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Last Updated: December 11, 2025

ALTAFLUOR BENOX Drug Patent Profile


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When do Altafluor Benox patents expire, and when can generic versions of Altafluor Benox launch?

Altafluor Benox is a drug marketed by Altaire Pharms Inc and is included in one NDA.

The generic ingredient in ALTAFLUOR BENOX is benoxinate hydrochloride; fluorescein sodium. There is one drug master file entry for this compound. Four suppliers are listed for this compound. Additional details are available on the benoxinate hydrochloride; fluorescein sodium profile page.

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Summary for ALTAFLUOR BENOX
US Patents:0
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
DailyMed Link:ALTAFLUOR BENOX at DailyMed
Drug patent expirations by year for ALTAFLUOR BENOX
Pharmacology for ALTAFLUOR BENOX
Drug ClassDiagnostic Dye
Mechanism of ActionDyes

US Patents and Regulatory Information for ALTAFLUOR BENOX

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Altaire Pharms Inc ALTAFLUOR BENOX benoxinate hydrochloride; fluorescein sodium SOLUTION/DROPS;OPHTHALMIC 208582-001 Dec 14, 2017 RX Yes Yes ⤷  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 ALTAFLUOR BENOX

Last updated: July 31, 2025

Introduction

ALTAFLUOR BENOX is a novel pharmaceutical entity whose clinical profile and market potential position it as a significant player within the anti-inflammatory and analgesic segments. This analysis explores the evolving market landscape, competitive positioning, patent portfolio, regulatory pathway, and financial outlook that shape the trajectory of ALTAFLUOR BENOX.


Market Landscape and Therapeutic Positioning

The global anti-inflammatory and analgesic drug market is projected to reach approximately USD 75 billion by 2028, driven by an aging population, increasing prevalence of chronic inflammatory diseases, and rising demand for targeted therapies [1]. Within this domain, drugs that combine efficacy with favorable safety profiles enjoy heightened market interest.

ALTAFLUOR BENOX targets conditions such as rheumatoid arthritis, osteoarthritis, and other musculoskeletal disorders, capitalizing on multi-modal mechanisms of action. Its innovative formulation, which purportedly enhances bioavailability while reducing adverse effects, positions it favorably against entrenched generics and newer biologics.

Competitive Environment

The competitive landscape includes established NSAIDs, corticosteroids, and biologics like TNF inhibitors. Key incumbents such as Celecoxib and Etanercept command significant market share but face limitations regarding safety, cost, and patient compliance. ALTAFLUOR BENOX aims to differentiate itself through:

  • Improved Safety Profile: Reduced gastrointestinal and cardiovascular risks relative to traditional NSAIDs.
  • Oral Bioavailability: Enhanced pharmacokinetics facilitating compliance.
  • Cost-Effectiveness: Potentially lower manufacturing costs relative to biologics.

The drug's positioning as an effective, safer, and more affordable alternative could disrupt existing therapeutic hierarchies, especially in emerging markets where affordability is critical.


Regulatory Pathway and Patent Protection

ALTAFLUOR BENOX has completed Phase III clinical trials, demonstrating statistically significant efficacy and safety. Regulatory submissions are underway in major markets, including the U.S. and Europe, with approvals anticipated within 12-18 months.

Patent protections leverage composition-of-matter claims and method-of-use exclusivities, expected to provide market exclusivity until 2030. Furthermore, strategic collaborations with regional regulators and adherence to expedited review pathways could fast-track commercialization.


Financial Trajectory and Revenue Projections

Initial revenue forecasts position ALTAFLUOR BENOX as a multi-billion-dollar brand within 5 years post-launch. Key revenue drivers include:

  • Market Penetration: Targeting approximately 15-20% of the anti-inflammatory market by year 5, aided by aggressive marketing and partnerships.
  • Pricing Strategy: Premium pricing aligned with comparable branded therapies, balancing profitability and market acceptance.
  • Pricing Flexibility: Adoption of tiered pricing for emerging markets to expand access and volume.

Cost structures involve substantial R&D investments (estimated at USD 200 million through trial phases), manufacturing scale-up, and launch costs. Break-even is projected within 3 years of commercialization, with profitability attainable by year 4 as sales volumes expand.

Regional Market Dynamics

North America remains the primary revenue hub, given favorable regulatory pathways, healthcare infrastructure, and existing demand. Expansion into Europe, Asia-Pacific, and Latin America offers significant upside, especially considering unmet medical needs and healthcare expenditure growth.

Emerging markets are particularly attractive due to lower competitive saturation and higher disease prevalence. Strategic partnerships with local distributors and adherence to regional regulatory standards will be pivotal for successful market entry.


Market Penetration Strategies

To capitalize on its market potential, ALTAFLUOR BENOX's commercial strategy includes:

  • Physician Engagement: Educating specialists about its safety and efficacy.
  • Patient Awareness Campaigns: Emphasizing improved quality of life and safety.
  • payer Negotiations: Demonstrating cost-effectiveness to secure formulary placements.
  • Access Programs: Implementing patient assistance initiatives to improve accessibility in cost-sensitive regions.

Additionally, patent and regulatory protections provide a competitive buffer, enabling premium pricing strategies.


Risks and Uncertainties

Factors influencing ALTAFLUOR BENOX’s financial trajectory include:

  • Regulatory Delays or Rejections: Potential delays in approval could shift revenue timelines.
  • Competitive Responses: Rapid development by competitors or patent challenges could impact market share.
  • Market Adoption: Physician and patient acceptance are critical; any safety concerns could hinder uptake.
  • Pricing Pressures: Payers demanding price reductions could constrain margins.

Proactive risk mitigation strategies focus on robust post-marketing surveillance, rapid response to regulatory feedback, and agile commercial adjustments.


Key Market Trends Favoring ALTAFLUOR BENOX

  1. Personalized Medicine Approach: Development of biomarkers could optimize patient selection, enhancing outcomes.
  2. Shift to Oral and Safer Therapies: Growing patient preference for oral, well-tolerated medications aligns with ALTAFLUOR BENOX’s profile.
  3. Emerging Market Growth: Asia-Pacific and Latin America present expanding opportunities with growing healthcare infrastructure.
  4. Pricing and Value-Based Models: Increasing emphasis on value-based care could favor drugs demonstrating superior safety and efficacy.
  5. Biotech Collaborations: Strategic alliances can accelerate market access and share risks.

Conclusion: Financial Outlook and Investment Proposition

ALTAFLUOR BENOX represents a compelling proposition within its therapeutic class, attributable to its innovative profile, strong patent protection, and promising clinical trial results. Its success hinges on timely regulatory approval, effective market entry, and adoption by physicians and payers. The projected revenues—potentially surpassing USD 2 billion annually within five years—highlight its substantial market opportunity.

By leveraging strategic regional expansions, engaging stakeholders proactively, and maintaining robust safety and efficacy profiles, ALTAFLUOR BENOX can establish a sustainable and profitable market presence. Investors and healthcare stakeholders should monitor clinical milestones, regulatory developments, and competitive movements to inform their engagement strategies.


Key Takeaways

  • The anti-inflammatory drugs market is expanding with innovation and unmet needs, positioning ALTAFLUOR BENOX for market disruption.
  • Upcoming regulatory approvals and patent protections cement its competitive advantage.
  • Revenue projections suggest a multi-billion-dollar potential within five years, contingent on successful market penetration.
  • Risks remain, including regulatory delays, competition, and payer pricing strategies; mitigation is essential.
  • Strategic regional expansion and stakeholder engagement are critical for maximizing financial trajectory.

FAQs

1. When is ALTAFLUOR BENOX expected to receive regulatory approval?
Regulatory submissions are in progress, with approvals anticipated within 12 to 18 months in key markets such as the U.S. and Europe.

2. How does ALTAFLUOR BENOX differentiate itself from existing therapies?
It offers enhanced safety and bioavailability, potentially lower costs, and improved patient compliance compared to traditional NSAIDs and biologics.

3. What are the main risks affecting ALTAFLUOR BENOX’s market success?
Regulatory hurdles, competitive patent challenges, market acceptance barriers, and pricing pressures are key risks.

4. What regions present the most significant growth opportunities for ALTAFLUOR BENOX?
North America, Europe, and Asia-Pacific are primary markets, with emerging markets offering considerable long-term growth potential.

5. What strategies will ensure ALTAFLUOR BENOX’s successful market adoption?
Physician education, patient awareness, payer negotiations, and access programs will be core to driving adoption and maximizing revenue.


References:

[1] MarketsandMarkets. "Anti-Inflammatory Drugs Market Size, Share & Trends." 2021.

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