BACTRIM DS Drug Patent Profile

When do Bactrim Ds patents expire, and what generic alternatives are available?

Bactrim Ds is a drug marketed by Sun Pharm Industries and is included in one NDA.

The generic ingredient in BACTRIM DS 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 Bactrim Ds

A generic version of BACTRIM DS was approved as sulfamethoxazole; trimethoprim by SUN PHARM INDUSTRIES on August 25^th, 1986.

Summary for BACTRIM DS

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	22
Clinical Trials:	65
Drug Prices:	Drug price information for BACTRIM DS
What excipients (inactive ingredients) are in BACTRIM DS?	BACTRIM DS excipients list
DailyMed Link:	BACTRIM DS at DailyMed

See drug prices for BACTRIM DS

Recent Clinical Trials for BACTRIM DS

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

Sponsor	Phase
Hospital Civil de Guadalajara	PHASE2
Ohio State University	PHASE4
Johns Hopkins University	Early Phase 1

See all BACTRIM DS clinical trials

Pharmacology for BACTRIM DS

Drug Class	Dihydrofolate Reductase Inhibitor Antibacterial Sulfonamide Antimicrobial
Mechanism of Action	Cytochrome P450 2C8 Inhibitors Cytochrome P450 2C9 Inhibitors Dihydrofolate Reductase Inhibitors Organic Cation Transporter 2 Inhibitors

US Patents and Regulatory Information for BACTRIM DS

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Sun Pharm Industries	BACTRIM DS	sulfamethoxazole; trimethoprim	TABLET;ORAL	017377-002	Approved Prior to Jan 1, 1982	AB	RX	Yes	Yes

Expired US Patents for BACTRIM DS

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sun Pharm Industries	BACTRIM DS	sulfamethoxazole; trimethoprim	TABLET;ORAL	017377-002	Approved Prior to Jan 1, 1982	RE28636

International Patents for BACTRIM DS

See the table below for patents covering BACTRIM DS around the world.

Country	Patent Number	Title	Estimated Expiration
Canada	1003331	COMPOSITION CONTAINING 5-METHYL-3- SULFANILAMIDOISOXAZOLE AND A BENZYL PYRIMIDINE

Market Dynamics and Financial Trajectory for BACTRIM DS

Last updated: February 10, 2026

Overview and Market Position
BACTRIM DS (sulfamethoxazole and trimethoprim) is an antibiotic combination used primarily for urinary tract infections (UTIs), Pneumocystis pneumonia (PCP), and certain bacterial infections. Its patent expired in the United States in 1995, leading to generic versions and a shift in market dynamics. Despite generic competition, BACTRIM DS remains a significant brand in infectious disease therapeutics, especially in hospital settings.

Market Size and Trends
Global antibiotics market size was valued at approximately USD 52 billion in 2021, with an expected compound annual growth rate (CAGR) of 3.5% from 2022 to 2027 (Grand View Research). The segment including BACTRIM DS holds a substantial share, driven by its established efficacy, safety profile, and incorporation into treatment protocols.

In the U.S., the antibiotics market was estimated at USD 17 billion in 2021. BACTRIM DS's sales are predominantly within the U.S. due to extensive use in HIV/AIDS prophylaxis and complicated urinary infections, with smaller contributions from Europe and Asia-Pacific.

Pricing Trends and Revenue
Being off-patent, BACTRIM DS prices have declined substantially. Average wholesale prices (AWP) for generic sulfamethoxazole/trimethoprim tablets range from USD 0.05 to USD 0.15 per tablet, equating to roughly USD 0.10–USD 0.30 per D-tablet (double strength). Brand-name formulations, when available, tend to be priced approximately 2–3 times higher but have limited market share.

Estimated annual sales for BACTRIM DS in the U.S. have ranged between USD 100 million and USD 200 million over the past five years, with recent declines driven by generic competition and antimicrobial stewardship policies.

Competitive Landscape
Genetic versions dominate the market, with major players including Mylan, Teva, and Sun Pharma. Market share remains fragmented, with no single entity holding more than 25% of the generic market for sulfamethoxazole/trimethoprim.

Alternative antibiotics—fosfomycin, nitrofurantoin, and ciprofloxacin—compete in urinary tract infection treatments, affecting BACTRIM DS's market share.

Regulatory and Prescribing Trends
The U.S. Food and Drug Administration (FDA) encourages antimicrobial stewardship to delay resistance. This impacts BACTRIM DS utilization. New federal guidelines emphasize narrow-spectrum antibiotics, reducing broad-spectrum antibiotic use, including BACTRIM DS in some settings.

However, BACTRIM DS remains crucial for HIV-related Pneumocystis pneumonia prevention, where it holds a strong indication and prescribed basis.

Future Financial Trajectory
The financial outlook for BACTRIM DS indicates stagnant or slightly declining revenues, aligned with the generic market trends. The introduction of new antibiotics or formulations could influence future sales but are currently limited.

Market analysts project an average annual decline of 2-4% in sales volume, attributable to antimicrobial stewardship. Value-based pricing pressures and global concerns about resistance will influence pricing strategies.

Potential Growth Drivers

• Rising HIV/AIDS prevalence in developing countries sustains demand for BACTRIM DS.
• Expansion of indications in skin, soft tissue infections, and multi-drug resistant bacterial infections.
• Development of new dosing formulations or combination therapies.

Risks and Challenges

• Increasing resistance reduces efficacy, prompting shifts toward alternative therapies.
• Policy shifts favoring restrictive antibiotic use may suppress sales.
• Price erosion due to generic competition persists.

Summary
BACTRIM DS maintains a stable presence in the infectious disease therapeutics market, mainly driven by specific indications. Its revenue trajectory faces downward pressures from generics, antimicrobial stewardship, and competition but remains relevant where existing treatment protocols rely on its use, especially in HIV prophylaxis.

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Key Takeaways

• BACTRIM DS is a mature, generic-dominated antibiotic with an estimated USD 100–200 million annual sales in the U.S.
• Market decline of 2–4% annually expected over the next five years due to generic competition and stewardship policies.
• Its primary growth in HIV-related prophylaxis and resistant bacterial infections.
• Pricing is low for generics but remains essential in specific indications.
• Future growth hinges on expanding indications and addressing resistance challenges.

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FAQs

1. How is the patent status influencing BACTRIM DS sales?
No patent protection exists since 1995, resulting in widespread generic availability, which drives down prices and limits brand-specific revenue.

2. What markets are most promising for BACTRIM DS in the future?
HIV/AIDS management and treatment of resistant bacterial infections in developing countries have the highest growth potential, driven by disease prevalence and drug formulation access.

3. How does antimicrobial stewardship affect BACTRIM DS?
Stewardship policies favor narrow-spectrum antibiotics, reducing outpatient and some inpatient use of BACTRIM DS, contributing to sales declines.

4. Are there any new formulations or combination therapies in development?
As of 2023, no significant new formulations for BACTRIM DS are in late-stage development. Advances are focused elsewhere in antibacterial treatments.

5. What are the main competitive threats?
Alternatives like nitrofurantoin and fosfomycin in urinary tract infections, along with rising resistance to sulfamethoxazole/trimethoprim, threaten BACTRIM DS’s market share.

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References

1. Grand View Research. Antibiotics Market Size. 2022.
2. FDA. Antimicrobial Stewardship policies. 2022.
3. IMS Health. US Antibiotics Market Data. 2021.
4. U.S. Patent and Trademark Office. Patent expiration dates. 1995.
5. EvaluatePharma. Generic Drugs Market Trends. 2022.