Epoprostenol sodium - Generic Drug Details

What are the generic sources for epoprostenol sodium and what is the scope of freedom to operate?

Epoprostenol sodium is the generic ingredient in three branded drugs marketed by Gland, Meitheal, Mylan, Sun Pharm, Glaxosmithkline Llc, and Actelion, and is included in six 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. Five suppliers are listed for this compound.

Summary for epoprostenol sodium

International Patents:	19
US Patents:	2
Tradenames:	3
Applicants:	6
NDAs:	6
Drug Master File Entries:	7
Finished Product Suppliers / Packagers:	5
Raw Ingredient (Bulk) Api Vendors:	33
Clinical Trials:	7
Patent Applications:	3,164
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
Sun Pharm	EPOPROSTENOL SODIUM	epoprostenol sodium	INJECTABLE;INJECTION	210473-001	Jan 15, 2021	AP2	RX	No	Yes
Actelion	VELETRI	epoprostenol sodium	INJECTABLE;INJECTION	022260-001	Jun 27, 2008	AP2	RX	Yes	Yes	8,598,227
Meitheal	EPOPROSTENOL SODIUM	epoprostenol sodium	INJECTABLE;INJECTION	078396-002	Apr 23, 2008		RX	No	Yes
Actelion	VELETRI	epoprostenol sodium	INJECTABLE;INJECTION	022260-002	Jun 28, 2012	AP2	RX	Yes	No	8,598,227
Meitheal	EPOPROSTENOL SODIUM	epoprostenol sodium	INJECTABLE;INJECTION	078396-001	Apr 23, 2008		RX	No	Yes
Gland	EPOPROSTENOL SODIUM	epoprostenol sodium	INJECTABLE;INJECTION	219237-001	Dec 29, 2025	AP2	RX	No	No
Glaxosmithkline Llc	FLOLAN	epoprostenol sodium	INJECTABLE;INJECTION	020444-001	Sep 20, 1995		DISCN	Yes	No

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	020444-001	Sep 20, 1995	4,335,139
Glaxosmithkline Llc	FLOLAN	epoprostenol sodium	INJECTABLE;INJECTION	020444-002	Sep 20, 1995	4,338,325
Glaxosmithkline Llc	FLOLAN	epoprostenol sodium	INJECTABLE;INJECTION	020444-002	Sep 20, 1995	4,883,812
Glaxosmithkline Llc	FLOLAN	epoprostenol sodium	INJECTABLE;INJECTION	020444-001	Sep 20, 1995	4,338,325
Glaxosmithkline Llc	FLOLAN	epoprostenol sodium	INJECTABLE;INJECTION	020444-002	Sep 20, 1995	4,335,139
Glaxosmithkline Llc	FLOLAN	epoprostenol sodium	INJECTABLE;INJECTION	020444-001	Sep 20, 1995	4,883,812
Glaxosmithkline Llc	FLOLAN	epoprostenol sodium	INJECTABLE;INJECTION	020444-001	Sep 20, 1995	4,539,333

International Patents for epoprostenol sodium

Country	Patent Number	Title	Estimated Expiration
China	101410119	Novel epoprostenol formulation and method of making thereof
South Korea	101351668
Hungary	E026166
South Korea	20090004867	NOVEL EPOPROSTENOL FORMULATION AND METHOD OF MAKING THEREOF
Canada	2641393	NOUVELLE FORMULATION D'EPOPROSTENOL ET SON PROCEDE DE FABRICATION (NOVEL EPOPROSTENOL FORMULATION AND METHOD OF MAKING THEREOF)
Russian Federation	2423130	КОМПОЗИЦИЯ, СОДЕРЖАЩАЯ ЭПОПРОСТЕНОЛ, И СПОСОБ ЕЕ ПОЛУЧЕНИЯ (EPOPROSTENOL-CONTAINING COMPOSITION AND METHOD OF ITS OBTAINING)
Brazil	PI0707488	método para a produção de uma composição de epoprostenol, composição farmacêutica e solução estável

Market Dynamics and Financial Trajectory for Epoprostenol Sodium

Last updated: February 19, 2026

Epoprostenol sodium, marketed as Flolan among other brands, is a prostacyclin analog primarily used to treat pulmonary arterial hypertension (PAH). It has patent exclusivity, limited generic competition, and a stable but niche market footprint.

Market Overview

Indication and Usage: Epoprostenol sodium is approved for class 1 and 4 PAH, improving exercise capacity and survival. Its administration involves continuous IV infusion, which influences market penetration and patient adherence.

Key Players:

• Ferring Pharmaceuticals: Manufactures Fostrap, a stable formulation of epoprostenol.
• Adamed: Distributes generic versions in select markets.
• Innovator Patents: Expired or nearing expiration in some regions, opening pathways for generics.

Pricing landscape:

• Originator drug prices in the U.S. typically exceed $35,000 per month per patient.
• Generic versions sell at approximately 10-15% discount, impacting revenue streams for proprietary formulations during patent life.

Market Size and Demand

In 2022, the global PAH market was valued at approximately $4.7 billion, with epoprostenol sodium representing roughly 15% of total PAH-specific treatments. The drug’s market share reflects its status as first-line therapy for severe PAH cases where other medications are ineffective or contraindicated.

Projected Revenue:	Year	Estimated Revenue (USD millions)	Notes
2023	$250	Maintains market with stable demand
2028	$300	Growth driven by increasing PAH diagnosis rates
2030	$330	Potential plateau unless new formulations emerge

Growth rates hover around 2-4% annually, primarily driven by increasing PAH diagnoses, improved healthcare access, and regulatory approvals for combination therapy.

Market Drivers

• Growing Prevalence: PAH affects an estimated 15-50 cases per million, with an increase in elderly populations contributing to rising prevalence.
• Limited Alternatives: The injectable route and complex administration restrict widespread adoption of newer oral therapies for severe PAH.
• Regulatory Landscape: Market entry barriers remain high due to the complexity of formulation stability and delivery devices. Patent expiration in key jurisdictions is imminent, possibly opening opportunities for generics.

Challenges

• Administration Complexity: Continuous infusion requires specialized equipment and monitoring, limiting patient market size.
• High Cost: Pricing pressures due to hospital budgets, insurance coverage limits, and emerging biosimilars.
• Emerging Therapies: Selexipag (Uptravi) and oral prostacyclin receptor agonists are gaining ground, possibly shifting treatment paradigms.

Patent and Regulatory Status

• Original patents in the U.S. and Europe expired or set to expire between 2024 and 2027, enabling generic development.
• Ferring’s stabilization patents for formulations extend exclusivity into early 2030s but face patent challenges in some jurisdictions.

Financial Trajectory

Revenue Expectations:

• The brand is expected to sustain stable revenue growth through 2025, driven by steady demand and limited competition.
• Post-2025, generics and biosimilars could threaten revenue streams, possibly reducing prices and margins.
• Investments into formulation improvements or alternative delivery methods could offset generic market erosion.

Cost Considerations:

• R&D investments in drug delivery innovations, such as inhalation or oral formulations, are increasing.
• Manufacturing costs for injectable formulations are high, influencing gross margins.

Valuation Factors:

• Patents, market share stability, and pipeline development influence valuation.
• Exposure to generic competition after patent expirations remains the primary risk.

Competitive Outlook

Competitor	Market Position	Key Strategy	Timeline for Entry
Ferring	Market leader	Maintain formulation patents	2024–2027
Generic entrants	Minority players	Price competition	2024–2026
Biotech firms	Early-stage	Develop novel delivery methods	2025–2028

Conclusions

Epoprostenol sodium exhibits a stable but attritive market segment with high barriers for new entrants, limited competitors due to complex administration, and prospects for revenue decline post-patent expiry. The key factors influencing its financial outlook include patent expirations, emerging therapy options, and developments in drug delivery technology.

Key Takeaways

• Epoprostenol sodium’s revenue depends on continued demand in severe PAH cases and limited competition.
• Patent expirations beginning in 2024 could lead to increased generic competition, pressuring prices and margins.
• Market growth remains modest (~2-4% annually), driven by rising PAH prevalence.
• Ongoing investments are shifting toward alternative formulations and delivery systems to sustain market share.
• Price sensitivity, high manufacturing costs, and newer therapies temper revenue projections.

FAQs

1. When do patents on epoprostenol sodium expire?
Patents are set to expire between 2024 and 2027 in major markets like the US and Europe.[1]

2. How do generics impact the market?
Generics are expected to reduce prices by 10-15%, eroding revenue for original manufacturers and increasing competition access.

3. What are alternative therapies for PAH?
Oral prostacyclin receptor agonists such as selexipag and combination therapies with endothelin receptor antagonists are gaining market share.

4. How does the administration route influence market size?
The requirement for continuous IV infusion limits patient accessibility and adherence, constraining market expansion.

5. What technological innovations could influence future sales?
Development of inhalable or oral formulations could expand the patient base and mitigate existing administration limitations.

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References

[1] Pharmaceutical Patent Data. (2022). Patent expiry timelines for pulmonary hypertension drugs.