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Last Updated: December 22, 2024

SULFATRIM-DS Drug Patent Profile


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Which patents cover Sulfatrim-ds, and what generic alternatives are available?

Sulfatrim-ds is a drug marketed by Superpharm and is included in one NDA.

The generic ingredient in SULFATRIM-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 Sulfatrim-ds

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

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Summary for SULFATRIM-DS
US Patents:0
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors: 22
Clinical Trials: 4
DailyMed Link:SULFATRIM-DS at DailyMed
Drug patent expirations by year for SULFATRIM-DS
Recent Clinical Trials for SULFATRIM-DS

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

SponsorPhase
National Cancer Institute (NCI)Phase 4
Roswell Park Cancer InstitutePhase 4
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Phase 3

See all SULFATRIM-DS clinical trials

US Patents and Regulatory Information for SULFATRIM-DS

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Superpharm SULFATRIM-DS sulfamethoxazole; trimethoprim TABLET;ORAL 070066-001 Jun 24, 1985 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

SULFATRIM-DS Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for SULFATRIM-DS

Introduction

SULFATRIM-DS, a combination antibiotic consisting of sulfamethoxazole and trimethoprim, is widely used to treat various bacterial infections. Understanding the market dynamics and financial trajectory of this drug is crucial for pharmaceutical companies, investors, and healthcare professionals.

Market Demand and Indications

SULFATRIM-DS is indicated for the treatment of several infections, including urinary tract infections, upper and lower respiratory tract infections, and pneumocystis jiroveci pneumonia, among others[2][5].

Urinary Tract Infections

The demand for SULFATRIM-DS is significant in the treatment of urinary tract infections, which are common and recurring. The antibiotic's efficacy in treating acute uncomplicated urinary tract infections makes it a preferred choice for many healthcare providers.

Respiratory Tract Infections

The drug is also effective in treating acute exacerbations of chronic bronchitis and other respiratory infections, contributing to its steady demand in this segment.

Competitive Landscape

The antibiotic market is highly competitive, with various brands and generics available. SULFATRIM-DS competes with other sulfamethoxazole and trimethoprim combinations, as well as other classes of antibiotics.

Generic Competition

The availability of generic versions of sulfamethoxazole and trimethoprim can impact the market share of branded products like SULFATRIM-DS. However, the brand's reputation and the trust of healthcare providers can help maintain its market position[4].

Patent and Exclusivity

Since the patents for sulfamethoxazole and trimethoprim have expired, the market is open to generic competition. This has led to a decrease in the prices of these antibiotics, affecting the revenue of branded products.

Pricing and Revenue

The pricing of SULFATRIM-DS is influenced by several factors, including production costs, regulatory approvals, and market competition.

Cost Considerations

The cost of SULFATRIM-DS is generally lower compared to newer antibiotics, making it an affordable option for many patients. However, the cost can vary depending on the region and the specific formulation (e.g., tablets vs. pediatric formulations)[1][2].

Revenue Trends

The revenue from SULFATRIM-DS has been relatively stable due to its established use and consistent demand. However, the increasing competition from generics and other antibiotics has put pressure on the pricing and revenue of branded products.

Regulatory Environment

Regulatory approvals and guidelines play a crucial role in the market dynamics of SULFATRIM-DS.

Approval and Licensing

SULFATRIM-DS is approved for use in various countries, including Canada, where it is marketed by AA Pharma Inc.[4].

Safety and Efficacy

Regulatory bodies closely monitor the safety and efficacy of SULFATRIM-DS. The drug is contraindicated in patients with certain conditions, such as marked renal impairment, and can cause severe adverse reactions like Stevens-Johnson syndrome and toxic epidermal necrolysis[1][2].

Side Effects and Safety Concerns

The safety profile of SULFATRIM-DS is a critical factor in its market dynamics.

Common Adverse Effects

Common side effects include hyperkalemia, gastrointestinal disturbances, and allergic skin reactions. More severe reactions, although rare, can be life-threatening[1][2].

Hyperkalemia Risk

A significant safety concern is the increased risk of hyperkalemia, particularly in elderly patients taking spironolactone. This has led to cautionary recommendations and monitoring guidelines[3].

Market Segmentation

The market for SULFATRIM-DS can be segmented based on patient demographics and infection types.

Geriatric Population

The drug is approved for use in geriatric patients, but with caution due to the increased risk of severe adverse reactions in this population[1].

Pediatric Use

SULFATRIM-DS is also available in pediatric formulations, catering to the needs of younger patients. The dosage and administration guidelines are specific to this age group to ensure safety and efficacy[1].

Future Outlook

The future outlook for SULFATRIM-DS is influenced by several factors, including antibiotic resistance, regulatory changes, and market competition.

Antibiotic Resistance

The increasing concern of antibiotic resistance could impact the long-term demand for SULFATRIM-DS. However, its continued efficacy against many susceptible strains ensures its relevance in the current antibiotic arsenal[2][3].

Market Expansion

There is potential for market expansion in regions where access to effective antibiotics is limited. However, this would require strategic marketing and distribution efforts.

Key Takeaways

  • Established Use: SULFATRIM-DS is widely used for treating various bacterial infections, ensuring a stable demand.
  • Competitive Landscape: The market is competitive, with both branded and generic versions available.
  • Pricing and Revenue: Pricing is influenced by competition and regulatory factors, affecting revenue.
  • Regulatory Environment: Strict safety and efficacy monitoring by regulatory bodies is crucial.
  • Safety Concerns: The drug has significant side effects, particularly hyperkalemia in elderly patients.
  • Future Outlook: The drug remains relevant despite antibiotic resistance concerns and competitive pressures.

FAQs

Q: What are the common indications for SULFATRIM-DS?

A: SULFATRIM-DS is used to treat urinary tract infections, upper and lower respiratory tract infections, and pneumocystis jiroveci pneumonia, among other infections.

Q: What are the potential side effects of SULFATRIM-DS?

A: Common side effects include hyperkalemia, gastrointestinal disturbances, and allergic skin reactions. Severe reactions like Stevens-Johnson syndrome and toxic epidermal necrolysis can also occur.

Q: Is SULFATRIM-DS safe for geriatric patients?

A: While SULFATRIM-DS is approved for geriatric patients, there is an increased risk of severe adverse reactions in this population, necessitating careful dosage adjustments and monitoring.

Q: How does the competitive landscape affect SULFATRIM-DS?

A: The presence of generic versions and other antibiotics in the market impacts the pricing and revenue of SULFATRIM-DS, but its established use and trust among healthcare providers help maintain its market position.

Q: What are the regulatory considerations for SULFATRIM-DS?

A: Regulatory bodies closely monitor the safety and efficacy of SULFATRIM-DS, and it is contraindicated in patients with certain conditions such as marked renal impairment.

Sources

  1. AA Pharma, Product Monograph - SULFATRIM, 2023.
  2. APO-SULFATRIM, APO-SULFATRIM sulfamethoxazole and trimethoprim tablets, 2017.
  3. Science.gov, sulfamethoxazole: Topics by Science.gov.
  4. Drug and Health Products Portal, Details for: SULFATRIM DS, 2019.
  5. Mayo Clinic, Sulfamethoxazole and trimethoprim (oral route).

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