AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM - Generic Drug Details

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

Amlodipine besylate; atorvastatin calcium is the generic ingredient in two branded drugs marketed by Apotex, Dr Reddys, Mylan, Zydus Pharms, and Pharmacia, and is included in five NDAs. Additional information is available in the individual branded drug profile pages.

Eight suppliers are listed for this compound.

Summary for AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM

US Patents:	0
Tradenames:	2
Applicants:	5
NDAs:	5
Finished Product Suppliers / Packagers:	8
Clinical Trials:	3
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM
DailyMed Link:	AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM at DailyMed

Recent Clinical Trials for AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM

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

Sponsor	Phase
Haining Health-Coming Biotech Co., Ltd.	Phase 2
Alphacait, LLC	Phase 2
Dr. Reddy's Laboratories Limited	Phase 1

See all AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM clinical trials

Pharmacology for AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM

Drug Class	Calcium Channel Blocker Dihydropyridine Calcium Channel Blocker HMG-CoA Reductase Inhibitor
Mechanism of Action	Calcium Channel Antagonists Cytochrome P450 3A Inhibitors Hydroxymethylglutaryl-CoA Reductase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM

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

C10AA	HMG CoA reductase inhibitors
C10A	LIPID MODIFYING AGENTS, PLAIN
C10	LIPID MODIFYING AGENTS
C	Cardiovascular system

Paragraph IV (Patent) Challenges for AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
CADUET	Tablets	amlodipine besylate; atorvastatin calcium	2.5 mg/40 mg	021540	1	2009-09-17
CADUET	Tablets	amlodipine besylate; atorvastatin calcium	5 mg/80 mg	021540	1	2009-04-07
CADUET	Tablets	amlodipine besylate; atorvastatin calcium	5 mg/10 mg 5 mg/20 mg 5 mg/40 mg 10 mg/10 mg 10 mg/20 mg 10 mg/80 mg	021540	1	2006-12-29

US Patents and Regulatory Information for AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Dr Reddys	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM	amlodipine besylate; atorvastatin calcium	TABLET;ORAL	203874-007	Mar 7, 2014	AB	RX	No	No
Dr Reddys	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM	amlodipine besylate; atorvastatin calcium	TABLET;ORAL	203874-006	Mar 7, 2014	AB	RX	No	No
Apotex	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM	amlodipine besylate; atorvastatin calcium	TABLET;ORAL	205199-004	Nov 18, 2019	AB	RX	No	No
Mylan	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM	amlodipine besylate; atorvastatin calcium	TABLET;ORAL	200465-002	Nov 29, 2013		DISCN	No	No
Dr Reddys	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM	amlodipine besylate; atorvastatin calcium	TABLET;ORAL	203874-005	Mar 7, 2014	AB	RX	No	No
Pharmacia	CADUET	amlodipine besylate; atorvastatin calcium	TABLET;ORAL	021540-009	Jul 29, 2004	AB	RX	Yes	No

Expired US Patents for AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pharmacia	CADUET	amlodipine besylate; atorvastatin calcium	TABLET;ORAL	021540-006	Jan 30, 2004	5,969,156*PED
Pharmacia	CADUET	amlodipine besylate; atorvastatin calcium	TABLET;ORAL	021540-008	Jan 30, 2004	RE40667*PED
Pharmacia	CADUET	amlodipine besylate; atorvastatin calcium	TABLET;ORAL	021540-002	Jan 30, 2004	RE40667*PED
Pharmacia	CADUET	amlodipine besylate; atorvastatin calcium	TABLET;ORAL	021540-011	Jul 29, 2004	5,969,156*PED
Pharmacia	CADUET	amlodipine besylate; atorvastatin calcium	TABLET;ORAL	021540-008	Jan 30, 2004	4,879,303*PED
Pharmacia	CADUET	amlodipine besylate; atorvastatin calcium	TABLET;ORAL	021540-002	Jan 30, 2004	6,455,574

AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Amlodipine Besylate and Atorvastatin Calcium

Introduction

Amlodipine besylate and atorvastatin calcium are two critical medications in the management of cardiovascular diseases. Amlodipine besylate is a calcium channel blocker used to treat hypertension and angina, while atorvastatin calcium is a statin that lowers cholesterol levels. Here, we delve into the market dynamics and financial trajectories of these drugs.

Amlodipine Besylate Market Dynamics

Global Market Size and Growth

The global amlodipine besylate market was valued at USD 1,867.0 million in 2023 and is projected to reach USD 2,539.5 million by 2031, growing at a CAGR of 3.98% from 2024 to 2031[1][4].

Regional Analysis

North America dominates the amlodipine besylate market, holding around 34.56% of the global market share in 2023, with a valuation of USD 645.2 million. This dominance is attributed to the high prevalence of hypertension and cardiovascular diseases, advanced healthcare infrastructure, and robust R&D activities in the region[1][4].

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 grow significantly at a CAGR of 4.67% due to the increasing adoption of e-commerce platforms for purchasing medications, driven by convenience and accessibility[1].

Drivers and Challenges

Key drivers include the rising prevalence of hypertension and cardiovascular diseases, increasing adoption of combination therapies, and advancements in pharmaceutical formulations. However, fierce competition from generic drugs leads to price erosion and reduced profit margins, posing a significant challenge[1][4].

Combination Therapies

The development of single-pill combinations, such as amlodipine besylate and atorvastatin, has been a significant trend. These combinations have been shown to improve patient adherence and reduce cardiovascular events in hypertensive patients with multiple risk factors[3].

Atorvastatin Calcium Market Dynamics

Global Market Size and Growth

The global atorvastatin calcium market is expected to grow from USD 230.4 million in 2023 to USD 571.0 million by 2033, at a CAGR of 9.5% during the forecast period from 2024 to 2033[2][5].

Regional Analysis

North America holds a significant market share of 40.1%, with revenues reaching USD 92.3 million. The Asia Pacific region is also poised for substantial growth, driven by government initiatives, research activities, and increasing public awareness of healthcare[2][5].

Type and Application Analysis

Biocatalysis emerges as the dominant type, commanding a 39% market share, while capsules are the preferred form of administration, accounting for 51% of the market share. This indicates a preference for eco-friendly production methods and efficient administration forms[2][5].

Drivers and Challenges

The market is driven by the growing demand for effective cholesterol-lowering medications, with healthcare professionals increasingly prescribing atorvastatin calcium to manage cardiovascular risk factors. Generic versions of atorvastatin calcium have become prominent, leading to cost-effectiveness and increased accessibility for patients[2][5].

Financial Trajectory

Amlodipine Besylate

• Revenue Projections: The market is expected to reach USD 2,539.5 million by 2031, growing at a CAGR of 3.98% from 2024 to 2031[1].
• Key Players: Major players include Pfizer, Mylan, Reddy’s Laboratories, Apotex, Teva Pharmaceutical, and others, who are focusing on differentiating their products through improved formulations and combination therapies[1][4].

Atorvastatin Calcium

• Revenue Projections: The market is anticipated to reach USD 571.0 million by 2033, growing at a CAGR of 9.5% from 2024 to 2033[2][5].
• Key Players: The market is dominated by generic versions, with key players leveraging biocatalysis and capsule formulations to maintain market share[2][5].

Impact of Combination Therapies

Amlodipine Besylate and Atorvastatin Calcium Combination

The single-pill combination of amlodipine besylate and atorvastatin calcium has shown significant benefits in reducing cardiovascular events and improving patient adherence. This combination is particularly effective in managing hypertensive patients with multiple risk factors, highlighting the potential for increased market growth through such formulations[3].

Regulatory and Healthcare Trends

Regulatory Approvals

Regulatory approvals and endorsements by health organizations play a crucial role in the expansion of both markets. These approvals ensure that these medications remain primary treatments for hypertension and cardiovascular diseases[1][2].

Healthcare Infrastructure

Advanced healthcare infrastructure in regions like North America and increasing investments in cardiovascular departments globally contribute to the sustained demand for these medications[1][4].

Consumer Behavior and Digital Health

Online Retail Growth

The COVID-19 pandemic has accelerated the shift towards online purchasing of medications, including amlodipine besylate and atorvastatin calcium. This trend is expected to continue, driven by convenience, accessibility, and competitive pricing[1].

Key Takeaways

• The amlodipine besylate market is projected to reach USD 2,539.5 million by 2031, driven by the rising prevalence of hypertension and cardiovascular diseases.
• The atorvastatin calcium market is expected to reach USD 571.0 million by 2033, growing at a CAGR of 9.5%.
• Combination therapies, such as the single-pill formulation of amlodipine besylate and atorvastatin calcium, are gaining traction due to their efficacy and patient adherence benefits.
• Online retail is a growing sales channel for both medications, driven by consumer preference for convenience and accessibility.
• Regulatory approvals and advancements in pharmaceutical formulations are key drivers for market growth.

FAQs

1. What is the current market size of the amlodipine besylate market?

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

2. Which region dominates the atorvastatin calcium market?

North America holds a significant market share of 40.1% in the atorvastatin calcium market[2][5].

3. What is the projected CAGR for the amlodipine besylate market from 2024 to 2031?

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

4. How does the combination of amlodipine besylate and atorvastatin calcium benefit patients?

The combination reduces cardiovascular events and improves patient adherence, particularly in hypertensive patients with multiple risk factors[3].

5. What is driving the growth of the online retail segment for these medications?

The growth is driven by the convenience, accessibility, and competitive pricing offered by online retail platforms, accelerated by the COVID-19 pandemic[1].

Cited Sources:

1. Kings Research: Amlodipine Besylate Market Size & Share Forecast [2031][1]
2. Market.us: Atorvastatin Calcium Market Size, Share | CAGR of 9.5%[2]
3. PubMed: A single-pill combination of amlodipine besylate and atorvastatin[3]
4. Market Research Future: Amlodipine Besylate Market Trends, Growth, Forecast 2032[4]
5. PharmiWeb: Maximum Revenue Outlook: Atorvastatin Calcium Market’s Upward Trajectory to 2033[5]