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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 selexipag 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 eighty-three patent family members in twenty-eight countries.

There is one drug master file entry for selexipag. One supplier is listed for this compound.

Summary for selexipag

International Patents:	83
US Patents:	4
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	1
Suppliers / Packagers:	1
Bulk Api Vendors:	36
Clinical Trials:	13
Patent Applications:	46
DailyMed Link:	selexipag at DailyMed

Pharmacology for selexipag

Drug Class	Prostacyclin Receptor Agonist
Mechanism of Action	Prostacyclin Receptor Agonists

Synonyms for selexipag

144383-EP2289518A1

144383-EP2292231A1

2-?[4-?[(5,?6-?DIPHENYLPYRAZINYL)(1-?METHYLETHYL)AMINO]BUTOXY]-?N-?(METHYLSULFONYL)-?ACETAMIDE

2-(4-((5,6-diphenylpyrazin-2-yl)(isopropyl)amino)butoxy)-N-(methylsulfonyl)acetamide

2-(4-((5,6-Diphenylpyrazin-2-yl)(propan-2-yl)amino)butoxy}-n-(methanesulfonyl)acetamide

2-(4-((5,6-Diphenylpyrazinyl)(1-methylethyl)amino)butoxy)-N-(methylsulfonyl)-acetamide

2-[4-[(5,6-Diphenyl-2-pyrazinyl)(1-methylethyl)amino]butoxy]-N-(methylsulfonyl)acetamide

2-[4-[[5,6-di(phenyl)pyrazin-2-yl]-propan-2-ylamino]butoxy]-N-methylsulfonylacetamide

2-{4-[(5,6-diphenylpyrazin-2-yl)(propan-2-yl)amino]butoxy}-N-(methanesulfonyl)acetamide

2-{4-[(5,6-diphenylpyrazin-2-yl)(propan-2-yl)amino]butoxy}-N-methanesulfonylacetamide

2-{4-[N-(5,6-diphenylpyrazin-2-yl)-N-isopropylamino]butyloxy}-N-(methylsulfonyl)acetamide

3938AH

475086-01-2

5EXC0E384L

ACT 293987

ACT-293987

ACT293987

AK298890

AKOS024457572

B7378

CHEBI:90844

CHEMBL238804

CS-3774

CTK8F0123

D09994

D0N2SR

DB11362

GTPL7552

HE092855

HY-14870

IN2104

KB-79567

KS-00000L89

MFCD10567093

MolPort-009-019-323

NS 304

NS-304

NS-304(Selexipag)

QXWZQTURMXZVHJ-UHFFFAOYSA-N

RT-014761

SCHEMBL674122

Selexipag (JAN/USAN/INN)

Selexipag [USAN:INN]

UNII-5EXC0E384L

Uptravi

Uptravi (TN)

ZINC3990451

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	207947-003	Dec 21, 2015		RX	Yes	No
Actelion Pharms Ltd	UPTRAVI	selexipag	TABLET;ORAL	207947-005	Dec 21, 2015		RX	Yes	No
Actelion Pharms Ltd	UPTRAVI	selexipag	TABLET;ORAL	207947-004	Dec 21, 2015		RX	Yes	No			Y	Y
Actelion Pharms Ltd	UPTRAVI	selexipag	TABLET;ORAL	207947-002	Dec 21, 2015		RX	Yes	No

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Non-Orange Book US Patents for selexipag

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No.	Title	Estimated Patent Expiration
8,809,334	Therapeutic compositions containing macitentan
9,597,331	Therapeutic compositions containing macitentan
9,340,516	Form-II crystal of 2-{4-[N-(5,6-diphenylpyrazin-2-yl)-N-isopropylamino]butyloxy}-N-(methylsu- lfonyl) acetamide, method for producing the same, and use thereof
9,440,931	Form-III crystal of 2-{4-[N-(5,6-diphenylpyrazin-2-yl)-N-isopropylamino]butyloxy}-N-(methylsu- lfonyl)acetamide and use thereof

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International Patents for selexipag

Country	Document Number	Estimated Expiration
Argentina	073031
Japan	2011530581
South Korea	20040015174
Canada	2764475

Supplementary Protection Certificates for selexipag

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
C0042	France		PRODUCT NAME: SELEXIPAG OU L'UN DE SES SELS; REGISTRATION NO/DATE: EU/1/15/1083 20160519
266	Luxembourg		PRODUCT NAME: SELEXIPAG OU UN SEL DE CELUI-CI; FIRST REGISTRATION DATE: 20160519
16/047	Ireland		PRODUCT NAME: SELEXIPAG OR SALT THEREOF; REGISTRATION NO/DATE: EU/1/15/1083 20160512
2016 00048	Denmark		PRODUCT NAME: SELEXIPAG ELLER ET SALT DERAF; REG. NO/DATE: EU/1/15/1083 20160519