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 Pharma Ltd, 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, 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:	109
Clinical Trials:	150
Patent Applications:	4,483
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
CTC Clinical Trial Consultants AB	Phase 1
EpiEndo Pharmaceuticals	Phase 1
Guangdong Raynovent Biotech Co., Ltd	Phase 1

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
Mt Adams	ISOPTIN	verapamil hydrochloride	INJECTABLE;INJECTION	018485-001	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Sun Pharm Industries	VERAPAMIL HYDROCHLORIDE	verapamil hydrochloride	TABLET;ORAL	071489-001	Jan 13, 1988		DISCN	No	No
Heritage	VERAPAMIL HYDROCHLORIDE	verapamil hydrochloride	TABLET;ORAL	071881-002	Oct 14, 2015	AB	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	020552-002	Feb 26, 1996	4,327,725
Pfizer	COVERA-HS	verapamil hydrochloride	TABLET, EXTENDED RELEASE;ORAL	020552-001	Feb 26, 1996	4,753,802
Pfizer	COVERA-HS	verapamil hydrochloride	TABLET, EXTENDED RELEASE;ORAL	020552-001	Feb 26, 1996	5,190,765

Verapamil hydrochloride Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Verapamil Hydrochloride

Market Overview

The Verapamil Hydrochloride market is experiencing significant growth, driven by its diverse and critical applications in treating various cardiovascular conditions. Here are the key points that outline the market dynamics and financial trajectory of this drug.

Market Size and Projections

The Verapamil Hydrochloride market was valued at USD 100 billion in 2023 and is projected to reach USD 140.71 billion by 2031, growing at a Compound Annual Growth Rate (CAGR) of 5% from 2024 to 2031[1].

Segmentation

The market is segmented based on several factors:

• Type: Immediate-release tablets, extended-release tablets, injectables, capsules, and oral solutions.
• Application: Hypertension, angina, arrhythmia, migraine prevention, and hypertrophic cardiomyopathy.
• Geography: North America, Europe, Asia-Pacific, South America, and the Middle East and Africa[1][4].

Drivers of Growth

Several factors are driving the growth of the Verapamil Hydrochloride market:

• Increasing Prevalence of Cardiovascular Diseases: The rising incidence of hypertension, angina, and other cardiovascular conditions, particularly among aging populations and those with inactive lifestyles, is a significant driver[1].
• Advancements in Pharmaceutical Formulations: Improvements in drug delivery technology and the development of new formulations are enhancing the effectiveness and patient adherence to Verapamil Hydrochloride[1].
• Healthcare Infrastructure Expansion: The enhancement of healthcare infrastructure in developing nations is expected to increase the availability and accessibility of Verapamil Hydrochloride, contributing to market growth[1].
• Strategic Alliances and Partnerships: Collaborations between pharmaceutical companies are crucial for expanding product portfolios and geographical reach, further driving market expansion[1].

Key Applications

Verapamil Hydrochloride is used in the treatment of various cardiovascular conditions:

• Hypertension: It helps in reducing blood pressure by relaxing blood vessels and decreasing the workload on the heart[5].
• Angina: By increasing the supply of blood and oxygen to the heart, Verapamil Hydrochloride helps in alleviating severe chest pain[5].
• Arrhythmia: It is used to treat heart rhythm problems by affecting the movement of calcium into the cells of the heart and blood vessels[5].
• Migraine Prevention: Verapamil Hydrochloride is also used to prevent migraines, although this is less common compared to its cardiovascular applications[1].

Pharmacokinetics and Pharmacodynamics

Understanding the pharmacokinetics and pharmacodynamics of Verapamil Hydrochloride is crucial for its effective use:

• Bioavailability: The bioavailability of Verapamil Hydrochloride ranges from 20% to 35% due to extensive first-pass metabolism in the liver[2].
• Elimination Half-Life: The elimination half-life varies from 2.8 to 7.4 hours in single-dose studies and increases to 4.5 to 12.0 hours with repetitive dosing. It is prolonged in patients with hepatic insufficiency and the elderly[2][3].
• Metabolism: Verapamil undergoes extensive metabolism in the liver, with twelve metabolites identified, including norverapamil, which has about 20% of the cardiovascular activity of verapamil[2].

Market Players

The Verapamil Hydrochloride market includes both established and emerging players:

• Key Companies: Mylan N.V., Teva Pharmaceutical Industries, Sandoz, Pfizer Inc., Glenmark Pharmaceuticals, Sun Pharmaceutical, Aurobindo Pharma, Cipla, Lupin Limited, and Dr. Reddy's Laboratories are some of the prominent companies in this market[1][4].

Regional Analysis

The market is geographically segmented, with different regions showing varying growth rates:

• North America and Europe: These regions are expected to maintain significant market shares due to advanced healthcare infrastructure and high prevalence of cardiovascular diseases.
• Asia-Pacific: This region is anticipated to show rapid growth due to increasing healthcare spending and a large patient population[1][4].

Challenges and Opportunities

While the market is growing, there are several challenges and opportunities to consider:

• Challenges: Adverse effects such as sinus bradycardia, second-degree AV block, and sinus arrest, especially in patients with severe left ventricular dysfunction, pose challenges. Additionally, the need for careful dosing in patients with hepatic insufficiency is a concern[2].
• Opportunities: The increasing demand for effective cardiovascular treatments, advancements in drug delivery technologies, and expanding healthcare infrastructure in developing nations present significant opportunities for growth[1].

Financial Trajectory

The financial trajectory of the Verapamil Hydrochloride market is positive, with several indicators pointing to sustained growth:

• Revenue Growth: The market is expected to grow from USD 100 billion in 2023 to USD 140.71 billion by 2031, indicating a robust financial outlook[1].
• Investment and Research: Continuous research and development in pharmaceutical formulations and drug delivery technologies are expected to attract significant investments, further boosting the market's financial performance[1].

Conclusion

The Verapamil Hydrochloride market is poised for significant growth driven by its critical applications in treating cardiovascular diseases, advancements in pharmaceutical technology, and expanding healthcare infrastructure. Understanding the market dynamics, including segmentation, drivers, and challenges, is essential for stakeholders to navigate and capitalize on the opportunities in this market.

Key Takeaways

• The Verapamil Hydrochloride market is valued at USD 100 billion in 2023 and is expected to reach USD 140.71 billion by 2031.
• The market is driven by the increasing prevalence of cardiovascular diseases, advancements in pharmaceutical formulations, and expanding healthcare infrastructure.
• Key applications include hypertension, angina, arrhythmia, and migraine prevention.
• The market includes prominent players such as Mylan N.V., Teva Pharmaceutical Industries, and Pfizer Inc.
• Regional growth varies, with Asia-Pacific expected to show rapid growth.

FAQs

Q: What are the primary applications of Verapamil Hydrochloride? A: Verapamil Hydrochloride is primarily used to treat hypertension, angina, arrhythmia, and hypertrophic cardiomyopathy.

Q: What is the expected CAGR of the Verapamil Hydrochloride market from 2024 to 2031? A: The market is expected to grow at a CAGR of 5% from 2024 to 2031.

Q: Which regions are expected to show significant growth in the Verapamil Hydrochloride market? A: North America, Europe, and Asia-Pacific are expected to show significant growth, with Asia-Pacific anticipated to have the most rapid growth.

Q: What are the key drivers of the Verapamil Hydrochloride market? A: The key drivers include the increasing prevalence of cardiovascular diseases, advancements in pharmaceutical formulations, and expanding healthcare infrastructure.

Q: What are some of the prominent companies in the Verapamil Hydrochloride market? A: Prominent companies include Mylan N.V., Teva Pharmaceutical Industries, Sandoz, Pfizer Inc., and Glenmark Pharmaceuticals.

Cited Sources

1. Market Research Intellect - Global Verapamil Hydrochloride Market Report
2. FDA - Verapamil Hydrochloride Tablet Label
3. DrugBank - Verapamil: Uses, Interactions, Mechanism of Action
4. Market Research Intellect - Global Verapamil Hydrochloride Tablets Market Report
5. Mayo Clinic - Verapamil (oral route) Description