AMLODIPINE BESYLATE; VALSARTAN - Generic Drug Details

What are the generic sources for amlodipine besylate; valsartan and what is the scope of patent protection?

Amlodipine besylate; valsartan is the generic ingredient in two branded drugs marketed by Alembic, Aurobindo Pharma, Hetero Labs, Lupin, Macleods Pharms Ltd, Mylan, Novel Labs Inc, Strides Pharma Intl, Teva Pharms Usa, Torrent, and Novartis, and is included in eleven NDAs. Additional information is available in the individual branded drug profile pages.

Ten suppliers are listed for this compound.

Summary for AMLODIPINE BESYLATE; VALSARTAN

US Patents:	0
Tradenames:	2
Applicants:	11
NDAs:	11
Finished Product Suppliers / Packagers:	10
Clinical Trials:	3
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for AMLODIPINE BESYLATE; VALSARTAN
DailyMed Link:	AMLODIPINE BESYLATE; VALSARTAN at DailyMed

Recent Clinical Trials for AMLODIPINE BESYLATE; VALSARTAN

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

Sponsor	Phase
Haining Health-Coming Biotech Co., Ltd.	Phase 2
Alphacait, LLC	Phase 2
HK inno.N Corporation	Phase 1

See all AMLODIPINE BESYLATE; VALSARTAN clinical trials

Pharmacology for AMLODIPINE BESYLATE; VALSARTAN

Drug Class	Angiotensin 2 Receptor Blocker Calcium Channel Blocker Dihydropyridine Calcium Channel Blocker
Mechanism of Action	Angiotensin 2 Receptor Antagonists Calcium Channel Antagonists Cytochrome P450 3A Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for AMLODIPINE BESYLATE; VALSARTAN

C08CA	Dihydropyridine derivatives
C08C	SELECTIVE CALCIUM CHANNEL BLOCKERS WITH MAINLY VASCULAR EFFECTS
C08	CALCIUM CHANNEL BLOCKERS
C	Cardiovascular system

C09CA	Angiotensin II receptor blockers (ARBs), plain
C09C	ANGIOTENSIN II RECEPTOR BLOCKERS (ARBs), PLAIN
C09	AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM
C	Cardiovascular system

Paragraph IV (Patent) Challenges for AMLODIPINE BESYLATE; VALSARTAN

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
EXFORGE	Tablets	amlodipine besylate; valsartan	5 mg/320 mg	021990	1	2007-11-26
EXFORGE	Tablets	amlodipine besylate; valsartan	10 mg/320 mg	021990	1	2007-11-09
EXFORGE	Tablets	amlodipine besylate; valsartan	5 mg/160 mg	021990	1	2007-10-22
EXFORGE	Tablets	amlodipine besylate; valsartan	10 mg/160 mg	021990	1	2007-10-01

US Patents and Regulatory Information for AMLODIPINE BESYLATE; VALSARTAN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Macleods Pharms Ltd	AMLODIPINE BESYLATE AND VALSARTAN	amlodipine besylate; valsartan	TABLET;ORAL	207292-004	Oct 11, 2024	AB	RX	No	No
Teva Pharms Usa	AMLODIPINE BESYLATE AND VALSARTAN	amlodipine besylate; valsartan	TABLET;ORAL	091235-002	Mar 30, 2015		DISCN	No	No
Strides Pharma Intl	AMLODIPINE BESYLATE AND VALSARTAN	amlodipine besylate; valsartan	TABLET;ORAL	090011-003	Mar 28, 2013	AB	RX	No	No
Macleods Pharms Ltd	AMLODIPINE BESYLATE AND VALSARTAN	amlodipine besylate; valsartan	TABLET;ORAL	207292-001	Oct 11, 2024	AB	RX	No	No
Novel Labs Inc	AMLODIPINE BESYLATE AND VALSARTAN	amlodipine besylate; valsartan	TABLET;ORAL	202829-003	Mar 30, 2015	AB	RX	No	No

Expired US Patents for AMLODIPINE BESYLATE; VALSARTAN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novartis	EXFORGE	amlodipine besylate; valsartan	TABLET;ORAL	021990-003	Jun 20, 2007	5,399,578*PED
Novartis	EXFORGE	amlodipine besylate; valsartan	TABLET;ORAL	021990-005	Jun 20, 2007	6,395,728
Novartis	EXFORGE	amlodipine besylate; valsartan	TABLET;ORAL	021990-002	Jun 20, 2007	5,399,578*PED
Novartis	EXFORGE	amlodipine besylate; valsartan	TABLET;ORAL	021990-003	Jun 20, 2007	6,294,197*PED
Novartis	EXFORGE	amlodipine besylate; valsartan	TABLET;ORAL	021990-003	Jun 20, 2007	6,395,728

Market Dynamics and Financial Trajectory for Amlodipine Besylate and Valsartan

Last updated: July 29, 2025

Introduction

Amlodipine besylate and valsartan are cornerstone antihypertensive agents with significant market footprints. These drugs address prevalent cardiovascular conditions, including hypertension and heart failure. Their market dynamics are influenced by regulatory landscapes, patent status, competitive landscape, evolving clinical guidelines, and global healthcare trends. This analysis delineates key drivers shaping their commercial trajectories, assesses their market potential, and identifies future growth prospects.

Product Overview

Amlodipine Besylate: A dihydropyridine calcium channel blocker, approved for hypertension and angina. It offers once-daily dosing and favorable side effect profiles, contributing to its broad acceptance.

Valsartan: An angiotensin II receptor blocker (ARB) used in hypertension and heart failure management. It gained prominence after pivotal trials demonstrated cardiovascular benefits with a favorable safety profile.

Market Drivers

1. Rising Prevalence of Cardiovascular Diseases (CVD)

Global epidemiological data reveal increasing CVD burden, driven by aging populations, lifestyle changes, and comorbidities such as obesity and diabetes. According to the World Health Organization, cardiovascular diseases remain the leading cause of death worldwide, propelling demand for antihypertensive medications like amlodipine and valsartan [1].

2. Expanding Treatment Guidelines and Clinical Adoption

Clinical practice guidelines increasingly recommend comprehensive antihypertensive management, often involving combination therapies of calcium channel blockers and ARBs. The synergistic efficacy of amlodipine and valsartan has fostered their combined use, especially in resistant hypertension cases.

3. Patent Expirations and Generic Competition

Many patents for branded formulations of amlodipine and valsartan expired in the late 2010s, triggering a surge in generic entries. This reduced cost barriers facilitated broader access but also intensified price competition, influencing market share dynamics.

4. Regulatory Changes and Safety Concerns

In 2018, several valsartan formulations were recalled globally due to contamination with N-nitrosodimethylamine (NDMA), a probable carcinogen, leading to regulatory scrutiny. While this temporarily impacted sales, market confidence restored through reformulations and new approvals [2]. Conversely, amlodipine faced minimal regulatory disruptions, maintaining its consistency in the market.

5. Development of Fixed-Dose Combinations (FDCs)

FDCs incorporating amlodipine and valsartan gained popularity owing to improved compliance, simplified regimens, and evidence of enhanced blood pressure control. The proliferation of these formulations has propelled sales growth and market penetration.

6. Emerging Markets and Population Growth

Rapid urbanization and increased healthcare infrastructure in Asia-Pacific, Latin America, and Africa expand market opportunities. The rising prevalence of hypertension and improving healthcare access in these regions are primary drivers.

Market Challenges

1. Concerns Regarding Sartan Contaminants

The NDMA contamination crisis adversely impacted vendor confidence, prompting recalls and regulatory constraints, particularly affecting valsartan's market environment [3].

2. Competition from Newer Therapeutics

Emergence of novel antihypertensive classes, such as neprilysin inhibitors and direct renin inhibitors, presents alternative options, potentially eroding market share for traditional drugs.

3. Patent Strategies and Biosimilar Development

While most patents for amlodipine and valsartan have expired, strategic patenting of combination therapies and formulations continues to influence pricing and exclusivity.

4. Pricing Pressures and Healthcare Cost Containment

Pricing transparency initiatives and reimbursement policies in developed countries pressure drug prices, especially for mature products with generic competition.

Financial Trajectory

Historical Performance

The global market for antihypertensives, including amlodipine and valsartan, was valued at approximately USD 15–20 billion in 2021, with a compounded annual growth rate (CAGR) of around 3%-5% over the prior decade [4].

Amlodipine: Maintains a dominant position owing to its patent-protected formulations until patent expiry around 2010-2018, with subsequent decline in branded sales but robust growth in generics. The global amlodipine market was valued at approximately USD 4 billion in 2021, with significant contributions from North America, Europe, and Asia.

Valsartan: Post-recall events, revenue declined materially in 2018-2019. However, reforms led to resurgence, with driven revenues reaching approximately USD 3–4 billion globally. Its market recovery was powered by reformulation, label expansion, and increased utilization.

Future Outlook and Growth Drivers

The VASNITE (ValsartanANhypertensive Therapy) market is projected to grow at a CAGR of about 4% through 2028, fueled by rising CVD prevalence and ongoing demand for effective, affordable antihypertensives [5].

Amlodipine is expected to sustain its base through volume growth in generic form, with a CAGR of around 3-4%. Combination formulations incorporating amlodipine with other antihypertensives are poised to drive incremental sales.

Impact of Biosimilars and Patent Litigation

Patent cliffs have historically accelerated generic entry, compressing margins but expanding market access. Ongoing patent litigations and settlements continue to shape the competitive landscape, especially in key markets like the U.S., EU, and Japan.

Pricing Trends

Price erosion post-patent expiry leads to declining per-unit revenue but volume-driven growth offsets some declines. Manufacturers focusing on differentiated formulations, fixed-dose combinations, and regional expansion can counteract price pressures.

Strategic Considerations

• Focus on Biosimilar & Generic Expansion: Leverage low-cost manufacturing and regional licensing to maximize market share.
• Invest in Combination Therapies: Develop and commercialize fixed-dose combination formulations to enhance adherence and market penetration.
• Navigate Regulatory Risks: Maintain rigorous quality controls to prevent contamination incidents and ensure continuous approval.
• Expand in Emerging Markets: Increase distribution channels and pricing strategies tailored to local healthcare systems.

Key Takeaways

• The global market for amlodipine besylate and valsartan remains robust, driven by increasing hypertension prevalence and expanding treatment guidelines.
• Patent expirations and generic competition have reduced prices but increased accessibility, sustaining high sales volumes.
• Safety concerns, notably valsartan NDMA contamination, temporarily impacted market confidence, but reformulations have restored supply stability.
• The development of fixed-dose combinations and entry into emerging markets are primary strategies for driving future growth.
• Competitive pressures from newer therapeutics and regulatory challenges require adaptive strategies focused on innovation, quality, and regional expansion.

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FAQs

1. How has the patent expiry of amlodipine and valsartan influenced their market?
Patent expirations facilitated the entry of generic versions, significantly reducing prices and expanding access. However, increased competition has compressed margins for branded manufacturers, emphasizing volume-driven sales and therapeutic diversification.

2. What regulatory issues have impacted valsartan's market trajectory?
The NDMA contamination recall in 2018 led to product withdrawals and reformulations, temporarily disrupting supply and sales. Ongoing regulatory scrutiny emphasizes manufacturing quality to prevent recurrence.

3. Are fixed-dose combinations of amlodipine and valsartan commercially successful?
Yes, fixed-dose combinations enhance patient adherence, streamline therapy, and exhibit increased sales growth. They are favored in resistant hypertension management and are expanding in market share globally.

4. What opportunities exist in emerging markets for these drugs?
Rapid urbanization, rising hypertension prevalence, and improving healthcare infrastructure offer extensive opportunities. Local manufacturing, tailored pricing, and strategic partnerships are critical for market penetration.

5. How might competition from newer antihypertensive agents affect amlodipine and valsartan?
Emerging therapies like neprilysin inhibitors and selective renin inhibitors could diminish market share if proven superior or cost-effective. Continuous innovation and combination therapy development are essential for maintaining relevance.

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References

[1] World Health Organization. "Cardiovascular Diseases (CVDs)." 2022.
[2] U.S. Food and Drug Administration. "Valsartan recalls and reformulations." 2018.
[3] European Medicines Agency. "NDMA contamination and regulatory response." 2019.
[4] MarketWatch. "Antihypertensive Drugs Market Forecast." 2022.
[5] Grand View Research. "Global Antihypertensive Drugs Market Size & Trends." 2022.