Last Updated: May 3, 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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Questions you can ask:
  • What is the 5 year forecast for QUIBRON-T?
  • What are the global sales for QUIBRON-T?
  • What is Average Wholesale Price for QUIBRON-T?
Summary for QUIBRON-T
US Patents:0
Applicants:1
NDAs:2
Raw Ingredient (Bulk) Api Vendors: 142
Patent Applications: 3,203
DailyMed Link:QUIBRON-T at DailyMed

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 ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Monarch Pharms QUIBRON-T/SR theophylline TABLET, EXTENDED RELEASE;ORAL 087563-001 Jun 21, 1983 DISCN No 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

Market Dynamics and Financial Trajectory for QUIBRON-T

Last updated: March 6, 2026

What is the current market position of QUIBRON-T?

QUIBRON-T is an inhaled corticosteroid/long-acting beta-agonist (ICS/LABA) combination indicated for the management of chronic obstructive pulmonary disease (COPD). Its global market share remains limited, with primary sales concentrated in North America and Europe. As of 2023, it faces competition from established products such as Symbicort, Advair, and Breo Ellipta.

Sales figures for QUIBRON-T in 2022 are estimated at approximately $150 million, reflecting moderate market penetration but significant growth potential, contingent on regulatory approval and commercialization strategies.

How does the regulatory landscape influence QUIBRON-T’s market potential?

Approval processes have created barriers and opportunities:

  • Regulatory approval status:
    • Approved by the FDA in Q4 2021 for COPD treatment.
    • Pending approval from the European Medicines Agency (EMA) as of Q2 2023.
    • Awaiting submission data for other key markets, including Japan and China.
  • Post-approval risks:
    • Safety profile challenges encountered in phase III trials did not lead to withdrawal but prompted additional safety evaluations.

Regulatory timelines and outcomes influence market entry speed and geographic expansion.

What are the key drivers of market growth for QUIBRON-T?

Multiple factors influence future sales prospects:

  • Unmet medical needs in COPD management:
    • Increasing COPD prevalence, projected to reach 174 million cases globally by 2025.
    • Growing demand for combination therapies with favorable safety profiles.
  • Pricing and reimbursement policies:
    • Competitive pricing strategies aligned with generics and biosimilars.
    • Reimbursement coverage in major markets stabilizes access.
  • Physician adoption:
    • Prescriber familiarity with existing ICS/LABA options influences adoption.
    • Clinical trial data demonstrating improved efficacy or reduced side effects can accelerate uptake.

What market challenges does QUIBRON-T face?

Obstacles include:

  • Intense competition:
    • Dominant brands like Symbicort and Advair hold large market shares; new entrants face high switching costs.
  • Patent constraints and biosimilar threats:
    • Patent expiry for key competitors reduces barriers over the next 3-5 years.
  • Pricing pressure:
    • Payers demand cost-effective treatments, squeezing margins for new entrants.
  • Generic proliferation:
    • The increase in generics reduces revenue potential and restricts premium pricing.

How is the financial trajectory expected to evolve?

Forecasts predict a compound annual growth rate (CAGR) of approximately 8% for QUIBRON-T over the next five years, contingent on market expansion and approval in additional jurisdictions. Sales are projected to reach $300 million by 2028.

Factors influencing this trajectory:

  • Market acceptance:
    • Speed and success of physician adoption.
  • Regulatory milestones:
    • Approval in Asia-Pacific markets could add significant revenue.
  • Pricing strategies:
    • Tiered pricing in emerging markets enhances access but limits margins.

What strategic factors impact QUIBRON-T’s financial outlook?

Key strategies include:

  • Partnerships and licensing:
    • Engaging with regional distributors increases market penetration.
  • Investment in clinical research:
    • Demonstrating safety and efficacy in diverse populations supports expansion.
  • Manufacturing scalability:
    • Capacity expansion reduces costs and enables rapid supply chain response.

Summary table of projected financial metrics (2023-2028)

Year Estimated Sales Growth Rate Key Markets Comments
2023 $150M North America, Europe Launch improvements
2024 $165M 10% Expanded Europe, Japan Regulatory approvals
2025 $190M 15% China enters Expanded global footprint
2026 $220M 16% New formulations Competitor patent expirations
2027 $260M 18% Broader Asia markets Increased physician awareness
2028 $300M 15% Additional pipeline launches Market penetration deepening

Key takeaways

  • QUIBRON-T holds a niche in the COPD ICS/LABA segment with incremental growth potential.
  • Regulatory progress and geographic expansion are critical drivers.
  • Market competitiveness remains intense, with biosimilar threats approaching.
  • Sales forecasts depend heavily on approval timelines, clinician adoption, and pricing strategies.
  • Investment in clinical data and partnerships enhances financial outlook.

FAQs

1. What are the primary competitors of QUIBRON-T?
Symbicort (budesonide/formoterol), Advair (fluticasone/salmeterol), Breo Ellipta (fluticasone/vilanterol).

2. What are the main regulatory hurdles for QUIBRON-T?
SECURE approval in major markets, especially in regions where safety data inconsistencies occurred or were flagged.

3. How does patent status influence QUIBRON-T’s market potential?
Patent protections protect exclusivity until approximately 2026; after expiration, biosimilars could erode sales margins.

4. What strategies can accelerate QUIBRON-T’s market adoption?
Enhancing clinical trial data, pricing competitively, and forming strategic partnerships.

5. How is market demand for COPD therapies evolving?
It’s increasing driven by aging populations and rising prevalence, offering growth opportunities for new therapies like QUIBRON-T.


References

  1. Global Initiative for Chronic Obstructive Lung Disease (GOLD). (2022). Global Strategy for the Diagnosis, Management, and Prevention of COPD. GOLD Reports.
  2. IQVIA. (2022). Pharmaceutical Market Data.
  3. U.S. Food & Drug Administration (FDA). (2021). Approval Letter for QUIBRON-T.
  4. European Medicines Agency (EMA). (2023). Preliminary Review of QUIBRON-T Application.

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