ILOPROST - Generic Drug Details

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

Iloprost is the generic ingredient in two branded drugs marketed by Actelion and Btg Intl, and is included in two NDAs. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Iloprost has two patent family members in one country.

There are four drug master file entries for iloprost. One supplier is listed for this compound.

Summary for ILOPROST

International Patents:	2
US Patents:	2
Tradenames:	2
Applicants:	2
NDAs:	2
Drug Master File Entries:	4
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	59
Clinical Trials:	102
What excipients (inactive ingredients) are in ILOPROST?	ILOPROST excipients list
DailyMed Link:	ILOPROST at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for ILOPROST

Constraining patent/regulatory exclusivity:

TREATMENT OF SEVERE FROSTBITE IN ADULTS TO REDUCE THE RISK OF DIGIT AMPUTATIONS

Dosage:

SOLUTION;INTRAVENOUS

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for ILOPROST

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

Sponsor	Phase
Pär Johansson	PHASE2
Novotech (Australia) Pty Limited	PHASE1
Pharmosa Biopharm Inc.	PHASE1

See all ILOPROST clinical trials

Pharmacology for ILOPROST

Drug Class

Prostacycline

Medical Subject Heading (MeSH) Categories for ILOPROST

Platelet Aggregation Inhibitors

Vasodilator Agents

Anatomical Therapeutic Chemical (ATC) Classes for ILOPROST

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

US Patents and Regulatory Information for ILOPROST

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Btg Intl	AURLUMYN	iloprost	SOLUTION;INTRAVENOUS	217933-001	Feb 13, 2024		RX	Yes	Yes	12,409,183
Actelion	VENTAVIS	iloprost	SOLUTION;INHALATION	021779-002	Dec 8, 2005		DISCN	Yes	No
Actelion	VENTAVIS	iloprost	SOLUTION;INHALATION	021779-003	Aug 7, 2009		DISCN	Yes	No
Btg Intl	AURLUMYN	iloprost	SOLUTION;INTRAVENOUS	217933-001	Feb 13, 2024		RX	Yes	Yes
Actelion	VENTAVIS	iloprost	SOLUTION;INHALATION	021779-001	Dec 29, 2004		DISCN	No	No

EU/EMA Drug Approvals for ILOPROST

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Bayer AG	Ventavis	iloprost	EMEA/H/C/000474Treatment of patients with primary pulmonary hypertension, classified as New York Heart Association functional class III, to improve exercise capacity and symptoms.	Authorised	no	no	no	2003-09-15

International Patents for ILOPROST

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2025019625
World Intellectual Property Organization (WIPO)	2022032141

Last updated: July 29, 2025

rket Dynamics and Financial Trajectory for ILOPROST

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Introduction

ILOprost, marketed under the brand name Iloprost, is a synthetic prostacyclin analogue developed primarily for treating pulmonary arterial hypertension (PAH). With FDA approval in 2004 and subsequent approvals worldwide, Iloprost's market behavior is driven by clinical efficacy, regulatory pathways, competitive landscape, and evolving healthcare policies. This report provides a comprehensive analysis of the current market dynamics and forecasts the financial trajectory for Iloprost, emphasizing factors influencing its growth and challenges.

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Pharmacological Profile and Clinical Landscape

Iloprost exerts vasodilatory effects on pulmonary vasculature by mimicking prostacyclin activity, reducing pulmonary arterial pressure, and improving exercise capacity in PAH patients. Its administration route involves inhalation via nebulization, with dosing schedules typically three to four times daily. The drug's proven efficacy and safety profile have sustained its role in PAH management, especially for patients unresponsive to or intolerant of oral therapies such as endothelin receptor antagonists or phosphodiesterase-5 inhibitors.

In clinical contexts, Iloprost is often used for patients with advanced disease or those preferring inhalation therapy, fitting a niche within the broader PAH therapeutic landscape. However, newer agents with oral or subcutaneous administration routes challenge its dominance, impacting market share and growth prospects.

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Market Dynamics

1. Regulatory and Reimbursement Environment

The regulatory pathway for Iloprost varies across regions, influencing its market access. In the United States, the Drug Enforcement Administration classifies Iloprost as a controlled substance, which introduces regulatory complexities but also ensures quality standards. Reimbursement policies in major markets such as the U.S., Europe, and Japan significantly affect drug uptake; favorable coverage facilitates wider access, whereas restrictive policies can hinder growth.

2. Competitive Landscape

Iloprost faces competition from several classes of PAH therapies:

• Endothelin receptor antagonists (e.g., bosentan, ambrisentan).
• Phosphodiesterase-5 inhibitors (e.g., sildenafil, tadalafil).
• Soluble guanylate cyclase stimulators (e.g., riociguat).
• Other inhaled agents and novel therapies.

While Iloprost offers advantages like localized delivery reducing systemic side effects, newer oral options provide enhanced convenience, leading to declining utilization in some settings.

3. Market Penetration and Adoption Challenges

Despite its proven efficacy, Iloprost’s adoption remains limited by factors such as:

• Patient preference for oral medications.
• Complex and time-consuming administration via inhalation.
• Cost considerations, particularly in regions with constrained healthcare budgets.

These factors suppress its penetration, especially in markets favoring more modern, user-friendly therapies.

4. Epidemiological Trends

PAH predominantly affects women aged 30-60, with an estimated global prevalence of 15-50 cases per million. An aging population and improved diagnostic techniques are likely to expand the identifiable patient pool, potentially favoring drugs like Iloprost in specialized treatment regimens.

5. Innovation and Pipeline Developments

Ongoing research aims to develop longer-acting inhaled formulations, combination therapies, and alternative delivery systems. These innovations could prolong Iloprost’s relevance if they address current limitations, such as dosing frequency and administration complexity.

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Financial Trajectory Analysis

Historical Revenue Trends

Data from pharmaceutical market research indicates that Iloprost's sales have plateaued or declined modestly over recent years in major markets, reflecting increased competition and shifting prescribing patterns. In 2021, the global market for inhaled prostacyclin analogues, including Iloprost, was valued at approximately $200 million, with a predicted compound annual growth rate (CAGR) of around 2-3% over the next five years.

Market Forecasting

Factors influencing future revenue include:

• Market Expansion: Increasing diagnosis rates of PAH, especially in developing countries, could open new markets, provided regulatory and reimbursement barriers are managed.
• Patent and Exclusivity Status: As a generic or off-patent molecule in some regions, pricing pressures are anticipated, affecting margins.
• Product Development: Introduction of improved inhalation devices or combination therapies involving Iloprost could stimulate renewed demand.
• Competitive Dynamics: The advent of newer oral therapies may further erode Iloprost’s market share in dominant regions like North America and Europe.

Based on current trends, the global Iloprost market is expected to experience modest growth, with potential to reach $250-275 million by 2028, assuming favorable adoption of innovations and expanding disease prevalence.

Profitability and Investment Outlook

Manufacturers face pressure from generic competition and the need for substantial marketing investments in competitive markets. Profit margins are likely to be squeezed unless product differentiation strategies or pipeline expansions are employed.

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Strategic Opportunities and Challenges

Opportunities

• Enhancing Delivery Technology: Development of once-daily inhalers or nebulizers can improve adherence.
• Expanding into Emerging Markets: Tailored strategies in Asia, Latin America, and Africa can unlock pent-up demand.
• Combination Therapy Development: Co-formulations with other PAH agents may optimize treatment protocols.

Challenges

• Market Saturation: Mature markets face slow growth unless driven by new formulations.
• Pricing and Reimbursement: Cost constraints and insurance limitations restrict access.
• Competitive Innovation: ORally-effective drugs threaten the inhaled prostacyclin niche.

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Conclusion

Iloprost remains a vital, albeit niche, agent within the PAH treatment portfolio. Its future financial trajectory hinges on technological advancements, strategic market expansion, and overcoming barriers posed by newer, more convenient therapies. While growth prospects are moderate, targeted efforts in product innovation and regional expansion could enhance its revenue prospects, particularly if aligning with evolving clinical guidelines favoring inhaled therapies for select patient populations.

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Key Takeaways

• Market maturity and competition limit Iloprost’s growth prospects, emphasizing the need for innovation.
• Advancements in inhalation devices and combination therapies offer pathways for extending market viability.
• Emerging markets present significant growth opportunities amid increasing PAH diagnosis rates.
• Pricing pressures and regulatory hurdles necessitate strategic responses to sustain profitability.
• The future health of Iloprost's market position depends on balancing technological improvements with evolving clinical and regulatory landscapes.

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FAQs

1. What are the primary drivers of Iloprost’s market growth?
Expanding PAH diagnosis, technological enhancements in inhalation delivery, and increased adoption in regions with growing healthcare infrastructure.

2. How does Iloprost compare to oral PAH therapies?
Iloprost offers targeted pulmonary vasodilation with fewer systemic side effects but is less convenient due to inhalation requirements, limiting its use relative to oral therapies.

3. What is the patent status of Iloprost?
As a generic or off-patent molecule in many regions, patent expiration has increased price competition, impacting margins.

4. Are there ongoing developments to improve Iloprost’s administration?
Yes, research focuses on developing longer-acting formulations and innovative inhaler devices to enhance patient compliance.

5. How can manufacturers capitalize on emerging PAH markets?
Through tailored regulatory strategies, affordable pricing, and clinical education to improve awareness and access in developing regions.

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References

[1] GlobalData. (2022). Pulmonary Arterial Hypertension Market Outlook.
[2] American College of Chest Physicians. (2021). PAH Treatment Guidelines.
[3] MarketWatch. (2022). Inhaled Therapy Devices Market Data.
[4] European Medicines Agency. (2019). Iloprost Summary of Product Characteristics.
[5] World Health Organization. (2020). Global Burden of Pulmonary Hypertension.