerland		PRODUCT NAME: MACITENTAN; REGISTRATION NO/DATE: SWISSMEDIC 61863 06.02.2014
2447254	2018015	Norway		PRODUCT NAME: 2-4-(N-(5,6-DIFENYLPYRAZIN-2- YL)-N- ISOPROPYLAMINO)BUTYLOKSY-N-; REG. NO/DATE: EU/1/15/1083 20160530

Similar Applicant Names

Applicants may be listed under multiple names.
Here is a list of applicants with similar names.

• Actelion