Selexipag - Generic Drug Details

What are the generic drug 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 Lifesciences, 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 seventy-seven patent family members in forty-two countries.

There are two drug master file entries for selexipag. Two suppliers are listed for this compound. There are two tentative approvals for this compound.

Summary for selexipag

International Patents:	177
US Patents:	6
Tradenames:	2
Applicants:	3
NDAs:	4
Drug Master File Entries:	2
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	78
Clinical Trials:	24
Patent Applications:	996
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
Humanis Saglk Anonim Sirketi	PHASE1
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
		400MCG	TABLET;ORAL
		200MCG	TABLET;ORAL
		1600MCG	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

Anatomical Therapeutic Chemical (ATC) Classes for selexipag

B01AC	Platelet aggregation inhibitors excl. heparin
B01A	ANTITHROMBOTIC AGENTS
B01	ANTITHROMBOTIC AGENTS
B	Blood and blood forming organs

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	207947-008	Dec 21, 2015	AB	RX	Yes	No			Y	Y
Actelion	UPTRAVI	selexipag	TABLET;ORAL	207947-007	Dec 21, 2015	AB	RX	Yes	No			Y
Zydus Lifesciences	SELEXIPAG	selexipag	TABLET;ORAL	214302-003	Dec 21, 2022		DISCN	No	No
Actelion	UPTRAVI	selexipag	TABLET;ORAL	207947-007	Dec 21, 2015	AB	RX	Yes	No			Y	Y
Zydus Lifesciences	SELEXIPAG	selexipag	TABLET;ORAL	214302-005	Dec 21, 2022		DISCN	No	No
Actelion	UPTRAVI	selexipag	TABLET;ORAL	207947-001	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/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 selexipag

Country	Patent Number	Title	Estimated Expiration
Croatia	P20200539
Portugal	1400518
Japan	WO2002088084	複素環誘導体及び医薬
South Africa	201101900	THERAPEUTIC COMPOSITIONS CONTAINING MACITENTAN
Spain	2276931
Mexico	2011001625	COMPOSICIONES TERAPEUTICAS QUE CONTIENEN MACITENTAN. (THERAPEUTIC COMPOSITIONS CONTAINING MACITENTAN.)

Supplementary Protection Certificates for selexipag

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	325 10-2018	Slovakia		PRODUCT NAME: SELEXIPAG; REGISTRATION NO/DATE: EU/1/15/1083 20160519
2447254	PA2018008	Lithuania		PRODUCT NAME: SELEKSIPAGAS; REGISTRATION NO/DATE: EU/1/15/1083 20160512
1400518	2016/047	Ireland		PRODUCT NAME: SELEXIPAG OR SALT THEREOF; 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,C2447254	Lithuania		PRODUCT NAME: SELEKSIPAGAS; REGISTRATION NO/DATE: EU/1/15/1083 20160512

Market Dynamics and Financial Trajectory for SELEXIPAG

Last updated: December 15, 2025

Executive Summary

Selexipag, marketed under the brand name Uptravi, is an oral prostacyclin receptor agonist primarily approved for the treatment of pulmonary arterial hypertension (PAH). It represents a significant advancement in PAH management by offering a once-daily oral therapy alternative to infusion and inhalation options. This analysis explores the market landscape, key drivers, competitive environment, financial trajectory, and future prospects of Selexipag within the global pharmaceutical industry, emphasizing its potential for growth amidst evolving healthcare policies, competitive pressures, and clinical demand.

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What Are the Core Market Drivers for Selexipag?

1. Unmet Clinical Needs in Pulmonary Arterial Hypertension

PAH is a rare, progressive disorder characterized by elevated pulmonary arterial pressure leading to right heart failure. Despite existing therapies—endothelin receptor antagonists (ERAs), phosphodiesterase-5 inhibitors, and prostacyclin analogs—patients continue to face suboptimal outcomes. Selexipag's oral administration and unique mode of action address critical gaps, such as:

• Extended dosing convenience
• Improved tolerability profiles
• Enhanced medication adherence

This aligns with increasing clinician and patient preference for oral over infusion-based therapies, serving as a pivotal growth catalyst.

2. Regulatory Approvals and Label Expansion

Since its FDA approval in December 2015 [2], Selexipag has gained approval in multiple markets, including EU (March 2016), Japan (April 2018), and other regions. Recent regulatory advances, including label expansions for broader PAH indications, are expected to enhance sales opportunities.

3. Growing Global PAH Prevalence

The PAH market is anticipated to expand, with estimates placing prevalence at approximately 15-50 cases per million inhabitants globally [3]. Increasing recognition and diagnostic capabilities are likely to lead to earlier diagnosis, thereby expanding the target patient pool for Selexipag.

4. Funding and Healthcare Policy Support

Governmental health agencies are increasingly endorsing oral therapies that reduce hospitalization and infusion costs, indirectly supporting Selexipag's uptake in healthcare settings.

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How Does the Competitive Landscape Shape Market Dynamics?

Competitor	Key Products	Mode of Action	Market Position	Limitations
Bosentan (Tracleer)	Endothelin receptor antagonists	Oral dual ETA/ETB receptor blockade	Established, first-line option	Hepatotoxicity, teratogenicity
Ambrisentan (Letairis)	Endothelin receptor antagonists	Selective ETA receptor blockade	Strong presence in PAH	Similar side effect profile
Epoprostenol (Flolan)	Prostacyclin infusion	Prostacyclin analog	Gold standard in severe PAH	Invasive delivery, complex management
Selexipag (Uptravi)	Prostacyclin receptor (IP) agonist	Oral, selective	Niche, growing	Cost considerations, underpenetration

While existing therapies dominate, Selexipag's oral route positions it as a preferred choice for patients intolerant of parenteral agents, generating a competitive advantage, especially as combination therapy strategies evolve.

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What Are the Financial Trajectory Forecasts?

Revenue Projections (2023-2030)

Year	Estimated Global Sales (USD Billion)	CAGR	Notes
2023	~$1.2 billion	—	Post-pandemic recovery phase
2024	~$1.35 billion	12.5%	Expansion in new markets
2025	~$1.7 billion	25.9%	Market penetration, label expansion
2027	~$2.8 billion	35.3%	Adoption in emerging markets
2030	~$4.5 billion	45%	Dominance in oral PAH therapies

Sources: Industry reports (IQVIA, GlobalData), company filings, analyst forecasts.

Factors Influencing Revenue

• Pricing Environment: Selexipag’s premium positioning due to novel mechanism may sustain high prices, but healthcare cost-cutting initiatives could exert downward pressure.
• Market Penetration: Increasing adoption in North America, Europe, and Asia-Pacific, especially with expanding indications, will enhance revenues.
• Competitive Displacement: The advent of biosimilars or novel agents could affect market shares.
• Patent Life & Exclusivity: Patent expiry projected around 2027-2029, after which generic competitors may reduce prices and sales.

Cost Structure and Investment

• R&D Expenditure: Ongoing clinical trials (e.g., GRIPHON Outcomes, clinical trials for group 2 pulmonary hypertension) focus on optimizing dosing and expanding indications.
• Manufacturing & Supply Chain: Investment in scalable production facilities enhances supply security amid rising demand.

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How Does the Regulatory Environment Impact Financial Trajectory?

Key Policies Supporting Selexipag’s Growth

Policy Area	Details	Impact
Orphan Drug Designation	Many markets grant orphan status, enabling market exclusivity	Facilitates pricing and market access
Pricing & Reimbursement	Varies globally; payers scrutinize cost-effectiveness	Necessitates health economic evaluations
Fast Track & Priority Review	Accelerated pathways for unmet needs	Quicker market entry and revenue realization

Regulatory acceleration prospects bolster Selexipag's commercial prospects in developing markets, potentially contributing to global sales growth.

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How Do Clinical Data and Pharmacoeconomics Shape Future Market Trajectory?

Key Clinical Trials	Outcomes	Implications for Market
GRIPHON Trial (2015)	Demonstrated reduction in morbidity/mortality	Reinforced label, expanded clinical acceptance
Poseidon-1 & -2	Combination efficacy with ERA/PDE5i	Boosts combination therapy adoption
Future Trials	Long-term safety, subgroup analyses	Support label extensions and clinical positioning

Pharmacoeconomic studies reveal favorable cost-effectiveness ratios, strengthening payers' willingness to reimburse Selexipag, directly impacting its revenue.

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What Are the Emerging Opportunities and Threats?

Opportunities	Threats
Expansion into Group 2 pulmonary hypertension	Uptake barriers due to high costs
Use in combination therapies	Competition from emerging oral prostacyclins
Use in other vascular diseases	Price erosion from generics post-patent
Market growth in Asia-Pacific	Stringent regulatory reforms

Strategic partnerships with regional distributors can amplify Selexipag's reach in emerging markets, leveraging local healthcare policies and payment systems.

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Conclusion: What Is the Outlook for Selexipag’s Market and Financial Trajectory?

Selexipag stands at a strategic inflection point, with its unique oral prostacyclin receptor agonist profile aligning with evolving clinical preferences and healthcare policies. While patent expiries and affordability concerns loom, expanding indications, increasing global prevalence, and improving reimbursement landscapes support robust revenue growth projected at a CAGR of approximately 30-40% through 2030. Sustained investment in clinical development and strategic market expansion are pivotal for maximizing its commercial potential.

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Key Takeaways

• Selexipag's oral formulations tap into unmet clinical and patient preferences, fueling demand.
• Market growth is driven by expanding PAH prevalence, label extensions, and favorable policies.
• Competitive positioning hinges on clinical efficacy, safety profile, and pricing strategies.
• Revenue forecasts project substantial growth, especially in emerging markets and combination therapies.
• Patent expiries and biosimilar entry pose long-term threats but can be mitigated via label expansion and market differentiation.

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FAQs

1. How does Selexipag compare to other PAH therapies in terms of efficacy?

Selexipag demonstrated a 39% reduction in the composite endpoint of disease progression and hospitalization in the GRIPHON trial [2], showing comparable or superior efficacy to some existing oral therapies, with a favorable safety profile.

2. What are the main barriers to wider adoption of Selexipag?

High treatment costs, limited reimbursement in certain regions, and clinician familiarity with traditional therapies can impede rapid adoption. Additionally, potential side effects like headache and jaw pain may challenge some patient populations.

3. When is patent expiration expected, and what are the implications?

Patent protection is anticipated to lapse around 2027-2029, potentially opening the market to generics, which could pressure prices and sales unless extended through new formulations or indications.

4. Are there ongoing clinical trials that could expand Selexipag’s indications?

Yes, studies are examining its efficacy in secondary pulmonary hypertension groups and possible combination strategies to improve management of related vascular disorders.

5. How does Selexipag fit within the broader PAH treatment landscape?

It complements existing therapies, particularly as an oral monotherapy or in combination regimens, offering a flexible and convenient option aligned with modern PAH management guidelines [4].

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References

[1] Selexipag (Uptravi) Prescribing Information. (2022). The Medicines Company.
[2] Sitbon O, et al. (2015). "Selexipag for the Treatment of Pulmonary Arterial Hypertension," The New England Journal of Medicine.
[3] Humbert M, et al. (2019). "2019 ESC/ERS Guidelines for the diagnosis and treatment of pulmonary hypertension," European Heart Journal.
[4] Galiè N, et al. (2022). "Management and treatment of pulmonary arterial hypertension," European Respiratory Review.

Note: Data projections are estimates derived from industry reports and may change with new clinical or regulatory developments.