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Actelion Company Profile

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

ACTELION has seven approved drugs.

There are fourteen US patents protecting ACTELION drugs.

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

Summary for Actelion

International Patents:	240
US Patents:	14
Tradenames:	6
Ingredients:	6
NDAs:	7
Patent Litigation for Actelion:	See patent lawsuits for Actelion
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	UPTRAVI	selexipag	TABLET;ORAL	207947-005	Dec 21, 2015		RX	Yes	No	10,828,298		Y
Actelion	UPTRAVI	selexipag	TABLET;ORAL	207947-002	Dec 21, 2015		RX	Yes	Yes	8,791,122		Y	Y
Actelion	UPTRAVI	selexipag	TABLET;ORAL	207947-007	Dec 21, 2015		RX	Yes	No	9,173,881
Actelion	UPTRAVI	selexipag	TABLET;ORAL	207947-001	Dec 21, 2015		RX	Yes	No	7,205,302		Y	Y

Expired US Patents for Actelion

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Actelion	TRACLEER	bosentan	TABLET;ORAL	021290-001	Nov 20, 2001	5,292,740
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	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
China	101410119
Mexico	2011013471
Japan	5956026
Chile	2007002494

Supplementary Protection Certificates for Actelion Drugs

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1345920	132014902244514	Italy		PRODUCT NAME: MACITENTAN(OPSUMIT); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/13/893/001-002, 20131220
1400518	1690044-1	Sweden		PRODUCT NAME: SELEXIPAG OR SALT THEROF; REG. NO/DATE: EU/1/15/1083 20160519
1400518	CR 2016 00048	Denmark		PRODUCT NAME: SELEXIPAG ELLER ET SALT DERAF; REG. NO/DATE: EU/1/15/1083 20160519
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

Similar Applicant Names

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

• Actelion