SEPTRA Drug Patent Profile

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

Septra is a drug marketed by Monarch Pharms and is included in three NDAs.

The generic ingredient in SEPTRA 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

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

Summary for SEPTRA

US Patents:	0
Applicants:	1
NDAs:	3
Raw Ingredient (Bulk) Api Vendors:	22
Clinical Trials:	23
DailyMed Link:	SEPTRA at DailyMed

Recent Clinical Trials for SEPTRA

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 clinical trials

US Patents and Regulatory Information for SEPTRA

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	sulfamethoxazole; trimethoprim	INJECTABLE;INJECTION	018452-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Monarch Pharms	SEPTRA DS	sulfamethoxazole; trimethoprim	TABLET;ORAL	017376-002	Approved Prior to Jan 1, 1982	AB	RX	No	No
Monarch Pharms	SEPTRA	sulfamethoxazole; trimethoprim	SUSPENSION;ORAL	017598-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Monarch Pharms	SEPTRA	sulfamethoxazole; trimethoprim	TABLET;ORAL	017376-001	Approved Prior to Jan 1, 1982	AB	RX	No	No
Monarch Pharms	SEPTRA GRAPE	sulfamethoxazole; trimethoprim	SUSPENSION;ORAL	017598-002	Feb 12, 1986		DISCN	No	No

Expired US Patents for SEPTRA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Monarch Pharms	SEPTRA	sulfamethoxazole; trimethoprim	TABLET;ORAL	017376-001	Approved Prior to Jan 1, 1982	4,209,513

International Patents for SEPTRA

See the table below for patents covering SEPTRA 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

Last updated: July 29, 2025

Introduction

SEPTRA, a combination antibiotic comprising sulfamethoxazole and trimethoprim, has long been a cornerstone in antimicrobial therapy, primarily for urinary tract infections, respiratory infections, and opportunistic infections in immunocompromised patients. Since its initial approval, SEPTRA has navigated an evolving landscape shaped by clinical efficacy, resistance issues, regulatory changes, and market competition. This analysis offers an in-depth review of the current market dynamics and financial trajectory of SEPTRA, focusing on factors influencing its demand, revenue streams, and strategic outlook.

Market Overview and Therapeutic Positioning

SEPTRA's pharmacological niche remains significant amid rising antimicrobial resistance (AMR) and the persistent need for effective combination antibiotics. According to the World Health Organization (WHO), resistance to sulfonamides and trimethoprim has increased globally, impacting prescribing practices [1]. Nonetheless, SEPTRA continues to be prescribed, especially for uncomplicated urinary tract infections (UTIs), certain pneumocystis pneumonia cases, and resilient bacterial infections.

Its broad-spectrum activity, low-cost manufacturing, and extensive clinical history reinforce its position within antimicrobial armamentaria. Despite the availability of newer agents, SEPTRA’s familiarity, established safety profile, and guideline endorsements sustain its utility.

Market Dynamics

1. Competitive Landscape and Market Share

SEPTRA faces competition from multiple classes of antibiotics, including fluoroquinolones, cephalosporins, and newer combination therapies. The emergence of antibiotic stewardship programs and restrictions on broad-spectrum antibiotic use have moderated its consumption. Nevertheless, SEPTRA retains a substantial share in specific niches, notably in prophylaxis against Pneumocystis jirovecii pneumonia (PCP), where it remains first-line therapy for HIV-positive patients [2].

Market share assessments indicate gradual decline due to alternative agents, but the drug’s legacy and ongoing indications sustain steady demand. For instance, the U.S. market for sulfamethoxazole/trimethoprim was valued at approximately USD 400 million in 2021, with projected modest growth rates driven by aging populations and chronic disease prevalence [3].

2. Resistance and Usage Trends

Antimicrobial resistance (AMR) concerns have compromised SEPTRA's efficacy for some indications, prompting shifts towards newer therapies. The increasing prevalence of resistant strains of Escherichia coli and other pathogens has led clinicians to reserve SEPTRA for cases where susceptibility is confirmed or where benefits outweigh resistance risks.

Consequently, this drives a trend toward targeted, rather than broad, use, which influences overall prescription volumes. Stewardship campaigns also restrict indiscriminate use, impacting revenue trajectories.

3. Regulatory and Patent Landscape

SEPTRA's patent protection has long expired, classifying it as a generic drug globally. The widespread availability of generics has led to a significant reduction in per-unit costs and a commoditization of the product. This has resulted in a compressed profit margin for manufacturers but ensures broad accessibility and stable demand.

Regulatory considerations include the need for ongoing post-marketing surveillance to monitor for adverse events and emerging resistance. Although no significant regulatory hurdles currently threaten SEPTRA’s market presence, evolving standards for antimicrobial stewardship and clinical guidelines influence prescribing patterns.

4. Impact of COVID-19 Pandemic

The COVID-19 pandemic indirectly affected SEPTRA’s market dynamics. While respiratory infection diagnoses temporarily declined due to lockdowns, opportunistic infections like PCP surged in immunocompromised populations, sustaining demand. Additionally, increased awareness of antimicrobial stewardship during the pandemic has led to more judicious use, marginally affecting sales.

Financial Trajectory and Revenue Outlook

1. Revenue Trends

Given its generic status, SEPTRA's revenue generation is primarily driven by volume rather than price premium. Analyst estimates suggest that the global sales of sulfamethoxazole/trimethoprim have experienced a gentle decline over the past five years, with annual revenues around USD 350-400 million.

The key factors influencing revenue include:

• Prescribing Trends: Shifts towards alternative agents for certain infections.
• Resistance Patterns: Rising resistance reduces use in some indications.
• Market Penetration: Continued use in prophylaxis and specific bacterial infections maintains baseline revenue.

2. Pricing Dynamics

Generic competition exerts downward pressure on pricing. Major generic manufacturers employ aggressive pricing strategies, further compressing margins. Nonetheless, steady demand in niche indications provides a reliable baseline.

3. Investment and Market Expansion

Limited direct investment in SEPTRA-specific R&D, owing to its age and patent status, indicates that most revenues are derived from manufacturing and distribution rather than innovation. However, market expansion could occur via:

• New Formulations: Developing pediatric or long-acting formulations.
• Combination Therapies: Incorporating SEPTRA into fixed-dose combinations for resistant infections.
• Regional Expansion: Targeting underpenetrated markets with high antimicrobial needs.

4. Future Revenue Projections

Projection models suggest that global revenues for SEPTRA and its equivalents will stabilize or experience slow decline, averaging 1-2% annual decrease through 2030. The primary driver will be the continued reliance in prophylactic and specific infectious contexts, offset by resistance and stewardship practices.

Market Challenges and Opportunities

Challenges

• Increasing Resistance: Diminished efficacy in some bacteria limits usage in primary indications.
• Antibiotic Stewardship: Policies aimed at reducing unnecessary antibiotic use constrain sales volumes.
• Generic Market Pressures: Margin compression due to intense price competition among generic manufacturers.

Opportunities

• Targeted Use Expansion: Developing rapid susceptibility testing can enable more precise use, maintaining demand.
• New Indications: Research into efficacy against resistant strains may open avenues for targeted markets.
• Regional Penetration: Expanding access in low- and middle-income countries where infections are prevalent and resistance less documented could sustain demand.

Regulatory and Market Outlook

Regulatory agencies increasingly emphasize responsible antibiotic use. This influences market factors, encouraging stewardship but also fostering innovation for derivatives or combination therapies with improved profiles. Manufacturers might explore reformulations or adjunct therapies to prolong SEPTRA’s relevance.

Key Takeaways

• Stable Niche Presence: Despite aging, SEPTRA remains vital in prophylaxis and resistant infection management, ensuring baseline demand.
• Revenue Decline Moderation: Generic status and broad accessibility underpin consistent sales, though steady decline is anticipated due to resistance and stewardship.
• Resistance as a Double-Edged Sword: Rising resistance limits certain uses but promotes exploration into newer indications and formulations.
• Market Forces: Price competition among generics and regulatory policies shape a challenging yet predictable financial trajectory.
• Innovation Opportunities: Focus on targeted indications, rapid diagnostics, and regional expansion can buffer income decline and prolong SEPTRA’s market relevance.

Conclusion

The financial trajectory of SEPTRA underscores a mature, commoditized drug face with inherent limitations but also stable demand in niche therapeutic areas. Strategies emphasizing responsible stewardship, innovation in formulation and indications, and regional expansion are essential for maintaining its market position. Stakeholders should remain vigilant regarding resistance patterns and evolving regulatory landscapes to navigate the complexities of antimicrobial markets effectively.

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FAQs

1. How has antimicrobial resistance affected SEPTRA’s market share?
Rising resistance among common pathogens diminishes SEPTRA’s efficacy, leading clinicians to reserve its use for cases confirmed to be susceptible. This results in a gradual reduction in overall prescribing volume but sustains demand in specific niches like PCP prophylaxis.

2. Can SEPTRA’s generic status influence future profitability?
Yes. While genericization reduces profit margins due to price competition, it ensures widespread access and steady sales volumes, especially in underserved regions, providing a predictable revenue stream.

3. Are there ongoing efforts to develop new formulations or combinations involving SEPTRA?
Limited R&D is directed more towards innovative antibiotics. However, some manufacturers explore fixed-dose combinations and targeted formulations to address resistant infections and improve patient compliance, potentially extending SEPTRA’s utility.

4. What role does antibiotic stewardship play in SEPTRA’s future?
Stewardship efforts promote judicious use of antibiotics, including SEPTRA. This restricts overprescription but can stabilize demand by preventing resistance-related efficacy declines, thereby shaping a more sustainable market.

5. What regional market opportunities exist for SEPTRA?
Low- and middle-income countries with high infectious disease burdens and less restrictive pharmaceutical regulation offer opportunities for regional market expansion, especially if local health authorities integrate SEPTRA into their standard treatment protocols.

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Sources

[1] World Health Organization. Global Antimicrobial Resistance Surveillance System (GLASS). 2022.

[2] Centers for Disease Control and Prevention. Opportunistic Infections in HIV/AIDS. 2021.

[3] MarketWatch. “Antibiotics Market Size & Share | Industry Analysis Report.” 2022.