SULFAMETHOXAZOLE AND TRIMETHOPRIM DOUBLE STRENGTH Drug Patent Profile

Which patents cover Sulfamethoxazole And Trimethoprim Double Strength, and when can generic versions of Sulfamethoxazole And Trimethoprim Double Strength launch?

Sulfamethoxazole And Trimethoprim Double Strength is a drug marketed by Fosun Pharma, Heritage Pharma Avet, Martec Usa Llc, Mutual Pharm, Roxane, and Watson Labs. and is included in six NDAs.

The generic ingredient in SULFAMETHOXAZOLE AND TRIMETHOPRIM DOUBLE STRENGTH is sulfamethoxazole; trimethoprim. There are twenty-seven drug master file entries for this compound. Forty-seven suppliers are listed for this compound. Additional details are available on the sulfamethoxazole; trimethoprim profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Sulfamethoxazole And Trimethoprim Double Strength

A generic version of SULFAMETHOXAZOLE AND TRIMETHOPRIM DOUBLE STRENGTH was approved as sulfamethoxazole; trimethoprim by SUN PHARM INDUSTRIES on August 25^th, 1986.

Summary for SULFAMETHOXAZOLE AND TRIMETHOPRIM DOUBLE STRENGTH

US Patents:	0
Applicants:	6
NDAs:	6
Raw Ingredient (Bulk) Api Vendors:	27
Clinical Trials:	163
DailyMed Link:	SULFAMETHOXAZOLE AND TRIMETHOPRIM DOUBLE STRENGTH at DailyMed

Recent Clinical Trials for SULFAMETHOXAZOLE AND TRIMETHOPRIM DOUBLE STRENGTH

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
University of California, San Francisco	PHASE4
McGill University Health Centre/Research Institute of the McGill University Health Centre	PHASE4
Hospital Civil de Guadalajara	PHASE2

See all SULFAMETHOXAZOLE AND TRIMETHOPRIM DOUBLE STRENGTH clinical trials

US Patents and Regulatory Information for SULFAMETHOXAZOLE AND TRIMETHOPRIM DOUBLE STRENGTH

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Fosun Pharma	SULFAMETHOXAZOLE AND TRIMETHOPRIM DOUBLE STRENGTH	sulfamethoxazole; trimethoprim	TABLET;ORAL	018598-004	May 19, 1982		DISCN	No	No
Mutual Pharm	SULFAMETHOXAZOLE AND TRIMETHOPRIM DOUBLE STRENGTH	sulfamethoxazole; trimethoprim	TABLET;ORAL	070007-001	Nov 14, 1984		DISCN	No	No
Heritage Pharma Avet	SULFAMETHOXAZOLE AND TRIMETHOPRIM DOUBLE STRENGTH	sulfamethoxazole; trimethoprim	TABLET;ORAL	070037-001	Jun 2, 1987		DISCN	No	No

Market Dynamics and Financial Trajectory for SULFAMETHOXAZOLE AND TRIMETHOPRIM DOUBLE STRENGTH

Last updated: March 23, 2026

What is the current landscape for SULFAMETHOXAZOLE AND TRIMETHOPRIM DOUBLE STRENGTH?

Sulfamethoxazole and trimethoprim double strength (SMX/TMP DS) is a widely used antibiotic combination, primarily prescribed for urinary tract infections (UTIs), bronchitis, and other bacterial infections. Its effectiveness and off-patent status have sustained steady demand historically. The market size was valued at approximately USD 1.1 billion in 2021, with projections indicating modest growth at a compounded annual growth rate (CAGR) of around 3% through 2028 ([1]).

What are the key market drivers and inhibitors?

Market Drivers

• Rising bacterial infections: Persistent prevalence of UTIs, respiratory infections, and skin infections maintains consistent demand.
• Generic availability: The drug is off-patent, with multiple manufacturers, substantially lowered prices, and broad accessibility.
• Global health initiatives: Efforts to increase access to affordable antibiotics in low-income regions expand market reach.

Market Inhibitors

• Antibiotic resistance: Increasing resistance, especially among E. coli strains, diminishes clinical effectiveness, leading to reduced prescribing ([2]).
• Regulatory restrictions: Growing restrictions on antibiotic sales to curb resistance pose challenges.
• Alternative treatments: Newer antibiotics with better efficacy profiles and fewer side effects, such as beta-lactams and fluoroquinolones, compete with SMX/TMP DS.

How does the competitive environment affect financial trajectories?

The product's generic status results in bleak margins for manufacturers, with retail prices averaging USD 2-4 per course in developed markets. International markets, especially in Africa and Asia, exhibit higher volume sales due to affordability needs, balancing revenue streams.

Major producers like Mylan and Teva hold significant market shares. Patent expirations in the early 2000s removed exclusivity, leading to price compression. This dynamic favors high-volume, low-margin strategies, with some manufacturers exploring formulations with extended shelf life or combination therapies to differentiate.

What are the regulatory and reimbursement considerations?

• Regulatory: The drug remains on the WHO Model List of Essential Medicines since 2009 ([3]).
• Reimbursement: In developed markets, coverage is universal for approved indications, supporting stable revenue. In developing regions, procurement depends on government and NGO funding, influencing sales volume.

Are there recent innovations or pipeline developments?

R&D efforts focus on overcoming resistance. Some attempts involve combination therapies or modified release formulations. However, no major patent filings or breakthrough innovations specific to SMX/TMP DS are publicly documented since 2018. Generic manufacturers continue to dominate distribution without significant new patent activity.

What is the future outlook?

Market growth will likely be slow, constrained by resistance and competition from newer antibiotics. Developing regions may provide volume growth, but price pressures will persist. Strategic opportunities for manufacturers include diversification into combination therapies, formulation improvements, or new delivery methods.

Summary comparison table of market factors

Aspect	Details
Market Size (2021)	USD 1.1 billion
CAGR (2022–2028)	3%
Price per course	USD 2–4 in developed markets
Major competitors	Mylan, Teva, Sandoz, generic producers
Patent status	Off-patent since early 2000s
Resistance impact	To limit use in some indications
Regulatory list	WHO Essential Medicines List (since 2009)

Key Takeaways

• The SMX/TMP DS market remains stable but slow-growing, driven by high-volume sales and broad access in emerging markets.
• Patent expirations and generic competition suppress margins, incentivizing price competition.
• Resistance reduces prescribing in certain infections, impacting demand.
• Limited pipeline activity restricts innovation-driven growth.
• Focus shifts to formulations, combination therapies, and geographic expansion.

FAQs

Q1: Will resistance significantly reduce the use of SMX/TMP DS?
A1: Yes, especially in infections caused by resistant E. coli strains, leading clinicians to prefer alternative antibiotics.

Q2: How are emerging markets influencing the market?
A2: They contribute to volume growth due to affordability and high infection prevalence, although margins remain thin.

Q3: Are there regulatory barriers to expanding SMX/TMP DS indications?
A3: Not substantially; however, evolving resistance patterns and guidelines limit off-label use.

Q4: Is there room for innovation in this product segment?
A4: Limited; efforts focus on addressing resistance rather than new formulations or patents.

Q5: How does the off-patent status affect profitability?
A5: It leads to increased competition and price compression but ensures consistent volume sales.

---

References

1. MarketWatch. (2022). Sulfamethoxazole and Trimethoprim Market Size & Trends.
2. WHO. (2019). Global antimicrobial resistance surveillance report.
3. World Health Organization. (2009). List of Essential Medicines.