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Last Updated: March 21, 2025

VENTAVIS Drug Patent Profile


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

Ventavis is a drug marketed by Actelion and is included in one NDA.

The generic ingredient in VENTAVIS is iloprost. There are four drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the iloprost profile page.

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Summary for VENTAVIS
Drug patent expirations by year for VENTAVIS
Drug Prices for VENTAVIS

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Recent Clinical Trials for VENTAVIS

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SponsorPhase
Hamad Medical CorporationPhase 2
ActelionPhase 4
National Cancer Institute (NCI)Phase 1

See all VENTAVIS clinical trials

Pharmacology for VENTAVIS
Drug ClassProstacycline

US Patents and Regulatory Information for VENTAVIS

ApplicantTradenameGeneric NameDosageNDAApproval DateTETypeRLDRSPatent No.Patent ExpirationProductSubstanceDelist Req.Exclusivity Expiration
Actelion VENTAVIS iloprost SOLUTION;INHALATION 021779-001 Dec 29, 2004 DISCN No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Actelion VENTAVIS iloprost SOLUTION;INHALATION 021779-002 Dec 8, 2005 DISCN Yes No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Actelion VENTAVIS iloprost SOLUTION;INHALATION 021779-003 Aug 7, 2009 DISCN Yes No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
>Applicant>Tradename>Generic Name>Dosage>NDA>Approval Date>TE>Type>RLD>RS>Patent No.>Patent Expiration>Product>Substance>Delist Req.>Exclusivity Expiration
Showing 1 to 3 of 3 entries

EU/EMA Drug Approvals for VENTAVIS

CompanyDrugnameInnProduct Number / IndicationStatusGenericBiosimilarOrphanMarketing AuthorisationMarketing 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
>Company>Drugname>Inn>Product Number / Indication>Status>Generic>Biosimilar>Orphan>Marketing Authorisation>Marketing Refusal
Showing 1 to 1 of 1 entries

Market Dynamics and Financial Trajectory for VENTAVIS (Iloprost)

Introduction to VENTAVIS (Iloprost)

VENTAVIS, also known as iloprost, is a prescription medication used to treat adults with certain types of severe pulmonary arterial hypertension (PAH). It is a prostacyclin analogue that helps to relax and widen the blood vessels in the lungs, improving blood flow and reducing the strain on the heart.

Market Growth Drivers

Increasing Prevalence of PAH

The global market for iloprost and other PAH treatments is driven significantly by the increasing prevalence of pulmonary arterial hypertension. According to the National Organization for Rare Disorders (NORD), nearly 500 to 1000 new cases of PAH are diagnosed each year in the U.S., which is expected to propel the market growth over the forecast period[1].

Strategic Collaborations and Acquisitions

The market is also influenced by strategic mergers, agreements, and acquisitions among major pharmaceutical companies. For instance, Johnson & Johnson's acquisition of Actelion Pharmaceuticals in 2017, which included Actelion's PAH franchise, has been a significant factor in market dynamics[2].

Clinical Trials and Product Development

Several clinical trials and product development initiatives are underway to enhance the efficacy and delivery of iloprost. For example, the collaboration between Bayer AG and Vectura Group Plc. to develop an upgraded version of the Breelib nebulizer, which improves the delivery of iloprost aerosol therapy, is a notable development[1].

Financial Performance of VENTAVIS

Sales Trends

VENTAVIS sales have experienced fluctuations over the years. In 2016, sales of Ventavis amounted to 73 million Swiss francs, which represented a decrease of 32% at constant exchange rates (CER) compared to 2015. This decline was part of a broader trend where other PAH treatments like Opsumit and Uptravi gained more traction[2].

Regional Market Share

North America has been a significant market for VENTAVIS, driven by the activities of key players in the region. For instance, in 2019, VisionGate received an exclusive worldwide right and license from Bayer AG to develop and commercialize iloprost betadex clathrate for lung cancer treatment and prevention, further solidifying the presence of iloprost in the North American market[1].

Competitive Landscape

Key Players

The market for iloprost is competitive, with key players including Actelion Pharmaceuticals (now part of Johnson & Johnson), Bayer AG, Vectura Group Plc., and VisionGate. These companies are focused on developing new products and improving existing ones to enhance their market share. The collaboration between Bayer AG and Vectura Group Plc. to upgrade the Breelib nebulizer is a prime example of this competitive strategy[1].

Market Segmentation

The global iloprost drugs market is segmented based on the route of administration, distribution channels, and regions. Understanding these segments is crucial for companies to tailor their strategies and maximize market penetration[1].

Challenges and Restraints

Side Effects

Despite its therapeutic benefits, iloprost has several side effects that can restrain market growth. These include kidney failure, dyspnea, chest pain, short breath, and swelling of limbs. Managing these side effects is a critical challenge for both patients and healthcare providers[1].

Generic Competition

The expiration of patents and the introduction of generic drugs can significantly impact the sales of branded PAH medications, including VENTAVIS. The Hatch-Waxman Act encourages the development of generic drugs, which are 70-80% cheaper than branded drugs, thereby affecting the overall revenue generation of the market[4].

Future Outlook

Market Projections

The global PAH market, which includes iloprost, is expected to grow substantially. By 2031, the market is projected to reach $9.53 billion, growing at a CAGR of 5.50% during the forecast period (2023-2031)[4].

Emerging Markets

Regions like Latin America are forecasted to show significant growth due to increasing government and per capita health spending, as well as initiatives by the World Health Organization (WHO). The rising prevalence of obesity and Type-2 diabetes in these regions is also expected to drive the market[4].

Key Takeaways

  • The increasing prevalence of PAH and strategic collaborations among pharmaceutical companies are key drivers of the iloprost market.
  • VENTAVIS sales have been impacted by the rise of other PAH treatments and the introduction of generic drugs.
  • North America remains a significant market for iloprost due to the activities of major players.
  • Managing side effects and navigating generic competition are critical challenges for the market.
  • The global PAH market, including iloprost, is expected to grow significantly by 2031.

FAQs

What is VENTAVIS used for?

VENTAVIS (iloprost) is used to treat adults with certain types of severe pulmonary arterial hypertension (PAH), a condition where blood vessels in the lungs become narrowed and stiff.

What are the side effects of VENTAVIS?

Common side effects of VENTAVIS include kidney failure, dyspnea, chest pain, short breath, and swelling of limbs.

Who are the key players in the iloprost market?

Key players in the iloprost market include Actelion Pharmaceuticals (now part of Johnson & Johnson), Bayer AG, Vectura Group Plc., and VisionGate.

How is the global PAH market expected to grow?

The global PAH market is expected to reach $9.53 billion by 2031, growing at a CAGR of 5.50% during the forecast period (2023-2031).

What impact do generic drugs have on the iloprost market?

Generic drugs, which are 70-80% cheaper than branded drugs, can significantly reduce the sales of branded PAH medications like VENTAVIS, affecting the overall revenue generation of the market.

Sources

  1. Coherent Market Insights: "Iloprost Drugs Market - Share, Size and Industry Analysis"
  2. GlobeNewswire: "Actelion announces excellent financial results for 2016"
  3. iHealthcareAnalyst: "Global Pulmonary Arterial Hypertension Market $6.7 Billion by 2031"
  4. StraitsResearch: "Pulmonary Arterial Hypertension Market Size, (PAH) Trends Outlook ..."

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