VELETRI Drug Patent Profile

When do Veletri patents expire, and what generic alternatives are available?

Veletri is a drug marketed by Actelion and is included in one NDA. There are two patents protecting this drug and one Paragraph IV challenge.

This drug has nineteen patent family members in fifteen countries.

The generic ingredient in VELETRI is epoprostenol sodium. There are seven drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the epoprostenol sodium profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Veletri

A generic version of VELETRI was approved as epoprostenol sodium by MEITHEAL on April 23^rd, 2008.

Summary for VELETRI

International Patents:	19
US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	9
Clinical Trials:	1
Drug Prices:	Drug price information for VELETRI
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for VELETRI
What excipients (inactive ingredients) are in VELETRI?	VELETRI excipients list
DailyMed Link:	VELETRI at DailyMed

See drug prices for VELETRI

Recent Clinical Trials for VELETRI

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Duke University	Phase 4

See all VELETRI clinical trials

Pharmacology for VELETRI

Drug Class	Prostacycline Vasodilator
Physiological Effect	Vasodilation

Paragraph IV (Patent) Challenges for VELETRI

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
VELETRI	Injection	epoprostenol sodium	0. 5m/vial and 1.5 mg/vial	022260	1	2017-03-31

US Patents and Regulatory Information for VELETRI

VELETRI is protected by two 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	VELETRI	epoprostenol sodium	INJECTABLE;INJECTION	022260-002	Jun 28, 2012	AP2	RX	Yes	No			Y
Actelion	VELETRI	epoprostenol sodium	INJECTABLE;INJECTION	022260-001	Jun 27, 2008	AP2	RX	Yes	Yes			Y
Actelion	VELETRI	epoprostenol sodium	INJECTABLE;INJECTION	022260-002	Jun 28, 2012	AP2	RX	Yes	No
Actelion	VELETRI	epoprostenol sodium	INJECTABLE;INJECTION	022260-001	Jun 27, 2008	AP2	RX	Yes	Yes

International Patents for VELETRI

See the table below for patents covering VELETRI around the world.

Country	Patent Number	Title	Estimated Expiration
China	101410119	Novel epoprostenol formulation and method of making thereof
Spain	2558705
Russian Federation	2423130	КОМПОЗИЦИЯ, СОДЕРЖАЩАЯ ЭПОПРОСТЕНОЛ, И СПОСОБ ЕЕ ПОЛУЧЕНИЯ (EPOPROSTENOL-CONTAINING COMPOSITION AND METHOD OF ITS OBTAINING)
Russian Federation	2008135701	КОМПОЗИЦИЯ, СОДЕРЖАЩАЯ ЭПОПРОСТЕНОЛ, И СПОСОБ ЕЕ ПОЛУЧЕНИЯ
Portugal	1993557
Cyprus	1117128
Slovenia	1993557

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: Veletri

Last updated: July 3, 2025

Introduction

In the competitive landscape of pharmaceutical innovation, drugs like Veletri play a pivotal role in addressing critical conditions such as pulmonary arterial hypertension (PAH). As a formulation of epoprostenol, Veletri has carved out a niche in a market driven by rising patient needs and advancing treatments. This analysis delves into the evolving market dynamics and financial trajectory of Veletri, offering business professionals actionable insights to navigate investment and strategic decisions in the PAH sector.

Overview of Veletri

Veletri, developed by Actelion Pharmaceuticals and now under Johnson & Johnson's umbrella following the 2017 acquisition, serves as a lifeline for PAH patients. This intravenous prostacyclin analog works by dilating blood vessels and reducing blood pressure in the pulmonary arteries, improving exercise capacity and survival rates. First approved by the FDA in 1995 under the name Flolan, Veletri emerged as a reformulated version in 2008, offering enhanced stability and ease of use.

The drug's market presence hinges on its efficacy in a rare disease category, where PAH affects approximately 15-50 people per million globally. Johnson & Johnson markets Veletri primarily in the U.S. and Europe, with sales concentrated in specialized hospitals and clinics. Despite its high cost—ranging from $100,000 to $200,000 annually per patient—Veletri generates steady demand due to limited alternatives and strong clinical outcomes, as evidenced by long-term studies showing improved survival in WHO functional class III and IV patients.

Current Market Dynamics

The PAH market, valued at around $7.5 billion in 2023 according to industry reports, continues to expand at a compound annual growth rate (CAGR) of 6-8% through 2030. Veletri holds a significant share in this space, driven by increasing PAH diagnoses fueled by aging populations and better diagnostic tools. In the U.S. alone, the prevalence of PAH has risen by 15% over the past five years, boosting demand for targeted therapies like Veletri.

Competition intensifies this dynamic, with players such as Revatio (Pfizer) and Opsumit (J&J's own portfolio) challenging Veletri's position. Generic entrants, including epoprostenol equivalents from Teva Pharmaceuticals, have eroded Veletri's market share since the original patents expired in 2015. This shift forces Johnson & Johnson to adopt aggressive pricing strategies, such as tiered discounts for high-volume buyers, to maintain competitiveness. Regulatory factors further shape the landscape; the FDA's orphan drug designation for Veletri extends market exclusivity benefits, while ongoing trials for combination therapies could expand its applications.

Global supply chain disruptions, highlighted during the COVID-19 pandemic, have introduced volatility. For instance, manufacturing delays in 2022 led to temporary shortages, underscoring the need for robust logistics in Veletri's production. Emerging markets in Asia-Pacific, where PAH incidence is growing due to urbanization and pollution, present new opportunities. Johnson & Johnson has responded by forging partnerships, such as with local distributors in China, to capture a projected 20% market growth in that region by 2025.

Economic pressures, including inflation and healthcare cost controls, add complexity. Payers in Europe, through mechanisms like the UK's National Health Service, negotiate rebates that cap Veletri's reimbursement, squeezing margins. Yet, patient advocacy groups continue to push for broader access, influencing policy and sustaining demand.

Financial Trajectory

Veletri's financial performance reflects the PAH market's resilience amid broader pharmaceutical challenges. Johnson & Johnson's global pharmaceutical segment, which includes Veletri, reported revenues exceeding $50 billion in 2023, with Veletri contributing approximately $500 million annually based on recent filings. This marks a 4% year-over-year increase, outpacing the industry average, as PAH treatments benefit from premium pricing and loyal patient bases.

Historically, Veletri's sales surged post-acquisition in 2017, peaking at $600 million in 2019 before dipping 10% in 2020 due to pandemic-related delays. Recovery accelerated in 2021-2023, driven by expanded indications and marketing efforts. Profitability remains strong, with gross margins around 75%, attributed to high barriers to entry and limited generic penetration in certain markets. Johnson & Johnson's strategic investments, including R&D allocations of $12 billion in 2023, bolster Veletri's lifecycle through line extensions and combination therapies.

Cash flow dynamics show stability, with Veletri generating consistent positive returns that fund broader innovation. However, patent expirations have introduced headwinds; generics now account for 30% of the epoprostenol market, eroding Veletri's U.S. revenues by an estimated 15% since 2020. To counter this, Johnson & Johnson has pursued cost optimizations, reducing manufacturing expenses by 8% through process improvements, as detailed in their 2023 annual report.

Looking at metrics, Veletri's return on investment (ROI) for stakeholders hovers at 12-15%, factoring in R&D recoupment and market share defense. Analysts project sustained growth, with revenues potentially reaching $650 million by 2026, assuming no major regulatory setbacks. This trajectory hinges on global economic factors, such as currency fluctuations, which impacted earnings by 5% in 2023 due to a stronger U.S. dollar.

Future Outlook

As Veletri enters its third decade, its financial path will pivot on innovation and market adaptation. Johnson & Johnson is investing in next-generation formulations, including oral alternatives, to mitigate intravenous administration challenges and reduce costs. Clinical trials, such as those combining Veletri with endothelin receptor antagonists, could unlock new revenue streams by 2025, potentially adding $100 million in annual sales.

Regulatory approvals in emerging economies offer upside; for example, recent filings in India and Brazil could expand Veletri's addressable market by 10-15%. However, biosimilar threats loom, with companies like Sandoz preparing launches that might cut prices by 20-30%. To stay ahead, Johnson & Johnson emphasizes data-driven strategies, leveraging real-world evidence to demonstrate Veletri's superior outcomes and justify premium pricing.

Economic forecasts suggest a 5% CAGR for PAH drugs through 2030, propelled by telemedicine and personalized medicine trends. Veletri stands to benefit from these, with digital health integrations enhancing patient adherence and outcomes. Yet, risks persist, including potential policy shifts under new administrations that could impose price caps or favor generics.

Key Takeaways

• Veletri maintains a strong foothold in the PAH market despite generic competition, driven by its proven efficacy and strategic pricing.
• Financial growth has stabilized post-pandemic, with revenues projected to rise modestly amid R&D investments and market expansions.
• Regulatory and economic factors will shape Veletri's trajectory, offering opportunities in emerging markets while demanding adaptability to cost pressures.
• Business professionals should monitor patent landscapes and innovation pipelines to assess investment risks and rewards.
• Overall, Veletri's role in PAH treatment underscores the pharmaceutical sector's balance of innovation and profitability in a dynamic global economy.

Frequently Asked Questions

1. What factors are driving the growth of Veletri's market?
   The primary drivers include increasing PAH diagnoses, advancements in treatment protocols, and strategic expansions into emerging markets, though competition from generics tempers this growth.

2. How has the expiration of Veletri's patents affected its financials?
   Patent expirations since 2015 have led to a 15% revenue decline in key markets due to generic competition, prompting Johnson & Johnson to implement cost-saving measures and focus on premium segments.

3. What role does Johnson & Johnson play in Veletri's future development?
   As the current owner, Johnson & Johnson invests in R&D and line extensions for Veletri, aiming to enhance its market position through new formulations and combination therapies.

4. How do global economic conditions impact Veletri's sales?
   Factors like inflation and currency fluctuations have reduced margins by up to 5% in recent years, while supply chain issues have caused intermittent shortages affecting revenue stability.

5. Is Veletri a viable long-term investment for pharmaceutical portfolios?
   Yes, for investors focused on niche markets, Veletri offers potential returns through sustained demand and innovation, though risks from generics and regulations require careful monitoring.

Sources

1. Johnson & Johnson. (2023). Annual Report. Retrieved from Johnson & Johnson corporate filings.
2. Grand View Research. (2023). Pulmonary Arterial Hypertension Market Size, Share & Trends Analysis Report. Retrieved from Grand View Research market reports.