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Last Updated: July 10, 2025

VELETRI Drug Patent Profile


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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 23rd, 2008.

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Drug patent expirations by year for VELETRI
Drug Prices for VELETRI

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Recent Clinical Trials for VELETRI

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SponsorPhase
Duke UniversityPhase 4

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Pharmacology for VELETRI
Drug ClassProstacycline Vasodilator
Physiological EffectVasodilation
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 ⤷  Try for Free ⤷  Try for Free Y ⤷  Try for Free
Actelion VELETRI epoprostenol sodium INJECTABLE;INJECTION 022260-001 Jun 27, 2008 AP2 RX Yes Yes ⤷  Try for Free ⤷  Try for Free Y ⤷  Try for Free
Actelion VELETRI epoprostenol sodium INJECTABLE;INJECTION 022260-002 Jun 28, 2012 AP2 RX Yes No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Actelion VELETRI epoprostenol sodium INJECTABLE;INJECTION 022260-001 Jun 27, 2008 AP2 RX Yes Yes ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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 ⤷  Try for Free
Spain 2558705 ⤷  Try for Free
Russian Federation 2423130 КОМПОЗИЦИЯ, СОДЕРЖАЩАЯ ЭПОПРОСТЕНОЛ, И СПОСОБ ЕЕ ПОЛУЧЕНИЯ (EPOPROSTENOL-CONTAINING COMPOSITION AND METHOD OF ITS OBTAINING) ⤷  Try for Free
Russian Federation 2008135701 КОМПОЗИЦИЯ, СОДЕРЖАЩАЯ ЭПОПРОСТЕНОЛ, И СПОСОБ ЕЕ ПОЛУЧЕНИЯ ⤷  Try for Free
Portugal 1993557 ⤷  Try for Free
Cyprus 1117128 ⤷  Try for Free
Slovenia 1993557 ⤷  Try for Free
>Country >Patent Number >Title >Estimated Expiration

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.

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