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Last Updated: March 19, 2026

CHLOROTHIAZIDE Drug Patent Profile


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

Chlorothiazide is a drug marketed by Abc Holding, Hikma Intl Pharms, Lederle, Pharmobedient, Sandoz, Watson Labs, Hikma, Am Regent, Fresenius Kabi Usa, Gland, Rk Pharma, Sagent Pharms Inc, and Sun Pharm. and is included in twenty-four NDAs.

The generic ingredient in CHLOROTHIAZIDE is chlorothiazide sodium. There are forty-two drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the chlorothiazide sodium profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Chlorothiazide

A generic version of CHLOROTHIAZIDE was approved as chlorothiazide sodium by FRESENIUS KABI USA on October 16th, 2009.

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  • What is the 5 year forecast for CHLOROTHIAZIDE?
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  • What is Average Wholesale Price for CHLOROTHIAZIDE?
Summary for CHLOROTHIAZIDE
US Patents:0
Applicants:13
NDAs:24

US Patents and Regulatory Information for CHLOROTHIAZIDE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Abc Holding CHLOROTHIAZIDE chlorothiazide TABLET;ORAL 085569-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Gland CHLOROTHIAZIDE SODIUM chlorothiazide sodium INJECTABLE;INJECTION 218630-001 Oct 3, 2024 AP RX No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Pharmobedient CHLOROTHIAZIDE-RESERPINE chlorothiazide; reserpine TABLET;ORAL 087744-001 May 6, 1982 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Pharmobedient CHLOROTHIAZIDE chlorothiazide TABLET;ORAL 084217-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Chlorothiazide Investment Scenario and Fundamentals Analysis

Last updated: February 3, 2026

Overview
Chlorothiazide is a thiazide diuretic used primarily for hypertension and edema management. It has been on the market since the 1950s, with well-established efficacy and safety profiles. The global market for antihypertensive drugs, including chlorothiazide, is projected to grow modestly due to increasing hypertension prevalence worldwide, especially in emerging markets. The drug's patent has long expired; thus, future growth relies on generic availability, market penetration, and regulatory dynamics.

Market Dynamics

Aspect Data/Source
Global antihypertensive drugs market Valued at USD 30 billion in 2022; CAGR 3.5% through 2030 [1]
Chlorothiazide market share Estimated under 5%; declining due to generics and competition [2]
Generic drug penetration Represents over 90% of prescriptions in developed markets [3]
Price trends Average retail price for chlorothiazide tablets decreased by ~60% since patent expiry; still significant in volume [4]

Investment Considerations

  • Patent and Regulatory Status
    Chlorothiazide is off-patent. No new regulatory exclusivity is available, limiting differentiation potential. Its status as a generic compound means pricing pressure and competition are high.

  • Manufacturing and Supply Chain
    The product's straightforward synthesis and established manufacturing processes support stable supply. However, global disruptions can impact raw material availability, affecting margins.

  • Competitive Landscape
    Numerous generic manufacturers produce chlorothiazide. Market share shifts depend on pricing strategies, quality assurance, and distribution reach. Limited innovation opportunities exist due to the drug's age.

  • Market Penetration and Usage Trends
    In developed markets, usage has declined in favor of newer antihypertensives with improved side-effect profiles, such as ACE inhibitors and ARBs. Emerging markets still use chlorothiazide due to low cost and familiarity.

  • Reimbursement and Pricing
    Reimbursement policies favor low-cost generics. Price erosion continues, impacting revenue potential. Large-volume distribution is critical to maintain profitability.

  • Regulatory Risks
    Changes in regulations, such as reforms aimed at reducing drug prices, could further compress margins. Any safety concerns or reformulations could impact product viability.

Financial Fundamentals

Parameter Data/Analysis
Revenue Estimation (2022) Based on high prescription volume; assumes ~100 million tablets sold globally at USD 0.01 per tablet, potential USD 1 billion in sales (volume-dependent).
Gross Margin Estimated at 30-40%, typical for generics due to price competition.
R&D and Regulatory Costs Minimal, mainly for manufacturing compliance and regulatory renewals.
Market Growth Rate Slight decline in mature markets; stable or growing in select emerging markets.

Investment Risks

  • Declining prescriptions in developed markets.
  • Price pressure from generic competition.
  • Potential shifts toward newer classes of antihypertensives.
  • Regulatory environment changes impacting pricing or distribution.
  • Volatility in raw material costs.

Strategic Outlook

While direct innovation is limited, opportunities exist in increasing manufacturing efficiency, expanding into underserved markets, or combining chlorothiazide with other antihypertensives. However, overall growth prospects remain constrained by market saturation and patent expiration.


Key Takeaways

  • Chlorothiazide's core value lies in its low cost and established efficacy.
  • Market growth is limited; decline in certain regions due to newer drug preferences.
  • Price erosion and high competition significantly impact revenue.
  • Low R&D investment required; primary focus on manufacturing optimization and market access.
  • Investment potential hinges on market share stability in emerging markets and supply chain resilience.

Frequently Asked Questions

  1. What is the future outlook for chlorothiazide in developed markets?
    Usage is declining due to the adoption of newer antihypertensives with better side-effect profiles. Market share is shrinking, impacting long-term revenue prospects.

  2. Are there any regulatory barriers to manufacturing or selling chlorothiazide?
    No significant regulatory barriers exist currently. As a generic off-patent drug, it faces standard manufacturing and quality compliance requirements.

  3. Can innovations or new formulations revive chlorothiazide sales?
    Limited. The drug's age and the focus on newer therapies reduce innovation opportunities. Lifestyle formulations or combination products could offer minor niche expansions.

  4. How does pricing pressure affect profitability?
    Prices have fallen substantially over the past decade. Margins are squeezed, with gross margins estimated at 30-40%, depending on manufacturing efficiency and volume.

  5. What are the key risks for an investor in chlorothiazide?
    Market saturation, decreasing prescription volume in mature markets, pricing competition, and potential regulatory reforms targeting drug prices.


Citations

[1] MarketWatch. (2022). Global antihypertensive drugs market size.
[2] IMS Health. (2021). Antihypertensive drug market analysis.
[3] FDA. (2020). Generic drug market share data.
[4] Health Economics. (2022). Price trends in off-patent diuretics.

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