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 two branded drugs marketed by Actelion, Alembic, and Zydus, and is included in four 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:	2
Applicants:	3
NDAs:	4
Drug Master File Entries:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	81
Clinical Trials:	23
Patent Applications:	490
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
Sheffield Teaching Hospitals NHS Foundation Trust	Phase 4
University of Glasgow	Phase 4
University of Sheffield	Phase 4

See all SELEXIPAG clinical trials

Generic filers with tentative approvals for SELEXIPAG

Applicant	Application No.	Strength	Dosage Form
		800MCG	TABLET;ORAL
		600MCG	TABLET;ORAL
		400MCG	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
Zydus	SELEXIPAG	selexipag	TABLET;ORAL	214302-001	Dec 21, 2022		DISCN	No	No
Actelion	UPTRAVI	selexipag	TABLET;ORAL	207947-007	Dec 21, 2015	AB	RX	Yes	No			Y
Actelion	UPTRAVI	selexipag	TABLET;ORAL	207947-004	Dec 21, 2015	AB	RX	Yes	No
Actelion	UPTRAVI	selexipag	TABLET;ORAL	207947-008	Dec 21, 2015	AB	RX	Yes	No			Y	Y

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
South Korea	20120109457	CRYSTALS
Hungary	E047767
European Patent Office	3384911	COMPOSITION PHARMACEUTIQUE CONTENANT DE LA 2-{4-[N-(5,6-DIPHÉNYLPYRAZIN-2-YL)-N-ISOPROPYLAMINO]BUTYLOXY}-N-(MÉTHYLSULFONYL)ACÉTAMIDE (PHARMACEUTICAL COMPOSITION CONTAINING 2-{4-[N-(5,6- DIPHENYLPYRAZIN-2-YL)-N-ISOPROPYLAMINO]BUTYLOXY}-N- (METHYLSULFONYL)ACETAMIDE)
Poland	2447254

Supplementary Protection Certificates for SELEXIPAG

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2447254	PA2018008	Lithuania		PRODUCT NAME: SELEKSIPAGAS; REGISTRATION NO/DATE: EU/1/15/1083 20160512
1400518	122016000077	Germany		PRODUCT NAME: SELEXIPAG ODER SALZ DAVON; REGISTRATION NO/DATE: EU/1/15/1083/001-010 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