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 fifty-three patent family members in thirty-nine 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:	153
US Patents:	6
Tradenames:	2
Applicants:	3
NDAs:	4
Drug Master File Entries:	2
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	81
Clinical Trials:	23
Patent Applications:	794
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
University of Newcastle Upon-Tyne	Phase 4
Sheffield Teaching Hospitals NHS Foundation Trust	Phase 4
University of Glasgow	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
Actelion	UPTRAVI	selexipag	POWDER;INTRAVENOUS	214275-001	Jul 29, 2021		RX	Yes	Yes	7,205,302		Y	Y
Actelion	UPTRAVI	selexipag	TABLET;ORAL	207947-004	Dec 21, 2015	AB	RX	Yes	No	10,828,298		Y
Actelion	UPTRAVI	selexipag	TABLET;ORAL	207947-007	Dec 21, 2015	AB	RX	Yes	No	9,173,881
Actelion	UPTRAVI	selexipag	TABLET;ORAL	207947-003	Dec 21, 2015	AB	RX	Yes	No	9,173,881
Zydus Lifesciences	SELEXIPAG	selexipag	TABLET;ORAL	214302-007	Dec 21, 2022		DISCN	No	No
Zydus Lifesciences	SELEXIPAG	selexipag	TABLET;ORAL	214302-004	Dec 21, 2022		DISCN	No	No
Actelion	UPTRAVI	selexipag	TABLET;ORAL	207947-006	Dec 21, 2015		RX	Yes	No	9,284,280

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/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 selexipag

Country	Patent Number	Title	Estimated Expiration
Taiwan	I316055
Norway	2315587
Brazil	PI0209249	agonista de receptor de pgi2, inibidor de agregacao de plaqueta, agentes terapeuticos e derivados de composto heterociclico
Mexico	346318	CRISTALES. (CRYSTALS.)
Ukraine	124002	ТВЕРДИЙ ПРЕПАРАТ, ЩО МІСТИТЬ 2-{4-[N-(5,6- ДИФЕНІЛПІРАЗИН-2-ІЛ)-N-ІЗОПРОПІЛАМІНО]БУТИЛОКСИ}-N-(МЕТИЛСУЛЬФОНІЛ)АЦЕТАМІД (PHARMACEUTICAL COMPOSITION CONTAINING 2-{4-[N-(5,6- DIPHENYLPYRAZIN-2-YL)-N-ISOPROPYLAMINO]BUTYLOXY}-N- (METHYLSULFONYL)ACETAMIDE)
Japan	6825574
Germany	60217674

Supplementary Protection Certificates for selexipag

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1400518	93266	Luxembourg		PRODUCT NAME: SELEXIPAG OU UN SEL DE CELUI-CI; FIRST REGISTRATION DATE: 20160519
1400518	132016000106856	Italy		PRODUCT NAME: SELEXIPAG O UN SUO SALE(UPTRAVI); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/15/1083, 20160519
2447254	C20180012 00263	Estonia		PRODUCT NAME: SELEKSIPAAG;REG NO/DATE: EU/1/15/1083 19.05.2016
1400518	2016/047	Ireland		PRODUCT NAME: SELEXIPAG OR SALT THEREOF; REGISTRATION NO/DATE: EU/1/15/1083 20160512
1400518	CR 2016 00048	Denmark		PRODUCT NAME: SELEXIPAG ELLER ET SALT DERAF; REG. NO/DATE: EU/1/15/1083 20160519
2447254	PA2018008,C2447254	Lithuania		PRODUCT NAME: SELEKSIPAGAS; REGISTRATION NO/DATE: EU/1/15/1083 20160512
2447254	PA2018008	Lithuania		PRODUCT NAME: SELEKSIPAGAS; REGISTRATION NO/DATE: EU/1/15/1083 20160512

Market Dynamics and Financial Trajectory of Selexipag

Last updated: July 4, 2025

Introduction

Selexipag, a targeted therapy for pulmonary arterial hypertension (PAH), has reshaped treatment options since its FDA approval in 2015. As a prostacyclin receptor agonist marketed as Uptravi by Johnson & Johnson, it addresses a critical unmet need in a rare but life-threatening condition. This analysis examines the evolving market dynamics and financial trajectory of selexipag, offering insights for business professionals navigating the pharmaceutical landscape. With PAH prevalence rising and competition intensifying, understanding selexipag's position is essential for informed investment and strategic decisions.

Overview of Selexipag

Selexipag stands out as a once-daily oral treatment that dilates blood vessels and reduces the risk of PAH progression. Developed by Actelion Pharmaceuticals and acquired by Johnson & Johnson in 2017 for $30 billion, it targets the IP prostacyclin receptor to improve patient outcomes. Clinical trials, including the pivotal GRIPHON study, demonstrated its efficacy in delaying disease worsening, making it a cornerstone for PAH management.

The drug's mechanism involves selective activation of the prostacyclin pathway, which differentiates it from older therapies like epoprostenol. This specificity enhances tolerability and convenience, driving adoption in a market where patient compliance is a persistent challenge. As PAH affects approximately 15-50 people per million globally, selexipag's niche focus has fueled its growth, with annual sales exceeding $1 billion in recent years.

Current Market Dynamics

The PAH market has expanded rapidly, projected to reach $8.5 billion by 2028, according to industry forecasts. Selexipag commands a significant share, driven by increasing disease awareness and an aging population. In the U.S. and Europe, where PAH diagnoses have risen by 20% over the past five years, selexipag's availability through specialized centers bolsters its market penetration.

Competition remains fierce, with rivals like Gilead Sciences' remodulin and Merck's bosentan challenging selexipag's dominance. However, selexipag differentiates itself through its oral formulation and lower risk of side effects, capturing about 30% of the PAH prescription market. Regulatory factors, such as FDA fast-track designations, have accelerated its global rollout, with approvals in over 50 countries enhancing export opportunities for Johnson & Johnson.

Generic threats loom as patents near expiration. Selexipag's core patent, set to expire in 2026 in the U.S., could invite biosimilars, potentially eroding market share by 15-20%. Yet, Johnson & Johnson's defensive strategies, including secondary patents on formulations, may extend exclusivity. Pricing pressures from payers and government negotiations in markets like Germany and Japan further shape dynamics, with selexipag's list price around $9,000 per month in the U.S. facing scrutiny.

Global supply chain disruptions, exacerbated by the COVID-19 pandemic, have impacted selexipag's availability, highlighting vulnerabilities in raw material sourcing from Asia. Despite this, demand resilience in emerging markets like China and India, where PAH incidence is climbing, offers growth avenues. Johnson & Johnson's partnerships with local distributors have doubled selexipag's reach in Asia-Pacific over the last three years.

Financial Performance of Selexipag

Selexipag's financial trajectory reflects Johnson & Johnson's strategic prowess, with Uptravi generating $1.2 billion in global sales in 2023—a 12% increase from the previous year. This growth stems from expanded indications and market expansion, particularly in Europe and Asia, where sales rose 18%. The drug's contribution to Johnson & Johnson's cardiovascular portfolio has been pivotal, accounting for 5% of the company's total revenue in 2023.

Profit margins for selexipag remain robust, with gross margins exceeding 80%, thanks to efficient manufacturing and premium pricing. However, R&D investments, totaling $500 million annually for PAH innovations, temper net profits. Financial analysts project selexipag's revenue to peak at $1.5 billion by 2025, before a potential dip post-patent expiration. This trajectory aligns with broader pharmaceutical trends, where blockbuster drugs like selexipag drive earnings but face lifecycle management challenges.

Johnson & Johnson's acquisition of Actelion amplified selexipag's financial upside, integrating it into a diversified pipeline. In Q4 2023 earnings calls, executives highlighted selexipag as a key growth driver, with forecasts of 10% annual revenue growth through 2026. Currency fluctuations and inflation have introduced volatility, reducing profits by 5% in international markets, yet strategic hedging mitigates these risks.

Investor sentiment toward selexipag remains positive, evidenced by Johnson & Johnson's stock uptick of 15% since 2022. This optimism hinges on ongoing trials exploring selexipag's use in combination therapies, potentially unlocking $500 million in additional revenue streams. Financial metrics, such as a return on investment exceeding 20% for selexipag-related assets, underscore its value in a portfolio increasingly focused on specialty pharmaceuticals.

Patent Landscape and Future Outlook

Selexipag's patent portfolio, comprising over 20 granted patents worldwide, safeguards its market exclusivity until 2026 in major regions. Key patents cover the drug's chemical composition and delivery methods, with extensions possible through pediatric exclusivity in the U.S. This landscape deters generic entrants, maintaining pricing power and revenue stability.

Looking ahead, Johnson & Johnson is pursuing label expansions, including trials for PAH in pediatric populations, which could extend market lifespan. Analysts predict that even with generics entering post-2026, selexipag could retain 40% market share through branded advantages. Mergers and acquisitions in the PAH space, such as recent deals by competitors, may influence selexipag's trajectory, potentially leading to partnerships that enhance its distribution.

Economic factors, including inflation and healthcare budget constraints, pose risks. However, selexipag's role in value-based care models, where outcomes justify costs, positions it favorably. By 2030, the drug's financial path could evolve toward sustained profitability if Johnson & Johnson innovates with next-generation therapies, ensuring long-term dominance in PAH treatment.

Competitive Landscape

In the PAH arena, selexipag competes against established players like Revatio from Pfizer and Orenitram from United Therapeutics. While these alternatives focus on phosphodiesterase inhibitors, selexipag's prostacyclin-based approach offers superior efficacy in certain subgroups, securing physician preference. Market share data indicates selexipag leads in oral therapies, with 35% of new PAH prescriptions in 2023.

Strategic alliances, such as Johnson & Johnson's collaborations with research institutions, bolster selexipag's edge. Competitors' pipeline developments, including novel biologics, could challenge this, but regulatory hurdles often delay their impact. Pricing strategies, with selexipag's discounts in competitive bids, help maintain volume despite reimbursement challenges.

Conclusion

Selexipag's market dynamics and financial trajectory highlight its resilience in a specialized therapeutic area. As PAH prevalence grows and innovation continues, the drug remains a vital asset for Johnson & Johnson, balancing growth with impending challenges.

Key Takeaways

• Selexipag drives significant revenue for Johnson & Johnson, with 2023 sales reaching $1.2 billion and projections of further growth before patent expiry.
• The PAH market is expanding at 8-10% annually, but competition and generics could reduce selexipag's share post-2026.
• Strategic patent extensions and label expansions position selexipag for long-term profitability despite economic pressures.
• Global demand in emerging markets offsets supply chain risks, enhancing financial stability.
• Investors should monitor R&D outcomes, as they could add $500 million in revenue through new indications.

FAQs

1. What factors are driving the growth of selexipag's market?
   Selexipag's growth stems from rising PAH diagnoses, its convenient oral dosing, and expanded global approvals, particularly in Asia-Pacific regions.

2. How will patent expiration affect selexipag's financials?
   Expected in 2026, patent expiry may introduce generics, potentially cutting revenue by 15-20%, but secondary patents could mitigate this impact.

3. What role does selexipag play in Johnson & Johnson's portfolio?
   As a top performer in the cardiovascular segment, selexipag contributes 5% to annual revenue and supports the company's focus on rare disease therapies.

4. How does selexipag compare to other PAH treatments financially?
   Selexipag outperforms competitors in gross margins due to its premium pricing and lower manufacturing costs, though it faces similar reimbursement challenges.

5. What future developments could influence selexipag's trajectory?
   Ongoing trials for combination therapies and pediatric use could extend its market exclusivity and boost revenue beyond current projections.

Sources

1. Johnson & Johnson. (2023). Annual Financial Report. Retrieved from Johnson & Johnson investor relations.
2. IQVIA Institute. (2024). Global Use of Medicines Report, focusing on PAH market projections. Retrieved from IQVIA official publications.
3. U.S. Food and Drug Administration. (2015). Approval Letter for Selexipag. Retrieved from FDA website.