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Last Updated: December 22, 2024

EPOPROSTENOL SODIUM Drug Patent Profile


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

Epoprostenol Sodium is a drug marketed by Meitheal, Mylan, and Sun Pharm. and is included in three NDAs.

The generic ingredient in EPOPROSTENOL SODIUM 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 Epoprostenol Sodium

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

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Drug patent expirations by year for EPOPROSTENOL SODIUM
Recent Clinical Trials for EPOPROSTENOL SODIUM

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

SponsorPhase
GlaxoSmithKlinePhase 4
ActelionPhase 4
United TherapeuticsPhase 4

See all EPOPROSTENOL SODIUM clinical trials

Pharmacology for EPOPROSTENOL SODIUM
Drug ClassProstacycline Vasodilator
Physiological EffectVasodilation
Medical Subject Heading (MeSH) Categories for EPOPROSTENOL SODIUM
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
Meitheal EPOPROSTENOL SODIUM epoprostenol sodium INJECTABLE;INJECTION 078396-001 Apr 23, 2008 AP1 RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Mylan EPOPROSTENOL SODIUM epoprostenol sodium INJECTABLE;INJECTION 213913-002 Jun 12, 2024 AP2 RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Meitheal EPOPROSTENOL SODIUM epoprostenol sodium INJECTABLE;INJECTION 078396-002 Apr 23, 2008 AP1 RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Mylan EPOPROSTENOL SODIUM epoprostenol sodium INJECTABLE;INJECTION 213913-001 Jun 12, 2024 AP2 RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Sun Pharm EPOPROSTENOL SODIUM epoprostenol sodium INJECTABLE;INJECTION 210473-002 Jan 15, 2021 AP2 RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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).

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