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. Additional information is available in the individual branded drug profile pages.

There are four drug master file entries for iloprost. Two suppliers are listed for this compound.

Summary for ILOPROST

US Patents:	0
Tradenames:	2
Applicants:	2
NDAs:	2
Drug Master File Entries:	4
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	59
Clinical Trials:	98
Patent Applications:	7,223
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
Peter Korsten	N/A
DiaMed GmbH	N/A
Charite University, Berlin, Germany	Phase 1/Phase 2

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	021779-001	Dec 29, 2004		DISCN	No	No
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
Btg Intl	AURLUMYN	iloprost	SOLUTION;INTRAVENOUS	217933-001	Feb 13, 2024		RX	Yes	Yes

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/000474 Treatment 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

Market Dynamics and Financial Trajectory for the Drug: Iloprost

Introduction

Iloprost, a prostacyclin PGI2 analog, is a crucial medication in the treatment of pulmonary arterial hypertension (PAH) and other conditions characterized by constricted blood vessels. Here, we delve into the market dynamics and financial trajectory of iloprost, highlighting key drivers, restraints, and significant financial milestones.

Market Size and Growth

The global iloprost market is projected to experience substantial growth, driven by increasing demand for effective treatments for PAH and other related conditions. As of 2022, the market was valued at USD 106.17 million and is expected to reach USD 212.23 million by 2030, growing at a CAGR of 11.50% during the forecast period[1].

Drivers of Market Growth

Growing Prevalence of PAH and Neuropathic Pain Disorders

The rising incidence of PAH and neuropathic pain disorders globally is a significant driver for the iloprost market. PAH, in particular, sees nearly 500 to 1000 new cases diagnosed each year in the U.S., contributing to the growing demand for iloprost[4].

Expanding Applications and Off-Label Usage

Iloprost's versatility in treating various medical conditions beyond its initial intended use, such as anxiety disorders, migraines, and restless legs syndrome, contributes to market growth. Off-label prescriptions by physicians and healthcare practitioners further broaden its market reach[1].

Rising Awareness and Education Initiatives

Increased awareness and educational initiatives about iloprost's benefits, optimal usage, and potential side effects are expected to enhance its acceptance and adoption. Educating healthcare professionals, patients, and caregivers can expand the market and foster responsible usage[1].

Restraints and Challenges

Concerns Regarding Abuse and Dependency

One significant restraint for the iloprost market is the concern regarding its potential for abuse and dependency. Reports of misuse and addiction, particularly when combined with other substances like opioids, have raised regulatory scrutiny and led to tighter control and monitoring of iloprost prescriptions[1].

Side Effects

Iloprost is associated with several side effects, including kidney failure, dyspnea, chest pain, short breath, and swelling of limbs. These side effects are expected to restrain market growth as they may deter some patients and healthcare providers from using the drug[4].

Financial Trajectory

Historical Sales Performance

In 2016, sales of Ventavis (iloprost) by Actelion Ltd amounted to 73 million Swiss francs, a decrease of 32% compared to 2015 due to competitive pressures. However, Actelion's overall financial performance was strong, with total product sales growing to CHF 2,412 million (+15% at CER)[2].

Acquisition and Market Impact

The acquisition of Actelion by Johnson & Johnson in 2017 for $30 billion significantly impacted the market. This deal included Johnson & Johnson acquiring Actelion's marketed products, including its PAH franchise, and global rights to advanced late-stage therapies. This acquisition has contributed to the market's growth by consolidating resources and enhancing distribution channels[2].

Regional Market Insights

North America

North America is expected to dominate the iloprost market, driven by the rise in product approvals and initiatives by government and pharmaceutical organizations to spread awareness about PAH. The region saw significant activity, including mergers and acquisitions, such as VisionGate's exclusive worldwide rights and license from Bayer AG for iloprost betadex clathrate in lung cancer treatment and prevention[4].

Asia-Pacific

The Asia-Pacific region is also expected to see significant growth due to the rising prevalence of PAH and other related conditions. This region is a focus area for many pharmaceutical companies looking to expand their market share[1].

Competitive Landscape

The global iloprost market is competitive, with key manufacturers including Actelion Pharmaceuticals, Bayer AG, Vectura Group Plc., and VisionGate. These companies are focused on developing new products and improving delivery mechanisms, such as the Breelib handheld nebulizer, to enhance their market share[4].

Clinical and Cost-Effectiveness

Studies have evaluated the clinical and cost-effectiveness of iloprost compared to other treatments for PAH. These evaluations often involve systematic reviews and economic models to assess the cost-effectiveness from the perspective of healthcare systems like the UK NHS. While iloprost has shown efficacy, its cost-effectiveness varies depending on the model and perspective used[5].

Key Takeaways

• Market Growth: The iloprost market is expected to grow significantly, driven by the increasing prevalence of PAH and expanding applications.
• Financial Performance: Historical sales have been impacted by competitive pressures, but acquisitions and consolidations have strengthened the market.
• Regional Insights: North America and Asia-Pacific are key regions driving market growth.
• Competitive Landscape: Major players are focusing on product development and improving delivery mechanisms.
• Clinical and Cost-Effectiveness: Iloprost's efficacy is well-documented, but its cost-effectiveness varies.

FAQs

What is iloprost used for?

Iloprost is primarily used to treat pulmonary arterial hypertension (PAH) and other conditions characterized by constricted blood vessels, such as systemic sclerosis and Raynaud syndrome[4].

What are the side effects of iloprost?

Common side effects include kidney failure, dyspnea, chest pain, short breath, and swelling of limbs. These side effects can restrain market growth[4].

Who are the key players in the iloprost market?

Key manufacturers include Actelion Pharmaceuticals, Bayer AG, Vectura Group Plc., and VisionGate[4].

What is the projected market size of iloprost by 2030?

The global iloprost market is expected to reach USD 212.23 million by 2030, growing at a CAGR of 11.50% during the forecast period[1].

How has the acquisition of Actelion by Johnson & Johnson impacted the iloprost market?

The acquisition has consolidated resources, enhanced distribution channels, and contributed to market growth by expanding the reach of iloprost and other PAH treatments[2].

Sources

1. Data Bridge Market Research: Global Iloprost Market – Industry Trends and Forecast to 2030.
2. GlobeNewswire: Actelion announces excellent financial results for 2016.
3. American Heart Association: Evaluation and Management of the Child and Adult With Fontan Circulation.
4. Coherent Market Insights: Iloprost Drugs Market - Share, Size and Industry Analysis.
5. PubMed: Clinical and cost-effectiveness of epoprostenol, iloprost, bosentan, sitaxentan and sildenafil for the treatment of adults with pulmonary arterial hypertension (PAH).