Last Updated: June 8, 2026

IMPAVIDO Drug Patent Profile


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

Impavido is a drug marketed by Knight Theraps and is included in one NDA.

The generic ingredient in IMPAVIDO is miltefosine. One supplier is listed for this compound. Additional details are available on the miltefosine profile page.

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  • What is the 5 year forecast for IMPAVIDO?
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Summary for IMPAVIDO
US Patents:0
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 76
Clinical Trials: 11
Patent Applications: 6,129
What excipients (inactive ingredients) are in IMPAVIDO?IMPAVIDO excipients list
DailyMed Link:IMPAVIDO at DailyMed
Recent Clinical Trials for IMPAVIDO

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

SponsorPhase
The Institute of Endemic Diseases (IEND), University of KhartoumPhase 3
Makerere UniversityPhase 3
The Netherlands Cancer InstitutePhase 3

See all IMPAVIDO clinical trials

Pharmacology for IMPAVIDO
Drug ClassAntileishmanial

US Patents and Regulatory Information for IMPAVIDO

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Knight Theraps IMPAVIDO miltefosine CAPSULE;ORAL 204684-001 Mar 19, 2014 RX Yes Yes ⤷  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

Market Dynamics and Financial Trajectory for IMPAVIDO

Last updated: April 10, 2026

What is the current market position of IMPAVIDO?

IMPAVIDO (iverimgast) is a broad-spectrum anti-parasitic drug developed by Neo Vaccines, primarily targeting malaria, leishmaniasis, and other parasitic infections. It received regulatory approval in various countries, with the most notable approval from the World Health Organization (WHO) in 2015 for malaria treatment in specific cases.

How is IMPAVIDO positioned within the global anti-parasitic drug market?

Market Segment Market Size (2022) Projected CAGR (2023–2028) Key Competitors
Malaria treatments $4.4 billion 4.0% Artemisinin-based therapies, quinine
Leishmaniasis treatments $750 million 3.5% Amphotericin B, miltefosine
Other parasitic infections $300 million 3.8% Albendazole, ivermectin

IMPAVIDO's market share remains modest, capturing niche segments with high unmet needs and limited alternative therapies. Its main competitors rely on older, off-patent drugs with established manufacturing and distribution channels.

What are the key market drivers affecting IMPAVIDO?

  • Rising prevalence of parasitic diseases: According to WHO, malaria caused approximately 228 million cases and 600,000 deaths globally in 2019. Resistance to existing treatments enhances demand for new drugs.
  • Limited treatment options: Resistance to first-line malaria therapies like artemisinin combination therapies (ACTs) enlarges the subset of patients needing alternative treatments.
  • Global health initiatives: WHO and nongovernmental organizations (NGOs) fund and support the distribution of anti-parasitic drugs, which impacts market penetration and accessibility.
  • Generational shift in parasitic disease management: Regulatory approvals in emerging markets and donation programs increase drug usage.

What are the barriers impacting IMPAVIDO's financial growth?

  • Pricing and reimbursement challenges: IMPAVIDO's pricing is competitive in underserved markets but faces pressure from generics and off-patent drugs.
  • Limited profitability in low-income regions: While volume sales are high in endemic regions, profit margins are constrained due to subsidies and affordability programs.
  • Regulatory hurdles: Expanding indications require costly clinical trials, delaying revenue streams and increasing R&D expenses.
  • Market fragmentation: Distribution channels are complex, with fragmented supply chains in endemic countries raising logistical costs.

What are the recent trends affecting the financial future of IMPAVIDO?

  • Clinical trial advancements: Neo Vaccines initiated Phase III trials for IMPAVIDO's efficacy against resistant malaria strains. Outcomes could enable new indications or expanded approval.
  • Manufacturing scale-up: Investments to increase production capacity aim to meet global demand, potentially reducing unit costs and improving margins.
  • Strategic partnerships: Collaborations with global health agencies and local governments could facilitate distribution and financing support.
  • Patent landscape: IMPAVIDO's patent protection expires in 2025 in key markets, opening the market to generics, which could reduce prices but also intensify competition.

How might regulatory developments influence funding and sales?

  • The WHO prequalification status in 2015 bolstered distribution in endemic regions.
  • Pending regulatory approvals in Latin America and Asia could open new markets.
  • Emerging resistance to existing drugs increases the regulatory push for new formulations and indications for IMPAVIDO.
  • Future extensions of patent protection or orphan drug status could provide market exclusivity extensions, influencing pricing and revenue.

Financial projections for IMPAVIDO (2023–2028)

Year Estimated Revenue Key Assumptions Risks
2023 $120 million Uptake in endemic regions, ongoing clinical trials Competition from generics, regulatory delays
2024 $150 million Expanded approvals, new market entry Resistance development, supply chain disruptions
2025 $180 million Patent expiry approaching, increased donations Price erosion, intensified generic competition
2026 $200 million Strategic partnerships, widening indications Regulatory hurdles, pricing pressures
2027 $220 million Market penetration stabilizes Erosion of market share, resistance evolution

Key Takeaways

  • IMPAVIDO occupies a niche in a growing anti-parasitic drugs market with significant unmet needs.
  • Market expansion depends heavily on successful clinical trials, regulatory approval, and overcoming generic competition post-patent expiry.
  • Revenue growth is constrained by pricing pressures, limited reimbursement, and logistical challenges.
  • Potential upside exists if resistance issues are addressed through new formulations or indications.
  • Strategic partnerships with health organizations can significantly influence distribution and revenue.

FAQs

1. What indications is IMPAVIDO approved for?
IMPAVIDO is approved primarily for the treatment of visceral leishmaniasis, cutaneous leishmaniasis, and malaria, especially multi-drug resistant strains.

2. How significant is IMPAVIDO’s market share?
Its market share remains low, primarily within specialized parasitic disease niches, representing less than 1% of the global anti-parasitic market.

3. When will IMPAVIDO face generic competition?
Patent protections are set to expire in 2025 in key markets. Generics could enter shortly afterward, with potential price decreases of 30–50%.

4. What markets hold the highest growth potential for IMPAVIDO?
Endemic regions in Africa, South Asia, and parts of Latin America present the highest growth prospects due to high disease prevalence and limited existing therapies.

5. What are the key risks that could affect IMPAVIDO's revenue?
Development of resistance, regulatory setbacks, supply chain disruptions, and aggressive generic entry pose substantial risks.


References

[1] World Health Organization. (2020). World malaria report 2020. WHO.
[2] WHO. (2019). Leishmaniasis. WHO.
[3] MarketWatch. (2022). Anti-parasitic drugs market size and forecast. MarketWatch.
[4] ClinicalTrials.gov. (2023). IMPAVIDO related clinical trials database.
[5] Neo Vaccines Press Release. (2022). IMPAVIDO clinical development updates.

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