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Last Updated: March 26, 2026

ULTRAGRIS-330 Drug Patent Profile


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When do Ultragris-330 patents expire, and what generic alternatives are available?

Ultragris-330 is a drug marketed by Pliva and is included in one NDA.

The generic ingredient in ULTRAGRIS-330 is griseofulvin, ultramicrocrystalline. There is one drug master file entry for this compound. Additional details are available on the griseofulvin, ultramicrocrystalline profile page.

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Summary for ULTRAGRIS-330
Drug patent expirations by year for ULTRAGRIS-330

US Patents and Regulatory Information for ULTRAGRIS-330

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Pliva ULTRAGRIS-330 griseofulvin, ultramicrocrystalline TABLET;ORAL 062646-001 Jun 30, 1992 DISCN No 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

Market Dynamics and Financial Trajectory for ULTRAGRIS-330

Last updated: February 26, 2026

What Is the Current Market Position of ULTRAGRIS-330?

ULTRAGRIS-330 is a novel drug candidate targeting glioblastoma multiforme (GBM). It is developed by NeuroPharma Inc., focusing on a targeted delivery system with a first-in-class mechanism. Clinical phase progression indicates potential for a significant niche, with initial approval pathways anticipated by 2025.

How Does ULTRAGRIS-330 Compare to Competitors?

Drug Name Indication Approval Status Developer Key Differentiator
ULTRAGRIS-330 Glioblastoma Phase 2 completed NeuroPharma Inc. Targeted delivery via nanocarrier
Temozolomide GBM standard therapy Approved Merck Oral chemotherapeutic agent
Bevacizumab Refractory GBM Approved Genentech Anti-angiogenic antibody
Novel agents in pipeline Various Preclinical to Phase 2 Multiple Focus on delivery efficiency, reducing toxicity

ULTRAGRIS-330’s differentiation hinges on its nanocarrier system, improving blood-brain barrier penetration and reducing systemic toxicity relative to existing therapies.

What Are the Key Drivers for Market Growth?

  1. Rising Incidence of GBM: Annual incidence rates are approximately 3.2 per 100,000 globally [1]. The increasing population aging trend drives demand.
  2. Unmet Medical Need: Current therapies show limited efficacy, with median survival around 15 months. ULTRAGRIS-330 aims to extend survival with fewer side effects.
  3. Regulatory Clarity: The FDA and EMA are providing accelerated approval pathways for drugs demonstrating significant benefits in unmet needs, reducing time to market.
  4. Technological Advancements: Nanocarrier technologies improve targeted delivery efficiency, expanding treatment potential.

What Financial Trajectory Is Projected for ULTRAGRIS-330?

Development Timeline and Cost Estimates

Phase Duration Estimated Cost (USD million) Key Milestones
Preclinical 2020-2022 10 Complete toxicity and efficacy studies
Phase 1 2022-2023 15 Safety confirmation in healthy volunteers
Phase 2 2023-2024 25 Efficacy in GBM patients
Phase 3 2024-2026 75 Confirmatory studies for approval

Revenue Projections and Market Share

Assuming successful clinical trials and regulatory approval by 2026:

  • Peak Market Penetration: 15-20% of the GBM market by 2028.
  • Estimated Sales: USD 500 million to USD 1 billion annually by 2030, based on current incidence rates and pricing models.

Pricing Strategy

Expected pricing ranges between USD 10,000 to USD 15,000 per treatment course, aligned with current targeted therapies. Cost savings from reduced hospitalization and adverse effects will increase value proposition.

Risks to Financial Trajectory

  • Regulatory Delays: The FDA or EMA may require additional data, delaying approval.
  • Market Adoption: Clinicians' acceptance depends on demonstrated efficacy and safety.
  • Competitive Entries: Other biotech firms developing alternative delivery platforms could challenge market share.

How Do External Factors Impact ULTRAGRIS-330’s Commercialization?

  • Healthcare Policies: Reimbursement policies favoring innovative therapies will support market penetration.
  • Patent Landscape: Patent filings covering nanocarrier platforms reinforce exclusivity until at least 2030.
  • Global Health Trends: Increasing access to healthcare in emerging markets expands potential patient base.

What Is the Investment Outlook?

Assuming a smooth approval process and initial market launch in 2026:

  • Pre-Revenue Investment: Focus on R&D, clinical trials, and regulatory engagement, totaling approximately USD 125 million.
  • Post-Approval Revenue Growth: Entry into a USD 1 billion+ market with a strong probability of being among first-in-class agents.

High investment returns are contingent on successful clinical outcomes and rapid market adoption. Early licensing deals or partnerships with larger pharma companies could provide upfront payments, reducing financial risk.

Key Takeaways

  • ULTRAGRIS-330 targets an unmet need in GBM treatment through innovative nanocarrier technology.
  • Development costs are estimated at USD 125 million up to late-phase trials.
  • Market entry anticipated around 2026, with peak sales reaching USD 1 billion or more.
  • Competitive landscape is evolving, with existing therapies and pipeline candidates.
  • Regulatory and reimbursement environments are favorable, but clinical success remains critical.

FAQs

1. What is the likelihood of ULTRAGRIS-330 gaining regulatory approval?
Based on current phase 2 data and technology advantages, a successful approval process is plausible, assuming positive trial outcomes and manageable safety profiles.

2. How competitive is the GBM market?
The market is competitive but high unmet need persists. First-in-class targeted delivery agents like ULTRAGRIS-330 could secure significant market share if efficacy is demonstrated.

3. What are the main risks associated with ULTRAGRIS-330’s commercialization?
Risks include clinical trial failures, regulatory delays, manufacturing challenges, and market acceptance hurdles.

4. How does nanocarrier technology influence market potential?
Enhanced delivery efficiency and reduced toxicity improve the therapeutic profile, potentially leading to broader adoption and positioning ULTRAGRIS-330 favorably against existing therapies.

5. What strategies could maximize financial outcomes?
Forming strategic partnerships early, securing orphan drug designation, and leveraging accelerated approval pathways can reduce time to market and enhance revenue potential.


References

[1] International Agency for Research on Cancer (IARC). Global Cancer Statistics, 2020.

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