Verapamil hydrochloride - Generic Drug Details

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

Verapamil hydrochloride is the generic ingredient in seven branded drugs marketed by Mylan, Rising, Azurity, Gd Searle Llc, Mt Adams, Abraxis Pharm, Bedford, Eugia Pharma, Fresenius Kabi Usa, Gland, Heritage, Hospira, Intl Medication, Luitpold, Mankind Pharma, Marsam Pharms Llc, Smith And Nephew, Solopak, Zydus Pharms, Amneal, Caplin, Exela Pharma, Micro Labs, Nephron, Somerset, Somerset Theraps Llc, Pfizer, Apotex Corp, Cadila Pharms Ltd, Glenmark Pharms Ltd, Ivax Sub Teva Pharms, Pliva, Strides Pharma Intl, Sun Pharm Inds Inc, Actavis Elizabeth, Chartwell Rx, Mutual Pharm, Sun Pharm Industries, Warner Chilcott, and Watson Labs, and is included in seventy-three NDAs. Additional information is available in the individual branded drug profile pages.

There are thirteen drug master file entries for verapamil hydrochloride. Forty-six suppliers are listed for this compound.

Summary for verapamil hydrochloride

US Patents:	0
Tradenames:	7
Applicants:	40
NDAs:	73
Drug Master File Entries:	13
Finished Product Suppliers / Packagers:	46
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	162
Patent Applications:	5,315
What excipients (inactive ingredients) are in verapamil hydrochloride?	verapamil hydrochloride excipients list
DailyMed Link:	verapamil hydrochloride at DailyMed

Recent Clinical Trials for verapamil hydrochloride

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Jaeb Center for Health Research	PHASE1
City of Hope Medical Center	PHASE1
University of Colorado, Denver	PHASE2

See all verapamil hydrochloride clinical trials

Pharmacology for verapamil hydrochloride

Drug Class	Calcium Channel Blocker
Mechanism of Action	Calcium Channel Antagonists Cytochrome P450 3A Inhibitors Cytochrome P450 3A4 Inhibitors P-Glycoprotein Inhibitors

Medical Subject Heading (MeSH) Categories for verapamil hydrochloride

Anti-Arrhythmia Agents

Calcium Channel Blockers

Vasodilator Agents

Anatomical Therapeutic Chemical (ATC) Classes for verapamil hydrochloride

C08DA	Phenylalkylamine derivatives
C08D	SELECTIVE CALCIUM CHANNEL BLOCKERS WITH DIRECT CARDIAC EFFECTS
C08	CALCIUM CHANNEL BLOCKERS
C	Cardiovascular system

Paragraph IV (Patent) Challenges for VERAPAMIL HYDROCHLORIDE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
VERELAN PM	Extended-release Capsules	verapamil hydrochloride	100 mg and 200 mg	020943	1	2006-07-20
VERELAN PM	Extended-release Capsules	verapamil hydrochloride	300 mg	020943	1	2006-05-19

US Patents and Regulatory Information for verapamil hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Somerset Theraps Llc	VERAPAMIL HYDROCHLORIDE	verapamil hydrochloride	SOLUTION;INTRAVENOUS	211015-001	Jun 18, 2018	AP	RX	No	No
Pliva	VERAPAMIL HYDROCHLORIDE	verapamil hydrochloride	TABLET;ORAL	072751-001	Feb 23, 1996		DISCN	No	No
Rising	VERAPAMIL HYDROCHLORIDE	verapamil hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	078306-003	Aug 9, 2007		DISCN	No	No
Watson Labs	VERAPAMIL HYDROCHLORIDE	verapamil hydrochloride	TABLET;ORAL	072924-001	Jun 29, 1993	AB	RX	No	No
Hospira	VERAPAMIL HYDROCHLORIDE	verapamil hydrochloride	INJECTABLE;INJECTION	070739-001	May 6, 1987		DISCN	No	No
Micro Labs	VERAPAMIL HYDROCHLORIDE	verapamil hydrochloride	SOLUTION;INTRAVENOUS	211370-002	Dec 28, 2018	AP	RX	No	No

Expired US Patents for verapamil hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pfizer	COVERA-HS	verapamil hydrochloride	TABLET, EXTENDED RELEASE;ORAL	020552-001	Feb 26, 1996	5,232,705
Pfizer	COVERA-HS	verapamil hydrochloride	TABLET, EXTENDED RELEASE;ORAL	020552-001	Feb 26, 1996	5,190,765
Azurity	VERELAN PM	verapamil hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	020943-003	Nov 25, 1998	4,863,742
Pfizer	COVERA-HS	verapamil hydrochloride	TABLET, EXTENDED RELEASE;ORAL	020552-001	Feb 26, 1996	5,785,994
Pfizer	COVERA-HS	verapamil hydrochloride	TABLET, EXTENDED RELEASE;ORAL	020552-002	Feb 26, 1996	5,232,705
Pfizer	COVERA-HS	verapamil hydrochloride	TABLET, EXTENDED RELEASE;ORAL	020552-002	Feb 26, 1996	5,252,338

Market Dynamics and Financial Trajectory for Verapamil Hydrochloride

Last updated: July 27, 2025

Introduction

Verapamil Hydrochloride, a calcium channel blocker primarily used for managing hypertension, angina pectoris, and certain arrhythmias, remains an essential component within cardiovascular therapeutics. As a well-established pharmaceutical, its market dynamics and financial prospects are shaped by evolving clinical applications, patent landscapes, manufacturing trends, and regulatory environments. This analysis delineates these factors, providing insights critical for stakeholders invested in its ongoing development or commercialization.

Market Overview and Therapeutic Significance

Verapamil Hydrochloride’s enduring clinical utility anchors its market stability. Originating in the mid-20th century and attaining widespread adoption, it addresses prevalent cardiovascular conditions with a comprehensive safety profile. The global antihypertensive market, estimated at USD 33.8 billion in 2021, underscores the drug's backing, with calcium channel blockers constituting a significant segment [1]. The demand drivers include rising hypertension prevalence worldwide, aging populations, and expanding indications such as migraine prophylaxis and certain neurovascular conditions.

Market Drivers

1. Growing Cardiovascular Disease (CVD) Burden:
   The World Health Organization reports CVD as the leading cause of death globally, accentuating the need for long-term antihypertensive therapies like verapamil. The World Heart Federation estimates over 120 million adults affected globally, with a rising trend attributable to urbanization, sedentary lifestyles, and obesity [2].

2. Expanded Indications and Formulations:
   Newer formulations of verapamil, including sustained and controlled-release tablets, enhance patient compliance. Additionally, off-label uses for migraine and vasospasm further broaden its market reach.

3. Generics Market Penetration:
   As patent exclusivities for original formulations lapse, generic versions flood emerging markets, substantially lowering prices and increasing accessibility. This trend improves volume sales but constrains profit margins for innovator companies.

4. Regulatory Approvals and Long-Term Approvals:
   Persistent regulatory approval in key markets such as the U.S., Europe, and Asia ensures continued availability. Stringent regulatory processes, however, may delay new formulations or indications, impacting revenue streams.

Market Challenges

• Pricing Pressure and Market Saturation:
  The generics landscape leads to aggressive pricing and commoditization, pressuring revenues. Companies must innovate through formulations or combination therapies.

• Competitive Landscape:
  A multitude of calcium channel blockers, including amlodipine and diltiazem, vie for market share. Newer agents with improved safety profiles, such as reduces in peripheral edema, pose substitution risks.

• Regulatory and Patent Litigation:
  Patent expirations have become commonplace, enabling entry of low-cost generics. Litigation barriers and patent litigations can temporarily delay market entry and impact revenues.

Manufacturing and Distribution Dynamics

Manufacturing excellence, cost management, and robust distribution channels are vital for sustained profitability. Major pharmaceutical companies have streamlined production processes, benefitting from economies of scale. The criticality of ensuring quality compliance (GMP standards) influences manufacturing costs and market confidence.

Financial Trajectory and Revenue Projections

Historical data indicate that verapamil hydrochloride’s global sales have stabilized, with slight declines in mature markets due to generic competition. However, sales in emerging markets are increasing, driven by expanding healthcare infrastructure and affordability.

• Revenue Estimates:
  A reported figure from a leading pharmaceutical analysis suggests global verapamil sales hovered around USD 300 million in 2021, with projected compound annual growth rates (CAGRs) of approximately 2-3% over the next five years, primarily driven by volume increases in Asia and Latin America [3].

• Profit Margins:
  Margins for branded formulations remain robust, but a shift towards generic supply has compressed profit margins to single digits in many regions. R&D investment in novel formulations or combination therapies could potentially elevate margins.

• Investment in Biosimilars or Novel Delivery:
  While traditional formulations dominate, some companies explore transdermal or implantable delivery systems, aiming to capture niche markets and command premium pricing.

Regulatory and Policy Impacts

Regulatory bodies continuously reassess drug classifications and efficacy claims. Policy shifts towards universal healthcare and drug price controls in markets like India or Europe aim to reduce costs but may also pose challenges to profit maximization. The influence of healthcare policies on reimbursement schemes directly affects sales trajectories.

Key Market Trends

• Digital and Data-Driven Approaches:
  Integration of digital health tools can improve adherence and thus market penetration.

• Strategic Mergers & Acquisitions:
  Companies consolidate to strengthen their cardiovascular portfolios, seeking to leverage combined market share and R&D capabilities.

• Focus on Personalization & Pharmacogenomics:
  Future developments may emphasize tailored therapies, although verapamil’s broad use limits immediate application of this trend.

Conclusion

The financial and market outlook for Verapamil Hydrochloride remains cautiously optimistic, balanced by entrenched generic competition and expanding therapeutic applications. Generics dominate its sales, but innovation in delivery systems or combination pharmaceuticals might present new revenue avenues. Global cardiovascular disease prevalence sustains baseline demand, though margins face compression. Companies investing strategically in manufacturing excellence, market expansion, and incremental innovation will likely realize steady, albeit modest, growth trajectories.

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Key Takeaways

• Stable Long-Term Demand: The global burden of cardiovascular diseases secures ongoing demand for verapamil hydrochloride, particularly in emerging markets.

• Generics Market Pressure: Patent expirations have intensified competition, exerting downward pressure on prices and margins but expanding access.

• Innovation as a Growth Lever: Developing novel formulations, combination drugs, or delivery methods can reinvigorate revenue streams.

• Regulatory Environment Impact: Policy shifts and regulatory approvals are critical determinants of market continuity and profitability.

• Global Expansion Opportunities: Emerging markets offer growth potential, contingent on affordability and healthcare infrastructure development.

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FAQs

1. What are the primary therapeutic uses of Verapamil Hydrochloride?
   Verapamil is mainly used to treat hypertension, angina pectoris, and certain arrhythmias. Off-label uses include migraine prophylaxis and vasospasm treatment.

2. How does patent expiration affect Verapamil Hydrochloride’s market?
   Patent expiration facilitates the entry of generic manufacturers, reducing prices, increasing accessibility, but decreasing profit margins for original developers.

3. Are there ongoing innovations in Verapamil formulations?
   Yes. Sustained-release formulations and combination therapies with other antihypertensives aim to improve efficacy and patient compliance.

4. How do regulatory policies influence the Verapamil market?
   Policies regarding drug approvals, price controls, and classifi­cations directly impact market access, sales volumes, and profitability.

5. What is the future growth potential for Verapamil Hydrochloride?
   While mature markets face saturation, emerging economies offer growth prospects driven by increasing cardiovascular disease prevalence and expanding healthcare infrastructure.

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References

1. GlobalData. (2022). "Antihypertensive Drugs Market Overview."
2. World Health Organization. (2021). "Cardiovascular Disease Facts."
3. IQVIA. (2022). "Pharmaceutical Market Trends and Revenue Forecasts."