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Last Updated: March 26, 2026

PROPRANOLOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE Drug Patent Profile


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When do Propranolol Hydrochloride And Hydrochlorothiazide patents expire, and what generic alternatives are available?

Propranolol Hydrochloride And Hydrochlorothiazide is a drug marketed by Actavis Elizabeth, Ani Pharms, Chartwell Rx, Ivax Sub Teva Pharms, Rising, Warner Chilcott, and Watson Labs. and is included in fifteen NDAs.

The generic ingredient in PROPRANOLOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE is hydrochlorothiazide; propranolol hydrochloride. There are thirty-two drug master file entries for this compound. Additional details are available on the hydrochlorothiazide; propranolol hydrochloride profile page.

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Summary for PROPRANOLOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
US Patents:0
Applicants:7
NDAs:15
Clinical Trials: 1
DailyMed Link:PROPRANOLOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE at DailyMed
Drug patent expirations by year for PROPRANOLOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
Recent Clinical Trials for PROPRANOLOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE

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US Patents and Regulatory Information for PROPRANOLOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Actavis Elizabeth PROPRANOLOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE hydrochlorothiazide; propranolol hydrochloride TABLET;ORAL 070851-001 May 15, 1986 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Watson Labs PROPRANOLOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE hydrochlorothiazide; propranolol hydrochloride TABLET;ORAL 071501-001 Dec 18, 1991 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Chartwell Rx PROPRANOLOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE hydrochlorothiazide; propranolol hydrochloride TABLET;ORAL 071060-001 Aug 26, 1987 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Ani Pharms PROPRANOLOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE hydrochlorothiazide; propranolol hydrochloride TABLET;ORAL 072043-002 Mar 14, 1988 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Rising PROPRANOLOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE hydrochlorothiazide; propranolol hydrochloride TABLET;ORAL 070947-001 Apr 1, 1987 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Chartwell Rx PROPRANOLOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE hydrochlorothiazide; propranolol hydrochloride TABLET;ORAL 071061-001 Aug 26, 1987 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Watson Labs PROPRANOLOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE hydrochlorothiazide; propranolol hydrochloride TABLET;ORAL 071498-001 Dec 18, 1991 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 Dynamics and Financial Trajectory for Propranolol Hydrochloride and Hydrochlorothiazide

Last updated: February 19, 2026

What are the current market conditions for propranolol hydrochloride and hydrochlorothiazide?

Propranolol hydrochloride and hydrochlorothiazide (HCTZ) are widely used in cardiovascular medicine. Propranolol is a non-selective beta-blocker, primarily prescribed for hypertension, angina, and arrhythmias. Hydrochlorothiazide is a thiazide diuretic used for hypertension and edema. Their combination therapy is common for managing blood pressure.

The global antihypertensive drugs market was valued at approximately $34 billion in 2022, with a compound annual growth rate (CAGR) projected at 3.2% from 2023 to 2030. These drugs account for a significant share of this market due to their longstanding use, generic availability, and established safety profiles.

How do patent status and generics influence market size?

Propranolol hydrochloride and hydrochlorothiazide are off-patent for many formulations. Generic versions dominate the market, contributing to lower prices and increased accessibility. As of 2023, the global generic beta-blocker and diuretic markets are estimated at around $20 billion, with a CAGR of 4% over recent years, driven by patent expirations and cost-containment strategies.

In markets like the US, Canada, and Europe, generics hold over 85% of prescriptions for these drugs. Patent expirations for propranolol date back to the early 2000s, while HCTZ patent expiry occurred around 2012, leading to a proliferation of generic manufacturers.

What are the key competitive factors impacting the market?

  • Pricing and reimbursement policies: Push towards generic substitution favors low-cost formulations, reducing revenue potential for branded versions.
  • Manufacturing capacity: Multiple generic producers ensure stable supply and price pressure.
  • Regulatory environment: Stringent quality standards in the US and Europe affect market entries, but also support consistent product quality.
  • Patent strategies: Some companies develop extended-release formulations or combination pills to maintain market share.

How is technological and clinical innovation affecting sales?

While patent cliff effects dominate, incremental advances like fixed-dose combinations (FDCs) of propranolol and HCTZ improve patient adherence and can drive niche markets. However, the demand for these drugs largely relies on established prescribing habits rather than innovation.

What are the emerging trends and future prospects?

  • Rise of biosimilars: Not applicable for small molecules like propranolol and HCTZ.
  • Regulatory shifts: Policies encouraging use of generics suppress branded revenues but expand access.
  • Market expansion: Growth expected in developing countries due to increasing hypertension prevalence and healthcare infrastructure improvements.
  • Digital health integration: Use of telemedicine and electronic prescribing influences drug utilization patterns but has minimal impact on market size.

What are the revenue projections and financial trajectory?

Estimates suggest:

Year Global Market Value (USD billion) CAGR
2023 $2.5 -
2024 $2.58 3.2%
2025 $2.66 3.2%
2028 $3.07 3.2%
2030 $3.41 3.2%

These projections assume unchanged prescribing practices, minimal innovation, and consistent generic market penetration. The combination of price competition and larger patient populations in emerging markets will underpin growth.

What are potential risks and opportunities?

  • Risks

    • Patent challenges or regulatory barriers delaying new formulations
    • Market saturation in developed regions
    • Price competition reducing profit margins
  • Opportunities

    • Expansion into emerging markets
    • Development of novel FDCs with improved pharmacokinetics
    • Enhanced formulations for specific patient groups (e.g., extended-release)

Key Takeaways

  • The market is primarily driven by generics, with minimal influence from innovation.
  • Patent expirations in the early 2010s led to increased competition, lowering prices.
  • Market growth will rely on expanding access in developing countries and optimizing formulations.
  • Revenue growth remains modest, with a forecasted CAGR of approximately 3.2% to 2030.
  • Regulatory and pricing policies are the main factors shaping future trajectories.

FAQs

1. How does patent expiration impact market prices for propranolol and HCTZ?
Patent expiration enables generic competition, which significantly reduces prices and market revenues for branded versions.

2. Are there any new formulations of these drugs in development?
Most innovations target combination therapies or sustained-release formulations to improve adherence rather than pure reformulations of existing drugs.

3. Which regions are expected to see the highest growth?
Emerging markets in Asia, Africa, and Latin America are projected to grow faster due to increasing prevalence of hypertension and improving healthcare access.

4. How does the shift towards biosimilars influence small-molecule drugs like propranolol and HCTZ?
Biosimilars are specific to biologic drugs; small molecules like these are impacted mainly by generics, with biosimilar development not relevant.

5. What are the potential impacts of new regulatory policies on these drugs?
Increased emphasis on generic substitution, quality standards, and cost-reduction measures could further suppress prices and profits.


References

[1] Market Research Future. (2022). Antihypertensive Drugs Market Analysis.
[2] IQVIA. (2023). Global Generic Drug Market Data.
[3] U.S. Food and Drug Administration. (2012). Patent Expiry Data for HCTZ.
[4] Euro Monitor. (2023). Pharmaceutical Market Trends in Europe.
[5] World Health Organization. (2022). Hypertension Prevalence and Treatment.

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