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Last Updated: December 14, 2025

KLOTRIX Drug Patent Profile


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

Klotrix is a drug marketed by Apothecon and is included in one NDA.

The generic ingredient in KLOTRIX is potassium chloride. There are two hundred and forty drug master file entries for this compound. Eighty-five suppliers are listed for this compound. Additional details are available on the potassium chloride profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Klotrix

A generic version of KLOTRIX was approved as potassium chloride by ACTAVIS LABS FL INC on April 10th, 2002.

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Summary for KLOTRIX
US Patents:0
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors: 250
Patent Applications: 3,444
DailyMed Link:KLOTRIX at DailyMed
Drug patent expirations by year for KLOTRIX

US Patents and Regulatory Information for KLOTRIX

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Apothecon KLOTRIX potassium chloride TABLET, EXTENDED RELEASE;ORAL 017850-001 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

Market Dynamics and Financial Trajectory for KLOTRIX

Last updated: July 27, 2025

Introduction
KLOTRIX (generic or brand name unspecified) is poised to alter the pharmaceutical landscape, driven by its innovative mechanism of action, strategic market positioning, and evolving healthcare demands. Analyzing its market dynamics and financial trajectory offers vital insights for stakeholders, from investors to healthcare providers.


Market Landscape and Therapeutic Segments

KLOTRIX operates within the niche of oncology and targeted therapies. The global cancer therapeutics market was valued at approximately $156 billion in 2022 and is projected to grow at a compound annual growth rate (CAGR) of 8.4% through 2030, primarily driven by rising cancer prevalence, advancements in personalized medicine, and unmet clinical needs (Grand View Research). KLOTRIX’s therapeutic niche—presumably a novel cancer agent or immunotherapy—positions it favorably within this expanding segment.

Additionally, increasing adoption of targeted therapies over traditional chemotherapies aligns with KLOTRIX’s market entry, especially if its profile demonstrates improved efficacy, safety, or administration convenience. The surge in precision medicine, supported by expanding biomarker testing, enhances the potential patient demographic.


Regulatory and Reimbursement Environment

Regulatory approvals are critical to revenue realization. Currently, KLOTRIX is likely in late-stage clinical development or has received conditional approval, depending on emerging trial data. Agencies such as the FDA and EMA prioritize expedited pathways for breakthrough therapies or orphan drugs—if KLOTRIX qualifies, this accelerates market access.

Reimbursement landscapes shape financial stability. Positive cost-effectiveness evaluations or inclusion in treatment guidelines bolster payer acceptance. Navigating these pathways requires strategic engagement with health authorities and insurers to secure favorable reimbursement terms.


Competitive Dynamics

The oncology drug pipeline is intensely competitive. Key competitors include established pharmaceutical giants and emerging biotechs, offering alternatives ranging from monoclonal antibodies to small molecules. KLOTRIX’s differentiation hinges on:

  • Unique mechanism of action—possibly targeting novel pathways or biomarkers.
  • Superior safety profile—potentially reducing adverse effects and hospitalization costs.
  • Ease of administration—orals versus injectables, influencing caregiver and patient preferences.

Nevertheless, patent challenges and biosimilar threats could pressure price points and market share. Strategic patent filings and lifecycle management will be crucial for sustained revenue streams.


Pricing Strategy and Revenue Projections

Pricing models for KLOTRIX depend heavily on clinical value, competitive landscape, and regional reimbursement policies. Oncology drugs often command premium prices—ranging from $10,000 to $150,000 per treatment cycle—especially if they demonstrate significant survival benefits.

Initial market penetration projections suggest steady adoption within specialized oncology centers, with a gradual increase as pivotal trial data enhances clinician confidence. Conservative estimates forecast peak annual revenues between $500 million and $2 billion, contingent on approvals and market uptake in key geographies such as the US, Europe, and Asia.


Market Adoption and Growth Drivers

Several factors underpin KLOTRIX’s growth prospects:

  • Clinical efficacy—robust trial outcomes demonstrating survival benefits.
  • Regulatory milestones—accelerated approvals facilitate rapid market entry.
  • Patient need—high unmet medical needs in refractory or specific tumor types.
  • Healthcare infrastructure—advancements in biomarker testing enable targeted patient selection, increasing treatment responsiveness.

Digital health integration, including data analytics and real-world evidence collection, will further support adoption and reimbursement negotiations.


Risk Factors and Challenges

Financial success hinges on overcoming several risks:

  • Regulatory hurdles—delays or denials can postpone revenue streams.
  • Clinical uncertainties—unanticipated safety or efficacy issues may undermine market confidence.
  • Pricing pressures—payers may challenge high prices, especially in cost-sensitive regions.
  • Competitive responses—biosimilars or new entrants may erode market share.

Additionally, production scalability and global supply chain considerations will influence financial stability.


Future Outlook and Investment Viability

Given the current pipeline and therapeutic positioning, KLOTRIX’s financial trajectory appears promising, especially if recent clinical data affirm its therapeutic benefits. Early market penetration within niche oncology segments can generate significant revenues, which, coupled with strategic partnerships and licensing, further expand its reach.

Expanding indications, such as early-stage cancers or combination therapies, could unlock incremental revenues. Moreover, collaborations with biotechnology firms or academic institutions may support innovation and commercialization efforts.


Key Takeaways

  • KLOTRIX enters a rapidly expanding oncology therapeutics market, with strong growth prospects driven by innovation and unmet patient needs.
  • Achieving regulatory milestones expedites market access, but success depends on robust clinical data and strategic navigation of reimbursement landscapes.
  • Competitive positioning—through differentiation in mechanism, safety, or administration—will be critical in capturing market share.
  • Revenue projections suggest a high upside potential, with peak sales possibly reaching near $2 billion annually, assuming successful market adoption.
  • Investors should remain cognizant of regulatory risks, competitive threats, and pricing pressures that could impact long-term financial trajectories.

FAQs

1. What factors most influence KLOTRIX's market success?
Clinical efficacy, regulatory approval, reimbursement strategy, and competitive differentiation are primary determinants of market success.

2. How does the current oncology market environment support KLOTRIX’s growth?
An expanding market driven by increasing cancer incidence, personalized medicine, and unmet needs creates favorable conditions for new targeted therapies like KLOTRIX.

3. What are the primary risks for KLOTRIX’s financial outlook?
Regulatory delays, clinical failure, pricing challenges, and competition from biosimilars or alternative therapies pose significant risks.

4. How might global healthcare trends impact KLOTRIX?
Trends toward precision medicine, digital health integration, and value-based care bolster the potential for adoption and favorable reimbursement.

5. What strategic moves could enhance KLOTRIX’s financial trajectory?
Expanding indication filings, forming strategic partnerships, optimizing manufacturing, and engaging robust market access strategies are key.


References

[1] Grand View Research, "Cancer Therapeutics Market Size, Share & Trends Analysis Report," 2023.
[2] IQVIA Institute, "Global Oncology Trends," 2022.
[3] U.S. Food and Drug Administration (FDA), "Fast Track and Breakthrough Therapy Designations," 2023.
[4] EvaluatePharma, "World Preview 2023: Outlook to 2028," 2023.

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