Actelion Company Profile

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ACTELION has eight approved drugs.

There are fifteen US patents protecting ACTELION drugs.

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

International Patents:	247
US Patents:	15
Tradenames:	6
Ingredients:	6
NDAs:	8
PTAB Cases with Actelion as petitioner:	See PTAB cases with Actelion as petitioner

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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	No	8,598,227	⤷ Try a Trial				⤷ Try a Trial
Actelion	VELETRI	epoprostenol sodium	INJECTABLE;INJECTION	022260-001	Jun 27, 2008	AP2	RX	Yes	Yes	8,318,802	⤷ Try a Trial	Y			⤷ Try a Trial
Actelion	UPTRAVI	selexipag	TABLET;ORAL	207947-005	Dec 21, 2015		RX	Yes	No	10,821,108	⤷ Try a Trial	Y			⤷ Try a Trial
Actelion	TRACLEER	bosentan	TABLET, FOR SUSPENSION;ORAL	209279-001	Sep 5, 2017		RX	Yes	Yes		⤷ Try a Trial				⤷ Try a Trial
Actelion	UPTRAVI	selexipag	TABLET;ORAL	207947-005	Dec 21, 2015		RX	Yes	No	9,284,280	⤷ Try a Trial				⤷ Try a Trial
Actelion	UPTRAVI	selexipag	TABLET;ORAL	207947-002	Dec 21, 2015	AB	RX	Yes	Yes	9,284,280	⤷ Try a Trial				⤷ Try a Trial
Actelion	UPTRAVI	selexipag	TABLET;ORAL	207947-003	Dec 21, 2015	AB	RX	Yes	No	9,284,280	⤷ Try a Trial				⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

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

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

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1345920	C300672	Netherlands	⤷ Try a Trial	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	⤷ Try a Trial	PRODUCT NAME: MACITENTAN; REG. NO/DATE: EU/1/13/893 20131220
1400518	CA 2016 00048	Denmark	⤷ Try a Trial	PRODUCT NAME: SELEXIPAG ELLER ET SALT DERAF; REG. NO/DATE: EU/1/15/1083 20160519
2447254	2018015	Norway	⤷ Try a Trial	PRODUCT NAME: 2-4-(N-(5,6-DIFENYLPYRAZIN-2- YL)-N- ISOPROPYLAMINO)BUTYLOKSY-N-; REG. NO/DATE: EU/1/15/1083 20160530
1400518	44/2016	Austria	⤷ Try a Trial	PRODUCT NAME: SELEXIPAG ODER EIN SALZ DAVON; REGISTRATION NO/DATE: EU/1/15/1083 (MITTEILUNG) 20160519
1400518	132016000106856	Italy	⤷ Try a Trial	PRODUCT NAME: SELEXIPAG O UN SUO SALE(UPTRAVI); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/15/1083, 20160519
1400518	532	Finland	⤷ Try a Trial
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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