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, 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
CJ HealthCare 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
Novel Labs Inc	AMLODIPINE BESYLATE AND VALSARTAN	amlodipine besylate; valsartan	TABLET;ORAL	202829-002	Mar 30, 2015	AB	RX	No	No
Teva Pharms Usa	AMLODIPINE BESYLATE AND VALSARTAN	amlodipine besylate; valsartan	TABLET;ORAL	091235-003	Mar 30, 2015		DISCN	No	No
Strides Pharma	AMLODIPINE BESYLATE AND VALSARTAN	amlodipine besylate; valsartan	TABLET;ORAL	090011-002	Mar 28, 2013	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
Lupin	AMLODIPINE BESYLATE AND VALSARTAN	amlodipine besylate; valsartan	TABLET;ORAL	090245-003	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	021990-002	Jun 20, 2007	5,399,578*PED
Novartis	EXFORGE	amlodipine besylate; valsartan	TABLET;ORAL	021990-005	Jun 20, 2007	6,294,197*PED
Novartis	EXFORGE	amlodipine besylate; valsartan	TABLET;ORAL	021990-005	Jun 20, 2007	5,399,578*PED
Novartis	EXFORGE	amlodipine besylate; valsartan	TABLET;ORAL	021990-005	Jun 20, 2007	6,395,728

AMLODIPINE BESYLATE; VALSARTAN Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Amlodipine Besylate and Valsartan

Introduction

Amlodipine besylate and Valsartan are two widely used antihypertensive medications that have seen significant market dynamics in recent years. This article delves into the current market trends, financial trajectories, and the factors influencing the prices and demand for these drugs.

Market Size and Growth

Amlodipine Besylate

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[3].

Valsartan

While specific market size figures for Valsartan are not provided, its market is closely tied to the broader antihypertensive market, which is experiencing significant growth driven by increasing prevalence of hypertension and cardiovascular diseases.

Demand Drivers

Rising Prevalence of Hypertension and Cardiovascular Diseases

The growing prevalence of hypertension and cardiovascular diseases is a primary driver for both Amlodipine Besylate and Valsartan. According to the WHO, approximately 1.28 million adults aged 30-79 in low and middle-income countries suffer from hypertension, with many remaining undiagnosed[3].

Increasing Adoption of Combination Therapies

The adoption of combination therapies, which often include Amlodipine Besylate and Valsartan, is on the rise. This trend is driven by the need for more effective management of hypertension and cardiovascular conditions[3].

Regulatory Approvals and Endorsements

Regulatory approvals and endorsements by health organizations further boost the market for these medications. For instance, the National Pharmaceutical Pricing Authority (NPPA) directives in India have influenced pricing strategies for essential medicines, including Valsartan[1].

Supply Chain and Pricing Dynamics

Supply Constraints

Both Amlodipine Besylate and Valsartan have faced supply constraints in recent months. In China, the post-Chinese New Year period saw a slowdown in manufacturing, leading to limited inventories and subsequent price increases[2]. Similarly, in the USA, drug shortages due to supply chain disruptions and regulatory oversight have impacted the availability of these medications[1].

Pricing Strategies

Manufacturers have strategically increased prices to leverage the high demand and supply constraints. For example, Valsartan prices surged in April 2024 due to persistent demand and dwindling supplies, prompting manufacturers to adjust their pricing strategies[1].

Regional Market Analysis

North America

North America dominates the Amlodipine Besylate market, with a significant share attributed to the high prevalence of hypertension and cardiovascular diseases in the region. Advanced healthcare infrastructure, high healthcare spending, and widespread insurance coverage ensure broad access to these medications[3][4].

Asia Pacific

The Asia Pacific region is experiencing rapid growth, driven by increasing awareness of cardiovascular health and government initiatives promoting preventive healthcare. This region is expected to witness a CAGR of 5.09% for Amlodipine Besylate from 2024 to 2031[3].

Europe

Europe also sees a notable demand for these medications, with business confidence and consumer confidence contributing to the upward trajectory of prices. The decline in inflation across the Eurozone has further relieved financial strains for consumers, leading to increased demand[2].

Distribution Channels

Hospital Pharmacies

Hospital pharmacies account for a significant share of the market for both Amlodipine Besylate and Valsartan. However, online retail is emerging as a key distribution channel, driven by the convenience and accessibility it offers, especially post-COVID-19[3].

Online Retail

The online retail segment is set to witness significant growth, with a CAGR of 4.67% for Amlodipine Besylate from 2024 to 2031. This growth is attributed to the increasing adoption of e-commerce platforms for purchasing medications[3].

Economic and Regulatory Factors

Economic Recovery

The rebound in the Eurozone economy, particularly in Germany, and the resilience of the US economy have led to increased consumer spending power, driving up demand for these medications[2].

Regulatory Directives

Regulatory actions, such as those by the NPPA in India, have significantly impacted pricing dynamics. These directives have led pharmaceutical companies to adjust their pricing strategies, contributing to the overall escalation in medication costs[1].

Future Outlook

Continued Demand

The demand for Amlodipine Besylate and Valsartan is expected to continue its upward trajectory, driven by sustained demand from end-consumers and the growing prevalence of hypertension and cardiovascular diseases[1][3].

Potential Rate Cuts

The potential implementation of rate cuts by central banks in developed economies could further stimulate demand for these medications, instilling optimism within the market[1].

Competitive Landscape

Generic Competition

The market for Amlodipine Besylate and Valsartan is characterized by robust competition from generic drugs. This competition leads to price erosion and reduced profit margins for manufacturers, necessitating a focus on differentiating products through improved formulations[3].

Key Players

Major pharmaceutical companies such as Pfizer Inc., Dr. Reddy’s Laboratories Limited, Cipla Limited, and others are key players in this market. These companies are investing in R&D to develop improved formulations and combination therapies to maintain market share[4].

Key Takeaways

• The global markets for Amlodipine Besylate and Valsartan are driven by rising demand for antihypertensive medications.
• Supply constraints and regulatory actions have led to price increases.
• North America and the Asia Pacific region are significant markets due to high prevalence rates and growing awareness.
• Online retail is emerging as a crucial distribution channel.
• The market is expected to continue growing, driven by sustained demand and economic recovery.

FAQs

Q: What are the primary drivers of the Amlodipine Besylate and Valsartan markets?

The primary drivers include the rising prevalence of hypertension and cardiovascular diseases, increasing adoption of combination therapies, and regulatory approvals.

Q: How have supply chain issues affected the prices of these medications?

Supply chain issues, such as manufacturing slowdowns and drug shortages, have led to supply constraints, prompting manufacturers to increase prices.

Q: Which regions are leading the market for these medications?

North America and the Asia Pacific region are significant markets, driven by high prevalence rates and growing awareness of cardiovascular health.

Q: What role does online retail play in the distribution of these medications?

Online retail is emerging as a key distribution channel, driven by convenience and accessibility, especially post-COVID-19.

Q: What is the expected future outlook for the demand of Amlodipine Besylate and Valsartan?

The demand is expected to continue its upward trajectory, driven by sustained demand from end-consumers and the growing prevalence of hypertension and cardiovascular diseases.

Sources

1. ChemAnalyst: Valsartan Prices Surge Globally, Driven by Rising Demand and Supply Constraints.
2. ChemAnalyst: Global Amlodipine Besylate Prices Surge in March as Demand Peaks and Supplies Dwindle.
3. Kings Research: Amlodipine Besylate Market Size & Share Forecast [2031].
4. Transparency Market Research: Amlodipine Market Size, Share, Growth, Current Analysis, 2034.