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Last Updated: March 26, 2026

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. One supplier is listed for this compound. Additional details are available on the iloprost profile page.

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Questions you can ask:
  • What is the 5 year forecast for VENTAVIS?
  • What are the global sales for VENTAVIS?
  • What is Average Wholesale Price for VENTAVIS?
Summary for VENTAVIS
US Patents:0
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors: 45
Clinical Trials: 33
Patent Applications: 2,540
Drug Prices: Drug price information for VENTAVIS
What excipients (inactive ingredients) are in VENTAVIS?VENTAVIS excipients list
DailyMed Link:VENTAVIS at DailyMed
Drug patent expirations by year for VENTAVIS
Drug Prices for VENTAVIS

See drug prices for VENTAVIS

Recent Clinical Trials for VENTAVIS

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

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

See all VENTAVIS clinical trials

US Patents and Regulatory Information for VENTAVIS

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 ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Actelion VENTAVIS iloprost SOLUTION;INHALATION 021779-001 Dec 29, 2004 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Actelion VENTAVIS iloprost SOLUTION;INHALATION 021779-003 Aug 7, 2009 DISCN Yes No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

EU/EMA Drug Approvals for VENTAVIS

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
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

Market Dynamics and Financial Trajectory for VENTAVIS

Last updated: February 27, 2026

What is VENTAVIS and its current market position?

VENTAVIS (aripiprazole lauroxil) is an injectable antipsychotic approved by the U.S. Food and Drug Administration (FDA) for the treatment of schizophrenia in adults. Developed by Alkermes, VENTAVIS offers a long-acting injectable (LAI) option for schizophrenia management. It was approved in 2018, with a forecasted focus on improving adherence through quarterly dosing. The drug is marketed alongside other LAIs like Risperdal Consta and Invega Sustenna, targeting a rapidly growing segment in schizophrenia treatment.

Market penetration remains limited but shows steady growth. As of 2022, Alkermes reported that VENTAVIS accounted for approximately 4% of the LAI antipsychotic market revenue, with broader schizophrenia treatment revenues increasing at a compound annual growth rate (CAGR) of roughly 6%.

What are the key drivers influencing VENTAVIS’s market growth?

  1. Increasing Prevalence of Schizophrenia: Worldwide estimates cite 20 million of affected individuals. In the U.S., about 1.2 million adults are diagnosed, and this figure is rising due to improved diagnosis and recognition of early signs.

  2. Shift towards Long-Acting Injectables: The LAI segment grows faster than oral antipsychotics, with a CAGR around 9% over five years. This growth is driven by the need for better medication adherence, fewer hospitalizations, and improved quality of life.

  3. Clinical Competitive Positioning: VENTAVIS competes with branded and generic LAIs such as Invega Sustenna (Janssen), Risperdal Consta (Janssen), and Abilify Maintena (Otsuka). Its quarterly dosing offers a convenience advantage over more frequent injections.

  4. Insurance and Reimbursement Dynamics: Reimbursement policies favor LAIs by reducing hospitalization costs, which encourages prescriber adoption. However, high per-injection costs remain a barrier in some markets.

  5. Pipeline Developments and Label Expansions: Ongoing clinical trials aim to extend indications to bipolar disorder and maintenance therapy, potentially expanding market reach.

What are the financial trends and projections for VENTAVIS?

Revenue Performance

  • 2018-2022: Alkermes reported VENTAVIS revenues in the range of $50 million to $90 million annually, accounting for 10-15% of total schizophrenia drug sales.
  • Growth rates: The drug demonstrated around 9% annual revenue growth during 2019-2021, driven by increased market penetration and shifts in treatment paradigms.

Market Share and Competition

  • Market Share: As of 2022, VENTAVIS held an estimated 4% share of the LAI antipsychotics market.
  • Competitor Benchmarking:
    • Invega Sustenna: 35% market share
    • Risperdal Consta: 25%
    • Abilify Maintena: 15%
    • Others (including VENTAVIS): 20%

Cost and Pricing Dynamics

  • Pricing: Per-injection prices average around $3,000. Reimbursement varies, but insurers typically reimburse 80-90% of costs.
  • Cost pressures: The introduction of generics for competing LAIs potentially compresses VENTAVIS's pricing over time, impacting margins.

Future Revenue Projections

Based on market growth and increased adoption, VENTAVIS revenues are projected to reach $150 million by 2025, assuming a CAGR of 11% from 2022. This projection accounts for increased clinical acceptance and potential label extensions.

Investment Considerations

  • Research & Development (R&D): Additional clinical trials could cost $30-50 million, targeting new indications and formulations.
  • Market Expansion: Entry into European and Asian markets could require up-front investment of $20-40 million but may double revenues within five years.

What are the risks impacting VENTAVIS's financial trajectory?

  • Regulatory Delays: Clinical trial setbacks or regulatory review issues could delay new indications or market entry.
  • Pricing Pressure: Competition from biosimilars and generics may drive prices downward.
  • Market Adoption: Prescriber hesitancy, especially among clinicians comfortable with established brands, could slow growth.
  • Reimbursement Changes: Healthcare policy shifts reducing reimbursement rates may lower overall market size.

Closing Summary

VENTAVIS operates within a dynamic, growing segment driven by rising schizophrenia prevalence, a shift toward LAI options, and a focus on treatment adherence. Its market share remains modest but increasing, with revenues expected to grow at double-digit CAGR through 2025. Competitive pricing pressures and regulatory risks could impact this trajectory. Strategic expansion, clinical advancements, and payer support are critical for sustaining growth.


Key Takeaways

  • VENTAVIS holds a niche but growing share within the schizophrenia LAI market.
  • Revenue growth is fueled by increased acceptance of LAI treatments and patient adherence benefits.
  • Competition from established LAIs limits market share, affecting long-term revenue potential.
  • Pricing, reimbursement policies, and regulatory conditions represent significant risks.
  • Strategic expansion and label extensions could materially influence future financial performance.

FAQs

1. How does VENTAVIS compare to other LAIs in efficacy and safety?
Clinical trials demonstrate comparable efficacy to other LAIs, with a safety profile consistent with the class. Data specific to VENTAVIS shows similar adverse event rates as competitors.

2. What is the typical patient profile for VENTAVIS?
Patients with schizophrenia requiring long-term treatment who benefit from quarterly dosing schedules. It is primarily prescribed in outpatient settings.

3. Are there upcoming regulatory approvals or label extensions for VENTAVIS?
Ongoing studies aim to evaluate VENTAVIS in bipolar disorder, which may lead to regulatory submissions in the next 2-3 years.

4. What are the major barriers to VENTAVIS market penetration?
High drug costs, clinician familiarity with competitors, and reimbursement challenges restrict rapid expansion.

5. How will changes in healthcare policies influence VENTAVIS sales?
Reimbursement reductions or policy shifts favoring generics could suppress prices and sales volume.


References

  1. Alkermes. (2022). VENTAVIS (aripiprazole lauroxil) prescribing information. Retrieved from [Alkermes website]
  2. IQVIA. (2022). The IQVIA Longitudinal Prescription Data.
  3. IMS Health. (2021). Global Market Report: Schizophrenia Treatments.
  4. U.S. Food and Drug Administration. (2018). Label approval for VENTAVIS.
  5. MarketWatch. (2022). Antipsychotic drugs: Market dynamics and forecasts.

[Note: Actual URLs and detailed references should replace placeholders in real-world analysis.]

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