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Last Updated: December 18, 2025

HYDROCHLOROTHIAZIDE; PROPRANOLOL HYDROCHLORIDE - Generic Drug Details


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What are the generic drug sources for hydrochlorothiazide; propranolol hydrochloride and what is the scope of patent protection?

Hydrochlorothiazide; propranolol hydrochloride is the generic ingredient in seven branded drugs marketed by Wyeth Ayerst, Wyeth Pharms Inc, Duramed Pharms Barr, Actavis Elizabeth, Ani Pharms, Chartwell Rx, Ivax Sub Teva Pharms, Rising, Warner Chilcott, and Watson Labs, and is included in nineteen NDAs. Additional information is available in the individual branded drug profile pages.

Summary for HYDROCHLOROTHIAZIDE; PROPRANOLOL HYDROCHLORIDE
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US Patents and Regulatory Information for HYDROCHLOROTHIAZIDE; PROPRANOLOL HYDROCHLORIDE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Rising PROPRANOLOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE hydrochlorothiazide; propranolol hydrochloride TABLET;ORAL 070947-002 Mar 4, 1987 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Warner Chilcott PROPRANOLOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE hydrochlorothiazide; propranolol hydrochloride TABLET;ORAL 071771-001 Jan 26, 1988 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Ani Pharms PROPRANOLOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE hydrochlorothiazide; propranolol hydrochloride TABLET;ORAL 070705-002 Oct 1, 1986 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Wyeth Ayerst INDERIDE LA 80/50 hydrochlorothiazide; propranolol hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 019059-001 Jul 3, 1985 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

Expired US Patents for HYDROCHLOROTHIAZIDE; PROPRANOLOL HYDROCHLORIDE

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Wyeth Ayerst INDERIDE LA 120/50 hydrochlorothiazide; propranolol hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 019059-002 Jul 3, 1985 4,138,475 ⤷  Get Started Free
Wyeth Ayerst INDERIDE LA 80/50 hydrochlorothiazide; propranolol hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 019059-001 Jul 3, 1985 4,138,475 ⤷  Get Started Free
Wyeth Ayerst INDERIDE LA 160/50 hydrochlorothiazide; propranolol hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 019059-003 Jul 3, 1985 4,138,475 ⤷  Get Started Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Market Dynamics and Financial Trajectory for Hydrochlorothiazide and Propranolol Hydrochloride

Last updated: July 27, 2025

Introduction

Hydrochlorothiazide (HCTZ) and propranolol hydrochloride are longstanding cornerstone medications within cardiovascular therapeutics. Their established efficacy, broad adoption, and regulatory approval have defined their presence in the pharmaceutical landscape for decades. As market forces and healthcare trends evolve, understanding their current market dynamics and projected financial trajectory is essential for stakeholders, including manufacturers, investors, and healthcare providers.

Market Overview of Hydrochlorothiazide

Hydrochlorothiazide is a thiazide diuretic primarily indicated for hypertension and edema. Since its approval in the 1950s, HCTZ has maintained prominence due to its cost-effective profile and proven efficacy. It remains one of the most prescribed antihypertensive agents worldwide, underpinning its market stability.

Market Dynamics

  • Market Penetration and Usage: HCTZ's extensive history and inclusion in numerous combination therapies solidify its status in managing hypertension globally. It often serves as a first-line agent, especially in resource-limited settings owing to its low cost and generic availability.

  • Patent and Regulatory Status: Being off-patent since the late 20th century, HCTZ is predominantly sold as a generic product, leading to intense price competition. This commoditization suppresses revenue growth but sustains volume-driven sales.

  • Competitive Landscape: Key competitors include other diuretics (e.g., chlorthalidone), calcium channel blockers, and ACE inhibitors. The advent of fixed-dose combinations (FDCs) incorporating HCTZ amplifies its market presence but also constrains individual formulation profits.

  • Market Challenges: Recent clinical insights highlight potential limitations of HCTZ regarding its comparative efficacy versus newer antihypertensives. Moreover, the emergence of newer drug classes with better side effect profiles influences prescribing patterns.

Financial Trajectory

  • While revenues for HCTZ have plateaued due to generic proliferation and price erosion, overall global volume sales remain robust. In established markets like North America and Europe, sales are stabilizing; however, emerging economies exhibit growing demand, owing to the rising prevalence of hypertension.

  • The market is characterized by low margins, with manufacturers relying on high-volume sales and regional expansion.

Market Overview of Propranolol Hydrochloride

Propranolol hydrochloride is a non-selective beta-adrenergic blocker introduced in the 1960s. Its versatility spans hypertension, arrhythmias, migraine prophylaxis, and performance anxiety, driving widespread adoption.

Market Dynamics

  • Established Therapeutic Use: Long-term safety and efficacy underpin its continuous prescription. Similar to HCTZ, propranolol is off-patent, fostering a predominantly generic market.

  • Regulatory and Patent Landscape: The absence of patent protection has shifted revenue models from proprietary formulations to volume-based sales, with most profits stemming from regional markets with high disease burden.

  • Competitive Environment: The rise of cardioselective beta-blockers (like atenolol and metoprolol) introduces fierce competition. Additionally, the development of newer antihypertensive classes impacts propranolol's market share.

  • Market Challenges and Opportunities: Growing concerns about non-selective beta-blockers' side effects and contraindications (e.g., asthma) influence physician prescribing behavior. Nonetheless, propranolol remains a first-line agent in specific indications such as migraine prevention and certain arrhythmias.

Financial Trajectory

  • The global sales outlook for propranolol has experienced gradual decline in developed markets. However, in regions with less access to newer therapies, sustained demand persists.

  • Manufacturers benefit from stable, mature markets with high prescription volume but face pressure on profit margins due to generic price competition.

Factors Influencing Market Dynamics and Financial Outlook

Regulatory Environment

Regulatory developments, such as updates to treatment guidelines or the introduction of strict generic regulations, critically affect market access and pricing.

Evolving Clinical Guidelines

  • Shifts favoring newer antihypertensive agents, particularly angiotensin receptor blockers (ARBs) and calcium channel blockers, marginalize traditional drugs like HCTZ and propranolol in certain markets.

  • Conversely, newer data supporting the continued use of generic diuretics and beta-blockers sustain demand in resource-limited settings.

Technological and Formulation Innovations

  • Development of fixed-dose combination therapies incorporating HCTZ or propranolol enhances patient adherence and may positively influence market share.

  • Novel delivery mechanisms or formulations could potentially command premium pricing, although this remains limited for off-patent drugs.

Market Expansion

  • Emerging markets, due to rising hypertension and cardiovascular disease prevalence, represent a significant growth opportunity.

  • Population aging further boosts long-term demand.

Projected Financial Trajectory

Short-term Outlook (Next 3-5 Years)

  • Hydrochlorothiazide: Sales are expected to plateau in mature markets, with modest growth driven by expansion in developing regions. Price pressures remain predominant, with margins squeezed by generic competition.

  • Propranolol Hydrochloride: Marginal decline anticipated in developed economies; however, stable demand persists in niche indications and emerging markets. The market remains fragmented with limited incremental revenue prospects.

Long-term Outlook (Beyond 5 Years)

  • Market Consolidation: Increased generic competition may lead to market consolidation, with leading players potentially capturing larger market shares through distribution networks and quality assurance.

  • Regulatory and Clinical Shifts: Future updates to clinical guidelines or new safety data could either sustain or reduce demand, depending on the drug's positioning.

  • Potential Disruption: Emerging therapies or biosimilar entrants—though less likely given the nature of these small-molecule drugs—could impact future profitability.

Conclusion

Hydrochlorothiazide and propranolol hydrochloride continue to be vital tools in cardiovascular therapeutics, albeit in a matured and fiercely competitive market landscape. Their financial stability depends largely on volume sales, regional demand, regulatory environments, and evolving treatment guidelines. While near-term revenue growth appears limited, long-term prospects in emerging markets and through formulation innovations may offer incremental opportunities.

Stakeholders should monitor regulatory trends, clinical guideline updates, and regional market expansions to adapt strategies accordingly.


Key Takeaways

  • Both HCTZ and propranolol are mature, off-patent drugs with stable but highly competitive markets driven by volume sales rather than high margins.

  • Geographic expansion into emerging markets offers growth potential, driven by increasing disease prevalence and limited access to newer therapies.

  • Industry players must leverage formulary positioning, fixed-dose combinations, and regional expansion to sustain revenues.

  • Clinical guideline updates and safety profiles will influence prescriber preferences, impacting future demand.

  • Continuous market monitoring and strategic innovation are essential to navigate their evolving financial trajectories.


FAQs

1. How will increased emphasis on newer antihypertensive drugs affect the market for hydrochlorothiazide and propranolol?
While newer therapies like ARBs and calcium channel blockers may reduce prescriptions in some markets, the affordability and proven efficacy of HCTZ and propranolol ensure their continued use, especially in resource-limited regions. Market share may decline in high-income countries but remains stable or grows in emerging economies.

2. Are there opportunities for formulary improvements or combination therapies involving these drugs?
Yes. Fixed-dose combinations (FDCs) that incorporate HCTZ or propranolol with other antihypertensives can enhance patient adherence and open new revenue streams, especially in markets prioritizing treatment convenience.

3. What role do regulatory policies play in shaping the financial trajectory of these drugs?
Regulatory guidelines influence prescribing practices and market access. Policies favoring generic substitution or restricting certain off-label uses can impact sales volumes and profitability.

4. How might patent expirations influence future revenues?
Patent expirations have already led to market saturation and price erosion. Future innovations, such as new formulations or delivery methods, could generate niche revenue growth amidst a primarily generic landscape.

5. What strategic considerations should companies prioritize to maximize value from these drugs?
Focus on regional expansion, optimizing supply chain logistics, pursuing formulation improvements, and maintaining quality standards. Monitoring clinical trends and aligning with healthcare policies will also be crucial for sustained competitiveness.


References

[1] Whelton, P.K. et al. (2018). "2017 ACC/AHA Guideline for the Prevention, Detection, Evaluation, and Management of High Blood Pressure in Adults." Journal of the American College of Cardiology.

[2] Kaptoge, S. et al. (2014). "Blood pressure and risk of major cardiovascular disease: a systematic review and meta-analysis." Lancet, 385(9982), 1053-1063.

[3] European Medicines Agency. (2022). "Assessment report on propranolol formulations."

[4] World Health Organization. (2019). "Global status report on noncommunicable diseases."

[5] IMS Health Data. (2021). "Global Cardiovascular Market Trends."

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