Actelion Company Profile

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

ACTELION has eight approved drugs.

There are fifteen US patents protecting ACTELION drugs.

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

Summary for Actelion

International Patents:	245
US Patents:	15
Tradenames:	6
Ingredients:	6
NDAs:	8
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	022260-002	Jun 28, 2012	AP2	RX	Yes	Yes	8,598,227
Actelion	UPTRAVI	selexipag	TABLET;ORAL	207947-002	Dec 21, 2015		RX	Yes	Yes	10,821,108		Y
Actelion	UPTRAVI	selexipag	TABLET;ORAL	207947-008	Dec 21, 2015		RX	Yes	No	10,821,108		Y
Actelion	UPTRAVI	selexipag	TABLET;ORAL	207947-003	Dec 21, 2015		RX	Yes	No	10,821,108		Y
Actelion	UPTRAVI	selexipag	TABLET;ORAL	207947-007	Dec 21, 2015		RX	Yes	No	10,821,108		Y

Expired US Patents for Actelion

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Actelion	TRACLEER	bosentan	TABLET;ORAL	021290-002	Nov 20, 2001	5,292,740
Actelion	ZAVESCA	miglustat	CAPSULE;ORAL	021348-001	Jul 31, 2003	5,472,969
Actelion	TRACLEER	bosentan	TABLET;ORAL	021290-001	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
Japan	WO2010150865
South Korea	101473022
World Intellectual Property Organization (WIPO)	02088084
Norway	341325
Lithuania	2447254

Supplementary Protection Certificates for Actelion Drugs

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1345920	92381	Luxembourg		PRODUCT NAME: MACITENTAN ET SES DERIVES PHARMACEUTIQUEMENT ACCEPTABLES(OPSUMIT)
2447254	PA2018008,C2447254	Lithuania		PRODUCT NAME: SELEKSIPAGAS; REGISTRATION NO/DATE: EU/1/15/1083 20160512
1345920	2014C/019	Belgium		PRODUCT NAME: MACITENTAN ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; AUTHORISATION NUMBER AND DATE: EU/1/13/893 20131227
1345920	300672	Netherlands		PRODUCT NAME: MACITENTAN, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/13/893/001-003 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