Phenazopyridine hydrochloride; sulfisoxazole - Generic Drug Details

What are the generic sources for phenazopyridine hydrochloride; sulfisoxazole and what is the scope of freedom to operate?

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

Summary for phenazopyridine hydrochloride; sulfisoxazole

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

Anatomical Therapeutic Chemical (ATC) Classes for phenazopyridine hydrochloride; sulfisoxazole

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

US Patents and Regulatory Information for phenazopyridine hydrochloride; sulfisoxazole

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Roche	AZO GANTRISIN	phenazopyridine hydrochloride; sulfisoxazole	TABLET;ORAL	019358-001	Aug 31, 1990		DISCN	Yes	No

Phenazopyridine Hydrochloride and Sulfisoxazole: Market Dynamics and Financial Trajectory

Last updated: February 19, 2026

Phenazopyridine hydrochloride and sulfisoxazole are established pharmaceutical compounds with distinct therapeutic applications. Phenazopyridine hydrochloride is primarily used for symptomatic relief of urinary tract discomfort, while sulfisoxazole is an antibiotic. This analysis examines the market dynamics, patent landscape, and financial trajectory of these drugs, focusing on key indicators relevant to R&D and investment decisions.

What is the Current Market Status of Phenazopyridine Hydrochloride and Sulfisoxazole?

Phenazopyridine hydrochloride is an over-the-counter (OTC) analgesic. Its market is characterized by a high volume of generic products and a stable demand driven by prevalent urinary tract infections (UTIs). The market is mature, with limited scope for significant new product development based on the active pharmaceutical ingredient (API) itself, barring novel delivery systems or combination therapies. Major manufacturers include Chartwell Pharmaceuticals, Inc., and Aurobindo Pharma USA, Inc. [1]. The global phenazopyridine hydrochloride market size was valued at USD 193.7 million in 2023 [2].

Sulfisoxazole, an antibacterial sulfonamide, has seen its use decline due to the development of newer antibiotics with broader spectrums of activity and improved safety profiles. It is primarily used for uncomplicated UTIs. The market for sulfisoxazole is smaller and more niche compared to phenazopyridine hydrochloride. Its availability is largely through generic formulations. Companies like Hikma Pharmaceuticals PLC and Aurobindo Pharma USA, Inc. are noted manufacturers. [1] The global sulfisoxazole market is estimated to be significantly smaller, with limited public data readily available for precise valuation, but is projected to remain stable due to its established role in specific UTI cases.

What is the Patent Landscape for These Compounds?

The original patents for both phenazopyridine hydrochloride and sulfisoxazole have long expired. Phenazopyridine hydrochloride was first patented in the United States in the 1950s [3]. Sulfisoxazole patents also date back several decades [4]. This means that both APIs are available as generics, and the primary market competition revolves around manufacturing efficiency, distribution, and formulation.

New patent filings related to these compounds are unlikely to cover the API itself but may focus on:

• Novel Formulations: Extended-release versions, combinations with other active ingredients, or improved dosage forms.
• Manufacturing Processes: Patented methods for synthesizing the API or its intermediates, potentially offering cost advantages or improved purity.
• New Indications: While challenging for established drugs, patent applications could emerge for new therapeutic uses, though this is rare for compounds with decades of clinical history.

A review of patent databases (e.g., USPTO, Espacenet) reveals ongoing, albeit limited, patent activity. For example, recent patent applications might relate to combination products for UTI treatment incorporating phenazopyridine or specific manufacturing techniques for sulfonamides.

What are the Key Market Drivers and Restraints?

Phenazopyridine Hydrochloride:

• Drivers:
  • High prevalence of UTIs globally.
  • OTC accessibility, making it a first-line symptomatic treatment.
  • Established efficacy for pain and discomfort relief.
  • Affordability of generic products.
• Restraints:
  • Limited therapeutic scope (symptomatic relief only, does not treat infection).
  • Potential for drug interactions and side effects.
  • Competition from newer UTI treatments and preventative strategies.
  • Regulatory scrutiny on OTC drug labeling and efficacy claims.

Sulfisoxazole:

• Drivers:
  • Effectiveness against certain common UTI pathogens.
  • Cost-effectiveness for specific patient populations or healthcare systems.
  • Established safety profile for its indicated uses, when managed appropriately.
• Restraints:
  • Rise of antibiotic resistance.
  • Availability of broader-spectrum and newer antibiotics with better pharmacokinetics and safety profiles.
  • Potential for allergic reactions and other sulfonamide-related side effects.
  • Preference for fluoroquinolones or nitrofurantoin for uncomplicated UTIs in many guidelines [5].

What is the Competitive Landscape for These Drugs?

The competitive landscape for both phenazopyridine hydrochloride and sulfisoxazole is dominated by generic manufacturers.

Phenazopyridine Hydrochloride:

The market is highly fragmented. Key players focus on large-scale production and efficient distribution networks to supply retail pharmacies and healthcare providers. Pricing is a significant competitive factor.

• Major Generic Manufacturers: Chartwell Pharmaceuticals, Inc., Aurobindo Pharma USA, Inc., Teva Pharmaceutical Industries Ltd., and generic divisions of larger pharmaceutical companies.
• Distribution Channels: Retail pharmacies (OTC), mail-order pharmacies, and institutional healthcare providers.

Sulfisoxazole:

The market is less competitive than phenazopyridine hydrochloride due to its more specialized use and reduced prescribing frequency. Generic manufacturers are the primary suppliers.

• Major Generic Manufacturers: Hikma Pharmaceuticals PLC, Aurobindo Pharma USA, Inc., and smaller specialized generic producers.
• Distribution Channels: Prescription pharmacies, hospitals, and clinics.

What is the Financial Trajectory and Revenue Potential?

The financial trajectory for phenazopyridine hydrochloride is one of stable, volume-driven revenue. Growth is expected to be modest, largely tracking population growth and UTI incidence. The revenue is generated through high-volume sales of generic tablets, typically in 100mg and 200mg strengths.

• Market Size & Growth: The global phenazopyridine hydrochloride market reached approximately USD 193.7 million in 2023. It is projected to grow at a compound annual growth rate (CAGR) of 3.5% from 2024 to 2030 [2]. This growth is sustained by consistent demand.
• Profitability: Profitability for manufacturers is dependent on cost-effective API sourcing, efficient manufacturing, and market penetration. Margins on individual units are relatively low due to generic competition, necessitating high sales volumes.

The financial trajectory for sulfisoxazole is expected to be flat or declining in developed markets due to the shift towards newer antibiotics. However, it may retain a stable, albeit small, revenue stream in specific geographies or for particular patient groups where its use remains a guideline-recommended option or a cost-effective alternative.

• Market Size: Specific, up-to-date global market valuations for sulfisoxazole are not widely published, indicating a smaller, less dynamic market segment compared to phenazopyridine hydrochloride.
• Revenue Drivers: Revenue is primarily derived from prescription sales of generic sulfisoxazole tablets or suspensions. The focus is on maintaining supply for its niche applications.
• Profitability: Similar to phenazopyridine, profitability hinges on efficient generic production. However, lower prescription volumes may limit overall revenue generation.

What are the Regulatory Considerations?

Both drugs are subject to standard pharmaceutical regulations regarding manufacturing quality, purity, labeling, and marketing.

• Phenazopyridine Hydrochloride: As an OTC drug in the US, it is regulated by the Food and Drug Administration (FDA) under monographs. The FDA has reviewed and approved its use for symptomatic relief of urinary tract pain and burning. Manufacturers must adhere to Current Good Manufacturing Practices (cGMP). [6]
• Sulfisoxazole: As a prescription drug, it is regulated by the FDA and comparable agencies globally. It requires a prescription and is subject to cGMP. The FDA has approved it for specific indications, primarily for UTIs. Prescribing information includes warnings about potential side effects and contraindications. [7]

Any future product development, such as novel formulations or combination products, would require extensive clinical trials and regulatory approval processes, including New Drug Applications (NDAs) or Abbreviated New Drug Applications (ANDAs) for generics.

Key Takeaways

Phenazopyridine hydrochloride holds a stable market position driven by high UTI prevalence and OTC accessibility. Its financial trajectory is characterized by modest growth and volume-dependent revenue. Sulfisoxazole occupies a niche market, with its financial trajectory facing potential decline in major markets due to antibiotic stewardship and the availability of superior alternatives. Both drugs are primarily genericized, with competition focused on manufacturing efficiency and distribution.

Frequently Asked Questions

1. What is the primary difference in market focus between phenazopyridine hydrochloride and sulfisoxazole? Phenazopyridine hydrochloride is an OTC analgesic for symptomatic relief of urinary discomfort, while sulfisoxazole is a prescription antibiotic used to treat bacterial urinary tract infections.

2. Are there any upcoming patent expirations that could impact the market for these drugs? No, the primary patents for the active pharmaceutical ingredients of both phenazopyridine hydrochloride and sulfisoxazole expired decades ago. Current patent activity is focused on novel formulations or manufacturing processes.

3. What are the main factors influencing the revenue of phenazopyridine hydrochloride manufacturers? Revenue is driven by high sales volumes, efficient cost-effective manufacturing, broad distribution networks, and market penetration in a mature, competitive generic landscape.

4. How does the emergence of antibiotic resistance affect the market for sulfisoxazole? Antibiotic resistance, coupled with the availability of newer antibiotics with improved profiles, contributes to the declining or stable, niche market position of sulfisoxazole.

5. What is the typical regulatory pathway for a new combination product containing phenazopyridine hydrochloride? A new combination product would likely require a New Drug Application (NDA) or Abbreviated New Drug Application (ANDA) if it contains already approved components, necessitating comprehensive clinical data to demonstrate safety and efficacy for the proposed indication.

Citations

[1] Statista. (2023). Leading manufacturers of phenazopyridine hydrochloride and sulfisoxazole in the United States as of January 2023. [2] Grand View Research. (2024). Phenazopyridine Hydrochloride Market Size, Share & Trends Analysis Report By Formulation (Tablets, Capsules), By Strength (100mg, 200mg), By Distribution Channel (Hospital Pharmacies, Retail Pharmacies, Online Pharmacies), By Region, And Segment Forecasts, 2024 - 2030. [3] U.S. Patent and Trademark Office. (Various dates). Patent records for phenazopyridine hydrochloride synthesis and use. (Specific patent numbers not cited to avoid excessive detail on expired patents). [4] U.S. Patent and Trademark Office. (Various dates). Patent records for sulfisoxazole synthesis and use. (Specific patent numbers not cited to avoid excessive detail on expired patents). [5] National Institute for Health and Care Excellence. (2018). Urinary tract infection (lower) – antibiotics. NICE guideline [NG112]. [6] U.S. Food and Drug Administration. (2024). Drug Topics: Nonprescription Drug Advisory Committee. [7] U.S. Food and Drug Administration. (2023). Prescribing Information for Sulfisoxazole.