You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: December 22, 2024

SULFAMETHOXAZOLE AND TRIMETHOPRIM AND PHENAZOPYRIDINE HYDROCHLORIDE Drug Patent Profile


✉ Email this page to a colleague

« Back to Dashboard


When do Sulfamethoxazole And Trimethoprim And Phenazopyridine Hydrochloride patents expire, and when can generic versions of Sulfamethoxazole And Trimethoprim And Phenazopyridine Hydrochloride launch?

Sulfamethoxazole And Trimethoprim And Phenazopyridine Hydrochloride is a drug marketed by Able and is included in one NDA.

The generic ingredient in SULFAMETHOXAZOLE AND TRIMETHOPRIM AND PHENAZOPYRIDINE HYDROCHLORIDE is phenazopyridine hydrochloride; sulfamethoxazole; trimethoprim. There are eight drug master file entries for this compound. Additional details are available on the phenazopyridine hydrochloride; sulfamethoxazole; trimethoprim profile page.

AI Research Assistant
Questions you can ask:
  • What is the 5 year forecast for SULFAMETHOXAZOLE AND TRIMETHOPRIM AND PHENAZOPYRIDINE HYDROCHLORIDE?
  • What are the global sales for SULFAMETHOXAZOLE AND TRIMETHOPRIM AND PHENAZOPYRIDINE HYDROCHLORIDE?
  • What is Average Wholesale Price for SULFAMETHOXAZOLE AND TRIMETHOPRIM AND PHENAZOPYRIDINE HYDROCHLORIDE?
Summary for SULFAMETHOXAZOLE AND TRIMETHOPRIM AND PHENAZOPYRIDINE HYDROCHLORIDE
Drug patent expirations by year for SULFAMETHOXAZOLE AND TRIMETHOPRIM AND PHENAZOPYRIDINE HYDROCHLORIDE

US Patents and Regulatory Information for SULFAMETHOXAZOLE AND TRIMETHOPRIM AND PHENAZOPYRIDINE HYDROCHLORIDE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Able SULFAMETHOXAZOLE AND TRIMETHOPRIM AND PHENAZOPYRIDINE HYDROCHLORIDE phenazopyridine hydrochloride; sulfamethoxazole; trimethoprim TABLET;ORAL 021105-001 Jun 26, 2001 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

SULFAMETHOXAZOLE AND TRIMETHOPRIM AND PHENAZOPYRIDINE HYDROCHLORIDE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Sulfamethoxazole, Trimethoprim, and Phenazopyridine Hydrochloride

Introduction

Sulfamethoxazole, trimethoprim, and phenazopyridine hydrochloride, often combined in medications like Zotrim, are widely used for treating urinary tract infections and other bacterial infections. This combination has been a staple in the pharmaceutical market for decades, and its market dynamics and financial trajectory are influenced by several key factors.

Historical Context and Market Presence

Introduced in 1968, sulfamethoxazole and trimethoprim have been popular due to their effectiveness, low cost, and widespread familiarity among healthcare professionals[3].

  • Market Share: This combination antibiotic has maintained a significant market share in the treatment of urinary tract infections, middle ear infections, bronchitis, and other bacterial infections.

Indications and Usage

The combination of sulfamethoxazole, trimethoprim, and phenazopyridine hydrochloride is specifically indicated for:

  • Urinary Tract Infections: Effective against susceptible strains of bacteria such as Escherichia coli, Klebsiella species, Enterobacter species, Morganella morganii, Proteus mirabilis, and Proteus vulgaris[1][2][5].
  • Symptomatic Relief: Phenazopyridine hydrochloride provides symptomatic relief for pain, burning, urgency, and other discomforts associated with lower urinary tract infections[1][2].

Dosage and Administration

The dosage regimen is critical for the efficacy and safety of this combination:

  • Trimethoprim/Sulfamethoxazole: One double-strength tablet (160 mg/800 mg) every 12 hours for 10 days[1][2].
  • Phenazopyridine Hydrochloride: One 200 mg tablet three times a day after meals, not exceeding 2 days[1][2].

Safety and Adverse Reactions

Despite its widespread use, this combination is associated with several adverse reactions:

  • Hematologic Toxicity: Rare but potentially serious blood dyscrasias such as agranulocytosis, aplastic anemia, and thrombocytopenia[3].
  • Drug Interactions: Notable interactions include increased risk of thrombocytopenia with diuretics, prolonged prothrombin time with warfarin, and increased levels of sulfonylureas and repaglinide, leading to hypoglycemia[1][2][3].
  • Methemoglobinemia: Both trimethoprim-sulfamethoxazole and phenazopyridine can cause methemoglobinemia, particularly when used concurrently[4].

Market Drivers

Several factors drive the market for this combination:

  • Prevalence of Urinary Tract Infections: The high incidence of urinary tract infections, especially in women, ensures a consistent demand for effective treatments.
  • Cost-Effectiveness: The low cost of sulfamethoxazole and trimethoprim makes it an attractive option for both patients and healthcare systems.
  • Familiarity and Efficacy: The long history of use and established efficacy contribute to its continued prescription by healthcare providers.

Market Challenges

Despite its market presence, there are challenges:

  • Antibiotic Resistance: The increasing resistance of bacteria to sulfamethoxazole and trimethoprim poses a significant threat to its long-term market viability.
  • Adverse Reactions and Interactions: The potential for serious adverse reactions and drug interactions requires careful patient monitoring and management.
  • Regulatory Scrutiny: Regulatory bodies closely monitor the use of antibiotics, and any changes in guidelines or recommendations can impact market dynamics.

Financial Trajectory

The financial performance of this combination is influenced by several factors:

  • Sales Volume: Consistent demand due to the prevalence of urinary tract infections and other bacterial infections contributes to stable sales volumes.
  • Pricing: The low cost of the medication helps in maintaining market share but can limit revenue growth.
  • Generic Competition: The availability of generic versions of sulfamethoxazole and trimethoprim can reduce the market share of branded products.
  • Research and Development: Continuous research into new antibiotics and treatment options can impact the long-term financial trajectory of this combination.

Key Takeaways

  • Established Market Presence: Sulfamethoxazole, trimethoprim, and phenazopyridine hydrochloride have a long history of use and a significant market share.
  • Cost-Effectiveness: The combination is cost-effective, making it a preferred option for many patients and healthcare systems.
  • Safety Concerns: The potential for adverse reactions and drug interactions necessitates careful patient management.
  • Market Challenges: Antibiotic resistance and regulatory scrutiny are key challenges that could impact the market dynamics.

FAQs

What are the primary indications for sulfamethoxazole, trimethoprim, and phenazopyridine hydrochloride?

These medications are primarily indicated for the treatment of urinary tract infections and for symptomatic relief of pain and discomfort associated with lower urinary tract infections.

What are the common adverse reactions associated with this combination?

Common adverse reactions include hematologic toxicity, methemoglobinemia, and various drug interactions that can lead to hypoglycemia, prolonged prothrombin time, and other complications.

How does antibiotic resistance impact the market for this combination?

Antibiotic resistance poses a significant threat to the long-term market viability of sulfamethoxazole and trimethoprim, as it reduces the efficacy of the medication and necessitates the development of new antibiotics.

What are the key drivers of the market for this combination?

Key drivers include the prevalence of urinary tract infections, the cost-effectiveness of the medication, and its established efficacy and familiarity among healthcare providers.

Are there any specific precautions for patients with impaired renal function?

Yes, patients with impaired renal function require a reduced dosage of trimethoprim/sulfamethoxazole, and the use of this combination is not recommended for those with creatinine clearance below 15 mL/min[1][2].

Sources

  1. RxList: Zotrim (Sulfamethoxazole, Trimethoprim, Phenazopyridine) - RxList
  2. FDA: NDA 21-105 Page 3 Rx only Sulfamethoxazole and Trimethoprim
  3. CMJ: Considerations when prescribing trimethoprim–sulfamethoxazole
  4. PubMed: A Case That Will Take Your Breath Away
  5. Mayo Clinic: Sulfamethoxazole and trimethoprim (oral route) - Mayo Clinic

More… ↓

⤷  Subscribe

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.