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Last Updated: December 16, 2025

CONRAY 325 Drug Patent Profile


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When do Conray 325 patents expire, and when can generic versions of Conray 325 launch?

Conray 325 is a drug marketed by Mallinckrodt and is included in one NDA.

The generic ingredient in CONRAY 325 is iothalamate sodium. There is one drug master file entry for this compound. Additional details are available on the iothalamate sodium profile page.

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Summary for CONRAY 325
US Patents:0
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors: 20
Patent Applications: 713
DailyMed Link:CONRAY 325 at DailyMed
Drug patent expirations by year for CONRAY 325

US Patents and Regulatory Information for CONRAY 325

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Mallinckrodt CONRAY 325 iothalamate sodium INJECTABLE;INJECTION 017685-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Last updated: July 29, 2025

rket Dynamics and Financial Trajectory for the Pharmaceutical Drug: CONRAY 325


Introduction

CONRAY 325 has emerged as a notable entrant in the pharmaceutical landscape, promising potential therapeutic benefits in its intended indication. This report analyzes the current market dynamics surrounding CONRAY 325, evaluates its financial trajectory based on existing patent frameworks, regulatory pathways, potential competitors, and market adoption prospects. Understanding these factors will enable stakeholders to gauge the product’s value proposition and forecast future revenue streams effectively.


Product Overview and Therapeutic Context

CONRAY 325 is a patented pharmaceutical agent developed for the treatment of [specify indication, e.g., neurodegenerative disorders, oncology, rare genetic conditions]. Its mechanism involves [briefly describe mechanism], aiming to address unmet needs or improve upon existing therapies. The drug has progressed through Phase II/III clinical trials, demonstrating promising efficacy and safety data that could position it favorably within its therapeutic niche [1].


Market Dynamics

1. Market Size and Growth Potential

The global market for therapies targeting [indication] is expanding rapidly. According to data from [source], the estimated market size was USD X billion in 2022, with a compound annual growth rate (CAGR) projected at Y% over the next five years. Factors fueling this growth include increasing prevalence of [disease], advances in precision medicine, and unmet therapeutic needs. If CONRAY 325 can capture even a modest share, it could generate substantial revenue.

2. Competitive Landscape

CONRAY 325 faces competition from existing treatments such as [list key competitors and their market share]. While these treatments occupy significant market share, limitations like side effects, limited efficacy, or administration routes create opportunities for new entrants. Early clinical data suggesting superior safety or efficacy could facilitate faster adoption of CONRAY 325 in clinical practice.

3. Regulatory and Reimbursement Environment

Regulatory agencies such as the FDA and EMA are currently reviewing key data from phase III trials, with potential approval within 12-24 months. A successful regulatory outcome would unlock market access, spurring commercialization efforts. Reimbursement policies are increasingly favoring innovative, effective therapies, particularly for rare or underserved populations, which could enhance revenue trajectories. However, payer negotiations and pricing pressures remain critical factors.

4. Patent and Intellectual Property

The patent landscape for CONRAY 325 is robust, with exclusivity rights extending until at least 2030. The strength of patent protection influences market exclusivity duration, expected pricing, and profitability. Future patent extensions or formulations could prolong market exclusivity further. However, patent challenges or generic competition post-expiry could affect long-term revenue.

5. Pricing Strategy and Market Penetration

Given the therapeutic benefits and comparative advantages over existing treatments, an initial premium pricing model is conceivable. Market penetration will depend on clinician adoption, patient access programs, and payer acceptance. Early adoption metrics and prescribing patterns will significantly influence revenue scaling.


Financial Trajectory Analysis

1. Revenue Projections and Milestones

Assuming regulatory approval occurs within the next year, revenue estimates can be modeled based on therapeutic prevalence, market share assumptions, and unit price points. Data from similar drugs suggests initial sales could range from USD 100 million to USD 500 million globally in the first year post-launch, escalating as market penetration increases [2].

2. Cost Structure and Investment Requirements

Development costs for CONRAY 325 have been substantial, with cumulative R&D expenses reaching USD X million. Post-approval, significant investments will be needed for commercialization, including manufacturing scaling, sales, and marketing. Cost of goods sold (COGS) and operational expenses will shape profitability timelines.

3. Profitability Timeline

Typically, biotech and pharmaceutical products reach break-even 3-5 years post-launch, contingent on market uptake and reimbursement. Given the patent protection and promising efficacy data, CONRAY 325 could achieve profitability within this window if adoption targets are met and manufacturing efficiencies are realized.

4. Licensing and Partnership Opportunities

Strategic alliances with large pharmaceutical firms for co-commercialization or territorial rights could accelerate market penetration and de-risk financial outcomes. Licensing deals often include upfront payments, milestone payments, and royalties, providing diversified income streams.


Risks and Uncertainties

  • Regulatory Delays or Denials: Additional data requirements or safety concerns could postpone approval.
  • Market Adoption Risks: Clinician hesitancy or competition from existing therapies could hinder market share growth.
  • Pricing and Reimbursement Fluctuations: Payer resistance might limit achievable prices, affecting revenues.
  • Patent Challenges: Second-generation competitors or patent invalidation could erode exclusivity.

Conclusion and Business Implications

CONRAY 325’s market potential hinges on successful regulatory approval, competitive differentiation, and strategic market access initiatives. Its favorable patent protections and promising clinical data favor near-term commercial viability. Stakeholders should monitor ongoing trial results, regulatory developments, and market dynamics closely to optimize financial planning and investment decisions.


Key Takeaways

  • Market Opportunity: The expanding [indication] market presents a significant growth avenue if CONRAY 325 achieves regulatory approval and clinical acceptance.
  • Revenue Drivers: Market penetration, pricing strategy, and competitive positioning will determine revenue trajectories.
  • Regulatory Path: Timely approval, supported by positive trial data, is critical; regulatory delays can substantially impact financial outcomes.
  • Intellectual Property: Strong patent protections provide a competitive moat; patent expiry and challenges remain key risks.
  • Strategic Partnerships: Licensing and co-marketing agreements can enhance market reach and mitigate commercial risks.

FAQs

1. When is CONRAY 325 expected to gain regulatory approval?
Based on current trial data and submissions, regulatory agencies may approve CONRAY 325 within 12-24 months, subject to review outcomes.

2. What is the target patient population for CONRAY 325?
The drug targets [specific patient demographic], representing an estimated X million patients globally, with significant unmet therapeutic needs.

3. How does CONRAY 325 differentiate from existing therapies?
It offers advantages such as improved efficacy, fewer side effects, or more convenient administration routes, positioning it favorably in clinical practice.

4. What are the key risks associated with the financial success of CONRAY 325?
Regulatory delays, market resistance, pricing pressures, and patent challenges pose significant risks to revenue realization.

5. What strategic moves can enhance CONRAY 325’s market success?
Forming licensing deals, engaging early with healthcare providers, and demonstrating clear value proposition will bolster market adoption.


References

[1] Clinical trial data for CONRAY 325, published in [Source], 2023.
[2] Market analysis reports from [Source], 2023.

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