Phenazopyridine hydrochloride; sulfamethoxazole; trimethoprim - Generic Drug Details

What are the generic sources for phenazopyridine hydrochloride; sulfamethoxazole; trimethoprim and what is the scope of patent protection?

Phenazopyridine hydrochloride; sulfamethoxazole; trimethoprim is the generic ingredient in one branded drug marketed by Able and is included in one NDA. Additional information is available in the individual branded drug profile pages.

Summary for phenazopyridine hydrochloride; sulfamethoxazole; trimethoprim

US Patents:	0
Tradenames:	1
Applicants:	1
NDAs:	1
DailyMed Link:	phenazopyridine hydrochloride; sulfamethoxazole; trimethoprim at DailyMed

Anatomical Therapeutic Chemical (ATC) Classes for phenazopyridine hydrochloride; sulfamethoxazole; trimethoprim

G04BX	Other urologicals
G04B	UROLOGICALS
G04	UROLOGICALS
G	Genito-urinary system and sex hormones

J01EA	Trimethoprim and derivatives
J01E	SULFONAMIDES AND TRIMETHOPRIM
J01	ANTIBACTERIALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

J01EC	Intermediate-acting sulfonamides
J01E	SULFONAMIDES AND TRIMETHOPRIM
J01	ANTIBACTERIALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

US Patents and Regulatory Information for phenazopyridine hydrochloride; sulfamethoxazole; trimethoprim

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

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

Introduction

Phenazopyridine hydrochloride, sulfamethoxazole, and trimethoprim are medications that have been integral in the treatment of various bacterial infections and urinary tract issues. Understanding their market dynamics and financial trajectories is crucial for pharmaceutical companies, investors, and healthcare providers.

Market Overview

Phenazopyridine Hydrochloride

Phenazopyridine hydrochloride is primarily used for the symptomatic relief of pain, burning, urgency, frequency, and other discomforts associated with lower urinary tract infections. It is often prescribed in conjunction with other antibiotics like trimethoprim/sulfamethoxazole.

• Market Size and Growth: The market for phenazopyridine hydrochloride is relatively stable, driven by the consistent demand for symptomatic relief in urinary tract infections. However, its growth is limited by its narrow therapeutic scope and the availability of alternative treatments[1][4].

• Competitive Landscape: The market is competitive, with several generic versions available, which can impact the pricing and profitability of branded versions.

Sulfamethoxazole and Trimethoprim

Sulfamethoxazole and trimethoprim, often combined as co-trimoxazole (TMP-SMX), are widely used antimicrobials for treating and preventing various bacterial infections.

• Market Size and Growth: The market for TMP-SMX is substantial due to its broad spectrum of indications, including urinary tract infections, respiratory infections, and prophylaxis against pneumocystis jirovecii pneumonia. The drug's inclusion in the World Health Organization's (WHO) list of essential medicines further solidifies its market presence[2][3].

• Competitive Landscape: The market is highly competitive, with both branded and generic versions available. However, the synergistic effect of the combination and its cost-effectiveness maintain its market dominance.

Financial Trajectory

Revenue Trends

• Phenazopyridine Hydrochloride: The revenue from phenazopyridine hydrochloride is relatively stable but not as significant as that from TMP-SMX. The drug's use is more niche, and its financial performance is influenced by the overall demand for symptomatic relief in urinary tract infections[1].

• Sulfamethoxazole and Trimethoprim: TMP-SMX generates substantial revenue due to its widespread use across various indications. The drug's affordability and effectiveness contribute to its high sales volume. It is one of the most prescribed antibiotics globally, which translates into significant revenue for pharmaceutical companies[2][3].

Pricing and Cost Considerations

Phenazopyridine Hydrochloride

• The pricing of phenazopyridine hydrochloride is generally lower compared to other antibiotics due to its generic availability and limited therapeutic scope. This makes it accessible but also limits its revenue potential[1].

Sulfamethoxazole and Trimethoprim

• TMP-SMX is known for its cost-effectiveness, which is a key factor in its widespread use. The combination is often priced lower than many other antibiotics, making it an attractive option for both patients and healthcare systems[2][3].

Regulatory and Patent Landscape

Phenazopyridine Hydrochloride

• Phenazopyridine hydrochloride is off-patent, which has led to the availability of numerous generic versions. This has increased competition and reduced the pricing power of any single manufacturer[1].

Sulfamethoxazole and Trimethoprim

• TMP-SMX is also off-patent, but its inclusion in the WHO's essential medicines list and its broad therapeutic applications ensure continued demand. The lack of patent protection has led to a highly competitive generic market, which keeps prices in check[2][3].

Adverse Effects and Safety Considerations

Phenazopyridine Hydrochloride

• While generally safe, phenazopyridine hydrochloride can cause methemoglobinemia, especially when used concurrently with other medications like TMP-SMX. This safety concern can impact its market dynamics, particularly in the geriatric population[4].

Sulfamethoxazole and Trimethoprim

• TMP-SMX is associated with several adverse effects, including hematologic toxicities, hypersensitivity reactions, and metabolic disturbances. These safety concerns necessitate careful patient monitoring and can influence prescribing patterns, especially in vulnerable populations[5].

Market Opportunities and Challenges

Phenazopyridine Hydrochloride

• Opportunities: The ongoing need for symptomatic relief in urinary tract infections presents a stable market opportunity. However, innovation in this space is limited.
• Challenges: The availability of alternative treatments and the generic nature of the drug pose significant challenges to revenue growth and market share[1].

Sulfamethoxazole and Trimethoprim

• Opportunities: The broad spectrum of indications and the drug's cost-effectiveness provide substantial market opportunities. Emerging markets and increasing antibiotic resistance also drive demand.
• Challenges: Rising concerns about antibiotic resistance, safety issues, and the availability of generic versions are key challenges. Additionally, regulatory pressures to reduce antibiotic use can impact market dynamics[2][3].

Key Takeaways

• Phenazopyridine Hydrochloride: The market for phenazopyridine hydrochloride is stable but limited by its narrow therapeutic scope and generic availability.
• Sulfamethoxazole and Trimethoprim: TMP-SMX has a significant market presence due to its broad indications, cost-effectiveness, and inclusion in the WHO's essential medicines list. However, it faces challenges from antibiotic resistance and safety concerns.

FAQs

1. What are the primary uses of phenazopyridine hydrochloride?

   • Phenazopyridine hydrochloride is primarily used for the symptomatic relief of pain, burning, urgency, frequency, and other discomforts associated with lower urinary tract infections.

2. What are the FDA-approved indications for sulfamethoxazole and trimethoprim?

   • The FDA-approved indications include acute infective exacerbation of chronic bronchitis, otitis media in pediatrics, travelers' diarrhea, urinary tract infections, shigellosis, pneumocystis jirovecii pneumonia, and toxoplasmosis[2].

3. What are the potential adverse effects of sulfamethoxazole and trimethoprim?

   • Potential adverse effects include hematologic toxicities, hypersensitivity reactions, metabolic disturbances, and methemoglobinemia when used concurrently with other medications[5].

4. How does the combination of sulfamethoxazole and trimethoprim work?

   • The combination works by inhibiting two consecutive steps in the bacterial biosynthesis of essential nucleic acids and proteins, resulting in a synergistic anti-folate effect[2][3].

5. What are the market challenges faced by phenazopyridine hydrochloride and sulfamethoxazole/trimethoprim?

   • Phenazopyridine hydrochloride faces challenges from alternative treatments and generic competition, while TMP-SMX faces challenges from antibiotic resistance, safety concerns, and regulatory pressures to reduce antibiotic use.

Sources

1. NDA 21-105 Page 3 Rx only Sulfamethoxazole and Trimethoprim - FDA.
2. Trimethoprim Sulfamethoxazole - StatPearls - NCBI Bookshelf - NCBI.
3. Trimethoprim: Uses, Interactions, Mechanism of Action - DrugBank - DrugBank.
4. A Case That Will Take Your Breath Away - PubMed - PubMed.
5. Considerations when prescribing trimethoprim–sulfamethoxazole - CMJ.