AMLODIPINE BESYLATE Drug Patent Profile

Which patents cover Amlodipine Besylate, and when can generic versions of Amlodipine Besylate launch?

Amlodipine Besylate is a drug marketed by 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, Alembic, Apotex, Dr Reddys, Neocubes Pharma, Amneal, Aurobindo Pharma Ltd, Dr Reddys Labs Inc, Heritage, Lupin Pharms, Rising, Teva Pharms, Watson Labs Inc, Hetero Labs, Macleods Pharms Ltd, Novel Labs Inc, Strides Pharma Intl, Teva Pharms Usa, Torrent, and Lupin Ltd. and is included in seventy-two NDAs.

The generic ingredient in AMLODIPINE BESYLATE is amlodipine besylate; hydrochlorothiazide; valsartan. There are fifty drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the amlodipine besylate; hydrochlorothiazide; valsartan profile page.

Summary for AMLODIPINE BESYLATE

US Patents:	0
Applicants:	55
NDAs:	72
Finished Product Suppliers / Packagers:	40
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	60
Patent Applications:	5,262
Drug Prices:	Drug price information 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
Overseas Pharmaceuticals, Ltd.	Phase 1
Guangzhou Health Start Pharmaceutical Techology Co.,Ltd	Phase 1

See all AMLODIPINE BESYLATE clinical trials

Pharmacology for AMLODIPINE BESYLATE

Drug Class	Calcium Channel Blocker Dihydropyridine 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
Puracap Pharm	AMLODIPINE BESYLATE	amlodipine besylate	TABLET;ORAL	078131-001	Sep 4, 2007		DISCN	No	No
Lupin	AMLODIPINE BESYLATE AND VALSARTAN	amlodipine besylate; valsartan	TABLET;ORAL	090245-002	Mar 30, 2015	AB	RX	No	No
Teva	AMLODIPINE BESYLATE	amlodipine besylate	TABLET;ORAL	076846-003	Jun 28, 2007	AB	RX	No	No
Novel Labs Inc	AMLODIPINE BESYLATE AND VALSARTAN	amlodipine besylate; valsartan	TABLET;ORAL	202829-004	Mar 30, 2015	AB	RX	No	No
Graviti Pharms	AMLODIPINE BESYLATE	amlodipine besylate	TABLET;ORAL	201380-002	Apr 13, 2012		DISCN	No	No
Epic Pharma Llc	AMLODIPINE BESYLATE	amlodipine besylate	TABLET;ORAL	078552-002	Apr 8, 2009	AB	RX	No	No
Neocubes Pharma	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM	amlodipine besylate; atorvastatin calcium	TABLET;ORAL	207762-011	Jan 11, 2019	AB	RX	No	No

Expired US Patents for AMLODIPINE BESYLATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Synthon Pharms	AMLODIPINE BESYLATE	amlodipine besylate	TABLET, ORALLY DISINTEGRATING;ORAL	022026-001	Sep 27, 2007	6,828,339
Synthon Pharms	AMLODIPINE BESYLATE	amlodipine besylate	TABLET, ORALLY DISINTEGRATING;ORAL	022026-002	Sep 27, 2007	6,828,339
Synthon Pharms	AMLODIPINE BESYLATE	amlodipine besylate	TABLET, ORALLY DISINTEGRATING;ORAL	022026-003	Sep 27, 2007	6,828,339

International Patents for AMLODIPINE BESYLATE

See the table below for patents covering AMLODIPINE BESYLATE around the world.

Country	Patent Number	Title	Estimated Expiration
European Patent Office	1448197
World Intellectual Property Organization (WIPO)	03043635
Norway	20042539
Australia	2002343257
Argentina	037565	FORMAS DE SALES DE AMLODIPINA Y PROCEDIMIENTOS PARA PREPARARLAS.

Supplementary Protection Certificates for AMLODIPINE BESYLATE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1507558	2012/018	Ireland		PRODUCT NAME: ALISKIREN OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, AMLODIPINE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF AND HYDROCHLOROTHIAZIDE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF.; NAT REGISTRATION NO/DATE: EU/1/11/730/001-060 20111122; FIRST REGISTRATION NO/DATE: SWITZERLAND 6167801-6167805 20110705
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	SPC/GB11/010	United Kingdom		PRODUCT NAME: THE COMBINATION OF A) TELMISARTAN, OPTIONALLY IN THE FORM OF PHARMACEUTICALLY ACCEPTABLE SALTS, AND B) AMLODIPINE, OPTIONALLY IN THE FORM OF PHARMACEUTICALLY ACCEPTABLE SALTS, ESPECIALLY AMLODIPINE BESYLATE; REGISTERED: UK EU/1/10/648/001 20101007; UK EU/1/10/648/002 20101007; UK EU/1/10/648/003 20101007; UK EU/1/10/648/004 20101007; UK EU/1/10/648/005 20101007; UK EU/1/10/648/006 20101007; UK EU/1/10/648/007 20101007; UK EU/1/10/648/008 20101007; UK EU/1/10/648/009 20101007; UK EU/1/10/648/010 20101007; UK EU/1/10/648/011 20101007; UK EU/1/10/648/012 20101007; UK EU/1/10/648/013 20101007; UK EU/1/10/648/014 20101007; UK EU/1/10/648/015 20101007; UK EU/1/10/648/016 20101007; UK
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
0503785	CA 2011 00026	Denmark		PRODUCT NAME: A COMBINATION OF OLMESARTAN MEDOXOMIL, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, AND AMLODIPINE BESYLATE AND HYDROCHLOROTHIAZIDE; NAT. REG. NO/DATE: 46260-46269 (DK) 20110323; FIRST REG. NO/DATE: DE 79810.00.00 20101216
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
1003503	05C0048	France		PRODUCT NAME: AMLODIPINE OU UN DE SES SELS D?ADDITION D?ACIDES PHARMACAUTIQUEMENT ACCEPTABLES/ ATORVASTATINE OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE IN FRANCE: NL 29929 DU 20050707; REGISTRATION NO/DATE AT EEC: NL 29929 DU 20050707

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.