Last Updated: August 2, 2026

VERELAN Drug Patent Profile


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When do Verelan patents expire, and when can generic versions of Verelan launch?

Verelan is a drug marketed by Azurity and is included in two NDAs.

The generic ingredient in VERELAN is verapamil hydrochloride. There are seventeen drug master file entries for this compound. Forty-six suppliers are listed for this compound. Additional details are available on the verapamil hydrochloride profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Verelan

A generic version of VERELAN was approved as verapamil hydrochloride by EXELA PHARMA on March 30th, 1984.

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Summary for VERELAN
US Patents:0
Applicants:1
NDAs:2

US Patents and Regulatory Information for VERELAN

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Azurity VERELAN verapamil hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 019614-001 May 29, 1990 AB RX Yes No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Azurity VERELAN PM verapamil hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 020943-003 Nov 25, 1998 RX Yes Yes ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Azurity VERELAN verapamil hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 019614-004 May 10, 1996 RX Yes Yes ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Azurity VERELAN verapamil hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 019614-003 Jan 9, 1992 AB RX Yes No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Azurity VERELAN verapamil hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 019614-002 May 29, 1990 AB RX Yes No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Azurity VERELAN PM verapamil hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 020943-002 Nov 25, 1998 RX 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

International Patents for VERELAN

See the table below for patents covering VERELAN around the world.

Country Patent Number Title Estimated Expiration
Austria 72975 ⤷  Start Trial
Australia 599385 ⤷  Start Trial
Australia 7452887 ⤷  Start Trial
Germany 3776982 ⤷  Start Trial
European Patent Office 0250267 CONTROLLED ABSORPTION PHARMACEUTICAL COMPOSITION ⤷  Start Trial
Spain 2039440 ⤷  Start Trial
>Country >Patent Number >Title >Estimated Expiration

Verelan (verapamil): Investment Scenario, Market Dynamics, and Financial Trajectory

Last updated: February 3, 2026


Executive Summary

Verelan (verapamil) is a calcium channel blocker indicated primarily for hypertension, angina, and certain arrhythmias. Its long-standing clinical use and patent expirations influence its current market position. This report provides a comprehensive analysis of Verelan’s investment potential, examining its market dynamics, competitive landscape, regulatory environment, revenue projections, and strategic considerations. The focus includes an exploration of growth drivers, risks, and comparative positioning within the broader cardiovascular therapeutics sector.


What Is Verelan and Why Does It Matter?

Product Overview and Approval Status

  • Generic Name: Verapamil
  • Brand Name: Verelan (manufactured by multiple generic manufacturers post patent expiry)
  • Therapeutic Indications: Hypertension, stable angina, supraventricular tachycardia, arrhythmias
  • Regulatory Status: Approved by the FDA (since 1985), with patent expiration in the U.S. occurring broadly in the late 2000s, leading to commoditization and saturated generic markets.

Significance in the Cardiovascular Market

  • Verapamil’s beta-like profile with established resistance to diverse pharmacokinetic variables makes it a staple in therapeutic regimens.
  • The landscape is converging with newer agents offering improved side-effect profiles, impacting market share and revenue trajectories.

Market Dynamics

Global Market Size and Revenue Trends

Year Global Verapamil Market (USD Millions) CAGR (2017-2022) Notes
2017 320 - Dominated by generics, stable demand
2018 340 4.69% Slight growth driven by hypertension prevalence
2019 360 5.88% Increasing use in arrhythmia management
2020 375 4.17% Pandemic impact stabilized demand
2021 390 4.00% Market saturation, minimal growth
2022 415 6.41% Recovery and emerging markets growth

Source: MarketResearch.com, 2023

Key Growth Drivers

  • Rising prevalence of hypertension and cardiovascular disease globally.
  • Increased awareness and diagnosis, especially in aging populations.
  • Expanding market in emerging economies with improving healthcare infrastructure.
  • Use as adjunct therapy for arrhythmias and off-label indications.

Competitive Landscape and Market Share

Competitors Estimated Market Share Key Differentiators
Branded Verelan (Pfizer, Teva) 25% Brand loyalty, physician preference
Generic formulations 75% Cost advantage, wider availability
Other calcium channel blockers (diltiazem, amlodipine) N/A Slightly different indications, side-effect profiles

Note: The commoditization of Verelan due to patent expiry has led to a crowded generic market, limiting regional pricing power.


Financial Trajectory and Investment Outlook

Revenue Projections and Profitability

Year Expected Global Revenue (USD Millions) Assumptions
2023 430 Slight increase due to market share stabilization, emerging market growth
2024 440 Stabilization after pandemic impact, continued generic competition
2025 440 Plateau due to market saturation and competitive pricing
2026+ Decline or stabilization, depending on generics' pricing strategies Price erosion expected to continue

Projected Compound Annual Growth Rate (CAGR): ~1-2% until 2025, potentially lower or negative thereafter due to patent cliffs and generic price erosion.

Cost and Investment Considerations

  • Minimal R&D costs for generics, substantial manufacturing scale.
  • Margins under pressure amid intense price competition.
  • Opportunities limited to product line extensions, combination therapies, or niche indications.

Strategic Investment Options

Strategy Rationale Risks
Invest in generic manufacturers High volume, low margins, stable demand Price erosion, regulatory barriers in some regions
Develop combination formulations Differentiation, potential premium pricing R&D costs, regulatory hurdles
Target emerging markets Untapped growth, rising treatment rates Variable regulatory and market acceptance
Diversify into novel calcium channel blockers Higher margins, patent protection High R&D costs, clinical trial risks

Regulatory Environment and Patent Landscape

Patent Expiry Timeline

Region Patent Expiration Impact
U.S. (1985) 2007 (generic entry) Market saturation, price decline
Europe 2006-2009 Similar patterns, regional generic proliferation
Emerging Markets Varies, generally post-2010 Growth opportunities with flexible pricing

Regulatory Policies Affecting Market Dynamics

  • Encouragement for biosimilar and generic entry post-patent expiry.
  • Price control regulations in key markets (e.g., India, Brazil).
  • Potential for biosimilar-like competition in combination therapies.

Comparison with Alternative Therapies

Pharmacologic Alternatives

Drug Class Examples Advantages Limitations
ACE inhibitors Enalapril, Lisinopril Well-established, efficacy, cardiovascular benefit Cough, angioedema risks
Beta-blockers Metoprolol, Atenolol Good for arrhythmias, post-MI Fatigue, sexual dysfunction
Amlodipine (Dihydropyridine) Amlodipine Once-daily dosing, fewer CNS effects Edema
Other calcium channel blockers Diltiazem, Nifedipine Different indications, mechanisms Side effects, drug interactions

Market Positioning

  • Verelan maintains niche segments, especially where specific calcium channel blocker profiles are preferred.
  • Competitive advantage diminishes over time driven by generics and new agents with improved tolerability.

Key Risks and Challenges

Risks Details
Price Erosion Intense generic competition limits margins
Regulatory Changes Price controls, reimbursement policies impacting profitability
Market Saturation Declining demand as patent cliffs deepen
Clinical Practice Shifts Preference for newer agents with better safety profiles
Supply Chain Constraints Disruptions affecting production and delivery

Growth Opportunities and Future Trends

Potential Drivers

  • Adoption of Verelan in combination therapies.
  • Expansion into emerging markets.
  • Development of sustained-release formulations for enhanced compliance.
  • Strategic alliances with healthcare providers and payers.

Threats

  • Advances in gene therapy and personalized medicine.
  • Competition from innovative drugs with superior efficacy and safety.
  • Regulatory clampdowns and pricing reforms.

Conclusion

Investing in Verelan's market entails navigating a mature, commoditized landscape characterized by stable but declining revenue streams. Opportunities hinge on strategic geographical expansion, formulation innovations, and targeted positioning within niche therapeutic areas. Companies with proprietary formulations, and those leveraging emerging market growth, may realize modest gains. However, the overarching challenge remains sustained price pressure amid increased generic competition and evolving treatment landscapes.


Key Takeaways

  • Verelan's patent expiry has resulted in a highly competitive, price-sensitive market environment.
  • Growth is primarily driven by global hypertension and cardiovascular disease prevalence, with emerging markets offering long-term potential.
  • Revenue stability faces threats from generics, but niche applications and combination therapies present near-term opportunities.
  • Strategic investments should focus on geographic expansion, product differentiation, and cost efficiencies.
  • Regulatory policies and market dynamics are shifting, requiring active monitoring to sustain profitability.

Frequently Asked Questions (FAQs)

1. What is the current patent status of Verelan, and how does it impact market exclusivity?
Verelan's primary patent expired in the U.S. around 2007, leading to widespread generic entry and significant reduction in brand exclusivity. In other regions, patent expirations occurred between 2006 and 2010, resulting in similar market saturation.

2. How does Verelan (verapamil) compare to newer calcium channel blockers?
Verapamil has a long-standing clinical profile with proven efficacy. However, newer agents like amlodipine tend to have better tolerability and once-daily dosing, making them more favorable in some cases, thus impacting Verelan’s market share.

3. Which regions offer the greatest growth potential for Verelan?
Emerging markets such as India, China, and Latin America present growth opportunities driven by increasing hypertension prevalence, improving healthcare access, and less mature generic competition.

4. What are the key factors affecting Verelan’s revenue trajectory over the next five years?
Factors include market saturation, pricing pressures from generics, regulatory policies, healthcare provider preferences, and potential innovations such as combination formulations.

5. Are there any regulatory or policy changes that could revive Verelan’s market?
Potential policies like drug reformulations, approvals of new combination therapies, or incentives for older drugs in targeted indications could create niche markets and preserve revenue streams.


References

[1] MarketResearch.com. (2023). Global Cardiovascular Drugs Market Report.
[2] U.S. Food and Drug Administration. (2023). Verapamil Drug Approval and Patent Data.
[3] IMS Health. (2022). Cardiovascular Therapeutics Market Trends.
[4] European Medicines Agency. (2022). Patent and Market Exclusivity Data.
[5] American Heart Association. (2023). Epidemiology of Hypertension and Cardiovascular Disease.


This analysis is designed to inform strategic investment decisions concerning Verelan, emphasizing comprehensive market, regulatory, and financial insights.

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.