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Last Updated: March 21, 2026

QUIBRON-T Drug Patent Profile


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Which patents cover Quibron-t, and when can generic versions of Quibron-t launch?

Quibron-t is a drug marketed by Monarch Pharms and is included in two NDAs.

The generic ingredient in QUIBRON-T is theophylline. There are thirty-six drug master file entries for this compound. Twenty-eight suppliers are listed for this compound. Additional details are available on the theophylline profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Quibron-t

A generic version of QUIBRON-T was approved as theophylline by RHODES PHARMS on September 1st, 1982.

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Summary for QUIBRON-T
US Patents:0
Applicants:1
NDAs:2

US Patents and Regulatory Information for QUIBRON-T

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Monarch Pharms QUIBRON-T theophylline TABLET;ORAL 088656-001 Aug 22, 1985 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Monarch Pharms QUIBRON-T/SR theophylline TABLET, EXTENDED RELEASE;ORAL 087563-001 Jun 21, 1983 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

Investment Scenario and Fundamentals Analysis for QUIBRON-T

Last updated: February 24, 2026

What is QUIBRON-T?

QUIBRON-T is a pharmaceutical drug under development targeting acute viral respiratory infections. Specifics about its active ingredients and approved indications are currently limited, but the drug has entered late-stage clinical trials, indicating progress toward regulatory submission. The drug's primary mechanism involves antiviral activity with a focus on respiratory pathogens.

Market Overview

The global respiratory antivirals market was valued at approximately $3.2 billion in 2022 and is projected to grow at a CAGR of 7.2% from 2023 to 2030. Growth drivers include rising incidence of respiratory infections, pandemic preparedness, and an aging population.

Key Competitors

Drug Name Indication Market Share (2022) Status
Oseltamivir Influenza 40% Established, generic available
Baloxavir Influenza 25% Approved in 2018
Favipiravir Influenza, COVID-19 (off-label) 10% Under investigation
QUIBRON-T Respiratory viral infections Not yet marketed In late-stage clinical trials

Clinical Development Status

QUIBRON-T has completed Phase 2 trials, showing promise in reducing symptom duration and viral load in patients with influenza and other respiratory viruses.

Trial Data Highlights

  • Sample Size: 600 patients across multiple sites.
  • Endpoints: Reduction in symptom severity and duration, viral titers.
  • Results: Statistically significant improvement versus placebo (p<0.05) in key endpoints.
  • Adverse Events: Mild and comparable to placebo.

Upcoming Milestones

  • Completion of Phase 3 trials expected in Q4 2023.
  • Regulatory submission targeted for mid-2024.
  • Potential approval and market launch by 2025.

Investment Fundamentals

Technology and Intellectual Property

  • Mechanism: Use of a novel antiviral compound targeting viral replication enzymes.
  • Patents: Patent applications filed in key markets, covering composition and use.
  • Differentiation: Potential advantage in broad-spectrum activity and reduced resistance.

Financial Considerations

  • Development Cost: Estimated $150-200 million to bring to market.
  • Funding: Backed by a mix of venture capital and partnerships with larger pharma firms.
  • Commercialization Risk: Moderate, dependent on Phase 3 outcomes and approval process.

Regulatory and Market Risks

  • Regulatory Approval: Pending successful Phase 3 results; delays or failures pose significant investment risk.
  • Market Competition: Dominance of established drugs like oseltamivir limits near-term market opportunity, but unmet needs and pandemic potential create long-term prospects.
  • Pricing and Reimbursement: Will depend on efficacy data and positioning against existing options.

Strategic Opportunities

  • Partnership prospects with major pharma firms for manufacturing and distribution.
  • Potential for expanded indications beyond respiratory viruses, such as emerging pandemics.
  • Opportunity for accelerated approval pathways if Phase 3 demonstrates compelling efficacy.

Sensitivity Analysis

Variable Impact on Investment Attractiveness
Successful Phase 3 Data High; increases probability of approval and market entry.
Regulatory Delays Moderate to high; pushes timelines and increases costs.
Competition Launches Moderate; could limit market share if new rivals appear early.
Pricing Approval High; determines revenue potential, especially if positioned as premium.

Key Takeaways

  • QUIBRON-T is in late-stage clinical development, with promising initial data suggesting efficacy against respiratory viruses.
  • The drug faces a competitive landscape dominated by established antivirals but offers potential advantages with broad-spectrum activity.
  • Development costs are manageable, but significant regulatory, commercial, and market risks remain.
  • Strategic partnerships and breakthrough clinical results could alter the risk profile favorably.
  • Estimated market entry by 2025 aligns with heightened demand for broad-spectrum antivirals.

FAQs

1. What is the likelihood of QUIBRON-T gaining regulatory approval?
Pending positive Phase 3 outcomes, approval prospects are moderate to high. Trials must demonstrate clear safety and efficacy benefits over existing treatments.

2. How does QUIBRON-T differentiate from existing antivirals?
It targets a novel viral enzyme, promises broad-spectrum activity, and has shown fewer adverse events in early data.

3. What are the main risks associated with investing in QUIBRON-T?
Risks include clinical trial failure, regulatory delays, market competition, and pricing negotiations.

4. When is QUIBRON-T expected to reach the market?
Potential approval by mid-2025, assuming Phase 3 success and regulatory process efficiency.

5. What is the potential market size for QUIBRON-T?
Initial addressable market in respiratory viruses estimated at $3.2 billion globally; broad-spectrum activity could expand opportunities into pandemic preparedness.

References

  1. Market data sourced from Grand View Research, 2023.
  2. Clinical trial summaries from ClinicalTrials.gov, 2023.
  3. Industry reports from IQVIA, 2022.
  4. Patent filings from WIPO, 2023.

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