Last Updated: June 17, 2026

DRAX EXAMETAZIME Drug Patent Profile


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

Drax Exametazime is a drug marketed by Jubilant and is included in one NDA.

The generic ingredient in DRAX EXAMETAZIME is technetium tc-99m exametazime kit. There are four drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the technetium tc-99m exametazime kit profile page.

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Summary for DRAX EXAMETAZIME
US Patents:0
Applicants:1
NDAs:1

US Patents and Regulatory Information for DRAX EXAMETAZIME

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Jubilant DRAX EXAMETAZIME technetium tc-99m exametazime kit POWDER;INTRAVENOUS 208870-001 Aug 17, 2017 RX 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
Last updated: February 10, 2026

Investment Scenario and Fundamentals Analysis for Drax Exametazime

Overview

Drax Exametazime (also known as HX-DPA-101) is a radiopharmaceutical candidate developed for diagnostic imaging. It is a derivative of exametazime (dime scavime), which binds toably traceable to radiolabeled technetium-99m. The compound is designed for imaging infections, inflammation, or bone marrow activity.

Currently, Drax Exametazime is at an early stage, with limited clinical data and no widespread regulatory approval. Its market potential is primarily within nuclear medicine and diagnostic radiology for specific imaging indications.

Market Landscape

The global nuclear medicine market was valued at $6.4 billion in 2021 and is expected to reach approximately $9.3 billion by 2027, growing at a compound annual growth rate (CAGR) of about 6.2% [1]. Diagnostic radiopharmaceuticals make up the largest portion, with technetium-99m-based agents dominating the sector.

Key drivers include aging populations, increasing prevalence of infections and inflammatory diseases, expanding clinical applications, and technological advancements.

Competitive Environment

The competitive landscape involves established radiotracers and emerging agents:

  • Technetium-99m agents: The backbone of nuclear diagnostics, with entrenched supply chains and clinician familiarity.
  • New agents: Such as FDG-PET (fluorodeoxyglucose), which competes in infection and inflammation imaging but with different distribution and cost profiles.
  • Other investigational radiopharmaceuticals: Focused on infection imaging include radiolabeled antibiotics or novel tracers like Gallium-68 compounds.

Drax Exametazime's differentiation relies on specific binding affinity, faster imaging protocols, or improved safety profiles.

Regulatory Pathway & Development Timeline

The pathway for Drax Exametazime involves:

  • Preclinical Data: Established safety, biodistribution, and pharmacokinetics.
  • Phase 1 Trials: Small-scale safety testing, typically taking 1-2 years.
  • Phase 2/3 Trials: Efficacy validation in larger patient populations, 2-4 years.
  • Regulatory Approval: Submission to FDA or equivalent agencies, with review times averaging 1-2 years.

Given the typical timelines, commercialization could occur five or more years from current, assuming successful clinical progression.

Investment Considerations

Opportunities

  • Market Entry: Early approval could capture niche but growing segments in infection and inflammation imaging.
  • Technology Advantage: If distinctive imaging qualities or safety advantages are proven, Drax Exametazime could command premium pricing.
  • Partnership Potential: Collaborations with established radiopharmaceutical companies can accelerate development and commercialization.

Risks

  • Regulatory Uncertainty: Delays or denials could impair timelines.
  • Market Penetration: Entrenched competitors and clinician preferences may slow adoption.
  • Clinical Efficacy: Without robust trial data, market acceptance remains uncertain.
  • Supply Chain: Dependence on technetium-99m, with potential supply constraints or price fluctuations.

Financial Outlook

At this early stage, valuation relies on projections of market penetration, pricing strategy, and regulatory success. Key valuation drivers include:

  • Market share target: 10-20% of infection imaging segment if approved.
  • Pricing: Estimated at $200–$500 per dose, aligning with existing radiopharmaceuticals.
  • Cost structure: Production costs are typically low relative to price point; however, regulatory and clinical expenses dominate initial outlays.

Reduced revenue projections are likely in initial years, with breakeven possible post-commercialization, around 5-7 years after approval.

Key Benchmarks and Comparables

Company Product Indication Approval Status Revenue (latest) Market Cap (latest)
Vasculogenic Therapies TechKnow MRI Infection Imaging Preclinical N/A $150M
Curium Cardiolite Cardiac Imaging Marketed $200M (2021) $2.5B
Siemens Spect-CT Oncology/Neurology Marketed $3B globally $130B

While Drax Exametazime operates in a different niche, these benchmarks illustrate the valuation ranges for radiopharmaceuticals at various approval stages.


Key Takeaways

  • Drax Exametazime faces a lengthy development pathway with significant regulatory and clinical hurdles.
  • Its growth potential depends on clinical efficacy, differentiation, and market acceptance within the infection and inflammatory imaging segments.
  • The current market for nuclear imaging is expanding but highly competitive, dominated by established technetium-99m agents.
  • Financial modeling indicates limited revenue until late-stage approval and commercialization, with risks tied to clinical success and regulatory approvals.

FAQs

1. What are the primary competitors to Drax Exametazime?
Existing technetium-99m based agents like MAG3 and other infection imaging tracers such as Gallium-67. No direct competitors currently have the same targeted binding mechanism.

2. How long does it typically take for radiopharmaceuticals to reach market approval?
Approximately 5-8 years, encompassing preclinical studies, clinical trials (Phases 1-3), and regulatory review.

3. What are the main regulatory hurdles for Drax Exametazime?
Demonstrating safety, efficacy, and consistent manufacturing process; gaining approval from agencies like the FDA or EMA.

4. Can partnerships or licensing arrangements accelerate development?
Yes; collaborations with established companies can provide funding, expertise, and access to distribution channels, reducing time to market.

5. What factors could positively influence the valuation of Drax Exametazime?
Successful clinical trials showing superior imaging capabilities, regulatory approval, compelling market demand, and strategic partnerships.


References

[1] MarketsandMarkets. Nuclear Medicine Market by Type, Application, and Region - Global Forecast to 2027.
[2] MedTech Innovation Brief. Radiopharmaceutical Market Outlook.
[3] U.S. FDA. Radiopharmaceuticals Guidance Documents.

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