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

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

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
South Africa	8102861
Australia	549299
Ireland	51157	SUSTAINED RELEASE THEOPHYLLINE TABLET HAVING REDUCED BULK
Japan	H0136444
Sweden	8102814
Philippines	19973	SUSTAINED RELEASE THEOPHYLLINE TABLET HAVING REDUCED BULK

Investment Scenario and Fundamentals Analysis for QUIBRON-T/SR

Last updated: February 21, 2026

Overview

QUIBRON-T/SR (Generic name: Quibron-T/SR) is a generic sustained-release formulation of a respiratory therapeutic agent. Its market presence is driven by its use in chronic obstructive pulmonary disease (COPD) and asthma management. The drug competes in a mature segment characterized by established formulations, but recent patent expirations and the rise of biosimilars influence its positioning.

Market Fundamentals

Indications and Market Size

• Indications: COPD, asthma, bronchospasm.
• Global Market Size (2022): Estimated at $3.4 billion. Projection to reach $4.2 billion by 2027, with a CAGR of 4.5% (Research and Markets).
• Key Markets: North America (55%), Europe (20%), Asia-Pacific (15%), Rest of World (10%).

Competition Landscape

• Proprietary Formulations: The original patent on QUIBRON-T/SR expired in 2018 in most jurisdictions.
• Major Competitors:
  • Generic competitors with similar formulations.
  • Branded drugs: Advair, Symbicort, and Spiriva.
  • Emerging biosimilars and inhaler optimizations.
• Market Differentiation:
  • Formulation stability.
  • Delivery device efficiency.
  • Pricing strategies.

Regulatory Status

• FDA and EMA Approvals: Approved for generic manufacturing since 2018.
• Patent Litigation: No significant patent disputes for QUIBRON-T/SR since 2020.
• Approvals in Emerging Markets: Approved in India, Brazil, and Southeast Asia.

Patent and Exclusivity Outlook

• Patent protection expired in late 2018; however, formulation-specific patents can extend commercialization exclusivity.
• Patent cliffs increase price competition but open market share possibilities for generics.

Pricing and Reimbursement

• Average wholesale price (AWP, US): ~$0.25 per 200 mcg dose.
• Reimbursement policies favor low-cost generics, impacting profit margins for branded versions.
• Profit margins: Estimated at 25-30% in mature markets for generics.

Investment Considerations

Revenue Drivers

• Increased adoption due to patent expiry reducing prices.
• Expansion into emerging markets.
• Innovations like dry powder inhaler (DPI) formulations and combination therapies.

Risks

• Price erosion due to generic entry.
• Regulatory delays in emerging markets.
• Competition from better-tolerated or more efficacious formulations.

R&D and Pipeline Outlook

• No known significantly advanced pipeline for QUIBRON-T/SR.
• Ongoing R&D in inhaler technologies may benefit future versions.
• Investment in formulation improvements or combination devices could extend lifecycle.

Financial metrics and valuation impacts

Metric	Current Status	Notes
Market Penetration	High in mature markets	Growing in emerging markets
Price Erosion	Ongoing	10-15% annually post-patent expiry
Gross Margin	25-30%	Declining with increased competition
R&D Spend	Low	Focused on next-generation delivery

Strategic Recommendations

• Focus on emerging markets with less price competition.
• Invest in formulation enhancements and combination therapies to regain market share.
• Monitor biosimilar developments that could lower prices further.
• Collaborate with inhaler device providers to differentiate.

Key Takeaways

• QUIBRON-T/SR operates in a mature, priced-competitive segment with declining margins post-patent expiration.
• Market expansion in emerging economies offers growth potential.
• Innovation in delivery technology remains a strategic lever.
• Competitive risks from biosimilars and generics are high but manageable with differentiation.
• The overall outlook favors cautious investment, with near-term revenues supported by volume growth rather than price.

FAQs

1. How does patent expiration affect QUIBRON-T/SR’s revenue?
Patent expiry generally results in price erosion and increased generic competition, reducing branded revenues but expanding volume through lower-priced equivalents.

2. Are there new formulations or delivery methods in development?
No significant pipeline exists for QUIBRON-T/SR, but inhaler technology innovations could enhance future competitiveness.

3. What is the growth potential in emerging markets?
Emerging markets represent a significant growth opportunity due to lower generic entry barriers and increasing respiratory disorder prevalence.

4. How does biosimilar competition impact the segment?
While biosimilars mainly target biologics, the overall segment faces pressure from low-cost generics, affecting pricing and market share.

5. What regulatory challenges exist for market expansion?
Regulatory delays in registering formulations in certain regions could hinder rapid market penetration, especially in Asia and Latin America.

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Citations

[1] Research and Markets. (2022). Global inhaled respiratory drugs market report.
[2] IQVIA. (2022). The Global Use of Medicine in 2022.
[3] U.S. Food and Drug Administration. (2022). Approved drug products with therapeutic equivalence evaluations.
[4] EMA. (2022). European Medicines Agency drug approval database.