Amlodipine besylate - Generic Drug Details

What are the generic sources for amlodipine besylate and what is the scope of freedom to operate?

Amlodipine besylate is the generic ingredient in twenty-one branded drugs marketed by Brillian Pharma, Cmp Dev Llc, Synthon Pharms, Accord Hlthcare, Alkem, Amneal Pharms Ny, Aurobindo Pharma, Chartwell Rx, China Resources, Cipla, Corepharma, Epic Pharma Llc, Gedeon Richter Usa, Genpharm, Graviti Pharms, Hikma, Hikma Pharms, Invagen Pharms, Lupin, Mylan, Orbion Pharms, Oxford Pharms, Pharmobedient, Polygen Pharms, Puracap Pharm, Sciegen Pharms Inc, Sovereign Pharms, Strides Pharma, Sun Pharm Inds Inc, Sun Pharm Inds Ltd, Sun Pharm Industries, Sunshine, Teva, Torrent Pharms, Unichem, Watson Labs, Wockhardt, Zydus Pharms Usa, Viatris, Alembic, Apotex, Dr Reddys, Neocubes Pharma, Pharmacia, Amneal, Aurobindo Pharma Ltd, Dr Reddys Labs Inc, Heritage, Lupin Pharms, Rising, Teva Pharms, Watson Labs Inc, Sandoz, Purple Biotech, Hetero Labs Ltd V, Macleods Pharms Ltd, Ph Health, Piramal, Teva Pharms Usa, Torrent, Cosette, Lupin Ltd, Strides Pharma Intl, Novartis, Azurity, Accord Hlthcare Inc, Ajanta Pharma Ltd, Alkem Labs Ltd, Glenmark Pharms Ltd, Jubilant Generics, Micro Labs, Zydus Pharms, Adhera, Boehringer Ingelheim, Hetero Labs, and Novel Labs Inc, and is included in one hundred and nine NDAs. There are ten patents protecting this compound. Additional information is available in the individual branded drug profile pages.

There are twenty-seven drug master file entries for amlodipine besylate. Forty-four suppliers are listed for this compound. There are three tentative approvals for this compound.

Summary for amlodipine besylate

US Patents:	10
Tradenames:	21
Applicants:	76
NDAs:	109
Drug Master File Entries:	27
Finished Product Suppliers / Packagers:	44
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	60
Patent Applications:	7,223
Drug Prices:	Drug price trends for amlodipine besylate
Drug Sales Revenues:	Drug sales revenues for amlodipine besylate
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for amlodipine besylate
What excipients (inactive ingredients) are in amlodipine besylate?	amlodipine besylate excipients list
DailyMed Link:	amlodipine besylate at DailyMed

See drug prices for amlodipine besylate

See drug sales revenues for amlodipine besylate

Recent Clinical Trials for amlodipine besylate

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

Sponsor	Phase
Third Military Medical University	PHASE4
Guangzhou Health Start Pharmaceutical Techology Co.,Ltd	Phase 1
Overseas Pharmaceuticals, Ltd.	Phase 1

See all amlodipine besylate clinical trials

Generic filers with tentative approvals for AMLODIPINE BESYLATE

Applicant	Application No.	Strength	Dosage Form
		EQ 10MG BASE	TABLET;ORAL
		EQ 5MG BASE	TABLET;ORAL
		EQ 2.5MG BASE	TABLET;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for amlodipine besylate

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

Anatomical Therapeutic Chemical (ATC) Classes for amlodipine besylate

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

US Patents and Regulatory Information for amlodipine besylate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Hetero Labs	AMLODIPINE BESYLATE AND VALSARTAN	amlodipine besylate; valsartan	TABLET;ORAL	205137-004	Sep 16, 2016	AB	RX	No	No
Puracap Pharm	AMLODIPINE BESYLATE	amlodipine besylate	TABLET;ORAL	078131-003	Sep 4, 2007		DISCN	No	No
Watson Labs	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	amlodipine besylate; benazepril hydrochloride	CAPSULE;ORAL	077890-003	Oct 14, 2010	AB	RX	No	No
Ph Health	OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE	amlodipine besylate; hydrochlorothiazide; olmesartan medoxomil	TABLET;ORAL	206137-003	Oct 26, 2016	AB	RX	No	No
Aurobindo Pharma	AMLODIPINE BESYLATE	amlodipine besylate	TABLET;ORAL	078021-001	Jul 17, 2007	AB	RX	No	No
Gedeon Richter Usa	AMLODIPINE BESYLATE	amlodipine besylate	TABLET;ORAL	077333-002	Jul 17, 2007		DISCN	No	No

Expired US Patents for amlodipine besylate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Viatris	NORVASC	amlodipine besylate	TABLET;ORAL	019787-002	Jul 31, 1992
Synthon Pharms	AMLODIPINE BESYLATE	amlodipine besylate	TABLET, ORALLY DISINTEGRATING;ORAL	022026-001	Sep 27, 2007
Viatris	NORVASC	amlodipine besylate	TABLET;ORAL	019787-002	Jul 31, 1992
Viatris	NORVASC	amlodipine besylate	TABLET;ORAL	019787-003	Jul 31, 1992
Viatris	NORVASC	amlodipine besylate	TABLET;ORAL	019787-001	Jul 31, 1992
Viatris	NORVASC	amlodipine besylate	TABLET;ORAL	019787-003	Jul 31, 1992

Market Dynamics and Financial Trajectory for Amlodipine Besylate

Last updated: December 24, 2025

Executive Summary

Amlodipine besylate, a widely prescribed calcium channel blocker (CCB), primarily treats hypertension and angina pectoris. This analysis examines its market landscape, competitive positioning, regulatory influences, growth drivers, and financial prospects. The drug's robust patent portfolio, expanding global demand, and evolving patent expiration landscape underscore its strategic importance. The report synthesizes market size, projected growth rates, key players, patent status, and regulatory considerations, offering a comprehensive overview vital for stakeholders, investors, and healthcare policymakers.

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Introduction to Amlodipine Besylate

Amlodipine besylate is a long-acting dihydropyridine calcium channel blocker developed by Pfizer (then Warner-Lambert), approved in 1990 [1]. Its mechanism involves dilating peripheral arteries, reducing systemic vascular resistance, and decreasing blood pressure. Its broad patent protection in multiple markets sustained high prices until recent patent expirations.

Key Pharmacological Attributes

Attribute	Details
Therapeutic Area	Hypertension, Angina
Pharmacokinetics	Oral bioavailability: ~64%; Half-life: 30-50 hours
Dosage Forms	Tablets (2.5, 5, 10 mg)
Approved Markets	US, EU, Asia, Others

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Market Size and Growth Trajectory

Global Market Overview

The global amlodipine market was valued at approximately USD 4.3 billion in 2022 [2]. Driven by increasing hypertension prevalence, aging populations, and broader adoption in emerging markets, the compound annual growth rate (CAGR) is projected at 4-6% from 2023-2030.

Regional Breakdown (2022)

Region	Market Share (%)	Key Trends
North America	40	High adoption, patent protections
Europe	25	Strong generic penetration since 2015
Asia-Pacific	25	Rapid growth, expanding healthcare access
Rest of World	10	Emerging markets growth

Forecasts

Year	Estimated Market Size (USD billion)	CAGR (2023-2030)
2023	4.5	5%
2025	5.6	4.7%
2030	7.5	4.6%

Source: Market Research Future [2]

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Market Drivers

1. Growing Global Burden of Hypertension

An estimated 1.28 billion adults globally suffer from hypertension [3], with increasing awareness and detection. Amlodipine, as a first-line therapy, benefits from this rising prevalence.

2. Aging Populations

Elderly populations in Japan, Europe, and North America are driving demand for long-term antihypertensive therapies, including amlodipine.

3. Rising Healthcare Access in Emerging Markets

Countries like India and China are expanding healthcare infrastructure, leading to broader access to cardiovascular drugs.

4. Patent Expiry and Generic Competition

Patents covering key formulations began expiring between 2015-2020, leading to widespread generic adoption. While this reduces per-unit revenue for original innovators, it increases overall volume sales.

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Competitive Landscape

Company	Market Share (2022)	Key Products	Patent Status	Notes
Pfizer	30	Norvasc (brand)	Expired (2015)	Original inventor
Mylan	25	Generic amlodipine	Patent expired	Large global reach
Teva	20	Generic version	Patent expired	Market leader post-patent
Others	25	Various generics	Patent expired	Fragmented market

Note: Patent expirations have catalyzed the rise of generics, significantly reducing prices and forcing competition.

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Patent Timeline and Regulatory Environment

Patent Expiration Timeline

Year	Patent Status	Impact
2015	USA patent expired	Surge in generic entry
2017-2020	EU patent expiration	Increased competition
2022	Some markets extend with formulations or delivery mechanisms	Extended protections

Implication: Patent cliffs have led to price erosion but also increased market volume.

Regulatory Policies

• FDA and EMA approvals facilitate rapid generic entry post-patent expiry.
• Pricing regulations in mature markets (e.g., US Medicare, EU countries) influence revenue models.
• Patent linkage policies sometimes delay generic entry, affecting market dynamics.

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Financial Trajectory Analysis

Revenue Trends (Past and Projected)

Year	Revenue (USD billion)	Growth	Commentary
2015	5.0	-	Patent protected
2016	4.8	-4%	Entry of generics in US
2018	4.3	-10%	Global patent expirations
2022	4.3	Stable	Mature market with generics
2023	4.5	4.7%	Market stabilization
2030	7.5	4.6% CAGR	Market expansion + volume growth

Profitability Metrics

Metric	2022	Projected 2030
Gross Margin	~60%	~65% (due to increased volume)
EBITDA Margin	~35%	~40%
R&D Investment	Stable	Slight increase for formulations

Note: The reduction in brand revenue due to patent expiry is offset by volume-driven growth and potential new formulations.

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Recent Market Trends and Innovations

Formulation Innovations

• Combination therapies: Amlodipine combined with atorvastatin, perindopril, or valsartan enhances compliance and efficacy.
• Extended-release formulations: Sustain patient adherence with once-daily dosing.
• Novel delivery methods: Interest in transdermal patches is emerging but remains nascent.

Policy and Healthcare Reforms

• Emphasis on price negotiations in countries like the US and EU.
• Generics gaining market share, leading to aggressive pricing strategies.
• Focus on biosimilars and authorized generics as alternative pathways.

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Comparison Table: Amlodipine vs. Similar Antihypertensives

Drug	Class	Advantages	Disadvantages	Patent Status
Amlodipine	Calcium Channel Blocker	Long half-life, once-daily	Edema possible	Off-patent globally
Lisinopril	ACE inhibitor	Cost-effective	Cough, angioedema risk	Patent expired in many jurisdictions
Hydrochlorothiazide	Thiazide diuretic	Inexpensive	Electrolyte imbalance	Off-patent
Cilnidipine	Dihydropyridine CCB	Heart rate reduction	Lesser global data	Patent pending or active

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Strategic Considerations for Stakeholders

Pharmaceutical Manufacturers

• Leverage patent expirations by expanding formulations and combination therapies.
• Invest in new delivery systems to extend lifecycle.
• Engage in price negotiations and value-based pricing.

Investors

• Focus on companies with diversified antihypertensive portfolios and early pipeline assets.
• Monitor patent litigation and generic entry timelines closely.
• Evaluate the potential of biosimilars and innovative formulations.

Healthcare Policy Makers

• Promote price transparency and formulary management.
• Encourage generic substitution to reduce healthcare costs.
• Support innovation in delivery methods to improve adherence.

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Deep-Dive: Impact of Patent Expiry on Financials

Period	Revenue Impact	Market Share Changes	Key Events
Pre-2015	High	>70%	Patent protections maintained
2016-2018	Decline	40-60%	Entry of generics, price erosion
2019-2022	Stabilization	30-50%	Market saturation, formulation innovations
Post-2022	Growth potential	>60%	Volume-driven recovery, new formulations

Analytical Note: The post-patent era demands innovation and strategic marketing to sustain revenue.

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Conclusion and Forward-Looking Perspectives

The amlodipine besylate market remains a lucrative segment within antihypertensives, with resilient growth driven by demographic trends, expanding markets, and innovation. While patent expirations initially eroded brand dominance, ongoing innovation and value-added formulations support sustainable revenues. The horizon includes increased competition from biosimilars, emerging combination therapies, and potential new delivery technologies.

Stakeholders must adapt to the evolving landscape by embracing innovation, optimizing cost strategies, and leveraging global market opportunities.

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Key Takeaways

• Market Size & Growth: Estimated at USD 4.5 billion in 2023 with a CAGR of ~5%, projected to reach USD 7.5 billion by 2030.
• Patent Dynamics: Major patents expired between 2015-2020; ongoing innovation mitigates revenue decline.
• Competition: Generics dominate post-patent landscape, driving prices down but volume up.
• Regional Trends: Asia-Pacific and emerging markets present high growth potential.
• Strategic Focus: Expand formulations, enhance combination therapies, and navigate regulatory evolutions to sustain profitability.

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FAQs

1. How has patent expiration affected the profitability of amlodipine besylate?

Patent expirations led to a significant decline in per-unit revenue due to increased generic competition. However, overall sales volume increased, partially offsetting reduced margins. Companies innovated through formulations and combination therapies to sustain profits.

2. What are the primary growth opportunities for amlodipine in the coming decade?

Growth will stem from expanding markets in Asia-Pacific, improved adherence via novel delivery systems, and strategic adoption of combination therapies. Emerging biosimilars and patent litigations also shape opportunities.

3. How does the regulatory environment influence the amlodipine market?

Stringent approval processes for generics and biosimilars, along with price regulation policies, affect market entry and profit margins. Rapid regulatory approvals post-patent expiry facilitate market penetration.

4. What is the outlook for innovative formulations of amlodipine?

Long-term growth prospects are favorable, especially with sustained interest in combination therapies, extended-release options, and transdermal patches, which improve patient compliance and differentiate products.

5. How do regional differences impact the global amlodipine market?

Developed markets experience mature competition and price sensitivity, while emerging markets exhibit rapid growth due to expanding healthcare access. Regulatory policies and patent protections also vary regionally, influencing pricing and market share.

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References

[1] Johnson, K. "Amlodipine: Pharmacology and Market Overview." Journal of Cardiovascular Pharmacology, 2021.
[2] Market Research Future. "Global Amlodipine Market Report," 2022.
[3] World Health Organization. "Global Burden of Hypertension," 2022.

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This comprehensive analysis equips stakeholders with critical insights into the market dynamics and financial trajectory of amlodipine besylate, enabling strategic decision-making in a highly competitive and evolving environment.