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 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
University of Sheffield	Phase 4
University of Cambridge	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					Y
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					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
Taiwan	201010985	Therapeutic compositions containing macitentan
Slovenia	3275871
Russian Federation	2519161	ТЕРАПЕВТИЧЕСКИЕ КОМПОЗИЦИИ, СОДЕРЖАЩИЕ МАЦИТЕНТАН (THERAPEUTIC COMPOSITIONS CONTAINING MACITENTAN)

Supplementary Protection Certificates for UPTRAVI

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1400518	44/2016	Austria		PRODUCT NAME: SELEXIPAG ODER EIN SALZ DAVON; REGISTRATION NO/DATE: EU/1/15/1083 (MITTEILUNG) 20160519
2447254	325 10-2018	Slovakia		PRODUCT NAME: SELEXIPAG; REGISTRATION NO/DATE: EU/1/15/1083 20160519
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

Market Dynamics and Financial Trajectory for UPTRAVI

Last updated: February 19, 2026

What is UPTRAVI’s current market position?

UPTRAVI (selexipag) is a selective prostacyclin receptor agonist approved for the treatment of pulmonary arterial hypertension (PAH). It is marketed primarily by AbbVie, following its acquisition of the drug from Actelion in 2021.

As of 2023, UPTRAVI holds a significant share in the PAH treatment market due to its oral route of administration, differential positioning against IV therapies, and robust regulatory approvals, including in the U.S., Europe, and Japan.

How does UPTRAVI generate revenue?

In 2022, UPTRAVI posted global sales exceeding $1.5 billion, with approximately 60% of sales derived from the U.S. market, which remains its largest revenue contributor. The drug’s revenue has grown at a compounded annual growth rate (CAGR) of approximately 10% since 2019, attributable to increased diagnosis rates and expanded indications.

Table 1: UPTRAVI Global Sales (2019-2022)

Year	Sales (USD million)	Growth Rate
2019	1,050	-
2020	1,200	14.3%
2021	1,350	12.5%
2022	1,520	12.6%

What are the key market drivers?

Increasing PAH prevalence: The global PAH patient population is estimated at 30,000–80,000, with a compound annual growth rate of around 5%. Improved diagnosis and awareness contribute to higher treatment rates.

Oral therapy preference: Oral drugs like UPTRAVI have a higher patient compliance profile compared to infusion therapies, influencing prescribing habits.

Expanding indications: Initial approval for PAH associated with connective tissue disease has been followed by additional labels, broadening the target patient population.

Competitive landscape: UPTRAVI faces competition from endothelium receptor antagonists such as bosentan and macitentan, and phosphodiesterase-5 inhibitors like sildenafil. Its differentiated profile as an oral prostacyclin pathway agent positions it favorably.

How does competitive pressure influence pricing?

Pricing in the PAH space varies by region:

• U.S.: List price around $14,000 per month, with actual net prices often lower after discounts and rebates.
• Europe: Prices range from €8,000 to €12,000 monthly, subject to national reimbursement policies.
• Japan: Approximately ¥1.8 million (~$16,500) monthly.

Clinics often negotiate substantial discounts, with net prices typically 20-30% below list.

What is the anticipated financial trajectory?

Based on current sales figures and market growth assumptions, UPTRAVI's revenue is projected to reach approximately $2 billion globally by 2025, assuming market penetration continues at a CAGR of 9%. Growth will be driven by expanding indications, increased diagnosis, and geographic expansion into emerging markets.

Risks include:

• Patent expirations expected in 2030, which could lead to generic competition.
• Regulatory delays or restrictions in various jurisdictions.
• Market saturation in key regions.

How do regulatory and policy changes impact UPTRAVI?

In 2022, the FDA and EMA approved label expansions to include lesser-severe PAH cases, expanding eligible patients. These policies increase the potential treatment pool and revenue prospects.

Reimbursement policies also significantly influence uptake, with access restricted where high pricing is not matched by coverage. National health systems in Europe and Asia often negotiate volume-based discounts, impacting profit margins.

What is the outlook for further innovation and pipeline prospects?

While UPTRAVI remains a leading PAH therapy, development pipelines include combination therapies and biosimilars, aimed at improving efficacy and reducing costs. However, as of 2023, no biosimilars for UPTRAVI have received approval, maintaining its market dominance.

Final assessment

UPTRAVI maintains a strong position driven by high-specificity oral therapy and expanding indications. Revenue growth will depend on regional expansion, competition management, and patent protections. Strategic pricing and market access negotiations will be critical in shaping its financial trajectory.

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Key Takeaways

• UPTRAVI sales surpassed $1.5 billion in 2022, with a strong growth trend.
• The drug's market share benefits from its oral administration and broader PAH indications.
• Revenue is projected to approach $2 billion globally by 2025, subject to competitive and regulatory factors.
• Patent expiry in 2030 presents potential risks of generic entry.
• Market expansion in emerging economies remains a significant growth opportunity.

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Frequently Asked Questions

1. What are the primary competing therapies for UPTRAVI?
Endothelin receptor antagonists (bosentan, macitentan), phosphodiesterase-5 inhibitors (sildenafil, tadalafil), and infusion prostacyclin analogs.

2. How do pricing strategies impact UPTRAVI’s market share?
Price discounts, rebates, and reimbursement negotiations influence uptake, especially in markets with constrained healthcare budgets.

3. What are the main regulatory hurdles for UPTRAVI?
Approval for new indications varies by region; delays or restrictions can impact sales growth.

4. How will patent expiration influence the market?
Patent expiry around 2030 could lead to biosimilar competition, pressuring prices and market share.

5. Are there any upcoming pipeline developments for UPTRAVI?
No direct pipeline sources; focus is on combination therapies and new formulations for PAH.

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References

1. Bloomberg Industry Research. (2023). Global Pulmonary Arterial Hypertension Market Report.
2. AbbVie. (2023). UPTRAVI Sales Data and Market Access.
3. FDA. (2022). Approval Announcements for PAH Indications.
4. EMA. (2022). Regulatory Decisions on UPTRAVI.
5. IQVIA. (2023). Global Pharmaceutical Market Trends.