Last Updated: May 3, 2026

benzthiazide - Profile


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What are the generic sources for benzthiazide and what is the scope of freedom to operate?

Benzthiazide is the generic ingredient in five branded drugs marketed by Solvay, Pvt Form, Ah Robins Inc, and Pfizer, and is included in four NDAs. Additional information is available in the individual branded drug profile pages.

Summary for benzthiazide
US Patents:0
Tradenames:5
Applicants:4
NDAs:4

US Patents and Regulatory Information for benzthiazide

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Solvay AQUATAG benzthiazide TABLET;ORAL 016001-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Solvay AQUATAG benzthiazide TABLET;ORAL 016001-002 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Pvt Form BENZTHIAZIDE benzthiazide TABLET;ORAL 083206-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Ah Robins Inc EXNA benzthiazide TABLET;ORAL 012489-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Pfizer FOVANE benzthiazide TABLET;ORAL 012128-002 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Pfizer URESE benzthiazide TABLET;ORAL 012128-003 Approved Prior to Jan 1, 1982 DISCN No 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

Investment Scenario and Fundamentals Analysis for Benzthiazide

Last updated: February 20, 2026

Benzthiazide is a thiazide-like diuretic primarily used to treat hypertension and edema. Its market presence is limited relative to more current alternatives, often influencing its investment appeal. Below is a detailed analysis of its market landscape, regulatory environment, patent status, manufacturing considerations, and growth prospects.

Market Overview and Demand Drivers

Benzthiazide, introduced in the 1960s, now occupies a niche within diuretic therapies. Its sales have declined over recent decades, primarily replaced by newer drugs with improved safety profiles or simplified dosing. Major factors influencing demand include:

  • Disease prevalence: Hypertension affects approximately 1.3 billion globally [1]. Diuretics remain a first-line treatment.
  • Competition: Drugs like hydrochlorothiazide (HCTZ) dominate, with large market share and lower cost. Benzthiazide competes in a saturated and price-sensitive market.
  • Prescriber preferences: Preference for medications with better side effect profiles diminishes benzthiazide's usage.
  • Regulatory approvals: Existing approvals continue, with no recent regulatory barriers reported.

Regulatory and Patent Landscape

  • Regulatory status: Benzthiazide is approved in multiple countries, including the US and EU, predominantly for hypertension and edema.
  • Patent protection: The original patent expired decades ago. No recent patent filings or extensions are active.
  • Market exclusivity: No exclusivity rights significant enough to influence price or supply. Generic manufacturers dominate the market.

Manufacturing and Supply Chain Considerations

  • Production complexity: Benzthiazide synthesis involves standard chemical processes, with established supply chains.
  • Raw materials: Commodity chemicals with stable availability.
  • Manufacturing costs: Low, due to longstanding synthesis routes and generic status.

Competitive Position and Growth Potential

  • Market share: Small, as newer thiazide derivatives capture most prescriptions.
  • Pricing: Low due to generic competition, constraining margins.
  • Pipeline potential: No known reformulations or combination products in advanced development stages.
  • Regulatory trends: No upcoming regulatory reforms likely to impact benzthiazide specifically.

Strategic Investment considerations

Criterion Status Notes
Market size Declining Driven by substitution and generic dominance
Growth prospects Limited Lack of innovation or pipeline activity
Regulatory environment Stable No recent policy shifts affecting benzthiazide
Competitive landscape Saturated Predominance of generics with minimal differentiation
Manufacturing costs Low Standard processes with stable raw material prices

Risks

  • Decreasing demand due to shifts toward newer drugs.
  • Price erosion from intense generic competition.
  • Absence of patent protection limits pricing power.
  • Possible regulatory pressures on old fixed-dose formulations.

Opportunities

  • Niche applications where cost is less critical.
  • Potential reformulation or fixed-dose combinations to extend lifecycle.
  • Strategic partnerships with generic firms to maintain low-cost supply.

Conclusion

Benzthiazide presents a limited growth profile for investors. Its decline in use, lack of patent protection, and saturated market diminish its investment appeal. It functions primarily as a low-cost, generic medication with stable supply but limited upside.

Key Takeaways

  • Benzthiazide operates within a mature, highly competitive market dominated by generics.
  • No patent protection or pipeline prospects elevate risk and constrain profitability.
  • Manufacturing is straightforward, supporting stable supply chains.
  • Demand continues to decline as newer therapies replace older diuretics.
  • Investment viability hinges on niche applications or reformulation efforts, which currently have limited traction.

FAQs

  1. What are the main competitors to benzthiazide? Hydrochlorothiazide and other newer thiazide diuretics dominate the market.
  2. Can benzthiazide's market be revived? Unlikely without reformulation or new indications; current market trends favor newer agents.
  3. Is benzthiazide available as a generic? Yes, it is widely available as a generic medication.
  4. Are there any patented formulations of benzthiazide? No recent patents or formulations are known.
  5. What is the future outlook for benzthiazide? Limited; focus remains on low-cost production and supply rather than growth.

References

  1. World Health Organization. (2021). Hypertension. https://www.who.int/news-room/fact-sheets/detail/hypertension

[1] World Health Organization. (2021). Hypertension.

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