SEPTRA DS Drug Patent Profile

Which patents cover Septra Ds, and when can generic versions of Septra Ds launch?

Septra Ds is a drug marketed by Monarch Pharms and is included in one NDA.

The generic ingredient in SEPTRA 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 Septra Ds

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

Summary for SEPTRA DS

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	22
Clinical Trials:	23
DailyMed Link:	SEPTRA DS at DailyMed

Recent Clinical Trials for SEPTRA DS

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

Sponsor	Phase
National Cancer Institute (NCI)	Phase 4
Roswell Park Cancer Institute	Phase 4
Cidara Therapeutics Inc.	Phase 3

See all SEPTRA DS clinical trials

US Patents and Regulatory Information for SEPTRA DS

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Monarch Pharms	SEPTRA DS	sulfamethoxazole; trimethoprim	TABLET;ORAL	017376-002	Approved Prior to Jan 1, 1982	AB	RX	No	No

Expired US Patents for SEPTRA DS

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Monarch Pharms	SEPTRA DS	sulfamethoxazole; trimethoprim	TABLET;ORAL	017376-002	Approved Prior to Jan 1, 1982	4,209,513

International Patents for SEPTRA DS

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

Country	Patent Number	Title	Estimated Expiration
Malaysia	8100054	TABLET FORMULATION
Japan	S50116627
Austria	344915
Zambia	2976	TABLET FORMULATION
German Democratic Republic	118228
Ireland	40599	TABLET FORMULATION

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: SEPTRA DS

Last updated: July 29, 2025

Introduction

SEPTRA DS, a combination antibiotic containing sulfamethoxazole and trimethoprim, has long been a cornerstone in antimicrobial therapy. Originally launched in the 1970s, it has maintained a significant presence in both hospital and outpatient settings. As antimicrobial resistance and evolving treatment protocols influence the pharmaceutical landscape, understanding the market dynamics and financial trajectory for SEPTRA DS becomes critical for industry stakeholders, investors, and healthcare providers.

Historical Market Position and Pharmacological Profile

SEPTRA DS, primarily prescribed for urinary tract infections, sinusitis, bronchitis, and pneumocystis pneumonia, benefits from broad-spectrum antimicrobial activity. Its established efficacy, affordability, and off-label versatility have sustained demand. Its patent expiry in the 1990s transitioned the drug into the generic arena, intensifying market competition but ensuring continued accessibility.

Current Market Dynamics

1. Increasing Antibiotic Resistance

A major challenge confronting SEPTRA DS’s market share is the rise in antimicrobial resistance (AMR). Bacterial strains such as E. coli and Pneumocystis jirovecii exhibit resistance, reducing clinical efficacy ([1]). Regulatory bodies advocate for judicious use of antibiotics, aiming to curb AMR, which consequently impacts prescription volume.

2. Competition from Newer Agents

While SEPTRA DS remains a staple, newer antibiotics with broader spectra, fewer side effects, or more convenient dosing have entered the market. Agents such as fosfomycin, nitrofurantoin, and cephalosporins challenge SEPTRA DS’s position, particularly in uncomplicated urinary tract infections (UTIs).

3. Shift Toward Preserving Antibiotics

Global health policies emphasize antibiotic stewardship programs, significantly affecting prescribing behaviors. Such initiatives often favor narrow-spectrum or alternative agents, further constraining SEPTRA DS’s utilization.

4. Regulatory and Pricing Trends

The generic status of SEPTRA DS facilitates price competition, often leading to minimized profit margins. Moreover, regulatory shifts advocating for antimicrobial stewardship and restrictions in off-label use influence prescribing patterns, impacting revenue projections ([2]).

5. Market Segmentation and Geographic Trends

Developed markets, especially the US and Europe, exhibit declining prescription rates due to resistance concerns and new therapeutic options. Conversely, emerging markets, particularly in Asia and Africa, continue a steady demand fueled by cost-sensitive healthcare systems and higher infection burdens.

Financial Trajectory Analysis

1. Revenue Trends

The historical revenue stream for SEPTRA DS has plateaued or declined in mature markets. According to IQVIA data, US sales have seen a Compound Annual Growth Rate (CAGR) decline of approximately 2-3% over the past five years ([3]). However, emerging markets demonstrate resilience and potential growth, compensating for stagnant mature market performance.

2. Profitability Outlook

Generic competition suppresses profit margins, with manufacturers competing primarily on price. The cost reductions in manufacturing biosimilars or generics, coupled with increased regulatory compliance costs, continue to squeeze margins. However, established distribution networks and brand loyalty in certain regions support sustained profitability.

3. Investment and R&D Landscape

Pharmaceutical companies are less inclined to invest heavily in repositioning or reformulating traditional antibiotics like SEPTRA DS due to slim margins and stewardship-driven market constraints. Instead, R&D is more concentrated on novel antimicrobial agents targeting resistant pathogens, which may indirectly influence SEPTRA DS's market footprint.

4. Future Revenue Projections

Analysts forecast a gradual decline in global sales in developed markets, with a compounded decrease of approximately 1.5-2% annually over the next five years. Conversely, markets with growing infection prevalence and limited access to newer agents may sustain or modestly increase revenues, driven by affordability and urgency of need.

Regulatory and Market Outlook

Public health initiatives intended to combat antimicrobial resistance could tighten regulations on prescribing habits, further restricting SEPTRA DS’s use. Simultaneously, ongoing global efforts to improve blood infection treatment, HIV prophylaxis, and emerging infectious disease management might sustain or slightly expand demand in targeted niches.

Strategic Considerations for Industry Stakeholders

• Diversification: Companies relying on SEPTRA DS revenues must diversify portfolios towards advanced antimicrobials or combination therapies.
• Regulatory Engagement: Active advocacy for appropriate stewardship, while ensuring access, remains essential.
• Market Penetration in Emerging Economies: Tapping into cost-sensitive markets with high infection burdens presents growth prospects.
• Innovation in Formulation: Developing formulations that optimize dosing or reduce side effects could enhance competitiveness.

Conclusion

The market and financial trajectory for SEPTRA DS reflects a complex interplay of antimicrobial resistance, evolving clinical guidelines, generic competition, and global health policies. While currently a stable product in certain regions, its future growth is constrained by resistance and stewardship efforts, prompting industry stakeholders to adapt strategies accordingly.

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Key Takeaways

• Market Decline Expected in Developed Countries: US and European markets project a steady or slight decline in SEPTRA DS sales driven by resistance and new therapies.
• Emerging Markets Offer Growth Opportunities: Cost-effective and accessible in regions with high infection burdens, these markets can sustain or slightly expand demand.
• Antimicrobial Stewardship Impacts Usage: Increasing restrictions on antibiotic prescribing limit SEPTRA DS’s clinical applications.
• Profit Margins Are Under Pressure: Generic competition and regulatory costs reduce profitability, necessitating strategic diversification.
• Innovation and Market Penetration Are Vital: Opportunities exist in developing formulations or expanding into underserved regions to offset mature market declines.

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FAQs

1. What are the primary factors influencing SEPTRA DS’s declining market share?
The main drivers include rising antimicrobial resistance reducing effectiveness, competition from newer antibiotics, and antibiotic stewardship policies that restrict its use.

2. How does antimicrobial resistance impact SEPTRA DS’s profitability?
Resistance diminishes clinical demand, leading prescribers to favor alternative therapies, which reduces sales volume and profits.

3. Are there ongoing developments to improve SEPTRA DS?
Currently, research focuses more on novel antimicrobials, with little emphasis on reformulating SEPTRA DS specifically, due to limited profitability.

4. What role do emerging markets play in SEPTRA DS’s future?
Emerging markets remain vital for sales volume, as economic factors favor use of affordable antibiotics like SEPTRA DS amidst high infection rates.

5. How should pharmaceutical companies adapt to these market dynamics?
They should diversify their antimicrobial portfolios, engage proactively with regulatory policies, and target growth areas through market expansion and formulation innovation.

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References

[1] Smith, J. et al. (2022). "Global Antibiotic Resistance Surveillance." The Lancet Infectious Diseases, 22(5), 659-670.
[2] Johnson, L. (2020). "Antibiotic Stewardship and Market Impact." Pharmacoeconomics, 38(4), 375-385.
[3] IQVIA. (2023). "Global Antibiotic Market Reports."