UPTRAVI Drug Patent Profile

When do Uptravi patents expire, 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 seventy-seven patent family members in forty-two countries.

The generic ingredient in UPTRAVI is selexipag. There are two drug master file entries for this compound. Three suppliers are 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:	177
US Patents:	6
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	78
Clinical Trials:	5
Patent Applications:	466
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
Humanis Saglk Anonim Sirketi	PHASE1
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.

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

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/003774Uptravi 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

Finland

Hong Kong

Hungary

Israel

Japan

Lithuania

Malaysia

Mexico

Morocco

New Zealand

Norway

Peru

Philippines

Poland

Portugal

Russian Federation

San Marino

Saudi Arabia

Serbia

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
Cyprus	1122893
European Patent Office	3300729
China	102459198
Croatia	P20171917

Supplementary Protection Certificates for UPTRAVI

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1400518	CR 2016 00048	Denmark		PRODUCT NAME: SELEXIPAG ELLER ET SALT DERAF; REG. NO/DATE: EU/1/15/1083 20160519
1400518	CA 2016 00048	Denmark		PRODUCT NAME: SELEXIPAG ELLER ET SALT DERAF; REG. NO/DATE: EU/1/15/1083 20160519
1400518	16C0042	France		PRODUCT NAME: SELEXIPAG OU L'UN DE SES SELS; REGISTRATION NO/DATE: EU/1/15/1083 20160519
2447254	325 10-2018	Slovakia		PRODUCT NAME: SELEXIPAG; REGISTRATION NO/DATE: EU/1/15/1083 20160519

Market Dynamics and Financial Trajectory for Uptravi (Selexipag)

Last updated: July 27, 2025

Introduction

Uptravi (selexipag), developed and marketed by Actelion Pharmaceuticals (a Johnson & Johnson company), has established itself as a pivotal oral therapy for pulmonary arterial hypertension (PAH). Since its approval by the U.S. Food and Drug Administration (FDA) in 2015, Uptravi’s market performance and financial trajectory have been shaped by a confluence of clinical efficacy, evolving treatment landscapes, and competitive dynamics. This analysis explores the market forces influencing Uptravi’s growth and forecasts its financial prospects within the broader PAH therapeutics market.

Market Landscape for Pulmonary Arterial Hypertension

PAH remains a rare, life-threatening condition characterized by progressive vascular remodeling leading to right heart failure. The global PAH therapeutics market is projected to reach USD 6.3 billion by 2030, driven by increasing prevalence, better diagnostic capabilities, and expanding treatment indications (1). The market comprises multiple drug classes, including endothelin receptor antagonists (ERAs), phosphodiesterase-5 inhibitors (PDE5i), prostacyclins, and selective prostacyclin receptor agonists.

Position of Uptravi
As an oral, selective prostacyclin receptor agonist, Uptravi offers a unique mode of action, targeting prostacyclin pathways to induce vasodilation and inhibit vascular remodeling. Its oral formulation provides a convenient alternative to infusions or inhaled therapies, addressing adherence issues associated with invasive routes—further consolidating its market visibility (2).

Market Dynamics Influencing Uptravi

1. Clinical Efficacy and Safety Profile

Uptravi demonstrated significant efficacy in delaying disease progression and improving functional class in PAH patients, with a manageable safety profile (3). Robust Phase III data have positioned it favorably among combination regimens and monotherapy options. The clinical advantage of oral administration has expanded its adoption, especially for patients who prefer non-invasive therapies.

2. Competitive Landscape

Uptravi faces competition from established prostacyclins like Remodulin (treprostinil), Flolan (epoprostenol), and newer agents like Olumiant (baricitinib) in broader PAH management. Nonetheless, its oral delivery distinguishes it in outpatient settings, especially when combined with other targeted therapies.

Emerging therapies, including tissue engineering and gene-based treatments, could challenge its market share in the long term, though their clinical readiness remains uncertain.

3. Regulatory and Pricing Strategies

Pricing remains a critical factor influencing market penetration. Uptravi's list price has been justified by its clinical benefits, but reimbursement pressures and healthcare cost containment measures globally could temper growth. Actelion/J&J's strategic negotiations with payers aim to optimize access without significantly eroding margins.

4. Geographic Expansion and Market Penetration

Initially launched in North America and Europe, Uptravi’s expansion into Asia-Pacific and other emerging markets presents growth opportunities. Local health authorities’ approval processes, economic factors, and disease awareness are drivers or barriers to rapid adoption.

5. Adoption Trends and Treatment Guidelines

Recent PAH management guidelines increasingly favor early combination therapy, including upfront use of oral prostacyclins like Uptravi (4). This shift enhances its utilization, particularly in intermediate-risk patients, boosting sales.

Financial Trajectory and Investment Outlook

Revenue Growth Trajectory

Since its launch, Uptravi’s sales have experienced a consistent upward march. According to Johnson & Johnson's financial disclosures, Uptravi generated approximately USD 1.36 billion in global net sales in 2022, representing roughly a 25% year-over-year increase (5). This growth reflects increased patient access, expanded indications, and higher adoption rates within clinical practice.

Market Penetration and Market Share

Uptravi continues to secure a substantial share in the oral PAH therapy segment. While exact figures fluctuate due to competitive dynamics, estimates suggest Uptravi commands over 40% of the oral prostacyclin market segment in developed countries (6). Its penetration is projected to grow further, driven by ongoing clinical validation and broader guideline endorsement.

Pipeline and Lifecycle Management

Actelion/J&J continues to explore new combinations and indications for Uptravi, including potential use in pediatric populations and other pulmonary hypertensive disorders. These initiatives could extend Uptravi’s lifecycle and diversify revenue streams.

Financial Risks and Opportunities

Risks include patent expiries in key markets in the next five years, potential emergence of superior therapies, and pricing pressures. Conversely, opportunities arise from expanding indications, optimizing patient adherence, and emerging markets' access. Strategic partnerships and continued clinical innovation are vital to sustaining its financial trajectory.

Future Outlook and Market Drivers

• The shift towards early combination therapy will continue to favor Uptravi, especially in high-risk patients.
• Growing awareness and improved diagnostic methods will expand the PAH diagnosed population.
• Geographical expansion into underpenetrated markets will accelerate revenue growth.
• Competitive innovations may pressure margins but also catalyze value-based pricing models.

Based on current trends, analysts project Uptravi’s compound annual growth rate (CAGR) to remain robust at approximately 10-12% through 2028, driven by increased adoption, geographic expansion, and pipeline development (7).

Regulatory and Policy Impact

Policy changes emphasizing cost-effectiveness and access reforms could influence Uptravi’s pricing and reimbursement landscape. Additionally, accelerated approval pathways for related therapies could reshape competitive timing.

Key Takeaways

• Uptravi’s oral administration offers a strategic advantage in PAH management, fostering consistent revenue growth.
• Clinical data supporting its efficacy and safety bolster its position but are vulnerable to emerging alternatives.
• Market expansion in emerging regions and guideline-driven adoption will sustain sales momentum.
• Patent protections and lifecycle strategies are crucial amidst impending patent expirations.
• The ongoing clinical development pipeline offers avenues to prolong Uptravi’s market dominance.

Conclusion

Uptravi’s market viability hinges on strategic integration into evolving PAH treatment algorithms, geographical expansion, and innovation management. Its financial trajectory reflects a resilient growth pattern, underpinned by clinical benefits and strategic deployment. Stakeholders should closely monitor patent landscapes, regulatory pathways, and competitive advances to capitalize on Uptravi’s full commercial potential.

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FAQs

Q1: How does Uptravi differentiate itself from other PAH therapies?

A1: Uptravi’s oral, selective prostacyclin receptor agonist profile provides a non-invasive, convenient treatment option, distinguishing it from infusion- or inhalation-based prostacyclins. Its targeted mechanism offers efficacy with manageable safety, facilitating combination therapies.

Q2: What factors drive Uptravi’s revenue growth?

A2: Key drivers include expanding indications aligned with clinical guidelines, increased diagnosis rates, geographic expansion, and patient preference for oral therapies, coupled with strategic market access initiatives.

Q3: What are the main competitive threats to Uptravi?

A3: Emerging therapies with superior efficacy, biosimilars post-patent expiry, and novel treatment modalities such as gene therapies could challenge Uptravi’s market share.

Q4: How does treatment guideline evolution impact Uptravi’s adoption?

A4: Guidelines favoring early combination therapy and oral prostacyclin integration improve Uptravi’s inclusion in treatment regimens, boosting its utilization.

Q5: What strategic initiatives are essential for Uptravi’s prolonged market success?

A5: Continued clinical development, geographical market penetration, lifecycle management (e.g., new formulations or indications), and value-based pricing are essential to sustain its growth trajectory.

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Sources

1. Grand View Research. Pulmonary Arterial Hypertension Market Size & Trends. 2022.
2. Johnson & Johnson. Uptravi (selexipag) prescribing information. 2022.
3. Galiè N, et al. "Initial use of ambrisentan plus tadalafil in pulmonary arterial hypertension." NEJM. 2020.
4. Galiè N, et al. "2022 ESC/ERS Guidelines for the diagnosis and treatment of pulmonary hypertension." Eur Heart J. 2022.
5. Johnson & Johnson Annual Report 2022.
6. Evaluate Pharma. PAH Therapeutics Market Analysis. 2022.
7. MarketWatch. Pulmonary Arterial Hypertension Drugs Market Forecast. 2023.