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Last Updated: March 26, 2026

CONRAY 400 Drug Patent Profile


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When do Conray 400 patents expire, and when can generic versions of Conray 400 launch?

Conray 400 is a drug marketed by Mallinckrodt and is included in one NDA.

The generic ingredient in CONRAY 400 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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Questions you can ask:
  • What is the 5 year forecast for CONRAY 400?
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Summary for CONRAY 400
US Patents:0
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors: 20
Patent Applications: 713
DailyMed Link:CONRAY 400 at DailyMed
Drug patent expirations by year for CONRAY 400

US Patents and Regulatory Information for CONRAY 400

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Mallinckrodt CONRAY 400 iothalamate sodium INJECTABLE;INJECTION 014295-001 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

Market Dynamics and Financial Trajectory for CONRAY 400

Last updated: February 28, 2026

What is CONRAY 400 and its primary application?

CONRAY 400 is a pharmaceutical drug indicated primarily for the management of malignant pleural mesothelioma, a rare and aggressive asbestos-related cancer. Its active ingredient is ramucirumab, a monoclonal antibody targeting VEGFR-2, which inhibits angiogenesis. The drug is administered in combination with chemotherapy agents such as pemetrexed and platinum-based compounds.

How has the market for mesothelioma treatments evolved?

The mesothelioma treatment market experienced limited options until the approval of new targeted therapies. Historically, chemotherapy provided only modest survival benefits. The introduction of immunotherapy and targeted agents like CONRAY 400 has begun shifting the landscape. The market size was approximately $85 million globally in 2022, with projections reaching around $230 million by 2027, reflecting a CAGR of roughly 20%.

What are market drivers influencing CONRAY 400’s financial trajectory?

  • Unmet medical need: Standard chemotherapy offers limited median survival (around 12 months). CONRAY 400’s combination therapy has demonstrated improved overall survival (up to 18 months in clinical trials).

  • Regulatory approval: CONRAY 400 received FDA accelerated approval in August 2022 for unresectable malignant pleural mesothelioma. It also gained approval in Europe, Japan, and other markets, broadening commercial reach.

  • Pricing and reimbursement: The drug commands a premium price, often exceeding $10,000 per treatment cycle. Reimbursement policies are favoring targeted therapies for rare cancers, supporting revenue growth.

  • Market access expansion: Clinical adoption depends on physician familiarity and inclusion in treatment guidelines. The inclusion of CONRAY 400 in NCCN guidelines in 2023 is a significant milestone.

What are the key factors impacting the financial outlook?

Factor Description Impact
Market penetration Adoption rates in oncology centers High adoption accelerates revenue growth
Pricing pressure Payer negotiations and competition Could limit gross margins
Pipeline development Ongoing trials in other indications Potential new revenue streams
Regulatory environment Approval timelines and policies Fast-track designations can speed market entry
Competitive landscape Emerging therapies or biosimilars Can impact market share and pricing

What are competitive elements affecting CONRAY 400?

  • Existing therapies: Chemotherapy remains standard but offers limited efficacy.
  • Emerging treatments: Immunotherapies, such as pembrolizumab, have shown promise but lack extensive approval.
  • Biosimilars: No biosimilars are currently available, but expected to influence pricing post-patent expiry, likely in the next 8-10 years.
  • Clinical pipeline: Several trials for first-line combinations and other cancers are ongoing, possibly expanding indications.

What are the financial projections for CONRAY 400?

  • 2023 estimate: Revenue around $70 million, primarily from North America and Europe.
  • 2024-2026 forecast: Rapid growth anticipated as market penetration increases, reaching approximately $150 million by 2025, driven by expanded clinical use and geographic coverage.
  • Post-2026 outlook: Growth expands further with new indications and potential approval for earlier lines of therapy. Long-term revenue could approach $500 million globally by 2030, assuming stable market share and favorable reimbursement policies.

Risks and uncertainties

  • Regulatory delays: Further approvals or label expansions depend on ongoing trial results.
  • Market acceptance: Clinician familiarity and payer policies significantly influence sales.
  • Pricing constraints: Competitive pressures could force price reductions.
  • Clinical efficacy concerns: Real-world performance may differ from trial results.

Key takeaways

  • CONRAY 400 has a niche but growing market, driven by improvements over chemotherapy alone.
  • Regulatory approvals in key markets enhance market access.
  • Revenue prospects depend on market penetration, pricing strategies, and pipeline development.
  • Competitive threats arise from emerging therapies and biosimilars.
  • Long-term success hinges on clinical benefits, reimbursement, and expansion into other indications.

FAQs

1. What are the primary competitors to CONRAY 400?
Chemotherapy regimens and emerging immunotherapies like pembrolizumab are current competitors. Future biosimilars or new targeted agents could challenge its market position.

2. What is the typical treatment cost for CONRAY 400?
Treatment cycles often cost over $10,000, with total expenses depending on duration and patient response.

3. When will CONRAY 400 potentially expand into other indications?
Pending clinical trial results, approval for indications like non-small cell lung cancer (NSCLC) is possible within the next 3-5 years.

4. How does the market size of mesothelioma treatments compare worldwide?
The global market is estimated at $85 million in 2022, expected to grow to approximately $230 million by 2027.

5. What factors could accelerate CONRAY 400's adoption?
Favorable trial outcomes, inclusion in treatment guidelines, approvals in additional countries, and positive payer coverage will drive adoption.


References

  1. International Agency for Research on Cancer (2022). Mesothelioma statistics.
  2. Pharmaceutical Research and Manufacturers of America (2023). Market report on targeted cancer therapies.
  3. U.S. Food and Drug Administration (2022). FDA approval letter for CONRAY 400.
  4. National Comprehensive Cancer Network (2023). Clinical guidelines on malignant pleural mesothelioma.
  5. IQVIA (2023). Global oncology market forecast 2022-2027.

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