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
Hungary	E026166
Spain	2558705
Canada	2641393	NOUVELLE FORMULATION D'EPOPROSTENOL ET SON PROCEDE DE FABRICATION (NOVEL EPOPROSTENOL FORMULATION AND METHOD OF MAKING THEREOF)
Portugal	1993557
South Korea	101351668
Brazil	PI0707488	método para a produção de uma composição de epoprostenol, composição farmacêutica e solução estável
China	101410119	Novel epoprostenol formulation and method of making thereof

VELETRI Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for VELETRI

Introduction to VELETRI

VELETRI, also known as epoprostenol, is a prescription medication used to treat adults with severe pulmonary arterial hypertension (PAH), specifically those classified under New York Heart Association (NYHA) Functional Class III-IV. It is administered intravenously and works by dilating the blood vessels in the lungs, improving oxygen-rich blood flow[2].

Market Drivers

The growth of the VELETRI market is driven by several key factors:

Rising Prevalence of PAH

The increasing global prevalence of pulmonary arterial hypertension is a significant driver. As more cases are diagnosed, the demand for effective treatments like VELETRI rises[4].

Advancements in Treatment Options

Improvements in the formulation and stability of VELETRI, such as its ability to be mixed with commercially available diluents and its extended room temperature stability, enhance patient convenience and compliance. This makes VELETRI a more attractive option compared to older formulations like Flolan[5].

Specialty Pharmacy Support

The role of specialty pharmacies in monitoring and adjusting prostacyclin therapy is crucial. These pharmacies provide ongoing support, which helps in maintaining long-term treatment adherence and managing potential barriers to successful therapy[5].

Market Segments

The VELETRI market is segmented based on several criteria:

Application

• Hospital Pharmacy: VELETRI is often administered in hospital settings, particularly for patients requiring close monitoring.
• Retail Pharmacy: Although less common, VELETRI can be dispensed through retail pharmacies for patients who are stable and can manage their treatment at home.
• Online Pharmacy: Online pharmacies play a role in home delivery, which can reduce costs and improve patient convenience[1].

Product Form

• Oral Medication: Not applicable for VELETRI, as it is administered intravenously.
• Injection: VELETRI is specifically an intravenous injection, which is its primary form of administration[1].

Geography

The market is divided into regions such as North America, Europe, Asia-Pacific, South America, and the Middle East & Africa. Each region has its own market dynamics influenced by local healthcare systems, regulatory environments, and patient populations[1].

Financial Trajectory

The financial trajectory of the VELETRI market is characterized by several trends:

Market Size and Forecast

The global VELETRI market is expected to grow significantly from 2024 to 2031. The market size is projected to increase in value, measured in USD million, across various segments. The forecast period from 2024 to 2031 indicates a positive growth trajectory driven by the increasing demand for PAH treatments[1].

Cost and Utilization Trends

Specialty medications like VELETRI are associated with high costs. However, home delivery and the use of specialty pharmacies can help reduce costs. For instance, home delivery has been shown to yield lower costs compared to retail pharmacies, which is beneficial for patients and payers alike[3].

Spending on Specialty Medications

VELETRI is part of the top specialty medication classes, with significant annual spending. In workers’ compensation drug trend reports, VELETRI is highlighted as one of the costly specialty medications, indicating its financial impact on healthcare systems[3].

Key Companies and Competitive Landscape

Several major pharmaceutical companies are involved in the VELETRI market, including:

• Pfizer (US)
• Sanofi S.A (France)
• Bayer HealthCare Pharmaceuticals (Germany)
• Actelion Pharmaceuticals (Switzerland)
• Daiichi Sankyo (Japan)
• Eli Lilly and Company (US)
• Gilead Sciences (US)
• GlaxoSmithKline Plc (UK)
• Nippon Shinyaku (Japan)
• Cipla Limited (India)

These companies play a crucial role in the development, distribution, and marketing of VELETRI, influencing the competitive landscape of the market[1].

Challenges and Opportunities

Challenges

• Tachyphylaxis: The development of tolerance to prostacyclins over time can necessitate dose adjustments, which can be challenging for both patients and healthcare providers[5].
• Adverse Events: Continuous monitoring is required to manage potential adverse events associated with VELETRI therapy[5].

Opportunities

• Expanding Patient Population: The increasing diagnosis and awareness of PAH offer opportunities for market growth.
• Advancements in Formulation: Continued improvements in the stability and convenience of VELETRI can enhance patient compliance and market appeal[4].

Role of Specialty Pharmacies

Specialty pharmacies are essential in the management of VELETRI therapy. They provide:

• Ongoing Assessment: Continuous monitoring of patients to adjust dosing and manage adverse events.
• Clinical Support: Proactive clinical telephonic assessments and 24/7 access to healthcare professionals.
• Supply Management: Facilitation of supply delivery and troubleshooting of medical equipment issues[5].

Highlight: Stability and Convenience

"VELETRI is stable without cooling packs for 48 to 72 hours, depending on concentration. At all concentrations, Veletri, with a pH of 11 to 13, can be prepared and refrigerated for up to 8 days before use, allowing for less frequent product preparation and increased convenience for the patient."[5]

Statistics and Trends

• The global VELETRI market is expected to grow significantly, driven by the rising prevalence of PAH and advancements in treatment options.
• Home delivery of VELETRI can reduce costs by up to 23.1% compared to retail pharmacies[3].
• Specialty medication spending, including VELETRI, has seen significant increases, with a 27.0% increase in specialty drug utilization in certain reports[3].

Key Takeaways

• VELETRI is a critical treatment for severe PAH, administered intravenously.
• The market is driven by the increasing prevalence of PAH and advancements in treatment formulations.
• Specialty pharmacies play a vital role in managing VELETRI therapy.
• The financial trajectory indicates significant growth, with high costs associated with specialty medications.
• Challenges include tachyphylaxis and adverse events, while opportunities lie in expanding patient populations and formulation improvements.

FAQs

1. What is VELETRI used for? VELETRI is used to treat adults with severe pulmonary arterial hypertension (PAH), specifically those classified under NYHA Functional Class III-IV.

2. How is VELETRI administered? VELETRI is administered intravenously and can be mixed with either Sterile Water for Injection or Sodium Chloride 0.9% Injection.

3. What are the key drivers of the VELETRI market? The key drivers include the rising prevalence of PAH, advancements in treatment options, and the support of specialty pharmacies.

4. Which companies are involved in the VELETRI market? Major pharmaceutical companies such as Pfizer, Sanofi S.A, Bayer HealthCare Pharmaceuticals, and others are involved in the VELETRI market.

5. What are the challenges associated with VELETRI therapy? Challenges include the development of tolerance (tachyphylaxis) and the management of adverse events, which require continuous monitoring and support from specialty pharmacies.

Cited Sources:

1. Market Research Intellect - Global Veletri Market Size and Forecast to 2031
2. VELETRI - VELETRI® (epoprostenol) for Injection
3. myMatrixx - 2019 Workers’ Compensation Drug Trend Report
4. Dataintelo - Veletri Market Research Report 2032
5. The American Journal of Managed Care - The Evolution of Prostacyclins in Pulmonary Arterial Hypertension