Amlodipine besylate; hydrochlorothiazide; olmesartan medoxomil - Generic Drug Details

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

Amlodipine besylate; hydrochlorothiazide; olmesartan medoxomil is the generic ingredient in two branded drugs marketed by Endo Operations, Teva Pharms Usa, Torrent, and Cosette, and is included in four NDAs. Additional information is available in the individual branded drug profile pages.

Six suppliers are listed for this compound.

Summary for amlodipine besylate; hydrochlorothiazide; olmesartan medoxomil

US Patents:	0
Tradenames:	2
Applicants:	4
NDAs:	4
Finished Product Suppliers / Packagers:	6
Clinical Trials:	4
DailyMed Link:	amlodipine besylate; hydrochlorothiazide; olmesartan medoxomil at DailyMed

Recent Clinical Trials for amlodipine besylate; hydrochlorothiazide; olmesartan medoxomil

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

Sponsor	Phase
Daiichi Sankyo Inc.	Phase 3
Daiichi Sankyo, Inc.	Phase 3
Daiichi Sankyo, Inc.	Phase 4

See all amlodipine besylate; hydrochlorothiazide; olmesartan medoxomil clinical trials

Pharmacology for amlodipine besylate; hydrochlorothiazide; olmesartan medoxomil

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; olmesartan medoxomil

C03AA	Thiazides, plain
C03A	LOW-CEILING DIURETICS, THIAZIDES
C03	DIURETICS
C	Cardiovascular system

C03AA	Thiazides, plain
C03A	LOW-CEILING DIURETICS, THIAZIDES
C03	DIURETICS
C	Cardiovascular system

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

US Patents and Regulatory Information for amlodipine besylate; hydrochlorothiazide; olmesartan medoxomil

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Torrent	OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE	amlodipine besylate; hydrochlorothiazide; olmesartan medoxomil	TABLET;ORAL	203580-005	Oct 26, 2016	AB	RX	No	No
Torrent	OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE	amlodipine besylate; hydrochlorothiazide; olmesartan medoxomil	TABLET;ORAL	203580-004	Oct 26, 2016	AB	RX	No	No
Endo Operations	OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE	amlodipine besylate; hydrochlorothiazide; olmesartan medoxomil	TABLET;ORAL	206137-004	Oct 26, 2016	AB	RX	No	No
Torrent	OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE	amlodipine besylate; hydrochlorothiazide; olmesartan medoxomil	TABLET;ORAL	203580-003	Oct 26, 2016	AB	RX	No	No

Expired US Patents for amlodipine besylate; hydrochlorothiazide; olmesartan medoxomil

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Cosette	TRIBENZOR	amlodipine besylate; hydrochlorothiazide; olmesartan medoxomil	TABLET;ORAL	200175-005	Jul 23, 2010	5,616,599*PED
Cosette	TRIBENZOR	amlodipine besylate; hydrochlorothiazide; olmesartan medoxomil	TABLET;ORAL	200175-001	Jul 23, 2010	5,616,599*PED
Cosette	TRIBENZOR	amlodipine besylate; hydrochlorothiazide; olmesartan medoxomil	TABLET;ORAL	200175-004	Jul 23, 2010	5,616,599*PED
Cosette	TRIBENZOR	amlodipine besylate; hydrochlorothiazide; olmesartan medoxomil	TABLET;ORAL	200175-003	Jul 23, 2010	5,616,599*PED

Amlodipine besylate; hydrochlorothiazide; olmesartan medoxomil Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Amlodipine Besylate, Hydrochlorothiazide, and Olmesartan Medoxomil

Introduction

The combination of amlodipine besylate, hydrochlorothiazide, and olmesartan medoxomil is a potent antihypertensive therapy used to manage high blood pressure. This article delves into the market dynamics, financial trajectory, and key factors influencing the demand and growth of this medication combination.

Market Size and Forecast

The market for amlodipine and olmesartan, key components of this combination, was valued at USD 597.95 million in 2023 and is projected to reach USD 824.65 million by 2031, growing at a CAGR of 4.10% from 2024 to 2031[1].

Mechanism of Action

• Amlodipine Besylate: A calcium channel blocker that relaxes blood vessels, improving blood flow.
• Olmesartan Medoxomil: An angiotensin II receptor blocker that prevents blood vessel constriction.
• Hydrochlorothiazide: A diuretic that helps the body get rid of excess water and salt.

These components work synergistically to provide effective blood pressure control, especially in patients who require multiple therapies[1].

Key Drivers of Market Growth

Increasing Prevalence of Hypertension

The global incidence of cardiovascular diseases, including hypertension, is rising. This trend is expected to drive the demand for effective antihypertensive medications like the combination of amlodipine besylate, hydrochlorothiazide, and olmesartan medoxomil[1].

Advancements in Drug Formulations

Advancements in drug formulations and the increasing emphasis on combination therapies for better patient outcomes are significant drivers. These advancements enhance the efficacy and tolerability of the medication, making it more appealing to both patients and healthcare providers[1].

Strong Healthcare Infrastructure

Regions like North America, with robust healthcare infrastructure, high awareness of cardiovascular diseases, and favorable reimbursement policies, contribute significantly to market growth. The presence of well-established pharmaceutical companies and advanced research and development facilities in these regions further supports market expansion[1].

Regional Market Analysis

North America

North America is the dominant region in the market, driven by a high prevalence of hypertension and strong regulatory support. The United States and Canada are key contributors due to their well-established healthcare systems and public health initiatives aimed at reducing cardiovascular risks[1].

Asia Pacific

The Asia Pacific region is the fastest-growing market, driven by rapid urbanization, rising disposable incomes, and increasing awareness of health and wellness. Countries like India and China are experiencing significant growth due to the rising prevalence of lifestyle-related diseases, including hypertension[1].

Market Segmentation

By Application

The global market is segmented into hospitals and drug stores. Hospitals dominate due to their comprehensive patient management capabilities, while drug stores are the fastest-growing segment, driven by increasing patient self-management of chronic conditions and a preference for over-the-counter access to antihypertensive medications[1].

Key Challenges

Generic Competition

The entry of generic versions poses a significant challenge, leading to price erosion and reduced profit margins for branded products. For instance, Aurobindo Pharma Limited and Hikma Pharmaceuticals have launched generic versions of amlodipine and olmesartan, which are expected to impact the market[1].

Adverse Drug Reactions

Potential side effects such as dizziness, swelling, or gastrointestinal issues may deter patients from continuing their prescribed treatment, impacting market demand. Studies have shown that the combination of these medications can augment the toxicities of individual components, although clinical studies have generally shown no significant pharmacokinetic interactions[2][5].

Regulatory Hurdles

The lengthy and complex approval process for new formulations and combination therapies can delay the introduction of innovative products, limiting growth opportunities. Regulatory bodies like the FDA and TGA scrutinize these medications thoroughly before approval[2][5].

Economic Factors

Economic instability and healthcare budget constraints can affect drug pricing and reimbursement policies, limiting access to essential medications, particularly in low- and middle-income countries[1].

Recent Developments

• Aurobindo Pharma Limited: Received final approval from the U.S. FDA for its Amlodipine and Olmesartan Medoxomil Tablets in multiple dosages, which is expected to cater to a significant market[1].
• Hikma Pharmaceuticals: Successfully launched its generic version of Amlodipine and Olmesartan in the U.S. market, expanding its generic product line[1].

Pharmacokinetics and Tolerability

Studies have shown that the combination of amlodipine, olmesartan, and hydrochlorothiazide does not significantly affect the pharmacokinetics of each component at the doses tested. However, amlodipine can increase the systemic exposure to olmesartan and hydrochlorothiazide due to its effect on intestinal motility[5].

Clinical Trials and Efficacy

Clinical trials, such as the COACH trial, have demonstrated the efficacy of the combination of olmesartan medoxomil and amlodipine besylate in controlling high blood pressure. These trials have shown that the combination can achieve blood pressure goals more effectively than monotherapy[3].

Conclusion

The market for amlodipine besylate, hydrochlorothiazide, and olmesartan medoxomil is driven by increasing demand for effective antihypertensive treatments, advancements in drug formulations, and strong healthcare infrastructure. However, it faces challenges from generic competition, adverse drug reactions, regulatory hurdles, and economic factors.

Key Takeaways

• The market is projected to grow at a CAGR of 4.10% from 2024 to 2031.
• North America and the Asia Pacific are key regions driving market growth.
• Generic competition and adverse drug reactions are significant challenges.
• Regulatory support and favorable reimbursement policies are crucial for market expansion.
• The combination therapy has shown efficacy in clinical trials and is preferred for its synergistic effects.

FAQs

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

The primary use is to manage high blood pressure (hypertension) in patients who require multiple therapies for effective control.

Which regions are driving the market growth for this medication combination?

North America and the Asia Pacific are the dominant and fastest-growing regions, respectively.

What are the key challenges facing the market for this medication combination?

Generic competition, adverse drug reactions, regulatory hurdles, and economic factors are significant challenges.

How does the combination of these medications affect their pharmacokinetics?

Amlodipine can increase the systemic exposure to olmesartan and hydrochlorothiazide due to its effect on intestinal motility, but clinical studies have shown no significant pharmacokinetic interactions at the doses tested[5].

What recent developments have impacted the market for this medication combination?

Recent approvals and launches of generic versions by companies like Aurobindo Pharma Limited and Hikma Pharmaceuticals have impacted the market[1].

Sources

1. Verified Market Research: Amlodipine And Olmesartan Market Size, Share, Trends & Forecast.
2. FDA: PHARMACOLOGY REVIEW(S) - accessdata.fda.gov.
3. Science.gov: Topics by Science.gov - amlodipine besylate aml.
4. FDA: CLINICAL PHARMACOLOGY AND BIOPHARMACEUTICS REVIEW ...
5. TGA: auspar-olmesartan-amlodipine-hydrochlorothiazide-131118.pdf.