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Selexipag - Generic Drug Details

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What are the generic drug sources for selexipag and what is the scope of freedom to operate?

Selexipag is the generic ingredient in one branded drug marketed by Actelion and is included in one NDA. There are six patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Selexipag has one hundred and forty-one patent family members in thirty-seven countries.

There are two drug master file entries for selexipag. One supplier is listed for this compound.

Summary for selexipag

International Patents:	141
US Patents:	6
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	66
Clinical Trials:	22
Patent Applications:	479
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for selexipag
What excipients (inactive ingredients) are in selexipag?	selexipag excipients list
DailyMed Link:	selexipag at DailyMed

Recent Clinical Trials for selexipag

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Janssen-Cilag Ltd.	Phase 2
University of Sao Paulo General Hospital	Phase 2
Janssen Research & Development, LLC	Phase 3

See all selexipag clinical trials

Pharmacology for selexipag

Drug Class	Prostacyclin Receptor Agonist
Mechanism of Action	Prostacyclin Receptor Agonists

Paragraph IV (Patent) Challenges for SELEXIPAG

Tradename	Dosage	Ingredient	NDA	Submissiondate
UPTRAVI	TABLET;ORAL	selexipag	207947	2019-12-23

US Patents and Regulatory Information for selexipag

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	207947-008	Dec 21, 2015		RX	Yes	No
Actelion	UPTRAVI	selexipag	TABLET;ORAL	207947-005	Dec 21, 2015		RX	Yes	No
Actelion	UPTRAVI	selexipag	TABLET;ORAL	207947-003	Dec 21, 2015		RX	Yes	No			Y	Y
Actelion	UPTRAVI	selexipag	TABLET;ORAL	207947-008	Dec 21, 2015		RX	Yes	No
Actelion	UPTRAVI	selexipag	TABLET;ORAL	207947-004	Dec 21, 2015		RX	Yes	No			Y
Actelion	UPTRAVI	selexipag	TABLET;ORAL	207947-001	Dec 21, 2015		RX	Yes	No

International Patents for selexipag

Country	Patent Number	Estimated Expiration
Australia	2009280843
Russian Federation	2011109084
Argentina	073031
Japan	4479152
South Africa	201109099
Singapore	11201804320Q

Supplementary Protection Certificates for selexipag

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1400518	44/2016	Austria		PRODUCT NAME: SELEXIPAG ODER EIN SALZ DAVON; REGISTRATION NO/DATE: EU/1/15/1083 (MITTEILUNG) 20160519
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
2447254	PA2018008	Lithuania		PRODUCT NAME: SELEKSIPAGAS; REGISTRATION NO/DATE: EU/1/15/1083 20160512
2447254	C20180012 00263	Estonia		PRODUCT NAME: SELEKSIPAAG;REG NO/DATE: EU/1/15/1083 19.05.2016
1400518	300836	Netherlands		PRODUCT NAME: SELEXIPAG OF EEN ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/15/1083 20160519
1400518	532	Finland