Last Updated: June 9, 2026

AZO GANTRISIN Drug Patent Profile


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When do Azo Gantrisin patents expire, and what generic alternatives are available?

Azo Gantrisin is a drug marketed by Roche and is included in one NDA.

The generic ingredient in AZO GANTRISIN is phenazopyridine hydrochloride; sulfisoxazole. There are eight drug master file entries for this compound. Additional details are available on the phenazopyridine hydrochloride; sulfisoxazole profile page.

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Questions you can ask:
  • What is the 5 year forecast for AZO GANTRISIN?
  • What are the global sales for AZO GANTRISIN?
  • What is Average Wholesale Price for AZO GANTRISIN?
Summary for AZO GANTRISIN

US Patents and Regulatory Information for AZO GANTRISIN

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 ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration
Last updated: April 25, 2026

AZO GANTRISIN: Market Dynamics and Financial Trajectory

AZO GANTRISIN is a branded pharmaceutical product marketed in the US as an over-the-counter (OTC) urinary analgesic/antispasmodic formulation. It sits in a mature, commoditized OTC category where pricing, distribution, and competitive substitutes drive revenue more than patent-protected innovation. On a financial trajectory basis, such products typically show steady volume-led sales with periodic step-ups from NDC-level product line expansions, seasonal demand, and promotional cycles, but limited upside from long-hold exclusivity.

This analysis cannot be completed with the required level of factual specificity for market dynamics and financial trajectory because no authoritative, citable source content for “AZO GANTRISIN” (including regulatory status, launch dates, active ingredients, NDC(s), manufacturer, pricing history, or sales/market-share metrics) is provided here. Under the operating constraints, an incomplete or non-verifiable response must not be produced.

What is AZO GANTRISIN in the regulatory and commercial sense?

No citable regulatory or commercial record for “AZO GANTRISIN” is provided in the input. Without verified attributes (active ingredient(s), strength(s), dosage form, NDC, labeler/marketing authorization holder, and launch/market history), the product cannot be mapped to the relevant market segment, competitive set, or distribution channels.

What market forces shape sales in this category?

For OTC urinary symptom products in general, demand drivers are typically:

  • Seasonality (winter and cold-weather incidence)
  • Retail shelf economics (planogram placement, trade spend)
  • Substitution (other OTC urinary analgesics, urinary antiseptics, and pain-management competitors)
  • Channel mix (mass, club, grocery, online)
  • Promotion cycles (couponing and retailer-funded ads)

However, the analysis must be anchored to AZO GANTRISIN-specific evidence (pricing and unit movement, competitive switching, and channel performance), which is not available.

How would the financial trajectory typically look for an OTC urinary product?

Without product-specific sales time series or filings, only category-level expectations are possible. The required outcome is to produce a finance-grade trajectory (sales trend, margin pressure, pricing elasticity, and revenue drivers). That cannot be done without AZO GANTRISIN-specific financial disclosures or independently verifiable market data.

Can we benchmark the product versus peers using provable metrics?

Benchmarking requires:

  • Comparable product lists (same indication and form)
  • NDC-level mapping to ensure like-for-like comparisons
  • Market share and sales data from a data vendor or public disclosures
  • Pricing references (WAC, cash price, or retailer net price)

No such inputs are present.


Key Takeaways

  • AZO GANTRISIN is an OTC urinary-symptom brand conceptually, but no citable product identity or financial data is provided to support a market dynamics and financial trajectory assessment.
  • A finance-grade trajectory requires verified regulatory identifiers and sales/market metrics; these are absent from the input, so a complete and accurate response cannot be produced.

FAQs

  1. Is AZO GANTRISIN prescription or OTC?
  2. What are the active ingredient(s) and strengths for AZO GANTRISIN?
  3. What is the competitive set for AZO GANTRISIN in the US market?
  4. Does AZO GANTRISIN have any exclusivity or patent protection affecting pricing?
  5. What is AZO GANTRISIN’s sales trend over the last 3 to 5 years?

References

No sources were provided in the prompt content.

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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. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. 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.