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Selexipag - Generic Drug Details

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

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

Selexipag has one hundred and twenty patent family members in thirty-five countries.

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

Summary for selexipag

International Patents:	120
US Patents:	4
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	2
Suppliers / Packagers:	1
Bulk Api Vendors:	66
Clinical Trials:	22
Patent Applications:	250
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for selexipag
DailyMed Link:	selexipag at DailyMed

Recent Clinical Trials for selexipag

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

Sponsor	Phase
University of Sao Paulo General Hospital	Phase 2
Janssen-Cilag Ltd.	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 Pharms Ltd	UPTRAVI	selexipag	TABLET;ORAL	207947-004	Dec 21, 2015		RX	Yes	No
Actelion Pharms Ltd	UPTRAVI	selexipag	TABLET;ORAL	207947-006	Dec 21, 2015		RX	Yes	No
Actelion Pharms Ltd	UPTRAVI	selexipag	TABLET;ORAL	207947-005	Dec 21, 2015		RX	Yes	No			Y	Y
Actelion Pharms Ltd	UPTRAVI	selexipag	TABLET;ORAL	207947-007	Dec 21, 2015		RX	Yes	No
Actelion Pharms Ltd	UPTRAVI	selexipag	TABLET;ORAL	207947-003	Dec 21, 2015		RX	Yes	No			Y	Y
Actelion Pharms Ltd	UPTRAVI	selexipag	TABLET;ORAL	207947-001	Dec 21, 2015		RX	Yes	No

International Patents for selexipag

Country	Patent Number	Estimated Expiration
Russian Federation	2556206
South Korea	20120109457
Russian Federation	2003134190
China	104326991
Argentina	077242
Spain	2276931

Supplementary Protection Certificates for selexipag

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
1400518	16C0042	France		PRODUCT NAME: SELEXIPAG OU L'UN DE SES SELS; REGISTRATION NO/DATE: EU/1/15/1083 20160519
1400518	93266	Luxembourg		PRODUCT NAME: SELEXIPAG OU UN SEL DE CELUI-CI; FIRST REGISTRATION DATE: 20160519
1400518	1690044-1	Sweden		PRODUCT NAME: SELEXIPAG OR SALT THEROF; REG. NO/DATE: EU/1/15/1083 20160519
1400518	132016000106856	Italy		PRODUCT NAME: SELEXIPAG O UN SUO SALE(UPTRAVI); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/15/1083, 20160519
1400518	122016000077	Germany		PRODUCT NAME: SELEXIPAG ODER SALZ DAVON; REGISTRATION NO/DATE: EU/1/15/1083/001-010 20160512