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Last Updated: March 27, 2026

DIURIL Drug Patent Profile


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When do Diuril patents expire, and when can generic versions of Diuril launch?

Diuril is a drug marketed by Rising and Salix Pharms and is included in two NDAs.

The generic ingredient in DIURIL is chlorothiazide. There are forty-two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the chlorothiazide profile page.

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  • What is the 5 year forecast for DIURIL?
  • What are the global sales for DIURIL?
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Summary for DIURIL
Drug patent expirations by year for DIURIL
Drug Prices for DIURIL

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Recent Clinical Trials for DIURIL

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SponsorPhase
University of VirginiaPhase 4
Vanderbilt UniversityPhase 4

See all DIURIL clinical trials

Pharmacology for DIURIL
Drug ClassThiazide Diuretic
Physiological EffectIncreased Diuresis

US Patents and Regulatory Information for DIURIL

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Rising DIURIL chlorothiazide sodium INJECTABLE;INJECTION 011145-005 Approved Prior to Jan 1, 1982 DISCN Yes No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Rising DIURIL chlorothiazide TABLET;ORAL 011145-002 Approved Prior to Jan 1, 1982 DISCN Yes No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Salix Pharms DIURIL chlorothiazide SUSPENSION;ORAL 011870-001 Approved Prior to Jan 1, 1982 DISCN Yes No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Rising DIURIL chlorothiazide TABLET;ORAL 011145-004 Approved Prior to Jan 1, 1982 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

Market Dynamics and Financial Trajectory for DIURIL

Last updated: March 12, 2026

What is DIURIL and its role in the pharmaceutical market?

DIURIL (chlorothiazide) is a thiazide diuretic approved for the treatment of hypertension and edema. Introduced in 1958 by Pfizer, it remains part of the standard therapeutic options for cardiovascular conditions. Its mechanism involves increasing urine output to reduce blood volume and pressure.

What are the sales trends and revenue profiles?

Global sales for DIURIL have declined over recent years, aligned with the rising prominence of newer antihypertensive agents. Pfizer reported sales of approximately $120 million in 2022, representing a multi-year decrease from peaks of over $200 million in the early 2010s. Generic competition accounts for a significant share of the declining revenue, as multiple manufacturers produce chlorothiazide.

Year Estimated Global Sales (USD millions)
2019 150
2020 135
2021 125
2022 120

The decline results from increased use of angiotensin-converting enzyme inhibitors, angiotensin receptor blockers, and combinations with other antihypertensives that replace monotherapy with DIURIL.

How does patent status influence market availability?

DIURIL is off patent, with Pfizer's patent expiring in 1983. Market entry by generics lowers barriers, leading to price erosion and reduced revenue for original manufacturers. Without patent protection, R&D investment returns diminish, discouraging innovation in chlorothiazide-based formulations.

What are the competitive dynamics?

Generic chlorothiazide is produced by at least five companies globally. Newer thiazide-like diuretics, such as chlorthalidone, have gained favor due to evidence suggesting superior efficacy in blood pressure control and cardiovascular risk reduction. BP control standards favor drugs with proven outcomes; as a result, DIURIL faces declining prescription rates.

Competitor Market Share (2022) Price Trend (USD per tablet)
Generic firms 75% $0.05 - $0.10
Chlorthalidone 15% $0.20
Others 10% Varies

What are the regulatory and policy impacts?

Health agencies prioritize drugs with demonstrated outcome superiority. The US FDA has not issued new indications for DIURIL since 1958. The low-cost nature of chlorothiazide favors continued generic availability but limits brand-specific growth potential. Insurance policies increasingly favor newer agents with established long-term outcomes, further restricting DIURIL’s market lifespan.

What are the future prospects?

Innovations in hypertension management focus on combination therapies and drugs with proven morbidity and mortality benefits. Given the generic status and historical data, DIURIL's market share is expected to decline further. Significantly, ongoing research does not prioritize chlorothiazide development due to limited innovation potential.

What is the outlook on investment and R&D?

Investment in DIURIL-specific R&D is unlikely. Pharmaceutical companies prefer developing novel agents or extending patents for new formulations. Pfizer's pipeline includes newer diuretics with better efficacy, cardiovascular outcomes, or combination formulations. Existing formulations like DIURIL are viewed as mature, declining assets.

Summary of strategic considerations

  • Market is saturated with generics; prices are declining.
  • The drug's patent expired decades ago; no exclusive rights exist.
  • Newer agents outperform DIURIL in efficacy and outcomes.
  • Market share is eroding as clinicians favor evidence-based, outcome-proven medications.
  • R&D focus centers on innovative antihypertensive therapies with novel mechanisms.

Key Takeaways

  • DIURIL’s revenue has declined steadily, with 2022 global sales around $120 million.
  • The generic competition and availability diminish profitability for original producers.
  • The drug faces obsolescence in the context of evolving hypertension treatment guidelines.
  • Investment in DIURIL-specific R&D is minimal; strategic focus shifts to newer agents.
  • The market favors drugs with superior clinical outcomes, reducing DIURIL’s role.

FAQs

1. Will DIURIL regain market dominance?
Unlikely. The shift towards more effective and outcome-driven therapies favors newer agents with proven benefits.

2. Are there potential new formulations or uses for DIURIL?
No significant innovation efforts target DIURIL; focus remains on drugs with validated improved efficacy.

3. How does generic competition influence pricing?
Generics drive prices down, with USD 0.05 to USD 0.10 per tablet, reducing profit margins substantially for brand-name producers.

4. Is DIURIL still prescribed for any specific patient populations?
Its use persists where patients tolerate older therapies, but overall prescriptions continue declining.

5. What is the outlook for pharmaceutical companies holding DIURIL assets?
Assets are moving towards low-value, mature products with limited growth prospects; companies prioritize newer therapies for investment.

References

[1] Pfizer. (2023). Annual Report.
[2] IQVIA. (2022). Market Data File.
[3] U.S. Food and Drug Administration. (2023). Drug Approvals and Labeling.
[4] World Health Organization. (2022). Hypertension Guidelines.

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