Selexipag - Generic Drug Details

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 and is included in two NDAs. There are six patents protecting this compound. Additional information is available in the individual branded drug profile pages.

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

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

Summary for selexipag

International Patents:	148
US Patents:	6
Tradenames:	1
Applicants:	1
NDAs:	2
Drug Master File Entries:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	74
Clinical Trials:	22
Patent Applications:	619
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

Generic filers with tentative approvals for SELEXIPAG

Applicant	Application No.	Strength	Dosage Form
		1600MCG	TABLET;ORAL
		1400MCG	TABLET;ORAL
		1200MCG	TABLET;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for selexipag

Drug Class	Prostacyclin Receptor Agonist
Mechanism of Action	Prostacyclin Receptor Agonists

Paragraph IV (Patent) Challenges for SELEXIPAG

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
UPTRAVI	For Injection	selexipag	1.8 mg/vial	214275	1	2022-07-29
UPTRAVI	Tablets	selexipag	0.2 mg, 0.4 mg, 0.6 mg, 0.8 mg, 1 mg, 1.2 mg, 1.4 mg and 1.6 mg	207947	4	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	207947-002	Dec 21, 2015		RX	Yes	Yes
Actelion	UPTRAVI	selexipag	TABLET;ORAL	207947-007	Dec 21, 2015		RX	Yes	No			Y	Y
Actelion	UPTRAVI	selexipag	TABLET;ORAL	207947-008	Dec 21, 2015		RX	Yes	No			Y
Actelion	UPTRAVI	selexipag	TABLET;ORAL	207947-004	Dec 21, 2015		RX	Yes	No			Y	Y
Actelion	UPTRAVI	selexipag	TABLET;ORAL	207947-002	Dec 21, 2015		RX	Yes	Yes			Y
Actelion	UPTRAVI	selexipag	TABLET;ORAL	207947-001	Dec 21, 2015		RX	Yes	No
Actelion	UPTRAVI	selexipag	TABLET;ORAL	207947-006	Dec 21, 2015		RX	Yes	No

EU/EMA Drug Approvals for selexipag

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Janssen Cilag International NV	Uptravi	selexipag	EMEA/H/C/003774 Uptravi is indicated for the long-term treatment of pulmonary arterial hypertension (PAH) in adult patients with WHO functional class (FC) II–III, either as combination therapy in patients insufficiently controlled with an endothelin receptor antagonist (ERA) and/or a phosphodiesterase type 5 (PDE-5) inhibitor, or as monotherapy in patients who are not candidates for these therapies., , Efficacy has been shown in a PAH population including idiopathic and heritable PAH, PAH associated with connective tissue disorders, and PAH associated with corrected simple congenital heart disease.,	Authorised	no	no	no	2016-05-12

International Patents for selexipag

Country	Patent Number	Title	Estimated Expiration
Japan	WO2017098998	２−｛４−［Ｎ−（５，６−ジフェニルピラジン−２−イル）−Ｎ−イソプロピルアミノ］ブチルオキシ｝−Ｎ−（メチルスルホニル）アセトアミドを含有する医薬組成物
Russian Federation	2556206	КРИСТАЛЛЫ (CRYSTALS)
Denmark	2315587
South Korea	20110045006
Taiwan	I446911
World Intellectual Property Organization (WIPO)	2017098998
China	104326991	CRYSTALs

Supplementary Protection Certificates for selexipag

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1400518	132016000106856	Italy		PRODUCT NAME: SELEXIPAG O UN SUO SALE(UPTRAVI); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/15/1083, 20160519
2447254	PA2018008,C2447254	Lithuania		PRODUCT NAME: SELEKSIPAGAS; REGISTRATION NO/DATE: EU/1/15/1083 20160512
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	122016000077	Germany		PRODUCT NAME: SELEXIPAG ODER SALZ DAVON; REGISTRATION NO/DATE: EU/1/15/1083/001-010 20160512
1400518	CA 2016 00048	Denmark		PRODUCT NAME: SELEXIPAG ELLER ET SALT DERAF; REG. NO/DATE: EU/1/15/1083 20160519
2447254	325 10-2018	Slovakia		PRODUCT NAME: SELEXIPAG; REGISTRATION NO/DATE: EU/1/15/1083 20160519