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Last Updated: March 16, 2025

SEPTRA Drug Patent Profile


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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-five suppliers are listed for this compound. Additional details are available on the sulfamethoxazole; trimethoprim profile page.

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Summary for SEPTRA
US Patents:0
Applicants:1
NDAs:3
Raw Ingredient (Bulk) Api Vendors: 22
Clinical Trials: 23
DailyMed Link:SEPTRA at DailyMed
Drug patent expirations by year for SEPTRA
Recent Clinical Trials for SEPTRA

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

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

See all SEPTRA clinical trials

US Patents and Regulatory Information for SEPTRA

ApplicantTradenameGeneric NameDosageNDAApproval DateTETypeRLDRSPatent No.Patent ExpirationProductSubstanceDelist Req.Exclusivity Expiration
Monarch Pharms SEPTRA sulfamethoxazole; trimethoprim TABLET;ORAL 017376-001 Approved Prior to Jan 1, 1982 AB RX No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Monarch Pharms SEPTRA DS sulfamethoxazole; trimethoprim TABLET;ORAL 017376-002 Approved Prior to Jan 1, 1982 AB RX No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Monarch Pharms SEPTRA sulfamethoxazole; trimethoprim SUSPENSION;ORAL 017598-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Monarch Pharms SEPTRA GRAPE sulfamethoxazole; trimethoprim SUSPENSION;ORAL 017598-002 Feb 12, 1986 DISCN No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Monarch Pharms SEPTRA sulfamethoxazole; trimethoprim INJECTABLE;INJECTION 018452-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
>Applicant>Tradename>Generic Name>Dosage>NDA>Approval Date>TE>Type>RLD>RS>Patent No.>Patent Expiration>Product>Substance>Delist Req.>Exclusivity Expiration
Showing 1 to 5 of 5 entries

International Patents for SEPTRA

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

CountryPatent NumberTitleEstimated Expiration
Canada 980688 TABLET FORMULATION ⤷  Try for Free
France 2260993 ⤷  Try for Free
India 141019 A METHOD OF PREPARING A TABLET OF A PHARMACEUTICAL FORMULATION ⤷  Try for Free
Japan S5545043 ⤷  Try for Free
Norway 146043 ⤷  Try for Free
>Country>Patent Number>Title>Estimated Expiration
Showing 1 to 5 of 5 entries

Market Dynamics and Financial Trajectory for the Drug: Septra

Introduction

Septra, a brand-name prescription drug, is a combination antibiotic consisting of sulfamethoxazole and trimethoprim. To understand its market dynamics and financial trajectory, it is crucial to delve into various factors influencing its pricing, competition, and market position.

Historical Pricing Trends

From 2000 to 2008, the pharmaceutical industry witnessed significant price increases for many brand-name drugs, including Septra. According to the Government Accountability Office (GAO), 416 brand-name drug products, including different strengths and dosage forms of the same drug brand, experienced extraordinary price increases during this period. Septra, being part of the anti-infective agents therapeutic class, was among those drugs that saw notable price hikes[1].

Factors Contributing to Price Increases

Several factors contributed to the extraordinary price increases of Septra and similar drugs:

Lack of Therapeutically Equivalent Drugs

The absence of generic or other brand-name drugs that treat the same condition can lead to limited competition. This lack of competition, often protected by patents and market exclusivity, allows drug companies to set higher prices to recoup research and development costs and earn a return on their investment[1].

Patent Protection and Market Exclusivity

Patent protection and market exclusivity play significant roles in limiting competition. These mechanisms temporarily shield the drug from generic competition, enabling the manufacturer to maintain higher prices[1].

Corporate Consolidations

The transfer of drug rights and corporate consolidations among pharmaceutical companies can reduce the number of drug options available, leading to greater market domination by a few companies and less competition. This consolidation can result in higher prices for drugs like Septra[1].

Market Competition and Dominance

The pharmaceutical market is characterized by a lack of traditional market discipline. Unlike other markets, healthcare providers often influence demand on behalf of patients, who may be unaware of the drug costs due to insurance coverage. This dynamic can lead to higher prices without a corresponding decrease in demand[1].

Financial Performance of Pharmaceutical Companies

To understand the financial trajectory of a drug like Septra, it is helpful to look at the financial performance of pharmaceutical companies. For instance, companies like Sarepta Therapeutics and Septerna, while not directly related to Septra, illustrate the financial complexities and challenges in the pharmaceutical industry.

Research and Development Expenses

Companies like Septerna invest heavily in research and development. For example, Septerna reported R&D expenses of $17.8 million in Q3 2024, which is typical for companies developing new drugs and treatments[2].

Revenue and Net Income

Sarepta Therapeutics, another pharmaceutical company, reported net product revenues of $429.8 million in Q3 2024, a 39% increase from the previous year. This growth indicates the potential financial success of drugs that gain market traction and approval[5].

Case Study: Daraprim and Antitrust Implications

The case of Daraprim, another brand-name drug, highlights the antitrust implications of price gouging in the pharmaceutical industry. Martin Shkreli's company, Vyera, increased the price of Daraprim from $17.50 to $750 per tablet, blocking generic competition. This egregious price increase led to antitrust violations and severe legal consequences, including a lifetime ban from the pharmaceutical industry for Shkreli[3].

Market Opportunities and Challenges

The global market for antibiotics like Septra is influenced by various opportunities and challenges:

Market Introduction and Segmentations

The Septra market, like other antibiotic markets, is segmented based on therapeutic classes, patient demographics, and geographic regions. Understanding these segments is crucial for marketing and sales strategies[4].

Regulatory Environment

Regulatory requirements and changes in healthcare policies can significantly impact the market dynamics of drugs like Septra. Compliance with these regulations is essential for maintaining market presence[1].

Financial Trajectory

The financial trajectory of Septra is tied to its market position, competition, and regulatory environment:

Revenue Streams

For a drug like Septra, revenue streams are primarily driven by sales to healthcare providers and pharmacies. The price per unit, as well as the volume of sales, determines the overall revenue.

Cost Structure

The cost structure includes research and development expenses, manufacturing costs, marketing expenses, and regulatory compliance costs. These costs are typically high in the pharmaceutical industry and can influence pricing strategies[2][5].

Key Takeaways

  • Pricing Trends: Septra has experienced significant price increases due to factors like lack of competition, patent protection, and corporate consolidations.
  • Market Dynamics: The pharmaceutical market lacks traditional market discipline, with healthcare providers influencing demand.
  • Financial Performance: Pharmaceutical companies invest heavily in R&D and can achieve significant revenue growth with successful drugs.
  • Regulatory Environment: Compliance with regulatory requirements is crucial for maintaining market presence.
  • Antitrust Implications: Excessive price gouging can lead to antitrust violations and severe legal consequences.

FAQs

What are the main factors contributing to the high prices of brand-name prescription drugs like Septra?

The main factors include the lack of therapeutically equivalent drugs, patent protection, market exclusivity, and corporate consolidations.

How does the regulatory environment impact the market dynamics of drugs like Septra?

The regulatory environment affects compliance costs, market exclusivity, and the approval process, all of which can influence pricing and competition.

What are the financial implications of high R&D expenses in the pharmaceutical industry?

High R&D expenses are necessary for drug development but can lead to higher prices to recoup these costs and ensure profitability.

Can antitrust laws affect the pricing strategies of pharmaceutical companies?

Yes, antitrust laws can significantly impact pricing strategies. Violations, as seen in the Daraprim case, can result in severe legal consequences.

How do corporate consolidations influence the market for drugs like Septra?

Corporate consolidations can reduce competition, leading to greater market domination by a few companies and potentially higher prices for drugs like Septra.

Sources

  1. GAO-10-201, Brand-Name Prescription Drug Pricing - Government Accountability Office
  2. Septerna Reports Third Quarter 2024 Financial Results and Recent Business Highlights - Stock Titan
  3. APPENDIX - Supreme Court - Supreme Court
  4. Global Septra Market [2024-2032] | Uncovering Hidden Opportunities in the Industry - Panhandle News Channel Nebraska
  5. Sarepta Therapeutics Announces Third Quarter 2024 Financial Results and Recent Corporate Developments - BioSpace

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