NORVASC Drug Patent Profile

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

Norvasc is a drug marketed by Viatris and is included in one NDA.

The generic ingredient in NORVASC is amlodipine besylate. There are fifty drug master file entries for this compound. Forty-five suppliers are listed for this compound. Additional details are available on the amlodipine besylate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Norvasc

A generic version of NORVASC was approved as amlodipine besylate by COREPHARMA on May 23^rd, 2007.

Summary for NORVASC

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	4
Raw Ingredient (Bulk) Api Vendors:	132
Clinical Trials:	58
Patent Applications:	4,227
Drug Prices:	Drug price information for NORVASC
What excipients (inactive ingredients) are in NORVASC?	NORVASC excipients list
DailyMed Link:	NORVASC at DailyMed

See drug prices for NORVASC

See drug sales revenues for NORVASC

Recent Clinical Trials for NORVASC

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

Sponsor	Phase
Accutest Research Laboratories (I) Pvt. Ltd.	Phase 1
Brillian Pharma Inc.	Phase 1
Overseas Pharmaceuticals, Ltd.	Phase 1

See all NORVASC clinical trials

Pharmacology for NORVASC

Drug Class	Calcium Channel Blocker Dihydropyridine Calcium Channel Blocker
Mechanism of Action	Calcium Channel Antagonists Cytochrome P450 3A Inhibitors

US Patents and Regulatory Information for NORVASC

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Viatris	NORVASC	amlodipine besylate	TABLET;ORAL	019787-001	Jul 31, 1992	AB	RX	Yes	No
Viatris	NORVASC	amlodipine besylate	TABLET;ORAL	019787-002	Jul 31, 1992	AB	RX	Yes	No
Viatris	NORVASC	amlodipine besylate	TABLET;ORAL	019787-003	Jul 31, 1992	AB	RX	Yes	Yes

Expired US Patents for NORVASC

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Viatris	NORVASC	amlodipine besylate	TABLET;ORAL	019787-002	Jul 31, 1992	4,572,909*PED
Viatris	NORVASC	amlodipine besylate	TABLET;ORAL	019787-002	Jul 31, 1992	4,879,303*PED
Viatris	NORVASC	amlodipine besylate	TABLET;ORAL	019787-001	Jul 31, 1992	4,572,909*PED

International Patents for NORVASC

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

Country	Patent Number	Title	Estimated Expiration
China	1023800
European Patent Office	0089167	DIHYDROPYRIDINE ANTI-ISCHAEMIC AND ANTIHYPERTENSIVE AGENTS, PROCESSES FOR THEIR PRODUCTION, AND PHARMACEUTICAL COMPOSITIONS CONTAINING THEM
Kenya	3778	DIHYDROPYRIDINE ANTI-ISCHAEMIC AND ANTIHYPERTENSIVE AGENTS,PROCESSES FOR THEIR PRODUCTION,AND PHARMACEUTICAL COMPOSITIONS CONTAINING THEM

Supplementary Protection Certificates for NORVASC

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0443983	2007C/043	Belgium		PRODUCT NAME: AMLODIPINE ET VALSARTAN; NATL. REGISTRATION NO/DATE: EU/1/06/370/001 20070118; FIRST REGISTRATION: CH 57771 20061222
0502314	C300478	Netherlands		PRODUCT NAME: TELMISARTAN, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, EN AMLODIPINE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER AMLODIPINEBESILAAT; REGISTRATION NO/DATE: EU/1/10/648/001-028 20101007
0678503	C300499	Netherlands		PRODUCT NAME: COMBINATIE OMVATTEND ALISKIREN OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, EN AMLODIPINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/11/686/001-056 20110114

Market Dynamics and Financial Trajectory of Amlodipine Besylate (NORVASC)

Introduction

Amlodipine besylate, commonly known by the brand name Norvasc, is a widely used medication for the treatment of hypertension and angina. The market for amlodipine besylate is driven by several key factors, including the rising prevalence of cardiovascular diseases, advancements in pharmaceutical formulations, and changes in consumer behavior. Here, we delve into the market dynamics and financial trajectory of this essential medication.

Market Size and Growth

The global amlodipine besylate market was valued at approximately USD 1,867.0 million in 2023 and is projected to reach USD 2,539.5 million by 2031, growing at a Compound Annual Growth Rate (CAGR) of 3.98% from 2024 to 2031[1].

Drivers of Market Growth

Rising Prevalence of Hypertension and Cardiovascular Diseases

Hypertension is a leading cause of cardiovascular diseases, contributing to over 7.5 million deaths annually, according to the World Health Organization (WHO). This escalating need for effective antihypertensive treatments drives the demand for amlodipine besylate[3].

Advancements in Pharmaceutical Formulations

Advancements in pharmaceutical research and technology have enhanced patient compliance and accessibility to amlodipine besylate. Improved formulations and combination therapies further contribute to the market's growth[1].

Regulatory Approvals and Endorsements

Regulatory approvals and endorsements by health organizations play a crucial role in ensuring that amlodipine besylate remains a primary treatment for hypertension and angina management[1].

Competitive Landscape

The amlodipine besylate market is characterized by a robust competitive landscape with numerous global and regional pharmaceutical companies. The ongoing patent expirations of major brands have fostered the availability of cost-effective generics, intensifying competition and broadening patient access to this medication[1].

Sales Channels

The market is segmented by sales channels into hospital pharmacies, drug store & pharmacies, online retails, and others. The online retail segment is expected to witness significant growth at a CAGR of 4.67% through the forecast period, driven by the increasing adoption of e-commerce platforms for purchasing medications[1].

Regional Analysis

North America

North America dominates the global amlodipine besylate market, with a market share of around 34.56% in 2023. This dominance is attributed to the high prevalence of hypertension and cardiovascular diseases, advanced healthcare infrastructure, high healthcare spending, and widespread insurance coverage in the region[1].

Asia Pacific

The Asia Pacific region is poised to experience rapid growth, registering a CAGR of 5.09% over the forecast period. This expansion is driven by increasing awareness regarding cardiovascular health and the rising prevalence of hypertension in emerging countries like India and China[1].

Financial Performance of Key Players

Viatris

Companies like Viatris, which operate in the generics market, have shown strong financial performance. Viatris reported total revenues of $3.8 billion in the third quarter of 2024, with operational revenue growth of ~3% on a divestiture-adjusted basis. The company's adjusted EBITDA grew ~4% to $1.3 billion, and adjusted EPS increased ~6% to $0.75 per share[2].

Impact of Digital Health Initiatives

The COVID-19 pandemic has accelerated the shift toward online purchasing of medications, highlighting the importance of digital health initiatives. Telehealth startups, such as Ro, have expanded their partnerships with major pharmaceutical companies like Pfizer to provide generic versions of amlodipine besylate through virtual mail-order pharmacies[4].

Investment Opportunities

The increasing prevalence of hypertension and the demand for effective antihypertensive treatments create a favorable investment climate. Pharmaceutical companies can explore opportunities in emerging markets where hypertension rates are rising and healthcare access is improving. Expanding product offerings and forming strategic partnerships can further enhance market presence[3].

Consumer Behavior and Market Trends

The rise of digital health initiatives and the growing comfort with online transactions among consumers are contributing to the growth of the online retail segment. This shift is driven by the convenience and accessibility offered by e-commerce platforms, which provide patients with easy access to a wide range of pharmaceutical products often at competitive prices[1].

Challenges and Opportunities

Patent Expirations

The ongoing patent expirations of major brands continue to foster the availability of cost-effective generics, which can both challenge branded products and expand patient access to essential medications[1].

Regulatory Framework

A strong regulatory framework, particularly in regions like North America, plays a crucial role in maintaining the market's growth. Early diagnosis and effective disease management initiatives further support the market expansion[1].

Key Takeaways

• The global amlodipine besylate market is projected to grow at a CAGR of 3.98% from 2024 to 2031.
• The market is driven by the rising prevalence of hypertension and cardiovascular diseases, advancements in pharmaceutical formulations, and regulatory approvals.
• North America dominates the market, while the Asia Pacific region is expected to experience rapid growth.
• Online retail is a significant and growing sales channel.
• Digital health initiatives and consumer comfort with online transactions are key market trends.

FAQs

What is the current market size of amlodipine besylate?

The global amlodipine besylate market was valued at approximately USD 1,867.0 million in 2023[1].

What is the projected growth rate of the amlodipine besylate market?

The market is projected to grow at a CAGR of 3.98% from 2024 to 2031[1].

Which region dominates the amlodipine besylate market?

North America dominates the global amlodipine besylate market, with a market share of around 34.56% in 2023[1].

What are the key drivers of the amlodipine besylate market?

The key drivers include the rising prevalence of hypertension and cardiovascular diseases, advancements in pharmaceutical formulations, and regulatory approvals[1][3].

How is the online retail segment performing in the amlodipine besylate market?

The online retail segment is expected to witness significant growth at a CAGR of 4.67% through the forecast period, driven by the increasing adoption of e-commerce platforms[1].

Sources

1. Kings Research: Amlodipine Besylate Market Size & Share Forecast [2031][1]
2. PR Newswire: Viatris Reports Third Quarter Financial Results for 2024[2]
3. Market Research Intellect: Amlodipine Besylate Market Size And Projection[3]
4. Reports and Data: Amlodipine Besylate Market Size & Trends[4]