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Last Updated: December 28, 2024

AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN - Generic Drug Details

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What are the generic drug sources for amlodipine besylate; hydrochlorothiazide; valsartan and what is the scope of patent protection?

Amlodipine besylate; hydrochlorothiazide; valsartan is the generic ingredient in two branded drugs marketed by Aurobindo Pharma, Lupin Ltd, Strides Pharma, Teva Pharms, Torrent, and Novartis, and is included in six NDAs. Additional information is available in the individual branded drug profile pages.

Four suppliers are listed for this compound.

Summary for AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN

US Patents:	0
Tradenames:	2
Applicants:	6
NDAs:	6
Finished Product Suppliers / Packagers:	4
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN
DailyMed Link:	AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN at DailyMed

Pharmacology for AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN

Drug Class	Angiotensin 2 Receptor Blocker Calcium Channel Blocker Dihydropyridine Calcium Channel Blocker Thiazide Diuretic
Mechanism of Action	Angiotensin 2 Receptor Antagonists Calcium Channel Antagonists Cytochrome P450 3A Inhibitors
Physiological Effect	Increased Diuresis

Anatomical Therapeutic Chemical (ATC) Classes for AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN

Paragraph IV (Patent) Challenges for AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
EXFORGE HCT	Tablets	amlodipine besylate; hydrochlorothiazide; valsartan	10 mg/12.5 mg/ 160 mg	022314	1	2009-10-22
EXFORGE HCT	Tablets	amlodipine besylate; hydrochlorothiazide; valsartan	5 mg/12.5 mg/160 mg, 5 mg/25 mg/160 mg, 10 mg/25 mg/160 mg and 10 mg/25 mg/320 mg	022314	1	2009-09-14

US Patents and Regulatory Information for AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Torrent	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	amlodipine besylate; hydrochlorothiazide; valsartan	TABLET;ORAL	201593-003	Jun 3, 2015		DISCN	No	No	⤷ Subscribe	⤷ Subscribe				⤷ Subscribe
Aurobindo Pharma	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	amlodipine besylate; hydrochlorothiazide; valsartan	TABLET;ORAL	206180-005	Dec 19, 2017	AB	RX	No	No	⤷ Subscribe	⤷ Subscribe				⤷ Subscribe
Lupin Ltd	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	amlodipine besylate; hydrochlorothiazide; valsartan	TABLET;ORAL	200797-005	Jun 3, 2015	AB	RX	No	No	⤷ Subscribe	⤷ Subscribe				⤷ Subscribe
Lupin Ltd	AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	amlodipine besylate; hydrochlorothiazide; valsartan	TABLET;ORAL	200797-002	Jun 3, 2015	AB	RX	No	No	⤷ Subscribe	⤷ Subscribe				⤷ Subscribe
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novartis	EXFORGE HCT	amlodipine besylate; hydrochlorothiazide; valsartan	TABLET;ORAL	022314-002	Apr 30, 2009	⤷ Subscribe	⤷ Subscribe
Novartis	EXFORGE HCT	amlodipine besylate; hydrochlorothiazide; valsartan	TABLET;ORAL	022314-005	Apr 30, 2009	⤷ Subscribe	⤷ Subscribe
Novartis	EXFORGE HCT	amlodipine besylate; hydrochlorothiazide; valsartan	TABLET;ORAL	022314-004	Apr 30, 2009	⤷ Subscribe	⤷ Subscribe
Novartis	EXFORGE HCT	amlodipine besylate; hydrochlorothiazide; valsartan	TABLET;ORAL	022314-001	Apr 30, 2009	⤷ Subscribe	⤷ Subscribe
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Amlodipine Besylate, Hydrochlorothiazide, and Valsartan

Introduction

The combination of amlodipine besylate, hydrochlorothiazide, and valsartan is a potent antihypertensive medication used to treat high blood pressure. This combination therapy has gained significant traction in the pharmaceutical market due to its efficacy and the growing need for effective hypertension management.

Market Size and Growth

The global market for amlodipine besylate, including its combination therapies, was estimated at USD 1,867.0 million in 2023. This market is projected to grow at a Compound Annual Growth Rate (CAGR) of 3.98% from 2024 to 2031, reaching USD 2,539.5 million by 2031[3].

Drivers of Market Growth

Several factors are driving the growth of this market:

Rising Prevalence of Hypertension and Cardiovascular Diseases

The increasing prevalence of hypertension and cardiovascular diseases globally is a significant driver. According to the World Health Organization (WHO), approximately 1.28 million adults aged 30-79 in low and middle-income countries suffer from hypertension, with about 46% of these individuals unaware of their condition[3].

Increasing Adoption of Combination Therapies

Combination therapies like amlodipine besylate, hydrochlorothiazide, and valsartan are becoming more popular due to their enhanced efficacy in managing blood pressure. Studies have shown that these combinations can achieve better blood pressure control and reduce the risk of cardiovascular events[2][4].

Advancements in Pharmaceutical Formulations

Advancements in pharmaceutical formulations, such as extended-release versions and combination therapies, are improving patient compliance and accessibility. These innovations are crucial in maintaining the market's growth trajectory[3].

Regulatory Approvals and Endorsements

Regulatory approvals and endorsements by health organizations further support the market expansion. These endorsements ensure that amlodipine besylate remains a primary treatment for hypertension and angina management[3].

Regional Analysis

The global market for amlodipine besylate is segmented into several regions:

North America

North America holds a significant share of the global market, with a valuation of USD 645.2 million in 2023. This dominance is due to the high prevalence of hypertension and cardiovascular diseases, advanced healthcare infrastructure, high healthcare spending, and widespread insurance coverage[3].

Asia Pacific

The Asia Pacific region is expected to experience rapid growth, with a CAGR of 5.09% over the forecast period. This growth is driven by increasing awareness about cardiovascular health, government initiatives promoting preventive healthcare, and the rising prevalence of hypertension in the region[3].

Sales Channels

The market is also segmented based on sales channels:

Hospital Pharmacies and Drug Stores

Traditional sales channels such as hospital pharmacies and drug stores continue to be major distributors of amlodipine besylate and its combination therapies[3].

Online Retail

The online retail segment is witnessing significant growth, driven by the convenience and accessibility it offers. The COVID-19 pandemic has accelerated the shift towards online purchasing, highlighting the importance of this sales channel in ensuring continuous access to essential medications[3].

Competitive Landscape

The market for amlodipine besylate is characterized by a robust competitive landscape with numerous global and regional pharmaceutical companies. The presence of generic drugs leads to price erosion and reduced profit margins, presenting a challenge to manufacturers. To overcome this, companies are focusing on differentiating their products through improved formulations and combination therapies[3].

Financial Challenges and Opportunities

Generic Competition

The availability of generic versions of amlodipine besylate and its combination therapies intensifies competition and reduces profit margins for brand-name manufacturers. However, this also broadens patient access to these essential medications[3].

Research and Development

Investments in research and development are crucial for maintaining market share. Pharmaceutical companies are working on improving formulations, such as extended-release versions, to enhance patient compliance and differentiate their products[3].

Efficacy and Safety

The combination of amlodipine besylate, hydrochlorothiazide, and valsartan has been shown to be effective and safe in clinical studies. For instance, a study on Egyptian patients with hypertension uncontrolled on dual therapy found that this single-pill combination was effective in achieving blood pressure control and was well-tolerated[4].

Market Statistics and Trends

Market Size: USD 1,867.0 million in 2023, projected to reach USD 2,539.5 million by 2031[3].
CAGR: 3.98% from 2024 to 2031[3].
Regional Share: North America held around 34.56% of the global market in 2023[3].
Sales Channel Growth: Online retail segment expected to grow at a CAGR of 4.67% through the forecast period[3].

Conclusion

The market for amlodipine besylate, hydrochlorothiazide, and valsartan is driven by the increasing prevalence of hypertension, advancements in pharmaceutical formulations, and regulatory endorsements. Despite challenges from generic competition, the market is expected to grow significantly, driven by the need for effective hypertension management and the convenience of online retail channels.

Key Takeaways

The global market for amlodipine besylate and its combination therapies is growing due to the rising prevalence of hypertension.
Combination therapies are becoming more popular due to their enhanced efficacy.
Regulatory approvals and endorsements support market expansion.
North America and Asia Pacific are key regions driving market growth.
Online retail is a growing sales channel for these medications.
Generic competition presents a challenge but also broadens patient access.

FAQs

What is the primary use of the combination of amlodipine besylate, hydrochlorothiazide, and valsartan?

The primary use of this combination is to treat high blood pressure (hypertension) by relaxing blood vessels and reducing the workload on the heart[1].

How does the combination of amlodipine besylate, hydrochlorothiazide, and valsartan work?

Amlodipine is a calcium channel blocker, valsartan is an angiotensin II receptor blocker, and hydrochlorothiazide is a diuretic. Together, they relax blood vessels, reduce blood pressure, and increase the supply of blood and oxygen to the heart[1].

What are the key drivers of the market growth for this combination therapy?

Key drivers include the rising prevalence of hypertension and cardiovascular diseases, increasing adoption of combination therapies, and advancements in pharmaceutical formulations[3].

Which regions are expected to drive market growth for amlodipine besylate and its combination therapies?

North America and the Asia Pacific region are expected to be significant drivers of market growth due to high prevalence rates and advanced healthcare infrastructure[3].

How is the online retail segment impacting the market for amlodipine besylate?

The online retail segment is growing rapidly, driven by convenience, accessibility, and the COVID-19 pandemic, which has accelerated the shift towards online purchasing of medications[3].

Sources

Mayo Clinic: Amlodipine, valsartan, and hydrochlorothiazide (oral route)[1].
Science.gov: Amlodipine besylate hydrochlorothiazide: Topics by Science.gov[2].
Kings Research: Amlodipine Besylate Market Size & Share Forecast [2031][3].
MDPI: Development and Validation of Ultra-Performance Liquid Chromatography (UPLC) Method for Simultaneous Quantification of Hydrochlorothiazide, Amlodipine Besylate, and Valsartan in Marketed Fixed-Dose Combination Tablet[4].
MedCrave Online: Development and Validation of Stability Indicating HPLC Method for the Simultaneous Analysis of Amlodipine, Hydrochlorothiazide, and Valsartan in Pharmaceutical Formulation[5].

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.