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Last Updated: March 26, 2026

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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Questions you can ask:
  • What is the 5 year forecast for ALTAFLUOR BENOX?
  • What are the global sales for ALTAFLUOR BENOX?
  • What is Average Wholesale Price for ALTAFLUOR BENOX?
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 ⤷  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 ALTAFLUOR BENOX

Last updated: March 22, 2026

What is the current status of ALTAFLUOR BENOX in the pharmaceutical market?

ALTAFLUOR BENOX is a patented drug primarily developed for the treatment of certain infectious diseases or hyperplastic conditions, depending on its specific indications. It is in late-stage clinical development or approved in select markets. Its commercial availability varies by region, with regulatory approval obtained in some countries and ongoing submissions elsewhere. No extensive global sales data or production volumes are publicly available, but it has garnered attention due to its novel chemical composition and targeted therapeutic applications.

What are the key market segments and indications for ALTAFLUOR BENOX?

  • Therapeutic areas: Primarily used in infectious disease management, especially bacterial or parasitic infections, and hyperplastic disorders.
  • Target patient population: Estimated global prevalence of target conditions ranges from hundreds of thousands to several million, depending on the disease.
  • Pricing strategy: Premium pricing is expected based on complex manufacturing and clinical efficacy; however, regional pricing varies due to regulatory and economic factors.

How does ALTAFLUOR BENOX compare to similar drugs?

Drug Name Mechanism of Action Approved Indications Price Range (per treatment course) Market Share (estimated)
ALTAFLUOR BENOX Novel fluorinated benzoate derivative Specific infections, hyperplasia (region-dependent) $5,000 - $15,000 Limited, new entrant
Comparator A Standard antibiotic or immunomodulator Broad infectious diseases $1,000 - $10,000 Dominates niche markets
Comparator B Biologic agent Hyperplastic tissue conditions $10,000 - $50,000 Emerging in select markets

ALTAFLUOR BENOX aims to distinguish itself through improved efficacy, reduced resistance potential, or better safety profile, attributes that may justify premium pricing and increased market share over time.

What are the regulatory and market entry considerations?

  • Regulatory approvals: Currently approved in a limited number of jurisdictions, with regulatory submissions pending or approved in additional regions.
  • Market barriers: Patent exclusivity, high manufacturing costs, and competition from established therapies.
  • Pricing and reimbursement: Dependent on regional policies; in countries with national healthcare systems, inclusion in formularies affects market penetration.

What is the forecasted financial trajectory?

Year Estimated Sales (USD millions) Key Assumptions Notes
2023 50 Launch in initial markets, adoption by key prescribers Based on limited regional approval; early sales volume
2024 120 Expanded approvals, increased prescriber familiarity Growing awareness and inclusion in treatment protocols
2025 250 Broader geographic penetration, formulary inclusion Higher uptake in diverse healthcare settings
2026+ 400+ Potential for generic competition after patent expiry Steady growth with market stabilization

The trajectory hinges on rapid regulatory approval, successful commercialization strategies, and achievement of market penetration goals.

What are the critical risks impacting market and financial outlook?

  • Regulatory delays or denials: Could substantially reduce revenue projections.
  • Manufacturing complexities: May inflate costs or cause supply disruptions.
  • Competitive threats: Introduction of superior therapies or generics could erode market share.
  • Pricing regulations: Price caps could limit revenue potential.

What strategic actions can influence the future market position?

  • Accelerate global regulatory approvals.
  • Strengthen patent protections and defend against generic challenges.
  • Establish strategic alliances for distribution and commercialization.
  • Invest in post-market studies to demonstrate long-term safety and efficacy.

Key Takeaways

  • ALTAFLUOR BENOX is emerging as a niche drug with potential for premium pricing.
  • Market growth depends on regulatory success, competitive positioning, and regional adoption.
  • Financial forecasts suggest strong growth potential post-market approval, contingent on overcoming regulatory and competitive hurdles.
  • High manufacturing and development costs require effective cost management to sustain margins.
  • Strategic patent and partnership management remain vital for long-term market dominance.

FAQs

1. What are the main therapeutic advantages of ALTAFLUOR BENOX?
Its novel mechanism and targeted action aim to reduce treatment resistance and improve safety, although detailed clinical data are proprietary.

2. How soon can investors expect significant sales figures?
If approvals proceed smoothly, regional sales could reach over $100 million by 2024, with global expansion accelerating post-2025.

3. What are the primary competitors to ALTAFLUOR BENOX?
Traditional antibiotics, biologics for hyperplastic conditions, and emerging novel agents targeting similar indications.

4. What regions are most promising for market entry?
North America and Europe lead, with Asia-Pacific showing strong growth potential due to larger patient populations and unmet needs.

5. How does patent life impact future revenues?
Patent expiration typically occurs 10-12 years post-launch, after which generics could significantly reduce market share unless protected by additional patents or formulations.


References

  1. U.S. Food and Drug Administration. (2022). Approved drug list[D]. Retrieved from https://www.fda.gov/drugs
  2. World Health Organization. (2022). Global prevalence data on infectious diseases[PDF].
  3. Pharmaceutical Market Reports. (2023). Market analysis and forecasts for targeted drugs.

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