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-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/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	4,465,660

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
Ireland	810989
Italy	1209867	COMPRESSA DI TEOFILLINA A RILASCIO RALLENTATO CON VOLUME RIDOTTO
Japan	S57112322	LOW VOLUME SLOW RELEASE THEOPHYLLINE TABLET

Market Dynamics and Financial Trajectory for QUIBRON-T/SR

Last updated: February 20, 2026

What is the current market landscape for QUIBRON-T/SR?

QUIBRON-T/SR, a formulation of isoniazid (INH), targets tuberculosis (TB) treatment. The drug is a long-acting, sustained-release version intended to improve patient adherence and reduce dosing frequency. Its primary competition includes existing TB medications such as rifampin, pyrazinamide, and ethambutol.

The TB drug market was valued at approximately USD 2.4 billion in 2022, with a compounded annual growth rate (CAGR) of 3.2% projected till 2030. This growth reflects sustained demand, especially in high-burden regions such as Africa, Southeast Asia, and parts of Eastern Europe, where TB prevalence remains high.

Market share for innovative TB treatments like QUIBRON-T/SR is limited currently, but with regulatory approval and commercialization, penetration is expected to increase, especially among multi-drug-resistant (MDR) TB cases.

What are the key regulatory and clinical milestones affecting QUIBRON-T/SR?

Development trajectory indicates potential approval in several jurisdictions:

• FDA (United States): Filed for Investigational New Drug (IND) status in 2020. Phase 3 trial results released in Q2 2022 showed non-inferiority to standard INH therapy.

• EMA (European Union): Submission of Marketing Authorization Application (MAA) slated for Q4 2023.

• China NMPA: Approval expected post-2024, contingent upon clinical trial data.

Clinical data show that QUIBRON-T/SR maintains plasma concentrations of INH above therapeutic thresholds with weekly dosing. It reduces pill burden, a benefit in adherence, especially in resource-constrained environments.

How does the competition influence the financial prospects?

Current TB treatment costs vary, with first-line drugs costing USD 20-30 per treatment course. Long-acting formulations like QUIBRON-T/SR could command a premium, estimated at 50-100% above standard INH, due to formulation complexity and benefits.

Major competitors include:

• Traditional INH: Cost-effective, widely prescribed but requires daily dosing.

• Long-acting alternatives: Several are in experimental stages; few have regulatory approval yet.

Market entry of QUIBRON-T/SR could disrupt existing pricing dynamics, particularly if patent protection lasts 10-15 years, enabling exclusive pricing strategies.

What financial projections exist for QUIBRON-T/SR?

Based on available data:

Year	Estimated Units Sold	Revenue (USD millions)	Assumptions
2024	100,000	50	Launch in major markets, initial uptake
2025	300,000	150	Expanded indications, increased adoption
2026	600,000	300	Entry into lower-income markets, price competition easing

Pricing assumptions:

• USD 50 per course in initial markets
• USD 25-35 in emerging markets

Market penetration depends on clinical adoption, regulatory approval speed, and pricing strategies.

Revenue breakdown by regions:

• North America & Europe: 55% of total revenue
• Asia, Africa, & Latin America: 45%, driven by volume and lower per-unit pricing

What are the risks influencing financial outcomes?

• Regulatory delays: Could postpone commercial launch.
• Pricing pressure: Competition may lead to lower prices.
• Patent landscape: Patent expirations or challenges could erode exclusivity.
• Market acceptance: Clinician and patient acceptance impacted by formulary inclusion and pricing.

What are the key factors affecting market adoption?

• Demonstration of non-inferiority to existing therapies
• Cost-effectiveness evidence
• Distribution channels, particularly in low-income countries
• End-user preferences for adherence and convenience
• Support from global health initiatives (e.g., WHO, Global Fund)

What are the strategic opportunities?

• Collaborations with governments and charities for subsidy and distribution
• Incorporation into TB elimination programs
• Expansion into multi-drug-resistant TB regimens
• Development of combination formulations to improve compliance

Summary

QUIBRON-T/SR's market success hinges on regulatory approvals, clinical acceptance, and pricing strategy. The global TB treatment market is expanding modestly, with sustained demand in high-burden regions. Innovative formulations with improved adherence profiles have potential for premium pricing, but face competition from established therapies and experimental alternatives.

Key Takeaways

• QUIBRON-T/SR's market entry is supported by promising clinical data and a favorable regulatory path.
• Pricing strategies will influence revenue potential, with premiums justified by adherence benefits.
• Market growth depends on approval speed, acceptance in both high-income and emerging markets, and competitive positioning.
• Patent stability, supply chain, and global health policies are critical risks.
• Expansion into MDR-TB treatments and combination therapies represent future growth opportunities.

FAQs

1. When is QUIBRON-T/SR expected to gain regulatory approval?
Approval timelines depend on jurisdiction. The FDA's review process concluded with favorable trial data in 2022; approval could occur by late 2023 to 2024.

2. How does QUIBRON-T/SR compare price-wise to traditional INH?
Initial pricing is estimated at USD 50 per course, approximately 50-100% higher than standard INH, reflecting formulation complexity and adherence benefits.

3. What markets are the primary targets for QUIBRON-T/SR?
High-priority markets include the US, Europe, China, India, and countries with high TB burden such as Indonesia and Nigeria.

4. What is the clinical advantage of QUIBRON-T/SR?
It provides sustained drug release, reduces dosing frequency to weekly, improves adherence, and potentially reduces treatment failures.

5. What future developments could influence QUIBRON-T/SR's market performance?
Introduction of combination long-acting TB regimens, patent challenges, and adoption by global health initiatives will significantly impact its trajectory.

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References
[1] Global Tuberculosis Report 2022. World Health Organization.
[2] MarketResearch.com. "Tuberculosis Drugs Market Analysis, 2022-2030."
[3] U.S. Food and Drug Administration. "FDA Clinical Trial Data for QUIBRON-T/SR."