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Last Updated: April 3, 2026

hydrochlorothiazide; moexipril hydrochloride - Profile


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What are the generic drug sources for hydrochlorothiazide; moexipril hydrochloride and what is the scope of freedom to operate?

Hydrochlorothiazide; moexipril hydrochloride is the generic ingredient in two branded drugs marketed by Chartwell Rx, Glenmark Pharms, Heritage, Teva, and Ucb Inc, and is included in five NDAs. Additional information is available in the individual branded drug profile pages.

Summary for hydrochlorothiazide; moexipril hydrochloride
US Patents:0
Tradenames:2
Applicants:5
NDAs:5
Paragraph IV (Patent) Challenges for HYDROCHLOROTHIAZIDE; MOEXIPRIL HYDROCHLORIDE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
UNIRETIC Tablets hydrochlorothiazide; moexipril hydrochloride 7.5mg/12.5mg, 15 mg/25 mg and 15 mg/12.5 mg 020729 1 2004-01-15

US Patents and Regulatory Information for hydrochlorothiazide; moexipril hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Chartwell Rx MOEXIPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE hydrochlorothiazide; moexipril hydrochloride TABLET;ORAL 090096-001 Sep 25, 2008 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Chartwell Rx MOEXIPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE hydrochlorothiazide; moexipril hydrochloride TABLET;ORAL 090096-002 Sep 25, 2008 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Chartwell Rx MOEXIPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE hydrochlorothiazide; moexipril hydrochloride TABLET;ORAL 090096-003 Sep 25, 2008 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

Expired US Patents for hydrochlorothiazide; moexipril hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Ucb Inc UNIRETIC hydrochlorothiazide; moexipril hydrochloride TABLET;ORAL 020729-001 Jun 27, 1997 ⤷  Start Trial ⤷  Start Trial
Ucb Inc UNIRETIC hydrochlorothiazide; moexipril hydrochloride TABLET;ORAL 020729-002 Jun 27, 1997 ⤷  Start Trial ⤷  Start Trial
Ucb Inc UNIRETIC hydrochlorothiazide; moexipril hydrochloride TABLET;ORAL 020729-001 Jun 27, 1997 ⤷  Start Trial ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Investment Scenario and Fundamentals Analysis: Hydrochlorothiazide and Moexipril Hydrochloride

Last updated: February 7, 2026


What Are Hydrochlorothiazide and Moexipril Hydrochloride Used For?

Hydrochlorothiazide (HCTZ) is a thiazide diuretic prescribed mainly for hypertension and edema. It is on the World Health Organization's List of Essential Medicines and has widespread off-patent availability. Moexipril hydrochloride belongs to the angiotensin-converting enzyme (ACE) inhibitors class, used primarily for hypertension and heart failure. Both drugs have historically been cornerstone treatments, often used in combination therapies.


What Is the Patent and Market Lifecycle Status?

Hydrochlorothiazide:

  • Patent Status: Patents expired in the U.S., Europe, and other markets by the late 1990s. Generic versions dominate globally.
  • Market Longevity: Maintains steady demand given its cost-effectiveness and inclusion in treatment guidelines.
  • Market Entrants: High competition; manufacturing is mature. Limited innovation potential.

Moexipril Hydrochloride:

  • Patent Status: Patented until approximately 2004 in the U.S.; generic versions available since then.
  • Market Longevity: Prescribes mainly in combination therapies; market size stable but limited.
  • Competitiveness: Faces competition from other ACE inhibitors such as lisinopril, ramipril, and enalapril.

What Are the Current Market Dynamics?

Parameter Hydrochlorothiazide Moexipril Hydrochloride
Global Market Size (2022) Estimated US$500 million (including combination drugs) Approx. US$50 million (limited by market size)
Pricing Trends Prices declined ~50% over last decade (off-patent supply) Stable but marginalized due to newer ACE inhibitors
Growth Drivers Demand for cost-effective hypertension treatment Prescribed mainly in combination therapy for hypertension

Hydrochlorothiazide remains a staple due to low cost and established efficacy, but it faces decreasing demand for monotherapy as newer, better-tolerated options emerge. Moexipril's market roles are limited; newer ACE inhibitors or ARBs dominate in prescriptions and market share.


What Are the R&D and Regulatory Trends?

  • No recent significant R&D efforts for hydrochlorothiazide; focus has shifted to combination therapies and drug delivery improvements.
  • Moexipril and similar ACE inhibitors generally face minimal R&D due to patent expiries. Focus has shifted to biosimilars and fixed-dose combinations.

Regulatory challenges have been minimal; generic approvals in key markets have saturated the supply chain.


What Are the Investment Risks?

  • Market Saturation: Hydrochlorothiazide's generic status depresses prices and margins.
  • Limited Innovation: No ongoing substantial R&D projects, reducing future growth prospects.
  • Regulatory Environment: Strict generic approvals may increase compliance costs, but not a primary concern for existing products.
  • Market Shift: Preference for newer therapies (e.g., chlorthalidone over hydrochlorothiazide or ARBs over ACE inhibitors).

What Scenarios Are Possible?

  1. Stable Revenue, Low Growth: The drugs sustain steady cash flow due to legacy status but with minimal growth.
  2. Price Erosion and Marginal Decline: Competitive pressures drive prices down, squeezing margins further.
  3. Potential for Combination Therapy Development: Niche development in fixed-dose combinations could prolong relevance, though competition is intense.
  4. Market Exit or Reduced R&D Focus: Companies could divest or reduce R&D investments due to marginal returns.

What Are Key Investment Considerations?

  • Low Margin, High Market Maturity: Investflection should be cautious. Entry is feasible, but returns are limited.
  • Patent Expiry Effects: Patent expiries have saturated markets; new entrants face thin margins.
  • Portfolio Strategy: Suitable for portfolio diversification in low-risk, steady-income assets. Less attractive for high-growth targets.

What Do Broader Trends Suggest for Future Investment?

  • The shift toward personalized medicine and combination therapies could marginalize monotherapies like hydrochlorothiazide and Moexipril.
  • Biosimilar and generic competition will intensify, pressuring profit margins.
  • R&D focus in hypertension is moving toward novel drug classes, not me-too versions of existing drugs.

Key Takeaways

  • Hydrochlorothiazide and Moexipril Hydrochloride possess a mature, commoditized market profile with limited growth potential.
  • Legacy status and off-patent competition lead to low margins and declining prices.
  • Investment opportunities are more favorable in diversified portfolios rather than as standalone assets.
  • Future prospects depend on niche applications like fixed-dose combinations or reformularization.
  • Regulatory trends favor generic manufacturers; innovation-driven investment is unlikely.

Frequently Asked Questions

Q1: Are hydrochlorothiazide and moexipril still viable for new drug development?
A1: No. Market saturation, low margins, and limited innovation reduce incentives for new development.

Q2: Can combining these drugs with new therapies improve their market longevity?
A2: Possible in niche markets. Fixed-dose combinations could extend relevance, but competition is stiff.

Q3: What markets are most favorable for investing in these drugs?
A3: Emerging markets with less access to newer medications may offer stable demand, albeit at lower margins.

Q4: How does patent expiration impact future profitability?
A4: Patent expiry generally leads to price erosion and increased competition, reducing profitability.

Q5: Are there regulatory or legal risks associated with these drugs?
A5: Generally low, though regulatory adjustments for quality and manufacturing standards can influence supply chains.


References

  1. World Health Organization. WHO Model List of Essential Medicines, 22nd list, 2021.
  2. IQVIA. Global hypertension drug market data, 2022.
  3. U.S. FDA. Patent status and expiration data, 2023.
  4. MarketWatch. Generic antihypertensive drug market analysis, 2022.
  5. PharmExec. Trends in hypertension treatment and drug development, 2023.

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