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
Roswell Park Cancer Institute	Phase 4
National Cancer Institute (NCI)	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		DISCN	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
Austria	344915
Austria	A108475
Australia	468465
Australia	7817075
Belgium	825496
Canada	980688	TABLET FORMULATION

Market Dynamics and Financial Trajectory for SEPTRA DS

Last updated: March 30, 2026

What is SEPTRA DS?

SEPTRA DS (sulfamethoxazole and trimethoprim) is an antibacterial medication used primarily to treat urinary tract infections, bronchitis, and other bacterial infections. It is administered in a double-strength tablet form, with typical dosing of two tablets twice daily.

Market Size and Competitive Landscape

Global Market Value

The global antibiotic market was valued at approximately $45 billion in 2022 and is projected to reach $58 billion by 2027, growing at a CAGR of 4.9% (Source: MarketsandMarkets). SEPTRA DS accounts for a significant share within this segment, especially in the mid-tier antibacterial drugs driven by its generic availability.

Key Competitors

• Bactrim (brand name for combination of sulfamethoxazole and trimethoprim)
• Septra (branded version, now largely replaced by generics)
• Other generics from manufacturers in India, China, and Europe
• New antibiotics targeting resistant strains, such as esketamine and other combination therapies

Market Segments

• Hospitals: 60% of prescriptions, driven by bacterial infection treatment in severe cases
• Outpatient clinics: 35%, mainly for urinary tract infections
• Long-term care facilities: 5%, for prophylactic use in certain conditions

Geographic Trends

• North America: Largest market, due to high prescription rates and antibiotic use regulations
• Europe: Significant, but slightly slower growth due to antimicrobial stewardship policies
• Asia-Pacific: Fastest growth, driven by increasing healthcare infrastructure and antibiotic demand

Patent and Regulatory Landscape

Patent Status

SEPTRA DS as a branded drug lost patent protection in the U.S. in 2014. Several manufacturers have since launched generics. Global patent statuses vary:

• United States: Patent expired, generics available
• European Union: Patent expired in 2015
• Other regions: Patent status varies; some developing countries lack patent enforcement for this molecule

Regulatory Approvals

• FDA: Approved for bacterial infections
• EMA: Approved, with usage guidelines aligned with FDA
• WHO: Recognized as essential medicine

Pricing and Reimbursement Trends

Cost Structures

• Brand name (SEPTRA): Historically priced at $50-$70 per 20-tablet pack
• Generics: Price competition reduces cost to $10-$20 per pack
• Reimbursement: Typically covered by insurance in high-income regions; government programs in low-income regions partially reimburse or subsidize access

Policy Impact

Antibiotic stewardship policies restrict overprescription, limiting revenue growth. Reimbursement pressures aim to control healthcare costs but may reduce profit margins for manufacturers.

Revenue Trends and Financial Outlook

Historical Revenue Data

• 2018: Estimated global sales of $1.2 billion (mainly generics)
• 2019: Slight decline to $1.1 billion due to increased generic competition
• 2020–2022: Stabilized around $1 billion, influenced by COVID-19 impacting healthcare utilization

Future Revenue Projections

• 2023–2027: Expected to flatline or decline modestly at a CAGR of -1% to -2%, affected by antibiotic stewardship and rising resistance
• Potential upside: New indications or combination formulations could restore growth

Impact of Resistance

Resistance to sulfamethoxazole/trimethoprim has increased, especially among MRSA and certain gram-negative bacteria, leading to reduced efficacy and shifts in prescribing practices.

Research and Development Outlook

Limited pipeline for fixed-dose combinations of SEPTRA DS. Ongoing research focuses on overcoming resistance through novel formulations and combination therapies with other classes. Investment into resistant bacterial strains may delay or offset declines in revenue.

Key Takeaways

• The market for SEPTRA DS is highly mature with significant generic competition.
• Patent expiry has driven down prices, compressing profit margins.
• Resistance development and antimicrobial stewardship policies limit future growth.
• North America and Europe dominate revenue, with high potential in Asia-Pacific.
• Future revenue prospects depend on innovation and resistance management.

FAQs

What factors are driving the decline of SEPTRA DS sales?
Patent expiration, increased antibiotic resistance, and stringent stewardship policies have led to reduced prescribing and lower sales.

Are there regulatory restrictions on the use of SEPTRA DS?
Yes, in some regions, prescribing guidelines emphasize antimicrobial stewardship, limiting unnecessary use.

What is the potential for new formulations or indications?
Limited pipeline; potential exists in combination therapies targeting resistant strains but is currently under exploration.

How will global resistance trends impact the market?
Rising resistance reduces effectiveness, potentially shifting prescribers toward newer drugs, further decreasing SEPTRA DS demand.

What role do generics play in the current market?
Generics dominate sales, offering affordable options and creating price competition that limits revenue growth for branded versions.

References

1. MarketsandMarkets. (2022). Antibiotics Market Report.
2. U.S. Food and Drug Administration. (2022). Approved Drug Products.
3. World Health Organization. (2022). Essential Medicines List.
4. European Medicines Agency. (2022). Pharmacovigilance Reports.
5. Congressional Budget Office. (2021). Antibiotic Use and Resistance Trends.

[1] Market research reports, regulatory filings, and healthcare policy analyses support these insights.