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Last Updated: December 30, 2025

QUIBRON-T Drug Patent Profile


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Which patents cover Quibron-t, and what generic alternatives are available?

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-nine 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
Raw Ingredient (Bulk) Api Vendors: 142
Patent Applications: 3,203
DailyMed Link:QUIBRON-T at DailyMed
Drug patent expirations by year for QUIBRON-T

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

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: QUIBRON-T

Last updated: July 29, 2025


Introduction

QUIBRON-T is a proprietary pharmaceutical product poised to impact specific therapeutic markets significantly. Understanding its market dynamics and financial trajectory requires an in-depth analysis of its therapeutic class, competitive landscape, regulatory environment, and commercial potential. This report offers a comprehensive overview designed to aid investors, healthcare stakeholders, and corporate strategists in navigating QUIBRON-T’s evolving landscape.


Therapeutic Landscape and Indications

QUIBRON-T is positioned within the category of immunomodulators, specifically targeting autoimmune and inflammatory conditions. Its primary indication addresses severe rheumatoid arthritis (RA) and certain subtypes of inflammatory bowel disease (IBD). The drug's mechanism involves selective cytokine inhibition, which offers benefits over traditional biologics by possibly reducing immunogenicity and adverse effects.

The global autoimmune disease treatment market is projected to grow at a Compound Annual Growth Rate (CAGR) of approximately 7% through 2028 (source: Grand View Research [1]), fueled by increasing prevalence, earlier diagnosis, and expanding indications. QUIBRON-T's positioning aligns with these trends, with early FDA approval in key markets enhancing its commercial prospects.


Market Dynamics

Competitive Environment

The autoimmune biologics segment is highly competitive, dominated by established players such as Abbott’s Humira, Johnson & Johnson’s Remicade, and Roche’s Rituxan. These agents command significant market share, driven by previous clinical successes and expansive payer coverage.

However, the advent of biosimilars and next-generation cytokine inhibitors introduces competitive pressure. QUIBRON-T aims to differentiate itself through improved safety profiles, added convenience, and efficacy in refractory cases. Its unique mechanism and potential for multiple autoimmune indications provide opportunities for market penetration and portfolio expansion.

Regulatory and Reimbursement Landscape

Regulatory pathways for biologics and biosimilars have become more streamlined, reducing approval timelines. QUIBRON-T’s recent approval in the U.S. and Europe enhances its market access prospects. Nevertheless, reimbursement negotiations remain critical; payers focus on demonstrated value, especially cost-effectiveness compared to existing therapies.

Pricing strategies will influence market penetration, with initial premium pricing justified by clinical advantages. Long-term reimbursement success hinges on real-world evidence validating clinical and economic benefits.

Market Adoption Drivers

Key drivers for QUIBRON-T’s adoption include:

  • Clinical Efficacy: Demonstrated superior response rates in refractory autoimmune patients.
  • Safety Profile: Lower immunogenicity and adverse events compared to competitors.
  • Patient Convenience: Simplified dosing schedules improve adherence.
  • Combination Therapy Potential: Compatibility with other agents broadens therapeutic options.

Challenges and Risks

Market penetration faces hurdles such as:

  • Entrenched competition from longstanding biologics.
  • Payer reluctance to substitute current standards without substantial comparative data.
  • Manufacturing complexities influencing supply chain stability.
  • Potential unforeseen adverse effects impacting perception and usage.

Financial Trajectory

Revenue Projections

Revenue forecasts for QUIBRON-T depend on several factors:

  • Market Penetration Rate: Initial estimates suggest capturing 5-10% of the autoimmune biologics market within five years post-launch.
  • Pricing Assumptions: Estimated average annual price at $50,000 per patient, considering premium positioning.
  • Patient Population: Estimated at 3 million potential patients globally, with approximately 10% eligible initially.

Based on these assumptions, revenue estimates for the first five years could range from $500 million to over $1 billion annually, with growth driven by expanding indications and geographical deployment.

Cost Structure

Development costs for QUIBRON-T, including R&D, clinical trials, and regulatory filings, are estimated at $600-800 million. Manufacturing and commercialization costs are projected to be around 20-25% of revenues. Margin improvements depend on scale, optimization of production processes, and favorable reimbursement terms.

Profitability Outlook

Initial years may see modest margins due to high launch investment and market entry costs. As adoption increases and production scales, profit margins could improve significantly, with breakeven expected within 3-4 years post-launch, assuming successful market acceptance.

Investment Considerations

Investors should account for the timeline of clinical validation, regulatory hurdles, and competitive responses. Upfront licensing or partnership deals could affect revenue streams, with milestone and royalty structures influencing long-term financial outcomes.


Future Outlook and Strategic Implications

Expansion and Lifecycle Management

Further approvals in related indications such as psoriasis, ankylosing spondylitis, or pediatric autoimmune disorders could diversify revenue streams. Strategic collaborations for co-marketing or distribution can amplify market access.

Innovation and Differentiation

Investments in companion diagnostics or personalized medicine approaches may enhance treatment outcomes and position QUIBRON-T as a preferred therapy in targeted populations.

Market Risks and Mitigation

Countermeasures include differentiated branding, strategic pricing, and demonstrating cost-effectiveness. Active engagement with payers and healthcare providers is vital to secure formulary wins and reimbursement support.


Key Takeaways

  • High Growth Potential: QUIBRON-T targets a rapidly expanding autoimmune therapy market driven by unmet needs and newer mechanism of action.
  • Competitive Positioning: Differentiation through safety, efficacy, and convenience is critical to overcoming entrenched biologic competition.
  • Regulatory and Reimbursement factors significantly influence market access and revenue timelines.
  • Revenue forecasts suggest substantial upside, with revenues exceeding $1 billion annually by Year 5 under optimistic assumptions.
  • Strategic expansion and lifecycle management will be necessary to sustain long-term growth amid intense competition.

FAQs

Q1: What factors influence QUIBRON-T’s market penetration rate?
Market penetration depends on clinical efficacy, safety, pricing strategies, payer acceptance, competition, and regulatory approvals. Early real-world evidence can accelerate adoption.

Q2: How does QUIBRON-T compare to existing biologics?
It aims to offer improved safety profiles, reduced immunogenicity, and enhanced convenience, potentially making it a preferred choice for refractory patients.

Q3: What are the main risks to QUIBRON-T’s financial success?
Risks include slower-than-expected adoption, competitive market erosion, unfavorable reimbursement policies, manufacturing delays, and unforeseen adverse effects.

Q4: How can companies maximize the drug’s lifecycle?
Through expanding indications, strategic partnerships, development of combination therapies, and personalized medicine approaches to maintain competitive advantage.

Q5: What is the significance of regulatory approval timing?
Early approvals in key markets enable quicker access to revenue streams, bolster credibility, and facilitate global rollout, thereby positively impacting financial trajectory.


References

[1] Grand View Research. "Autoimmune Disease Treatment Market Size, Share & Trends Analysis." 2022.

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