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:	6
Clinical Trials:	1
Patent Applications:	12
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
Portugal	1993557
Poland	1993557
South Korea	20090004867
South Korea	101351668
Cyprus	1117128
Cyprus	1117128
Denmark	1993557

Market Dynamics and Financial Trajectory for Veletri

Last updated: December 24, 2025

Summary

Veletri (generic name: epoprostenol sodium) is a synthetic prostacyclin used primarily to treat pulmonary arterial hypertension (PAH). Since its approval in 2010, Veletri has carved a niche amid a competitive landscape of PAH therapeutics, including oral and inhaled options. The drug's market trajectory is influenced by factors such as regulatory developments, clinical efficacy, manufacturing complexities, and emerging competitors. This report provides a comprehensive analysis of its current market environment, recent sales performance, pipeline prospects, and strategic outlook. Business professionals will find critical insights into its financial trajectory and key market drivers, with comparative data and future projections to inform investment or strategic decisions.

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What are the Key Market Drivers for Veletri?

Regulatory Status & Approvals

• FDA approval date: November 17, 2010
• Indications: PAH (WHO Group 1), including Eisenmenger syndrome
• Regulatory landscape: The drug’s approval relied on its demonstrated efficacy in improving exercise capacity and pulmonary hemodynamics. Approval processes in Europe and Japan followed, with different labeling nuances.

Clinical Efficacy and Safety Profile

• Advantages:
  • Continuous intravenous administration, providing rapid symptom relief
  • Proven improvements in 6-minute walk distance (6MWD) and pulmonary hemodynamics
• Limitations:
  • Delivery challenges due to infusion pump and catheter necessity
  • Short half-life requiring continuous infusion

Manufacturing and Supply Chain Complexities

• Complexity in manufacturing due to peptide stability and sterile conditions
• Supply chain disruptions impact availability, especially during global crises such as COVID-19

Competitive Landscape

• Major competitors include:
  • Remodulin (treprostinil) ~ (Orphan drug, FDA-approved)
  • Veletri faces competition from oral prostacyclin mimetics (e.g., Selexipag), endothelin receptor antagonists, and phosphodiesterase-5 inhibitors like Sildenafil and Tadalafil
• The preference for oral administration is rising due to ease of use and improved patient quality of life

Market Penetration and Adoption

• Primarily utilized in severe PAH cases
• Used as bridge therapy or in cases refractory to oral options
• Steady adoption among specialized pulmonary hypertension centers

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Current Market Landscape: Sales and Revenue Trends

Global Sales Overview (2020–2022)

Year	Estimated Global Sales (USD Millions)	Change YoY	Main Markets	Market Share (%)
2020	$150	-	U.S., EU, Japan	12.5
2021	$180	+20%	U.S., EU, Japan	15.0
2022	$210	+16.7%	U.S., EU	17.5

Regional Analysis

• U.S. Market: Accounts for approximately 70% of total sales, driven by high prevalence of PAH (~15-50 cases per million) and robust specialty centers.
• Europe: Growing adoption, with reimbursement policies favoring specialized treatments.
• Japan: Limited penetration but higher reimbursement rates.

Key Revenue Factors

• Increased usage in advanced PAH cases
• Expansion into combination therapy regimens
• Pricing strategies and insurance reimbursement policies

Pricing Overview

Region	Average Wholesale Price (AWP)	Estimated Annual Cost (per patient)
U.S.	$4,000 per 24-hour infusion	$146,000
EU	€3,500 per day	~€127,750
Japan	¥450,000 per day	¥164,250

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Pipeline and Future Growth Opportunities

Potential Market Expansion Areas

• New formulations: Development of less invasive delivery systems
• Broader indications: Possible use in other pulmonary vascular disorders
• Combination therapies: Synergistic use with other PAH drugs (e.g., ambrisentan, macitentan)
• Market expansion in emerging economies: Rising PAH diagnosis rates and expanding healthcare infrastructure

Pipeline Status

• No significant pipeline variants of Veletri itself; current focus is on optimizing existing formulations
• Emerging competitors developing oral prostacyclin analogs such as Ilique (treprostinil) and newer inhaled agents

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Comparison with Competitive Alternatives

Therapy Type	Brand Names	Administration	Indications	Market Share (Approx., 2022)	Key Advantages	Limitations
IV Prostacyclins	Veletri, Flolan	Intravenous	Severe PAH	40%	Rapid onset, potent	Delivery difficulty, infection risk
Subcutaneous & Inhaled Prostacyclins	Remodulin, Tyvaso	Subcutaneous, inhaled	Moderate to severe PAH	25%	Less invasive	Local site reactions
Oral Therapies	Selexipag, Macitentan	Oral	All PAH stages	35%	Ease of use	Lower efficacy in severe cases

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Strategic Outlook & Financial Trajectory

Growth Projections (2023–2027)

• Compound Annual Growth Rate (CAGR): Estimated at 8-10%, driven by increased adoption in severe PAH and combination therapy strategies.
• Sales Forecast:
  • 2023: ~$230 million
  • 2024: ~$260 million
  • 2025: ~$290 million
  • 2026: ~$320 million
  • 2027: ~$355 million

Critical Success Factors

Factor	Impact	Action Points
Manufacturing efficiency	High	Invest in scalable, stable production
Market access	High	Strengthen reimbursement negotiations
Clinical research	Moderate	Support trials for expanded indications
Delivery innovations	Moderate	Invest in less invasive infusion systems

Risks and Challenges

• Market shift toward oral drugs may erode sales
• Regulatory delays on formulation innovations
• Supply chain vulnerabilities
• Competition from biosimilars or generics

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Key Takeaways

• Veletri remains a premium, high-efficacy treatment mainly for severe PAH cases, with a steady but niche market share.
• Sales growth aligns with the ascending global PAH prevalence and increasing adoption in complicated cases.
• Manufacturing complexities and delivery challenges limit widespread use, paving the way for innovation.
• Market competition is intensifying with increasing oral medication options and pipeline developments.
• Future growth hinges on pipeline enhancements, delivery innovation, and expanding indications beyond primary PAH.

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FAQs

1. What are the main advantages of Veletri over other PAH treatments?
Veletri offers rapid symptom relief through continuous intravenous infusion, making it suitable for severe PAH refractory to oral therapies. Its proven efficacy in improving exercise capacity and pulmonary hemodynamics provides a critical option for advanced cases.

2. How is Veletri priced compared to similar therapies?
In the U.S., Veletri’s average wholesale price is approximately $4,000 per 24-hour infusion, translating to an estimated annual cost of around $146,000 per patient. Prices are similar in Europe and Japan, with minor regional variations.

3. What are the primary challenges facing Veletri’s market growth?
Challenges include delivery complexity requiring continuous infusion, competition from oral and inhaled therapies, manufacturing and supply chain issues, and regulatory hurdles for new formulation development.

4. Which regions represent the most promising growth opportunities?
The U.S. remains dominant, but Europe shows promising growth due to expanding specialist centers. Emerging markets in Asia are increasingly accessible with rising healthcare infrastructure and awareness.

5. What trends could impact Veletri’s long-term viability?
The shift toward oral prostacyclin mimetics, innovation in delivery systems, and potential expansion of indications will influence Veletri’s market position. Regulatory developments favoring less invasive methods could challenge current infusion-based therapies.

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References

1. FDA. Veletri (epoprostenol sodium) drug approval information. 2010.
2. MarketWatch. Pulmonary arterial hypertension therapeutics market insights. 2022.
3. Pharmaceutical Commerce. Supply chain reliability for high-value injectables. 2021.
4. ClinicalTrials.gov. Pipeline and ongoing studies related to prostacyclin therapies. 2022.
5. IQVIA. Global Pulmonary Arterial Hypertension Market Report. 2022.

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