UPTRAVI Drug Patent Profile

Which patents cover Uptravi, and what generic alternatives are available?

Uptravi is a drug marketed by Actelion and is included in two NDAs. There are six patents protecting this drug and two Paragraph IV challenges.

This drug has one hundred and fifty-one patent family members in thirty-eight countries.

The generic ingredient in UPTRAVI is selexipag. There are two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the selexipag profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Uptravi

A generic version of UPTRAVI was approved as selexipag by ALEMBIC on October 11^th, 2023.

Summary for UPTRAVI

International Patents:	151
US Patents:	6
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	81
Clinical Trials:	4
Patent Applications:	216
Drug Prices:	Drug price information for UPTRAVI
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for UPTRAVI
What excipients (inactive ingredients) are in UPTRAVI?	UPTRAVI excipients list
DailyMed Link:	UPTRAVI at DailyMed

See drug prices for UPTRAVI

Recent Clinical Trials for UPTRAVI

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

Sponsor	Phase
University of Newcastle Upon-Tyne	Phase 4
Sheffield Teaching Hospitals NHS Foundation Trust	Phase 4
University of Glasgow	Phase 4

See all UPTRAVI clinical trials

Pharmacology for UPTRAVI

Drug Class	Prostacyclin Receptor Agonist
Mechanism of Action	Prostacyclin Receptor Agonists

Paragraph IV (Patent) Challenges for UPTRAVI

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 UPTRAVI

UPTRAVI is protected by six US patents.

Patents protecting UPTRAVI

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	207947-007	Dec 21, 2015	AB	RX	Yes	No
Actelion	UPTRAVI	selexipag	TABLET;ORAL	207947-005	Dec 21, 2015		RX	Yes	No			Y
Actelion	UPTRAVI	selexipag	TABLET;ORAL	207947-008	Dec 21, 2015	AB	RX	Yes	No
Actelion	UPTRAVI	selexipag	TABLET;ORAL	207947-007	Dec 21, 2015	AB	RX	Yes	No			Y
Actelion	UPTRAVI	selexipag	TABLET;ORAL	207947-008	Dec 21, 2015	AB	RX	Yes	No			Y
Actelion	UPTRAVI	selexipag	TABLET;ORAL	207947-004	Dec 21, 2015	AB	RX	Yes	No			Y	Y
Actelion	UPTRAVI	selexipag	TABLET;ORAL	207947-005	Dec 21, 2015		RX	Yes	No			Y

EU/EMA Drug Approvals for UPTRAVI

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 UPTRAVI

When does loss-of-exclusivity occur for UPTRAVI?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Australia

Brazil

Canada

Chile

China

Colombia

Croatia

Cyprus

Denmark

Ecuador

European Patent Office

Hong Kong

Hungary

Israel

Japan

Lithuania

Malaysia

Mexico

Morocco

New Zealand

Norway

Peru

Philippines

Poland

Portugal

Russian Federation

Singapore

Slovenia

South Africa

South Korea

Spain

Taiwan

Ukraine

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering UPTRAVI around the world.

Country	Patent Number	Title	Estimated Expiration
Japan	2015180683	マシテンタン含有治療用組成物 (THERAPEUTIC COMPOSITIONS CONTAINING MACITENTAN)
Croatia	P20192204
Portugal	3300729
Japan	2015187148	マシテンタン含有治療用組成物 (THERAPEUTIC COMPOSITIONS CONTAINING MACITENTAN)
Mexico	2011013471	CRISTALES. (CRYSTALS.)
Israel	259461	תכשיר רוקחות המכיל 2-{4-[n-(6,5-דיפנילפיראזין-2-איל)-n-איזופרופילאמינו]בוטילאוקסי}-n-(מתילסולפוניל)אצטאמיד (Pharmaceutical composition containing 2-{4-[n-(5,6- diphenylpyrazin-2-yl)-n-isopropylamino]butyloxy}-n- (methylsulfonyl)acetamide)
Canada	2764475	CRISTAUX (CRYSTALS)

Supplementary Protection Certificates for UPTRAVI

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
2447254	C20180012 00263	Estonia		PRODUCT NAME: SELEKSIPAAG;REG NO/DATE: EU/1/15/1083 19.05.2016
2447254	325 10-2018	Slovakia		PRODUCT NAME: SELEXIPAG; REGISTRATION NO/DATE: EU/1/15/1083 20160519
2447254	PA2018008,C2447254	Lithuania		PRODUCT NAME: SELEKSIPAGAS; REGISTRATION NO/DATE: EU/1/15/1083 20160512
1400518	300836	Netherlands		PRODUCT NAME: SELEXIPAG OF EEN ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/15/1083 20160519
2447254	PA2018008	Lithuania		PRODUCT NAME: SELEKSIPAGAS; REGISTRATION NO/DATE: EU/1/15/1083 20160512
1400518	44/2016	Austria		PRODUCT NAME: SELEXIPAG ODER EIN SALZ DAVON; REGISTRATION NO/DATE: EU/1/15/1083 (MITTEILUNG) 20160519