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
Overseas Pharmaceuticals, Ltd.	Phase 1
Guangzhou Health Start Pharmaceutical Techology Co.,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
Piramal	OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE	amlodipine besylate; hydrochlorothiazide; olmesartan medoxomil	TABLET;ORAL	210718-002	May 14, 2025	AB	RX	No	No
Graviti Pharms	AMLODIPINE BESYLATE	amlodipine besylate	TABLET;ORAL	201380-002	Apr 13, 2012		DISCN	No	No
Genpharm	AMLODIPINE BESYLATE	amlodipine besylate	TABLET;ORAL	077362-002	Jul 9, 2007		DISCN	No	No
Azurity	WIDAPLIK	amlodipine besylate; indapamide; telmisartan	TABLET;ORAL	219423-003	Jun 5, 2025		DISCN	Yes	No			Y
Torrent	AMLODIPINE AND OLMESARTAN MEDOXOMIL	amlodipine besylate; olmesartan medoxomil	TABLET;ORAL	202933-004	Nov 25, 2016		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	019787-001	Jul 31, 1992
Viatris	NORVASC	amlodipine besylate	TABLET;ORAL	019787-003	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	019787-002	Jul 31, 1992

Market Dynamics and Financial Trajectory for Amlodipine Besylate

Last updated: July 27, 2025

Introduction

Amlodipine besylate stands as a cornerstone medication within calcium channel blockers, widely prescribed for hypertension and angina. Its global market scope is vast, driven by the escalating prevalence of cardiovascular diseases (CVDs), aging populations, and the expanding therapeutic landscape. As a long-established generic drug, amlodipine besylate’s market dynamics are influenced by patent expirations, competitive forces, regulatory factors, and evolving healthcare priorities. This analysis delineates the current market environment, financial trends, key drivers, challenges, and future outlook.

Market Overview

Global Market Size & Growth

The global amlodipine market is projected to reach approximately USD 4.7 billion by 2027, with a compound annual growth rate (CAGR) of around 4.8% from 2022 to 2027 [1]. The widespread adoption of amlodipine for hypertension management, combined with rising CVD prevalence—expected to affect 1.13 billion people globally by 2030 [2]—fuels sustained demand.

Geographical Distribution

• North America: Dominates due to high hypertension awareness, healthcare expenditure, and established pharmaceutical infrastructure.
• Asia-Pacific: Exhibits rapid growth owing to expanding healthcare access, increasing urbanization, and high CVD burden.
• Europe: Maintains significant market share with mature healthcare systems and emphasis on preventative care.

Patent and Generic Landscape

Originally developed by Pfizer in the late 1980s, amlodipine’s patent expired in the early 2010s, catalyzing a surge in generic entrants. The reduced drug prices have intensified competitive pricing pressures but widened access, expanding market penetration.

Market Drivers

Rising Prevalence of Hypertension and Cardiovascular Disease

Non-communicable diseases (NCDs) such as hypertension directly correlate with age, lifestyle, and urbanization trends. WHO reports hypertension affects 1.28 billion adults globally, with medication like amlodipine serving as frontline therapy [3].

Generic Drug Adoption and Price Competition

Post-patent expiry, generic manufacturers have driven down prices, making amlodipine an affordable and accessible treatment option globally. This has significantly widened its consumer base, especially in emerging markets.

Healthcare Infrastructure Expansion

Health systems worldwide are integrating chronic disease management programs, which emphasize affordable and proven therapies like amlodipine, bolstering demand.

Regulatory Approvals and Label Expansion

Recent approvals for combination therapies and new formulations—such as extended-release versions—have expanded therapeutic options, sustaining market growth.

Public and Private Sector Initiatives

Government strategies to combat NCDs and cardiovascular health campaigns promote amlodipine use, further driving demand.

Market Challenges

Pricing and Competitive Pressures

Intensified generic competition has resulted in aggressive price cuts, pressuring profit margins for manufacturers. Market saturation in developed countries also limits growth potential.

Regulatory Hurdles

Stringent regulatory requirements for formulations, bioequivalence studies, and manufacturing standards can delay entry for new formulations or generic versions, impacting revenue streams.

Patent Disputes and Litigation

While primary patents have expired, secondary patents or formulation patents may pose barriers. Legal disputes can slow market expansion or deter new entrants.

Shift Towards Novel Therapies

Development of novel antihypertensives, combination therapies, and personalized medicine poses competitive threats by offering alternative treatment paradigms.

Manufacturing and Supply Chain Risks

Global supply chain disruptions, especially in raw materials, can impact manufacturing costs and inventory levels.

Financial Trajectory and Revenue Trends

Historical Performance

Amlodipine’s revenue has exhibited steady growth since patent expiry, primarily driven by generic penetration. Leading pharmaceutical companies, including Pfizer, Teva, Mylan, and Sun Pharma, generate substantial revenues from amlodipine formulations.

Current Revenue Dynamics

In 2022, the global amlodipine market generated approximately USD 4.2 billion, with major contributions from North America (38%), Europe (22%), and Asia-Pacific (28%) [1]. The remaining percentage includes Latin America and Middle East/Africa regions.

Pricing Trends

Generic competition has driven per-unit prices down by an average of 35% over the past five years. Despite price erosion, overall revenues remain stable owing to volume increases.

Forecasted Financial Trajectory

Analysts project a compound annual growth rate of approximately 3-5% over the next five years, stabilized by increased regional coverage, formulations, and healthcare initiatives. However, revenue growth may plateau in mature markets due to saturation.

Impact of New Formulations

Introduction of fixed-dose combination products with other antihypertensives (e.g., amlodipine with torasemide or valsartan) anticipates boosting sales, especially in markets emphasizing adherence and simplified regimens.

Future Outlook

Innovation and Formulation Pipelines

While fixed-dose combination therapies are trending, innovative formulations such as once-daily extended-release versions are expected to sustain relevance. Research into biosimilar and biotechnological adjuncts, though limited for small molecules like amlodipine, could influence future competitive dynamics.

Emerging Markets Focus

High growth potential resides predominantly in developing nations where hypertension control remains suboptimal. Market expansion strategies focusing on affordability, patient compliance, and distribution are critical.

Regulatory and Policy Impact

Government health policies advocating for accessible hypertension treatment and expanding insurance coverage can positively influence market size. Conversely, increased regulatory stringency could slow new formulation approvals.

Competitive Landscape Evolution

Consolidation among generic manufacturers and patent litigations will likely shape market shares. Developing low-cost manufacturing capabilities remains advantageous.

Potential Disruptors

Emerging drug classes, such as neprilysin inhibitors or more targeted therapies, could potentially shift the treatment landscape. However, for the foreseeable future, amlodipine’s established efficacy and cost-effectiveness sustain its market position.

Conclusion

Amlodipine besylate’s market trajectory combines resilience, driven by therapeutic efficacy, affordability, and expanding global burden of hypertension. While pricing pressures and competitive dynamics challenge profit margins, ongoing innovation in formulations and strategic market penetration—particularly in emerging economies—will sustain its revenue streams. Stakeholders must navigate regulatory landscapes, competitive pressures, and evolving treatment standards to optimize financial outcomes.

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Key Takeaways

• Stable Demand: Rapidly growing hypertensive population worldwide ensures consistent demand for amlodipine, especially post-patent expiration.
• Price Competition: Generic proliferation has lowered prices substantially, constraining margins but expanding access.
• Market Expansion Opportunities: Emerging markets and fixed-dose combinations present significant growth avenues.
• Innovation Focus: Formulation enhancements and combination therapies are key to maintaining market relevance.
• Regulatory and Competitive Challenges: Navigating patent litigations, regulatory standards, and competitive strategies are vital for sustained profitability.

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FAQs

1. What factors are driving the global demand for amlodipine besylate?
   The primary drivers include the rising prevalence of hypertension globally, aging populations, increased healthcare infrastructure, and the affordability of generic versions following patent expiry [1][2].

2. How has patent litigation affected amlodipine’s market?
   Expiration of key patents facilitated generic entry, increasing competition and reducing prices, which has expanded access but pressured manufacturer margins.

3. What are the future growth prospects for amlodipine besylate?
   Growth is expected to persist through emerging market expansion, new fixed-dose formulations, and strategic formulations, though overall growth may slow as markets mature [1].

4. Are there emerging alternatives to amlodipine for hypertension treatment?
   Yes, newer drug classes such as angiotensin receptor-neprilysin inhibitors (ARNIs) and personalized medicines could influence future treatment choices, but amlodipine remains a first-line, cost-effective therapy.

5. What role will regulatory policies play in shaping the amlodipine market?
   Regulations impacting drug approval pathways, patent protections, and health coverage will significantly influence market accessibility, innovation, and financial outlooks.

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References

[1] MarketWatch. (2022). Global Amlodipine Market Size, Share & Trends Analysis Report.
[2] World Health Organization. (2021). Global status report on noncommunicable diseases 2021.
[3] WHO. (2019). Hypertension fact sheet.