QUIBRON-T/SR Drug Patent Profile

When do Quibron-t/sr patents expire, and what generic alternatives are available?

Quibron-t/sr is a drug marketed by Monarch Pharms and is included in one NDA.

The generic ingredient in QUIBRON-T/SR 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/sr

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

Summary for QUIBRON-T/SR

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	142
Patent Applications:	3,203
DailyMed Link:	QUIBRON-T/SR at DailyMed

US Patents and Regulatory Information for QUIBRON-T/SR

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/SR	theophylline	TABLET, EXTENDED RELEASE;ORAL	087563-001	Jun 21, 1983		DISCN	No	No

Expired US Patents for QUIBRON-T/SR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Monarch Pharms	QUIBRON-T/SR	theophylline	TABLET, EXTENDED RELEASE;ORAL	087563-001	Jun 21, 1983

International Patents for QUIBRON-T/SR

See the table below for patents covering QUIBRON-T/SR around the world.

Country	Patent Number	Title	Estimated Expiration
Kenya	3722	SUSTAINED RELEASE THEOPHYLLINE TABLET HAVING REDUCED BULK
South Africa	8102861
Sweden	452550	TABLETT MED FORDROJD FRIGORING AV TEOFYLLIN
Japan	S57112322	LOW VOLUME SLOW RELEASE THEOPHYLLINE TABLET
Finland	811356

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

Last updated: July 29, 2025

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Introduction

QUIBRON-T/SR (name placeholder for the purpose of this analysis) represents a significant entrant in the pharmaceutical landscape, purportedly targeting a niche or widespread medical condition. As a sustained-release formulation, its market potential hinges on a complex interplay of regulatory approval, competitive landscape, clinical efficacy, pricing strategies, and healthcare adoption. This comprehensive analysis explores the current market dynamics influencing QUIBRON-T/SR and forecasts its financial trajectory based on industry trends, key growth drivers, and potential challenges.

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Market Overview

The global pharmaceutical industry continues its swift evolution fueled by innovation, aging populations, and expanding healthcare access. The sustained-release (SR) segment, specialized for controlled drug delivery, accounts for an increasingly dominant share. The market for SR formulations is projected to grow at a CAGR of approximately 6-8% over the next five years, driven by demand for improved patient compliance and convenience [1].

QUIBRON-T/SR aligns with these trends, offering benefits such as reduced dosing frequency, minimized side effects, and enhanced therapeutic outcomes. Its targeted pharmacological class and therapeutic indications critically shape market penetration and acceptance.

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Regulatory Milestones and Pathways

Regulatory approval forms the backbone of a drug’s commercial success. QUIBRON-T/SR’s trajectory has been influenced by:

• FDA and EMA Approvals: Initial filings and subsequent approval timelines have direct implications on market entry and revenue realization. Early-phase clinical trial success and robust safety data underpin positive regulatory decisions.

• Orphan Drug Designation or Fast Track: If applicable, these designations could expedite approval processes, enabling quicker access to market and potential premium pricing.

• Patent Portfolio and Exclusivity: Patents covering the formulation, delivery mechanism, or therapeutic use can create significant market barriers for competitors, providing a protected window for revenue growth.

Clinical Efficacy and Market Acceptance

Clinical trial outcomes are pivotal. Evidence demonstrating superior efficacy or safety profile over existing standards will likely catalyze market acceptance. For QUIBRON-T/SR, key factors include:

• Therapeutic Indication: Whether tailored for chronic or acute conditions influences the volume of target patient populations.

• Patient Compliance Data: Demonstrated improvements in adherence via SR formulation bolster commercial appeal.

• Real-world Evidence (RWE): Growing emphasis on RWE can influence prescribing habits and formulary placements.

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Competitive Landscape

The competitive environment for QUIBRON-T/SR comprises:

• Direct Competitors: Other SR formulations or alternative delivery systems for the same indication.

• Generic and Biosimilar Threats: Once exclusivity expires, generic competitors could erode market share. Strategic patent estates are vital to delay this.

• Market Penetration Strategies: Alliances with healthcare providers, incentivized formulary inclusion, and patient support programs are essential for adoption.

Prominent players in the relevant segment include established pharmaceutical giants with significant R&D and marketing capacities, necessitating aggressive positioning for QUIBRON-T/SR.

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Pricing and Reimbursement Dynamics

Pricing strategies are contingent upon clinical benefits, manufacturing costs, and payer negotiations. High-value propositions like reduced dosing or improved safety profiles justify premium pricing. Additionally, reimbursement policies, especially within major markets like the US, Europe, and Japan, directly affect revenue potential.

Securing formulary coverage and favorable reimbursement pathways can accelerate market adoption, especially for therapies targeting widespread conditions.

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Market Penetration and Adoption Drivers

Key drivers influencing QUIBRON-T/SR's financial outlook include:

• Physician Acceptance: Physicians prioritize efficacy, safety, ease of use, and cost. Educational initiatives and robust clinical data are crucial.

• Patient Acceptance: Tolerance, convenience, and affordability influence adherence.

• Distribution Channels: Partnerships with pharmacies, hospitals, and managed care organizations facilitate broader reach.

Financial Trajectory Forecast

Considering current industry trends, the following trajectory outlines potential revenue streams:

• Year 1-2: Limited sales predominantly from clinical trials, early adopters, and initial regulatory approvals. Revenue might range from $10-50 million, dependent on approval timelines.

• Year 3-4: Post-market launch, aggressive marketing, and expanding geographic footprints can push sales toward $200-300 million. Uptake accelerates with positive real-world data.

• Year 5 and Beyond: With patent protections intact and expanded indications, revenues could exceed $500 million, contingent upon market share capture and competitive dynamics.

Multiple factors, including the success of clinical trials, payer negotiations, and global expansion strategies, influence this trajectory.

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Challenges and Risks

Several obstacles could hinder favorable financial outcomes:

• Regulatory Delays: Prolonged approval timelines or additional data requirements inflate costs and delay revenue.

• Competitive Responses: Entry of competing SR formulations or biosimilars can suppress market share.

• Pricing Pressures: Payers’ increasing push for cost containment may force price reductions.

• Manufacturing Risks: Complex formulations like SR systems demand high manufacturing precision; disruptions can impact supply and revenues.

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Emerging Trends and Future Outlook

The integration of digital health tools, patient-centric formulations, and personalized medicine trends are set to influence QUIBRON-T/SR’s positioning. Strategic collaboration with healthcare providers and payers is essential. Global expansion, especially in emerging markets where unmet needs are pronounced, can significantly bolster long-term revenue.

Advances in nanotechnology and novel delivery systems may introduce next-generation SR formulations, requiring ongoing innovation and adaptation from the manufacturer.

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Key Takeaways

• Regulatory and Patent Strategy Are Critical: Navigating approval pathways and securing patent protections are vital for early market dominance.

• Market Acceptance Hinges on Clinical Data: Demonstrating superior efficacy and safety will be decisive in clinician and patient adoption.

• Pricing and Reimbursement Determine Revenue Potential: Strategic negotiations and value-based pricing are essential to maximize profit margins.

• Competitive Landscape Demands Innovation and Aggressive Marketing: Differentiation via clinical benefits and comprehensive marketing plans are necessary.

• Global Expansion Offers Substantial Growth Opportunities: Emerging markets with unmet needs present meaningful avenues for revenue growth.

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FAQs

1. What factors most influence the regulatory approval of QUIBRON-T/SR?
Regulatory agencies prioritize safety, efficacy, manufacturing quality, and clinical trial robustness. Early engagement and fulfilling all submission requirements streamline approval.

2. How does patent protection impact QUIBRON-T/SR’s market longevity?
Patents safeguard exclusive rights, delaying generic entry, and enabling premium pricing. Patent disputes or expirations can significantly impact revenues.

3. What are the primary challenges in commercializing SR formulations like QUIBRON-T/SR?
Manufacturing complexity, ensuring consistent drug release profiles, market acceptance, pricing pressures, and reimbursement hurdles pose notable challenges.

4. How critical is market expansion in the financial forecast of QUIBRON-T/SR?
Expanding into new geographies amplifies sales potential, diversifies revenue streams, and mitigates risks associated with reliance on a single market.

5. What competitive tactics can enhance QUIBRON-T/SR’s market share?
Investments in clinical research, strategic alliances, payer negotiations, patient education, and innovative delivery system enhancements foster market penetration.

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Sources

[1] Global Data, "Sustained-Release Drug Market Outlook," 2022.