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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 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 patent family members in thirty-three countries.

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

Summary for selexipag

International Patents:	100
US Patents:	4
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	2
Suppliers / Packagers:	1
Bulk Api Vendors:	50
Clinical Trials:	17
Patent Applications:	62
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
Actelion	Phase 2/Phase 3
Actelion	Phase 4
Actelion	Phase 2

See all selexipag clinical trials

Recent Litigation for selexipag

Identify potential future generic entrants

District Court Litigation

Case Name	Date
NIPPON SHINYAKU CO., LTD. v. KAPPOS	2010-07-06

See all selexipag litigation

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-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

AC-30209

ACT 293987

ACT-293987

AK298890

AKOS024457572

B7378

BCP09146

CHEBI:90844

CHEMBL238804

CS-3774

CTK8F0123

D09994

DB11362

GTPL7552

HY-14870

KB-79567

KS-00000L89

MolPort-009-019-323

NCGC00370833-01

NS 304

NS 304; ACT 293987; Uptravi

NS-304

NS-304(Selexipag)

QXWZQTURMXZVHJ-UHFFFAOYSA-N

RT-014761

SB17055

SCHEMBL674122

Selexipag (JAN/USAN/INN)

Selexipag [USAN:INN]

Selexipag(NS-304)

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	207947-008	Dec 21, 2015		RX	Yes	Yes
Actelion Pharms Ltd	UPTRAVI	selexipag	TABLET;ORAL	207947-006	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	207947-007	Dec 21, 2015		RX	Yes	No			Y	Y
Actelion Pharms Ltd	UPTRAVI	selexipag	TABLET;ORAL	207947-006	Dec 21, 2015		RX	Yes	No
Actelion Pharms Ltd	UPTRAVI	selexipag	TABLET;ORAL	207947-002	Dec 21, 2015		RX	Yes	No			Y	Y

International Patents for selexipag

Country	Patent Number	Estimated Expiration
Japan	5956026
Norway	2447254
South Africa	201101900
Mexico	2011013471
Ukraine	108849
Denmark	2315587

Supplementary Protection Certificates for selexipag

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1400518	2016/047	Ireland		PRODUCT NAME: SELEXIPAG OR SALT THEREOF; REGISTRATION NO/DATE: EU/1/15/1083 20160512
1400518	CR 2016 00048	Denmark		PRODUCT NAME: SELEXIPAG ELLER ET SALT DERAF; REG. NO/DATE: EU/1/15/1083 20160519
1400518	1690044-1	Sweden		PRODUCT NAME: SELEXIPAG OR SALT THEROF; REG. NO/DATE: EU/1/15/1083 20160519
1400518	93266	Luxembourg		PRODUCT NAME: SELEXIPAG OU UN SEL DE CELUI-CI; FIRST REGISTRATION DATE: 20160519
1400518	16C0042	France		PRODUCT NAME: SELEXIPAG OU L'UN DE SES SELS; REGISTRATION NO/DATE: EU/1/15/1083 20160519
2447254	PA2018008	Lithuania		PRODUCT NAME: SELEKSIPAGAS; REGISTRATION NO/DATE: EU/1/15/1083 20160512