Last Updated: May 1, 2026

Benzthiazide - Generic Drug Details


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What are the generic sources for benzthiazide and what is the scope of patent protection?

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.

There is one drug master file entry for benzthiazide.

Summary for benzthiazide
US Patents:0
Tradenames:5
Applicants:4
NDAs:4
Drug Master File Entries: 1
Raw Ingredient (Bulk) Api Vendors: 63
DailyMed Link:benzthiazide at DailyMed

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
Pvt Form BENZTHIAZIDE benzthiazide TABLET;ORAL 083206-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Solvay AQUATAG benzthiazide TABLET;ORAL 016001-001 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
Pfizer FOVANE benzthiazide TABLET;ORAL 012128-002 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

Market and Financial Landscape for Benzthiazide

Last updated: February 7, 2026

Overview and Current Market Position

Benzthiazide, a thiazide diuretic, is primarily used to treat hypertension and edema. It has been available since the 1950s, with multiple generic formulations. Market entry remains stable as generic competition limits pricing power, but overall demand has plateaued with the shift toward newer diuretics.

Market Size and Growth

In 2022, the global diuretic market was valued at approximately $2.5 billion. Benzthiazide's specific share is minimal; the broader demand stems from the hypertensive and edema patient populations, estimated at multiple hundreds of millions worldwide. The growth rate for benzthiazide remains flat at around 1-2%, reflecting stagnating demand for traditional diuretics and increasing adoption of combination therapies with newer agents.

Competitive Landscape

The market comprises a few key generic manufacturers, with no recent patent barriers. The low entry barriers foster price competition. Top players include Teva Pharmaceutical Industries, Sandoz (Novartis), and Sun Pharmaceutical Industries.

Pricing and Revenue Trends

Average wholesale prices for benzthiazide tablets have declined by approximately 20% over the past five years due to generic competition. Revenue estimates for major generics producers suggest annual sales per company in the range of $10 million to $50 million globally. The potential for volume growth remains constrained by the dominance of combination drugs and newer antihypertensive classes.

Regulatory and Patent Landscape

Benzthiazide has been off patent for decades. No significant patent protections currently exist. Regulatory bodies such as the FDA have granted approvals for numerous generic versions, streamlining market entry.

Development Pipeline and Innovation

There are no major ongoing clinical trials or formulation innovations explicitly targeting benzthiazide. The focus in antihypertensive therapy shifts toward combination drugs with longer duration and fewer side effects, decreasing the prospective demand for standalone benzthiazide formulations.

Financial Trajectory Projections

  • Revenue: Expected to remain stable or decline marginally, given current market dynamics, with potential annual decreases of 2-3% for manufacturers relying solely on benzthiazide.
  • Profitability: Margins are thin, impacted by price erosion. Companies reporting gross margins of 25-35% on generic diuretics face challenges in maintaining profitability.
  • R&D Investment: Minimal, as the drug is established; most firms allocate R&D funds elsewhere.

Market Risks and Opportunities

  • Risks:
    • Increasing generic price pressures.
    • Transition toward combination therapies reducing standalone drug demand.
    • Regulatory changes favoring newer, patent-protected drugs.
  • Opportunities:
    • Potential niche uses, such as in specific patient subsets resistant to other diuretics.
    • Reformulation or fixed-dose combinations integrating benzthiazide to extend lifecycle.

Summary

Benzthiazide's market remains mature with limited growth prospects. Competitive dynamics favor generic manufacturers with established production, but margins are under pressure. The trajectory indicates continued stagnation or slight decline unless new formulations or indications emerge.


Key Takeaways

  • Market value for benzthiazide is declining due to generics and shift to newer antihypertensive agents.
  • Revenue stability is threatened by price erosion, with no new patent protections.
  • The drug's role diminishes as combination therapies dominate hypertension treatment.
  • Future prospects depend on niche applications or lifecycle extension strategies.
  • Major players focus on innovation in related combination drugs rather than benzthiazide monotherapy.

FAQs

  1. What is the current patent status of benzthiazide?
    It has been off patent for decades; no active patent protections exist.

  2. How does the market for benzthiazide compare to other diuretics?
    It has a smaller market share, with other diuretics like hydrochlorothiazide dominating due to longer usage and more established prescribing patterns.

  3. Are there any ongoing clinical trials for benzthiazide?
    No significant clinical trials are currently underway specifically for benzthiazide.

  4. Can benzthiazide be used in combination therapies?
    Yes, but it is increasingly replaced by fixed-dose combinations with other antihypertensives, which may diminish the demand for standalone benzthiazide.

  5. What are the main drivers for future viability of benzthiazide?
    Niche therapeutic needs or reformulation into combination drugs may offer future opportunities.


References

[1] MarketResearch.com, "Global Diuretics Market," 2022.
[2] IQVIA, "Generics Market Trends," 2022.
[3] FDA Database, "Approved Generic Drugs," 2023.

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