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 three patent family members in two countries.

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

Summary for ILOPROST

International Patents:	3
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:	103
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
University of Sao Paulo General Hospital	NA
Pär Johansson	PHASE2
Novotech (Australia) Pty Limited	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
Actelion	VENTAVIS	iloprost	SOLUTION;INHALATION	021779-002	Dec 8, 2005		DISCN	Yes	No
Btg Intl	AURLUMYN	iloprost	SOLUTION;INTRAVENOUS	217933-001	Feb 13, 2024		RX	Yes	Yes
Btg Intl	AURLUMYN	iloprost	SOLUTION;INTRAVENOUS	217933-001	Feb 13, 2024		RX	Yes	Yes
Btg Intl	AURLUMYN	iloprost	SOLUTION;INTRAVENOUS	217933-001	Feb 13, 2024		RX	Yes	Yes			Y
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
Denmark	202630963	METHOD OF USING ILOPROST FOR TREATING FROSTBITE
World Intellectual Property Organization (WIPO)	2025019625
World Intellectual Property Organization (WIPO)	2022032141

ILOPROST Market Analysis and Financial Projection

Last updated: February 15, 2026

What Are the Current Market Dynamics for Iloprost?

Iloprost is a synthetic prostacyclin analog used primarily to treat pulmonary arterial hypertension (PAH) and some other vascular conditions, including critical limb ischemia. Its market has experienced shifts driven by regulatory approvals, competition, and evolving treatment guidelines.

Market Size and Segments

• Global Market Value: The pulmonary arterial hypertension segment for iloprost revenue approached USD 250 million in 2022, with projections to reach approximately USD 380 million by 2030, growing at a compound annual growth rate (CAGR) of about 6.2% (Source: Grand View Research).
• Regional Distribution: North America leads with around 45% market share, driven by high disease awareness, established healthcare infrastructure, and approval for inhaled formulations. Europe accounts for approximately 30%, with the remainder split between Asia-Pacific and emerging markets.
• Indications Expansion: Beyond PAH, off-label use in critical limb ischemia influences demand, especially in regions with limited revascularization options.

Drivers and Barriers

Drivers:

• Approval of inhaled and intravenous formulations broadens application.
• Increasing prevalence of pulmonary hypertension, projected at 1-2 cases per million annually.
• Growing healthcare expenditure enhances access and adoption.

Barriers:

• Presence of generic competitors lowers prices.
• The requirement for administration via inhalation or infusion limits ease of use.
• Emerging therapies, such as oral prostacyclin receptor agonists, threaten market share.

Competitive Landscape

• Key Players: United Therapeutics, Bayer, and Actelion (now part of Johnson & Johnson) have invested in product formulations and expansion.
• Patents: Existing patents protect inhaled iloprost formulations until approximately 2030, after which generics are expected to enter the market.
• Regulatory Environment: Approvals from agencies like the FDA and EMA are stable, with ongoing monitoring for safety updates.

How Is the Financial Trajectory of Iloprost Evolving?

Revenue Trends

• Revenues for iloprost have showed modest but steady growth over the past five years.
• Sector-specific margins range between 20% and 35%, reflecting pricing pressures and cost of manufacturing.

Year	Estimated Revenue (USD Millions)	Notes
2018	210	Baseline
2019	225	Slight growth
2020	230	Pandemic impact negligible
2021	245	Recovery and increased uptake
2022	250	Continued growth
2023	260	Forecasted
2030	380	Projected, assuming steady growth

Cost Structure and Profitability

• Manufacturing costs are driven by synthesis complexity and delivery systems.
• Clinical development expenses are decreasing due to established use in PAH.
• Pricing strategies are influenced by reimbursement policies and generics.

Investment and R&D Outlook

• Companies are exploring inhaled formulations with improved delivery systems.
• R&D investments focus on extending indications, including potential neurovascular applications.
• Phase 2 and 3 trials for new delivery methods are underway, aiming to enhance convenience and compliance.

Regulatory and Market Risks

• Patent expirations could impact profit margins post-2030.
• Competition from oral prostacyclins like selexipag and newer agents could erode market share.
• Pricing pressures and reimbursement cuts pose ongoing risks.

What Are the Key Market Trends and Opportunities?

• Developing inhaled formulations with better bioavailability.
• Expanding into underserved markets with rising hypertension prevalence.
• Collaborating with biotech firms to develop combination therapies.
• Leveraging real-world evidence to support label expansions.

Summary

Iloprost remains a targeted therapy within a niche but growing segment. Its revenue trajectory is steady, with potential acceleration following new formulation approvals and expanded indications. Competitive pressures and patent cliffs are significant considerations for long-term profitability.

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Key Takeaways

• The global iloprost market was valued at USD 250 million in 2022, projected to reach USD 380 million by 2030 at a CAGR of 6.2%.
• North America dominates market share, driven by disease prevalence and healthcare infrastructure.
• Revenue growth is supported by approved inhaled formulations and expanding indications but faces challenges from generics and new oral therapies.
• Investment in improved inhalation systems and combination therapies represents key growth opportunities.
• Patent expiration around 2030 could expose the market to increased generic competition.

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FAQs

1. When will patent protections for iloprost formulations expire?
Patent protections for inhaled formulations are expected to expire around 2030, opening the market for generics.

2. What are the main competitors to iloprost?
Competitive threats include oral prostacyclin receptor agonists, such as selexipag, and other inhaled or intravenous therapies approved for PAH.

3. Can iloprost be used for indications beyond pulmonary hypertension?
Yes. Off-label use includes critical limb ischemia, though these are not extensive or approved indications.

4. How does the development of new formulations influence the market?
Innovations that improve delivery, efficacy, and convenience can increase patient adherence and expand market size.

5. What regulatory trends could impact iloprost?
Regulatory agencies are scrutinizing safety data and may approve simplified delivery systems or new indications, affecting market dynamics.

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References

1. Grand View Research. Pulmonary Arterial Hypertension Treatment Market Analysis (2022).
2. FDA and EMA databases for drug approvals and patents.
3. Industry reports on generic drug entry and competitive landscape (2022-2023).