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-nine 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	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
Denmark	52875
Australia	7817075
Denmark	143247
Norway	750467

SEPTRA DS Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for SEPTRA DS

Introduction

SEPTRA DS, a combination antibiotic containing trimethoprim and sulfamethoxazole, is a widely used medication for treating various bacterial infections. To understand its market dynamics and financial trajectory, it is essential to delve into several key factors, including market competition, pricing strategies, regulatory environment, and the broader pharmaceutical industry trends.

Market Competition

The antibiotic market, where SEPTRA DS operates, is characterized by a mix of generic and brand-name drugs. However, SEPTRA DS, being a brand-name drug, faces competition from both other brand-name antibiotics and generic versions of similar drugs.

• Generic Competition: Generic versions of trimethoprim and sulfamethoxazole are widely available, which can significantly impact the market share of SEPTRA DS. Generic drugs are often cheaper, making them more attractive to patients and healthcare providers looking to reduce costs[1].
• Brand-Name Competition: Other brand-name antibiotics in the same therapeutic class also compete with SEPTRA DS. This competition can drive pricing strategies and influence market share.

Pricing Strategies

Pricing in the pharmaceutical industry is complex and influenced by several factors, including research and development costs, market exclusivity, and regulatory incentives.

• Patent Protection and Market Exclusivity: Drugs like SEPTRA DS benefit from patent protection and market exclusivity, which can limit competition and allow for higher pricing. However, once patents expire, generic competition increases, potentially reducing prices[1].
• Extraordinary Price Increases: Some brand-name drugs experience extraordinary price increases, often due to limited competition and the absence of therapeutically equivalent drugs. While SEPTRA DS may not have seen such drastic price hikes, it is still subject to the broader pricing dynamics in the industry[1].

Regulatory Environment

The regulatory environment plays a crucial role in the market dynamics of pharmaceuticals.

• FDA Regulations: The FDA regulates the approval, manufacturing, and marketing of drugs. SEPTRA DS must comply with FDA guidelines to maintain its market presence. Any changes in FDA regulations or approval processes can impact the drug's market trajectory[4][5].
• Antitrust Laws: Cases like the one involving Martin Shkreli and Daraprim highlight the importance of antitrust laws in preventing monopolistic practices that can lead to price gouging. Such laws ensure that companies do not engage in anticompetitive behavior, maintaining a fair market environment[3].

Financial Trajectory

The financial performance of a drug like SEPTRA DS is influenced by various factors, including sales revenue, research and development expenses, and market expansion.

• Sales Revenue: The revenue generated by SEPTRA DS would depend on its market share, pricing, and the volume of sales. In a competitive market, maintaining or increasing sales revenue can be challenging, especially with the presence of generic alternatives.
• Research and Development Expenses: Companies investing in drugs like SEPTRA DS often have significant research and development expenses. These costs can be recouped through higher pricing during the period of market exclusivity[1].
• Market Expansion: Expanding into new markets or increasing penetration in existing markets can boost revenue. However, this requires significant investment in marketing, sales, and possibly clinical trials to demonstrate the drug's efficacy in different populations.

Industry Trends

The pharmaceutical industry is undergoing significant changes that impact the market dynamics and financial trajectory of drugs like SEPTRA DS.

• Consolidation and Mergers: The increasing pace of consolidation among pharmaceutical companies can lead to fewer companies producing and marketing drugs, resulting in greater market domination and potentially less competition. This can affect the pricing and availability of drugs like SEPTRA DS[1].
• Shift to Specialty Drugs: There is a trend towards developing specialty drugs that target niche markets. While SEPTRA DS is not a specialty drug, the overall shift in the industry can influence how resources are allocated and how companies prioritize their product portfolios[1].

Case Study: Sarepta Therapeutics

Although Sarepta Therapeutics is not directly related to SEPTRA DS, the company's financial performance and strategies provide insights into the broader pharmaceutical industry.

• Revenue Growth: Sarepta Therapeutics saw significant revenue growth in 2023, driven by the success of its gene therapy and other products. This growth is indicative of the potential for innovative drugs to capture substantial market share and revenue[2].
• Expansion and Development Costs: The company's increased expenses in areas such as clinical trials, professional services, and facility expansion highlight the ongoing investment required to maintain and grow market presence in the pharmaceutical industry[2].

Key Takeaways

• Market Competition: SEPTRA DS faces competition from both generic and brand-name antibiotics.
• Pricing Strategies: Pricing is influenced by patent protection, market exclusivity, and regulatory incentives.
• Regulatory Environment: Compliance with FDA regulations and antitrust laws is crucial.
• Financial Trajectory: Revenue is influenced by market share, pricing, and sales volume, while expenses include research and development, marketing, and clinical trials.
• Industry Trends: Consolidation, mergers, and the shift to specialty drugs impact the broader industry dynamics.

FAQs

1. What are the main competitors for SEPTRA DS in the market?

   • SEPTRA DS competes with both generic versions of trimethoprim and sulfamethoxazole and other brand-name antibiotics in the same therapeutic class.

2. How do patent protection and market exclusivity affect SEPTRA DS?

   • These protections limit competition, allowing the drug company to recoup research and development costs and earn a return on investment.

3. What role do FDA regulations play in the market dynamics of SEPTRA DS?

   • FDA regulations govern the approval, manufacturing, and marketing of SEPTRA DS, ensuring compliance and maintaining market presence.

4. How does the trend of consolidation in the pharmaceutical industry impact SEPTRA DS?

   • Consolidation can lead to fewer companies producing and marketing drugs, potentially resulting in greater market domination and less competition.

5. What are the key factors influencing the financial trajectory of SEPTRA DS?

   • The financial trajectory is influenced by sales revenue, research and development expenses, market expansion, and the overall competitive landscape.

Sources

1. GAO-10-201, Brand-Name Prescription Drug Pricing - U.S. Government Accountability Office.
2. Sarepta Therapeutics Announces Fourth Quarter and Full-Year 2023 Financial Results and Recent Corporate Developments - Sarepta Therapeutics.
3. APPENDIX - Supreme Court - Supreme Court of the United States.
4. SEPTRA® Tablets SEPTRA® DS (Double Strength) Tablets - FDA.
5. Septra DS - accessdata.fda.gov - FDA.