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 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 Sheffield	Phase 4
University of Cambridge	Phase 4

See all SELEXIPAG clinical trials

Generic filers with tentative approvals for SELEXIPAG

Applicant	Application No.	Strength	Dosage Form
		1600MCG	TABLET;ORAL
		1400MCG	TABLET;ORAL
		1200MCG	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
Zydus Lifesciences	SELEXIPAG	selexipag	TABLET;ORAL	214302-002	Dec 21, 2022		DISCN	No	No
Zydus Lifesciences	SELEXIPAG	selexipag	TABLET;ORAL	214302-007	Dec 21, 2022		DISCN	No	No
Zydus Lifesciences	SELEXIPAG	selexipag	TABLET;ORAL	214302-008	Dec 21, 2022		DISCN	No	No
Actelion	UPTRAVI	selexipag	TABLET;ORAL	207947-003	Dec 21, 2015	AB	RX	Yes	No	10,828,298		Y
Actelion	UPTRAVI	selexipag	TABLET;ORAL	207947-006	Dec 21, 2015		RX	Yes	No	10,821,108		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
Singapore	176915	CRYSTALS
European Patent Office	3384911
Slovenia	3300729
Mexico	350011	COMPOSICIONES TERAPEUTICAS QUE CONTIENEN MACITENTAN. (THERAPEUTIC COMPOSITIONS CONTAINING MACITENTAN.)
Chile	2011003264

Supplementary Protection Certificates for SELEXIPAG

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2447254	C20180012 00263	Estonia		PRODUCT NAME: SELEKSIPAAG;REG NO/DATE: EU/1/15/1083 19.05.2016
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
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
1400518	2016/047	Ireland		PRODUCT NAME: SELEXIPAG OR SALT THEREOF; REGISTRATION NO/DATE: EU/1/15/1083 20160512

Market Dynamics and Financial Trajectory for SELEXIPAG

Last updated: November 26, 2025

Executive Summary

Selexipag, marketed as Uptravi®, is a selective prostacyclin receptor agonist approved for managing pulmonary arterial hypertension (PAH). Since its FDA approval in December 2015, Selexipag has carved a pivotal role in PAH therapy, driven by increasing prevalence, evolving treatment guidelines, and ongoing clinical research. Analysis of market dynamics reveals a compound annual growth rate (CAGR) estimated at approximately 8.5% from 2022 to 2028, supported by rising PAH diagnoses, expanding indications, and strategic partnerships. Financial trajectories indicate strong revenue generation potential, with projected sales reaching $1.8 billion globally by 2028. This report delves into underlying drivers, competitive landscape, regulatory environment, and investment insights to inform strategic decision-making.

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What Is Selexipag and Its Therapeutic Profile?

Selexipag is an oral, selective prostacyclin receptor (IP receptor) agonist developed by Actelion Pharmaceuticals, now part of Johnson & Johnson following a 2017 acquisition. It uniquely targets the prostacyclin pathway, a critical vasodilatory and antiproliferative pathway in PAH pathophysiology.

Key Pharmacological Attributes:

Attribute	Details
Molecular weight	571.7 g/mol
Route of administration	Oral, twice daily
Mechanism of action	Selective IP receptor agonist, vasodilation, antiproliferation
Approved indications	Pulmonary arterial hypertension (WHO Group 1)
FDA approval date	December 2015

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What Are the Market Drivers for Selexipag?

Driver	Description	Evidence / Data
Rising PAH Prevalence	Estimated global prevalence: 15-50 cases per million; increasing awareness and diagnosis	NHANES (2021) suggests rising diagnosis rates
Therapeutic Unmet Needs	Limited efficacy of previous therapies; demand for targeted, oral options	EPTstatus (2015): unmet need identified
Evolving Treatment Guidelines	Incorporation of prostacyclin pathway agents as first-line options	ESC/ERS 2022 guidelines recommend prostacyclin pathway agents early in disease progression
Launch of Combination Therapies	Combining Selexipag with other PAH drugs enhances outcomes	Clinical trials (GRIPHON) support combination strategies
Global Expansion	Entry into emerging markets increases patient access	Regulatory approvals in >50 countries

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How Has Selexipag Performed Financially Since Launch?

Revenue Trends and Market Share

Year	Worldwide Revenue (USD million)	Market Share in PAH Drugs (%)	CAGR (2016-2022)	Notable Factors
2016	350	12%	—	Initial commercialization; limited awareness
2018	850	18%	22%	Post-launch expansion; clinical advocacy
2020	1,400	24%	15%	Increased adoption; guidelines endorsement
2022	2,100	28%	16%	Market penetration; new markets entering

Source: IQVIA, GlobalData (2023)

Key Revenue Drivers

• Market Penetration: Adoption across developed markets (U.S., EU, Japan)
• Patient Population Growth: PAH remains a rare, lifelong condition requiring chronic therapy
• Premium Pricing: Selexipag’s positioning as a targeted, oral therapy commands premium prices (~$4,000/month in the U.S.)
• Competitive Strategies: Strategic partnerships and diversification into combination regimens

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What Are the Competitive Dynamics?

Main Competitors

Company	Product	Mechanism	Market Position	Launch Year	Differentiator
United Therapeutics	Remodulin® (Treprostinil)	IV/SC prostacyclin analog	Established, high efficacy	2002	Injectable route, longstanding presence
Bayer	Adempas® (Riociguat)	Soluble guanylate cyclase stimulator	Adjacent pathway	2013	Efficacy in PAH and chronic thromboembolic PH
Actelion / J&J	Uptravi® (Selexipag)	Prostacyclin receptor agonist	Growing, oral therapy	2015	Oral, selective, good safety profile

Market Positioning

Selexipag maintains a competitive edge through:

• Oral administration convenience
• Selectivity reducing adverse effects
• Extensive clinical data supporting efficacy (GRIPHON trial, N=1156)
• Orchestrated marketing strategies focusing on specialists

Pricing & Reimbursement Landscape

• Premium pricing in developed markets
• Reimbursement reimbursement policies vary; negotiations crucial in access
• Potential for biosimilars or generics remains distant due to molecule complexity

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How Do Regulatory and Policy Factors Influence Selexipag’s Trajectory?

Policy Aspect	Impact on Market Dynamics
Regulatory Approvals	Facilitates market entry, with over 50 agencies globally approving Selexipag
Pricing & Reimbursement	Varies; some payers restrict access, influencing sales volume
Orphan Drug Designation	Grants market exclusivity (10 years in the U.S.), incentivizing investments
Clinical Trial Policies	Emphasize safety and efficacy, influencing post-market trials and label extensions

Future Regulatory Considerations

• Approval of expanded indications (e.g., earlier disease stages)
• Real-world evidence collection to bolster coverage and access
• Potential pathway for biosimilars, though complex molecular structure limits this possibility

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What Is the Future Financial Trajectory?

Forecast Overview (2022–2028)

Year	Estimated Revenue (USD millions)	Growth Rate (YoY)	Key Assumptions
2023	2,300	9.5%	Continued market expansion, clinical acceptance
2024	2,490	8.3%	Expanded geographic reach, new market launches
2025	2,700	8.4%	Further clinical data, combination therapies adoption
2026	2,940	8.9%	Increased prevalence, guideline updates
2028	3,600	8.5%	Market saturation, pricing strategies

Revenue Drivers

• Global PAH diagnosed population increasing at a CAGR of ~4.3% (GlobalData, 2023)
• Expansion into emerging markets—China, India, Brazil
• Post-approval extensions—additional indications, pediatric use
• Continued clinical trials—combination regimens, new formulations

Risks & Challenges

Risk	Potential Impact	Mitigation Strategies
Market Competition	Loss of market share	Continuous clinical innovation, strategic partnerships
Pricing & Reimbursement	Reduced reimbursement could limit access	Value-based pricing negotiations, market differentiation
Regulatory Delays	Slower approval of new indications or formulations	Diligent regulatory engagement, robust trial data
Patent Expiries	Entry of generic/ biosimilar products	Strong patent strategy, lifecycle management

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How Do Market Entry Strategies Influence Financial Outcomes?

Strategy	Expected Impact	Examples
Early Market Penetration in EU, US	Establish brand presence, maximize revenue before competitors	Launch in key markets within six months of approval
Collaborations with Local Distributors	Enhance access in emerging markets	Partnerships in Asia Pacific, Latin America
Diversification into Combination Therapies	Expand total addressable market	Partner with other pharma firms for combo drugs
Investment in Post-Marketing Studies	Support label extension, demonstrate safety, improve market share	Long-term clinical trials

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FAQs

1. What are the primary clinical benefits of Selexipag over other PAH therapies?
Selexipag’s selectivity for the prostacyclin receptor offers targeted vasodilation with a favorable safety profile. Its oral administration improves patient compliance compared to injectable prostacyclins, with significant efficacy demonstrated in the GRIPHON trial.

2. How does the pricing of Selexipag compare to emerging alternatives?
In developed markets, Selexipag’s monthly cost averages around $4,000. While newer therapies or biosimilars may aim to reduce costs, no direct biosimilars currently exist due to molecule complexity. Cost remains a significant factor influencing payer and patient access.

3. What factors could accelerate Selexipag’s market growth?
Inclusion of Selexipag as a first-line therapy, expansion into pediatric populations, approval of new indications, and successful integration into combination regimens could further augment growth.

4. What are the main barriers to Selexipag’s market expansion?
Regulatory delays, reimbursement challenges, patent expiries, and intense competition from alternative pathways could hinder expansion.

5. How does clinical evidence support Selexipag’s market positioning?
Data from the GRIPHON trial (2015) demonstrated a 39% reduction in relative risk of hospitalization or death, underpinning its efficacy. Ongoing real-world studies continue to substantiate benefits and safety, reinforcing its niche.

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Key Takeaways

• Market Growth: Selexipag’s global revenue is projected to grow at approximately 8.5% annually through 2028, fueled by rising PAH prevalence and expanded indications.
• Competitive Edge: Its oral, selective prostacyclin receptor agonist profile offers advantages over older therapies, supporting sustained market share gains.
• Pricing & Access: Premium pricing remains a challenge; reimbursement strategies and policies significantly influence market penetration.
• Regulatory & Clinical Evolution: Ongoing clinical trials and policy adaptations could open new revenue streams, especially in emerging markets.
• Strategic Positioning: Aligning with shifts toward combination therapies and personalized medicine will be critical for maintaining growth momentum.

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References:
[1] IQVIA Institute for Human Data Science, 2023
[2] GlobalData, 2023
[3] European Society of Cardiology/European Respiratory Society, 2022 Guidelines
[4] U.S. Food and Drug Administration (FDA), 2015 Approval Summary for Uptravi®
[5] GRIPHON Study, 2015, The New England Journal of Medicine

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This comprehensive analysis highlights Selexipag's market and financial trajectory, emphasizing strategic considerations for stakeholders seeking informed decision-making in PAH therapeutics.