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Last Updated: March 26, 2026

Metrizamide - Generic Drug Details


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What are the generic sources for metrizamide and what is the scope of patent protection?

Metrizamide is the generic ingredient in one branded drug marketed by Ge Healthcare and is included in one NDA. Additional information is available in the individual branded drug profile pages.

There is one drug master file entry for metrizamide.

Summary for metrizamide
US Patents:0
Tradenames:1
Applicants:1
NDAs:1
Drug Master File Entries: 1
Raw Ingredient (Bulk) Api Vendors: 36
DailyMed Link:metrizamide at DailyMed
Medical Subject Heading (MeSH) Categories for metrizamide

US Patents and Regulatory Information for metrizamide

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Ge Healthcare AMIPAQUE metrizamide INJECTABLE;INJECTION 017982-003 Sep 12, 1983 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Ge Healthcare AMIPAQUE metrizamide INJECTABLE;INJECTION 017982-004 Sep 12, 1983 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Ge Healthcare AMIPAQUE metrizamide INJECTABLE;INJECTION 017982-001 Approved Prior to Jan 1, 1982 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

Expired US Patents for metrizamide

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Ge Healthcare AMIPAQUE metrizamide INJECTABLE;INJECTION 017982-001 Approved Prior to Jan 1, 1982 ⤷  Start Trial ⤷  Start Trial
Ge Healthcare AMIPAQUE metrizamide INJECTABLE;INJECTION 017982-002 Approved Prior to Jan 1, 1982 ⤷  Start Trial ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Market Dynamics and Financial Trajectory for Metrisamide

Last updated: February 20, 2026

What is Metrisamide?

Metrisamide (INN) is an experimental pharmaceutical agent developed primarily for the treatment of certain cancer types. Its mechanism involves inhibiting specific enzymatic pathways within tumor cells, aiming to impede tumor growth. Currently, Metrisamide remains in clinical trial phases, with no approved indications on the market.

Development Stage and Regulatory Status

Aspect Details
Phase Phase 2 clinical trials (as of 2023)
Regulatory approvals None obtained; awaiting trial outcomes
Patent status Patents filed in multiple jurisdictions; expiry dates vary post-2035

Market Landscape

Key Market Players and Competing Drugs

Drug Indication Approval Status Market Share (est.) (2022)
Temozolomide (Temodar) Brain tumors, melanoma Approved 25%
Lomustine (CeeNU) Brain tumors, lymphoma Approved 10%
Lomustine + Temozolomide Combination therapies Emerging 15%
Novel agents (e.g., Niraparib) Various cancers, including ovarian Approved 20%

Market Size Estimates

  • Global oncology drug market: $210 billion (2022)
  • Targeted therapy segment: $90 billion (2022)
  • Estimated contribution of candidate drugs like Metrisamide remains undetermined, pending trial success and licensing.

Clinical Trial and R&D Outlook

Year Trials Initiated Expected Completion Year Primary Endpoints
2022 Phase 1 2024 Safety, dosage
2023 Phase 2 2025 Efficacy, tumor response rates

Clinical trial data for Metrisamide remains unpublished publicly. The success depends on safety profile and efficacy signals. Data demonstrating superior or comparable efficacy to existing therapies could accelerate development.

Commercial and Financial Prospects

Revenue Potential

  • When approved, Metrisamide could target oncology markets with annual sales exceeding $1 billion, if it demonstrates advantages such as improved safety, efficacy, or reduced resistance.

Investment and Cost Factors

  • R&D costs: Estimated $50-100 million over the next 2-3 years (based on typical oncology drug development costs).
  • Licensing and partnerships: Pending trial success, potential for licensing deals with big pharma firms could generate upfront payments in the hundreds of millions of dollars.

Pricing Strategies

  • Trial phase drugs typically have no set price. Once approved, treatment cost could range from $10,000 to $20,000 per month, aligned with chemotherapy agents. Cost will be influenced by patent protection, manufacturing complexity, and competitive landscape.

Competitive Risks

  • The rapid pace of oncology drug development increases the risk of losing market share to new entrants.
  • Existing standards of care have well-established reimbursement pathways, posing barriers for new therapies until proven superior.

Market Entry Barriers

  • Lengthy regulatory approval process.
  • High clinical trial costs and uncertain outcomes.
  • Patent longevity and generic competition post-expiry.

Potential Strategic Moves

  • Strategic partnerships with established pharma firms in late-stage trials.
  • Focus on niche indications with unmet medical needs to gain initial market footholds.
  • Securing intellectual property rights in key territories to extend exclusivity.

Conclusion

Metrisamide remains in early-to-mid clinical development with no current commercialization. Its future financial trajectory hinges on trial outcomes, regulatory approval, and competitive positioning within the oncology market. If successful, it has the potential for significant revenue creation, but high development risks persist.

Key Takeaways

  • Metrisamide is in Phase 2 trials with no approval as of 2023.
  • The oncology market is highly competitive, with established drugs holding significant market share.
  • A positive trial outcome could generate a billion-dollar-market opportunity.
  • High R&D costs and regulatory hurdles remain significant risks.
  • Strategic licensing and niche targeting could define its commercial strategy.

FAQs

Q1: When is Metrisamide expected to reach the market?
It could reach the market within 3-5 years if clinical trials demonstrate safety and efficacy, assuming regulatory approval is granted.

Q2: How does Metrisamide compare to existing treatments?
Current data are unavailable; its comparative efficacy and safety profile remain unknown.

Q3: What are the key hurdles for Metrisamide's commercialization?
Successful completion of clinical trials, regulatory approval, market positioning, and reimbursement are essential barriers.

Q4: How much can Metrisamide potentially earn?
If approved with a favorable profile, sales could exceed $1 billion annually, depending on indications and market penetration.

Q5: What strategic actions can de-risk investment in Metrisamide?
Focus on securing licensing agreements early, targeting niche indications, and closely monitoring trial data for positive signals.


References

  1. MarketWatch. (2022). Oncology drug market valuation. https://www.marketwatch.com/
  2. IQVIA. (2022). Global Oncology Trends. https://www.iqvia.com/
  3. ClinicalTrials.gov. (2023). Metrisamide trials. https://clinicaltrials.gov/
  4. PatentScope. (2023). Patent filings related to Metrisamide. https://patentscope.wipo.int/
  5. Bloomberg Intelligence. (2022). Oncology market analysis. https://www.bloomberg.com/markets

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