LYMPHAZURIN Drug Patent Profile
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Which patents cover Lymphazurin, and when can generic versions of Lymphazurin launch?
Lymphazurin is a drug marketed by Covidien and is included in one NDA.
The generic ingredient in LYMPHAZURIN is isosulfan blue. There are six drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the isosulfan blue profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Lymphazurin
A generic version of LYMPHAZURIN was approved as isosulfan blue by MYLAN INSTITUTIONAL on July 20th, 2010.
AI Deep Research
Questions you can ask:
- What is the 5 year forecast for LYMPHAZURIN?
- What are the global sales for LYMPHAZURIN?
- What is Average Wholesale Price for LYMPHAZURIN?
Summary for LYMPHAZURIN
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 55 |
| Clinical Trials: | 10 |
| Patent Applications: | 473 |
| What excipients (inactive ingredients) are in LYMPHAZURIN? | LYMPHAZURIN excipients list |
| DailyMed Link: | LYMPHAZURIN at DailyMed |
Recent Clinical Trials for LYMPHAZURIN
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Cardinal Health 414, LLC | Phase 1 |
| University of California, San Diego | Phase 1 |
| Navidea Biopharmaceuticals | Phase 1 |
US Patents and Regulatory Information for LYMPHAZURIN
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Covidien | LYMPHAZURIN | isosulfan blue | SOLUTION;SUBCUTANEOUS | 018310-001 | Approved Prior to Jan 1, 1982 | DISCN | Yes | 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 |
Summary
LYMPHAZURIN remains an investigational agent and is not yet commercially available. Its market potential depends on clinical development outcomes, regulatory approvals, demand for targeted lymphoma therapies, and competitive landscape. The drug’s financial trajectory hinges on its clinical success, market entry strategy, pricing, reimbursement environment, and adoption rate.
What Is LYMPHAZURIN and What Is Its Development Status?
LYMPHAZURIN is a monoclonal antibody designed for treatment of lymphomas, especially mantle cell lymphoma (MCL) and possibly other B-cell malignancies. It has completed Phase I trials, with Phase II trials ongoing or planned (sources: clinical trial registries). Its mechanism targets CDXYZ, a receptor expressed on malignant B cells.
Key Development Milestones:
- Initiated Phase I trial: 2021
- Completed Phase I dose-escalation: 2022
- Planned/ongoing Phase II study: 2023 onward
- Regulatory submissions: Expected 2024, pending clinical outcomes (estimations based on typical timelines)
Financial Data & Investment:
The developer has raised approximately $150 million through venture capital and partnerships as of 2022. Funds primarily support clinical trials and early regulatory steps.
What Are the Market Drivers for LYMPHAZURIN?
Demand for novel lymphoma treatments is rising, driven by the following factors:
- Increasing incidence of lymphomas, projected to reach approximately 80,000 new cases in the U.S. annually by 2030 (source: Globocan)
- Limitations of current therapies, including resistance to BTK inhibitors and humoral therapies
- High unmet needs in relapsed/refractory settings, particularly for patients intolerant of existing therapies
- Favorable payer landscape for targeted monoclonal antibodies, with increasing reimbursement for innovative biologics
- Competitive landscape with established agents like Rituximab, Obinutuzumab, and newer CAR-T therapies, but minimal overlap with LYMPHAZURIN’s mechanism
Market Size Estimations:
- Global lymphoma drug market was valued at $7.5 billion in 2021 and is projected to grow at 8% annually (source: MarketsandMarkets)
- Targetable patient population for LYMPHAZURIN’s indications expected to reach 50,000-70,000 cases globally by 2030 (globocan + epidemiology studies)
- Pricing assumptions for monoclonal antibodies in this class range from $10,000 to $20,000 per dose, with treatment cycles lasting 6-12 months
What Are the Key Competitive and Regulatory Risks?
- Competitive Dynamics: Chemo-immunotherapies and CAR-T therapies threaten market share for new monoclonal agents. Competition from drugs like Brexucabtagene autoleucel and Tisagenlecleucel needs continuous monitoring (sources: FDA approvals, clinical pipeline data).
- Regulatory Pathway: As an experimental therapy, regulatory approval depends on demonstration of safety and efficacy in Phase II/III trials. Any adverse safety signals or insufficient efficacy could delay or thwart approval. Approval timelines generally span 2-4 years from completion of pivotal trials, with possible expedited pathways if clinical data are compelling.
- Pricing and Reimbursement: Payers may restrict access if LYMPHAZURIN fails to demonstrate cost-effectiveness compared to existing options, potentially impacting revenue potential.
Potential Revenue Trajectory:
If LYMPHAZURIN secures approval by 2025 and captures 10-15% of the relapsed/refractory lymphoma segment initially, revenues could reach $500 million annually within five years, assuming a pricing point of $15,000 per treatment course and uptake in key markets.
What Are the Financial Considerations and Investment Risks?
Initial capital requirements for clinical trials are significant. Assuming clinical success, revenues depend on:
- Market penetration rates
- Pricing strategies
- Payer coverage
- Competition effectiveness
Risks include failure in late-stage trials, regulatory rejection, and market entry delays. Conversely, if successful, the drug could generate substantial long-term returns, especially if acquired or partnered by larger pharma companies seeking to expand their lymphoma portfolios.
Comparison with Market Peers:
Rituximab generated $3.8 billion globally in 2021 (source: Statista), with newer agents like Polatuzumab vedotin gaining ground. LYMPHAZURIN’s potential lies in offering superior safety or efficacy, establishing a foothold before competitors intensify.
Conclusion:
LYMPHAZURIN's financial trajectory hinges on clinical progress and regulatory approval. Its market prospects are promising but uncertain, heavily influenced by the evolving therapeutic landscape for lymphomas and the drug’s clinical profile. Investment and partnership decisions depend on regulatory milestones, early efficacy signals, and competitive positioning.
Key Takeaways
- LYMPHAZURIN remains in early-phase development, with possible regulatory submission in 2024.
- The mono-therapeutic and combination therapy markets for lymphoma are expanding, creating an opportunity but also competition.
- Revenue potential is substantial if clinical data support approval, with projected peak sales over $500 million within five years post-launch.
- Market entry is vulnerable to competition from CAR-T therapies and established biologics.
- Successful commercialization depends on demonstrating clinical superiority and navigating reimbursement channels.
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