EPOPROSTENOL SODIUM - Generic Drug Details

What are the generic drug sources for epoprostenol sodium and what is the scope of patent protection?

Epoprostenol sodium is the generic ingredient in three branded drugs marketed by Meitheal, Mylan, Sun Pharm, Glaxosmithkline Llc, and Actelion, and is included in five NDAs. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Epoprostenol sodium has nineteen patent family members in fifteen countries.

There are seven drug master file entries for epoprostenol sodium. Four suppliers are listed for this compound.

Summary for EPOPROSTENOL SODIUM

International Patents:	19
US Patents:	2
Tradenames:	3
Applicants:	5
NDAs:	5
Drug Master File Entries:	7
Finished Product Suppliers / Packagers:	4
Raw Ingredient (Bulk) Api Vendors:	42
Clinical Trials:	7
Patent Applications:	1,477
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for EPOPROSTENOL SODIUM
What excipients (inactive ingredients) are in EPOPROSTENOL SODIUM?	EPOPROSTENOL SODIUM excipients list
DailyMed Link:	EPOPROSTENOL SODIUM at DailyMed

Recent Clinical Trials for EPOPROSTENOL SODIUM

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

Sponsor	Phase
GlaxoSmithKline	Phase 4
Actelion	Phase 4
United Therapeutics	Phase 4

See all EPOPROSTENOL SODIUM clinical trials

Pharmacology for EPOPROSTENOL SODIUM

Drug Class	Prostacycline Vasodilator
Physiological Effect	Vasodilation

Medical Subject Heading (MeSH) Categories for EPOPROSTENOL SODIUM

Antihypertensive Agents

Platelet Aggregation Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for EPOPROSTENOL SODIUM

B01AC	Platelet aggregation inhibitors excl. heparin
B01A	ANTITHROMBOTIC AGENTS
B01	ANTITHROMBOTIC AGENTS
B	Blood and blood forming organs

Paragraph IV (Patent) Challenges for EPOPROSTENOL SODIUM

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 EPOPROSTENOL SODIUM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Mylan	EPOPROSTENOL SODIUM	epoprostenol sodium	INJECTABLE;INJECTION	213913-002	Jun 12, 2024	AP2	RX	No	No
Sun Pharm	EPOPROSTENOL SODIUM	epoprostenol sodium	INJECTABLE;INJECTION	210473-001	Jan 15, 2021	AP2	RX	No	Yes
Meitheal	EPOPROSTENOL SODIUM	epoprostenol sodium	INJECTABLE;INJECTION	078396-001	Apr 23, 2008	AP1	RX	No	No
Glaxosmithkline Llc	FLOLAN	epoprostenol sodium	INJECTABLE;INJECTION	020444-001	Sep 20, 1995	AP1	RX	Yes	Yes
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

Expired US Patents for EPOPROSTENOL SODIUM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Glaxosmithkline Llc	FLOLAN	epoprostenol sodium	INJECTABLE;INJECTION	020444-002	Sep 20, 1995
Glaxosmithkline Llc	FLOLAN	epoprostenol sodium	INJECTABLE;INJECTION	020444-001	Sep 20, 1995
Glaxosmithkline Llc	FLOLAN	epoprostenol sodium	INJECTABLE;INJECTION	020444-002	Sep 20, 1995
Glaxosmithkline Llc	FLOLAN	epoprostenol sodium	INJECTABLE;INJECTION	020444-002	Sep 20, 1995
Glaxosmithkline Llc	FLOLAN	epoprostenol sodium	INJECTABLE;INJECTION	020444-001	Sep 20, 1995
Glaxosmithkline Llc	FLOLAN	epoprostenol sodium	INJECTABLE;INJECTION	020444-001	Sep 20, 1995

International Patents for EPOPROSTENOL SODIUM

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

EPOPROSTENOL SODIUM Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Epoprostenol Sodium

Introduction

Epoprostenol sodium, a prostaglandin used primarily to treat pulmonary arterial hypertension (PAH), has been a crucial medication in the cardiovascular therapeutic landscape. Here, we delve into the market dynamics and financial trajectory of this drug.

Market Size and Growth

The epoprostenol sodium market is anticipated to experience steady growth over the coming years. According to market research, the market size is expected to increase at a Compound Annual Growth Rate (CAGR) of 3 to 5 percent, reaching an estimated valuation by 2031[1][4].

Indications and Usage

Epoprostenol sodium is specifically indicated for the treatment of PAH, including idiopathic, heritable, and PAH associated with connective tissue diseases. It works by relaxing the blood vessels in the lungs, thereby reducing the workload on the heart and improving exercise capacity in patients with WHO Functional Class III-IV symptoms[2][5][3].

Product Forms and Administration

The medication is available in powder form for solution for infusion, with two common strengths: 0.5 mg and 1.5 mg. It must be reconstituted with a diluent and administered via continuous intravenous infusion. The solution can be stored for up to 8 days at 2°C to 8°C and must be used within specific time frames at various temperatures[2][3][5].

Side Effects and Safety Profile

While epoprostenol sodium is effective, it comes with a range of potential side effects. Common side effects include headache, jaw pain, nausea, vomiting, diarrhea, and joint pain. Serious side effects can include allergic reactions, bleeding due to platelet aggregation inhibition, and signs of infection or reaction at the catheter site. Patients must be closely monitored for these adverse effects[2][5].

Market Drivers

Several factors drive the growth of the epoprostenol sodium market:

• Increasing Prevalence of PAH: The rising incidence of PAH, coupled with the lack of a cure, ensures a steady demand for effective treatments like epoprostenol sodium.
• Advancements in Healthcare: Improvements in healthcare infrastructure and access to specialized treatments contribute to the market's expansion.
• Regulatory Approvals: Continuous regulatory approvals and updates in treatment guidelines support the market's growth[1][4].

Market Constraints

Despite the growth potential, there are several constraints:

• High Cost: Epoprostenol sodium is a costly medication, which can limit its accessibility, especially in regions with limited healthcare funding.
• Complex Administration: The need for continuous intravenous infusion and the associated risks of infection and other complications can be a deterrent for some patients.
• Side Effects: The significant side effect profile requires careful patient monitoring, which can add to the overall cost and complexity of treatment[2][5].

Competitive Landscape

The market for PAH treatments is competitive, with several other medications available. However, epoprostenol sodium remains a key player due to its efficacy and long-standing presence in the market. Other treatments, such as bosentan and sildenafil, also compete for market share, but epoprostenol sodium's unique mechanism of action and established use maintain its position[3][5].

Financial Performance

The financial performance of epoprostenol sodium is influenced by its market size, growth rate, and the revenue generated from sales. With a projected CAGR of 3 to 5 percent, the market is expected to see significant revenue growth. The medication's high price point, despite the costs associated with its administration and monitoring, contributes to substantial revenue for pharmaceutical companies like GlaxoSmithKline, which holds the marketing authorization for Flolan (epoprostenol sodium)[1][4].

Regional Market Analysis

The market for epoprostenol sodium varies by region, with developed countries like the United States and those in Europe showing higher demand due to better healthcare infrastructure and higher diagnosis rates. Emerging markets also present opportunities for growth as healthcare access improves and awareness of PAH increases[1][4].

Future Outlook

The future outlook for epoprostenol sodium is positive, driven by the increasing need for effective PAH treatments. Ongoing research and advancements in delivery systems could further enhance its market position. However, the introduction of new treatments and generic alternatives may pose challenges to its market share.

Key Takeaways

• Market Growth: Expected CAGR of 3 to 5 percent.
• Indications: Primarily for PAH treatment.
• Administration: Continuous intravenous infusion.
• Side Effects: Range from minor to serious, requiring careful monitoring.
• Market Drivers: Increasing PAH prevalence, healthcare advancements, and regulatory approvals.
• Constraints: High cost, complex administration, and significant side effects.
• Financial Performance: Substantial revenue due to high price point and growing market.

FAQs

Q: What is epoprostenol sodium used for?

A: Epoprostenol sodium is used to treat pulmonary arterial hypertension (PAH), which is high blood pressure in the blood vessels between the heart and lungs[2][5].

Q: How is epoprostenol sodium administered?

A: It is administered via continuous intravenous infusion after reconstitution with a diluent[2][3][5].

Q: What are the common side effects of epoprostenol sodium?

A: Common side effects include headache, jaw pain, nausea, vomiting, diarrhea, and joint pain. Serious side effects can include allergic reactions and signs of infection at the catheter site[2][5].

Q: Why is epoprostenol sodium expensive?

A: The medication is costly due to its complex production process, the need for continuous infusion, and the associated monitoring and healthcare costs[2][5].

Q: What is the market outlook for epoprostenol sodium?

A: The market is expected to grow at a CAGR of 3 to 5 percent, driven by increasing PAH prevalence and advancements in healthcare[1][4].

Sources

1. Market Research Intellect: Epoprostenol Sodium Market Size And Forecast.
2. NPS MedicineWise: Flolan for Injection.
3. European Union Risk Management Plan: Module 1.8.2 European Union Risk Management Plan for Flolan (epoprostenol sodium).
4. News Channel Nebraska: Epoprostenol Sodium Market Size 2024: Research by Global Trends.
5. Mayo Clinic: Epoprostenol (intravenous route).