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Last Updated: December 22, 2024

SULFATRIM-SS Drug Patent Profile


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When do Sulfatrim-ss patents expire, and what generic alternatives are available?

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

The generic ingredient in SULFATRIM-SS 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-ss

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

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

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

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

See all SULFATRIM-SS clinical trials

US Patents and Regulatory Information for SULFATRIM-SS

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Superpharm SULFATRIM-SS sulfamethoxazole; trimethoprim TABLET;ORAL 070065-002 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-SS Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Sulfamethoxazole and Trimethoprim (SULFATRIM-SS)

Introduction

Sulfamethoxazole and trimethoprim, commonly known as SULFATRIM-SS, is a widely used antimicrobial combination that treats and prevents various bacterial infections. This article delves into the market dynamics and financial trajectory of this drug, exploring its usage, pricing, competition, and regulatory aspects.

Mechanism of Action and Clinical Uses

Sulfamethoxazole and trimethoprim work synergistically to inhibit bacterial folate synthesis, making them effective against a broad range of bacterial infections, including urinary tract infections, middle ear infections, bronchitis, and more[1][5].

Market Demand

The demand for SULFATRIM-SS is driven by its efficacy and cost-effectiveness. It is particularly popular for treating common infections such as urinary tract infections and respiratory tract infections. The drug's affordability and wide range of applications contribute to its high demand in both developed and developing countries.

Pricing Dynamics

The pricing of SULFATRIM-SS is influenced by several factors, including the presence of generic versions, regulatory policies, and market competition. Generic versions of the drug are significantly cheaper than the branded versions, which has led to a shift towards generic prescriptions. For instance, the retail dollar gross margin on generic drugs is typically higher than on branded drugs, incentivizing pharmacists to dispense generics[3].

Generic Substitution

Generic substitution laws play a crucial role in the pricing and market share of SULFATRIM-SS. These laws allow pharmacists to substitute branded drugs with their generic equivalents, which has led to a significant reduction in prices. Studies have shown that the market share of generic drugs increases substantially after the patent expiration of the branded version, resulting in lower prices for consumers[3].

Competition

The market for SULFATRIM-SS is highly competitive, with multiple manufacturers producing both branded and generic versions. The competition is further intensified by the presence of other antimicrobial agents. However, the synergistic effect of sulfamethoxazole and trimethoprim makes this combination a preferred choice for many infections, maintaining its market share despite competition.

Regulatory Aspects

Regulatory bodies play a critical role in shaping the market dynamics of SULFATRIM-SS. Health Canada, for example, conducts safety reviews to assess potential risks associated with the drug, such as the risk of hemophagocytic lymphohistiocytosis. These reviews help in ensuring the safe use of the drug and can impact its market trajectory[4].

Financial Trajectory

The financial performance of SULFATRIM-SS is robust due to its widespread use and cost-effectiveness. Here are some key financial aspects:

Revenue Generation

The revenue generated from SULFATRIM-SS is substantial, driven by its high prescription rates and affordability. The drug is often prescribed for both acute and chronic infections, ensuring a steady stream of revenue.

Cost Savings

The use of generic versions of SULFATRIM-SS results in significant cost savings for both patients and healthcare systems. Studies have shown that generic substitution can lead to savings of up to 25% compared to branded drugs[3].

Market Share

Despite the presence of other antimicrobial agents, SULFATRIM-SS maintains a significant market share due to its efficacy and cost-effectiveness. The market share is further bolstered by the preference of healthcare providers for this combination due to its synergistic anti-folate effect.

Side Effects and Contraindications

While SULFATRIM-SS is generally well-tolerated, it has several side effects and contraindications that can impact its market dynamics. For instance, the drug is contraindicated in patients with known hypersensitivity to sulfonamides, pregnancy, and severe renal or liver disease. These contraindications can limit its use in certain patient populations, affecting its overall market performance[1][5].

Hyperkalemia Risk

One significant concern associated with SULFATRIM-SS is the risk of hyperkalemia, particularly in older patients taking spironolactone. Studies have shown that the use of SULFATRIM-SS in these patients can increase the risk of hospital admission for hyperkalemia, which may impact its prescription rates in certain patient groups[2].

Conclusion

Sulfamethoxazole and trimethoprim (SULFATRIM-SS) is a vital antimicrobial combination with a strong market presence due to its efficacy, cost-effectiveness, and wide range of clinical uses. The market dynamics are influenced by generic substitution laws, regulatory reviews, and competition from other antimicrobial agents. Despite potential side effects and contraindications, SULFATRIM-SS remains a preferred choice for many bacterial infections, ensuring a robust financial trajectory.

Key Takeaways

  • Efficacy and Cost-Effectiveness: SULFATRIM-SS is effective against a broad range of bacterial infections and is cost-effective, making it a preferred choice.
  • Generic Substitution: Generic versions significantly reduce costs and increase market share.
  • Regulatory Aspects: Health Canada and other regulatory bodies ensure the safe use of the drug through safety reviews.
  • Financial Performance: The drug generates substantial revenue due to high prescription rates and cost savings.
  • Side Effects and Contraindications: The drug has several side effects and contraindications that can limit its use in certain patient populations.

FAQs

Q: What is the mechanism of action of SULFATRIM-SS?

A: SULFATRIM-SS works by inhibiting bacterial folate synthesis. Sulfamethoxazole competes with p-aminobenzoic acid (PABA) to inhibit dihydropteroate synthase, while trimethoprim inhibits dihydrofolate reductase, halting the production of tetrahydrofolate[1].

Q: What are the common clinical uses of SULFATRIM-SS?

A: SULFATRIM-SS is used to treat urinary tract infections, middle ear infections, bronchitis, and other bacterial infections[1][5].

Q: How does generic substitution impact the market for SULFATRIM-SS?

A: Generic substitution laws allow pharmacists to dispense generic versions of SULFATRIM-SS, reducing costs and increasing market share for generic drugs[3].

Q: What are the potential side effects and contraindications of SULFATRIM-SS?

A: The drug can cause side effects such as hyperkalemia and is contraindicated in patients with known hypersensitivity to sulfonamides, pregnancy, and severe renal or liver disease[1][5].

Q: How does the risk of hyperkalemia affect the use of SULFATRIM-SS?

A: The risk of hyperkalemia, particularly in older patients taking spironolactone, can increase the risk of hospital admission and may impact prescription rates in certain patient groups[2].

Sources

  1. Trimethoprim Sulfamethoxazole - StatPearls - NCBI Bookshelf
  2. Science.gov: Sulfamethoxazole
  3. Economic Effects of State Drug Product Selection Laws - FTC
  4. Drug and Health Products Portal: SULFATRIM PEDIATRIC
  5. Mayo Clinic: Sulfamethoxazole and Trimethoprim (Oral Route)

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