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	OPSUMIT	macitentan	TABLET;ORAL	204410-001	Oct 18, 2013		RX	Yes	Yes	8,367,685		Y
Actelion	UPTRAVI	selexipag	TABLET;ORAL	207947-004	Dec 21, 2015	AB	RX	Yes	No	9,284,280
Actelion	UPTRAVI	selexipag	TABLET;ORAL	207947-007	Dec 21, 2015	AB	RX	Yes	No	9,173,881
Actelion	UPTRAVI	selexipag	TABLET;ORAL	207947-002	Dec 21, 2015	AB	RX	Yes	Yes	10,828,298		Y
Actelion	UPTRAVI	selexipag	TABLET;ORAL	207947-003	Dec 21, 2015	AB	RX	Yes	No	7,205,302		Y	Y
Actelion	UPTRAVI	selexipag	TABLET;ORAL	207947-003	Dec 21, 2015	AB	RX	Yes	No	9,173,881

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	021290-002	Nov 20, 2001	5,292,740
Actelion	TRACLEER	bosentan	TABLET;ORAL	021290-001	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
	for Oral Suspension	32 mg		2019-02-08
	Tablets	10 mg		2017-10-18

International Patents for Actelion Drugs

Country	Patent Number	Estimated Expiration
Denmark	2315587
Mexico	2018006343
Japan	WO2010150865
Portugal	1345920
Portugal	2447254
Malaysia	154591

Supplementary Protection Certificates for Actelion Drugs

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1345920	502	Finland
2447254	C20180012 00263	Estonia		PRODUCT NAME: SELEKSIPAAG;REG NO/DATE: EU/1/15/1083 19.05.2016
0526708	C300097	Netherlands		PRODUCT NAME: BOSENTAN, DESGEWENST IN DE VORM VAN EEN ZOUT OF EEN HYDRAAT OF IN DE VORM VAN EEN ESTER VAN DE HYDROXYLGROEP VAN DE 2-HYDROXYETHOXY REST MET EEN ZUUR MET DE FORMULE R5-OH, WAARIN R5 EEN C1-7-ALKANOYL, BENZOYL, OF HETEROCYCLYCARBONYL VOORSTELT; NATL. REGISTRATION NO/DATE: U/1/02/220/001 - 005 20020515; FIRST REGISTRATION: CH IKS 58841 01 - 02 20020228
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
1345920	SPC/GB14/018	United Kingdom		PRODUCT NAME: MACITENTAN, WHICH IS N-(5-(4-BROMOPHENYL)-6-(2((5-BROMOPYRIMIDIN-2-YL)OXY)ETHOXY)PYRIMIDIN-4-YL)-N'-PROPYLSULFURIC DIAMIDE; REGISTERED: UK EU/1/13/893 20131220
1345920	1490025-2	Sweden		PRODUCT NAME: MACITENTAN; REG. NO/DATE: EU/1/13/893 20131220

Similar Applicant Names

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

• Actelion