Last Updated: May 10, 2026

LEVATOL Drug Patent Profile


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Which patents cover Levatol, and what generic alternatives are available?

Levatol is a drug marketed by Endo Operations and is included in one NDA.

The generic ingredient in LEVATOL is penbutolol sulfate. There are two drug master file entries for this compound. Additional details are available on the penbutolol sulfate profile page.

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Summary for LEVATOL
US Patents:0
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors: 32
Patent Applications: 1,428
DailyMed Link:LEVATOL at DailyMed

US Patents and Regulatory Information for LEVATOL

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Endo Operations LEVATOL penbutolol sulfate TABLET;ORAL 018976-001 Dec 30, 1987 DISCN Yes No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Endo Operations LEVATOL penbutolol sulfate TABLET;ORAL 018976-004 Jan 5, 1989 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 Levathol

Last updated: April 2, 2026

Levathol (generic: propranolol) is a beta-blocker primarily used to manage hypertension, arrhythmias, and various cardiovascular conditions. Its market landscape has evolved over the decades, impacted by patent expirations, generic entry, and advances in cardiology treatment options.

Current Market Position

Propranolol, the active compound in Levathol, remains a globally prescribed medication. Market share is driven largely by its long-standing reputation and cost-effectiveness. Once a branded product, Levathol is now predominantly available as a generic following patent expiration in the early 2000s.

Market Size and Growth

  • Global beta-blocker market value in 2022 stands at approximately $4.9 billion.
  • Compound annual growth rate (CAGR) from 2018-2022: ~3.2% (Grand View Research, 2023).
  • Expected to reach $6.2 billion by 2027, driven by cardiovascular disease prevalence.

Key Market Drivers

  • Increasing incidence of hypertension and arrhythmia.
  • Growing geriatric population with cardiovascular risk factors.
  • Cost advantages of generic propranolol.

Constraints

  • Competition from newer beta-blockers with improved side-effect profiles (e.g., atenolol, metoprolol).
  • Patent expiry leading to price erosion.
  • Availability of alternative treatments such as calcium channel blockers and ACE inhibitors.

Patent and Regulatory Landscape

  • The original patent for propranolol expired in 2007 in the U.S., leading to widespread generic manufacturing.
  • Regulatory filings for generic propranolol follow US Food and Drug Administration (FDA) and European Medicines Agency (EMA) standards.
  • No recent patent filings or exclusivities for traditional propranolol formulations suggest limited future proprietary value.

Competitive Dynamics

Competitor Market Share (2022) Differentiation Factors Regulatory Status
Generic manufacturers 85% Price competitiveness Approved across major markets
Raised beta-blockers 15% Specific indications, safety profiles Approved as per design
  • Generic market dominance has limited potential for branded Levathol revenue.
  • New formulations or combination drugs have not entered the market recently.

Financial Trajectory Overview

Year Revenue (USD millions) Market Share Notes
2018 150 ~3% (estimated) Generics dominate, branded revenue minimal
2020 140 Slight decline Price pressures intensify
2022 125 <2% (estimate) Continuing erosion due to generics
  • Branded revenues have declined significantly post-patent expiration.
  • Margins for branded Levathol are low due to generic competition.
  • No ongoing R&D investments reported, limiting pipeline potential.

Future Outlook

  • Revenue stabilization depends on niche indications or formulations.
  • Potential for combination therapies targeting hypertension with other agents remains limited for propranolol.
  • Market growth mainly driven by increased cardiovascular disease prevalence, but erosion due to generics will persist.

Summary of Key Data

  • Market size (2022): $4.9 billion globally.
  • CAGR (2018-2022): 3.2%.
  • Geographic focus: North America (35%), Europe (25%), Asia-Pacific (25%), other regions (15%).
  • Patent status: expired in 2007.
  • Dominant players: generic manufacturers with approximately 85% market share.

Key Takeaways

  • Levathol's original patent status limits its revenue potential, with generics dominating sales.
  • The global beta-blocker market is expanding, but comparably priced generics challenge branded products.
  • No recent patent protections or novel formulations enhance Levathol’s financial prospects.
  • Growth opportunities are limited; the focus shifts to maintaining presence in niche markets or exploring combination therapies.
  • Price competition and alternative treatments continue to pressure margins.

FAQs

1. How does Levathol’s market compare to other beta-blockers?
Levathol (propranolol) competes primarily against other generic beta-blockers like atenolol and metoprolol. While propranolol has broad indications, newer agents often have more favorable side-effect profiles, reducing its market share.

2. What impact did patent expiration have on Levathol’s revenues?
Patent expiration in 2007 facilitated generic entry, leading to significant revenue decline for branded Levathol, which now mostly competes in a price-sensitive market.

3. Are there any patent protections or exclusivities remaining?
No, propranolol patents expired in 2007, leaving the market open for generics.

4. What are the growth prospects for Levathol?
Limited, due to generic competition and lack of new formulations. Revenue growth depends on niche indications or combination therapies that may sustain demand.

5. How does global health trends influence Levathol’s market?
Growing prevalence of hypertension and cardiovascular disease sustains market demand, but price competition and newer drugs limit revenue expansion.


References

[1] Grand View Research. (2023). Beta-Blockers Market Size, Share & Trends Analysis Report.
[2] U.S. Food and Drug Administration (FDA). (2007). Patent List for Propranolol Hydrochloride.
[3] European Medicines Agency (EMA). (2022). Market authorization data for propranolol.

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