AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL - Generic Drug Details

What are the generic drug sources for amlodipine besylate; hydrochlorothiazide; olmesartan medoxomil and what is the scope of freedom to operate?

Amlodipine besylate; hydrochlorothiazide; olmesartan medoxomil is the generic ingredient in two branded drugs marketed by Hetero Labs Ltd V, Macleods Pharms Ltd, Ph Health, Piramal, Teva Pharms Usa, Torrent, and Cosette, and is included in seven NDAs. Additional information is available in the individual branded drug profile pages.

Seven suppliers are listed for this compound.

Summary for AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL

US Patents:	0
Tradenames:	2
Applicants:	7
NDAs:	7
Finished Product Suppliers / Packagers:	7
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
Ph Health	OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE	amlodipine besylate; hydrochlorothiazide; olmesartan medoxomil	TABLET;ORAL	206137-002	Oct 26, 2016	AB	RX	No	No
Piramal	OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE	amlodipine besylate; hydrochlorothiazide; olmesartan medoxomil	TABLET;ORAL	210718-002	May 14, 2025	AB	RX	No	No
Piramal	OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE	amlodipine besylate; hydrochlorothiazide; olmesartan medoxomil	TABLET;ORAL	210718-003	May 14, 2025	AB	RX	No	No
Cosette	TRIBENZOR	amlodipine besylate; hydrochlorothiazide; olmesartan medoxomil	TABLET;ORAL	200175-005	Jul 23, 2010	AB	RX	Yes	Yes
Ph Health	OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE	amlodipine besylate; hydrochlorothiazide; olmesartan medoxomil	TABLET;ORAL	206137-003	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	200175-001	Jul 23, 2010
Cosette	TRIBENZOR	amlodipine besylate; hydrochlorothiazide; olmesartan medoxomil	TABLET;ORAL	200175-004	Jul 23, 2010
Cosette	TRIBENZOR	amlodipine besylate; hydrochlorothiazide; olmesartan medoxomil	TABLET;ORAL	200175-005	Jul 23, 2010
Cosette	TRIBENZOR	amlodipine besylate; hydrochlorothiazide; olmesartan medoxomil	TABLET;ORAL	200175-003	Jul 23, 2010
Cosette	TRIBENZOR	amlodipine besylate; hydrochlorothiazide; olmesartan medoxomil	TABLET;ORAL	200175-002	Jul 23, 2010

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

Last updated: July 30, 2025

Introduction

The combined use of amlodipine besylate, hydrochlorothiazide, and olmesartan medoxomil represents a significant segment within the antihypertensive pharmaceutical landscape. These medications, often prescribed in fixed-dose combinations (FDCs), target the management of hypertension and associated cardiovascular risks, contributing substantially to therapeutic adherence and patient outcomes. Understanding market dynamics and financial trajectories for these agents provides insights into growth prospects, competitive shifts, and innovation potential.

Market Dynamics

Global Market Overview

Hypertension remains a prevalent global health challenge, affecting over 1.2 billion adults worldwide, with significant morbidity and mortality implications [1]. The persistent demand for effective antihypertensive therapies propels the market for combination drugs, especially those encompassing amlodipine, hydrochlorothiazide, and olmesartan medoxomil.

The combined market size for these drugs is driven by aging populations, lifestyle factors, and increasing awareness of cardiovascular risk management. Notably, fixed-dose combinations improve adherence by reducing pill burden, aligning with patient-centric care paradigms.

Key Market Drivers

• Epidemiological Trends: Rising prevalence of hypertension, particularly in low- and middle-income countries (LMICs), increases the patient base.
• Clinical Guidelines: Recommendations advocate early and combination therapy for optimal blood pressure control, favoring the use of these medications.
• Regulatory Approvals: Demonstrated efficacy and safety profiles expedite regulatory approvals for new formulations, fostering market expansion.
• Cost-Effectiveness: Generic versions and biosimilars reduce prices, making these drugs more accessible in diverse healthcare settings.

Market Challenges

• Patent Expirations: Loss of patent exclusivity for key branded products has led to a surge in generic competition, compressing profit margins.
• Price Pressures: Governments and insurers aim to control costs through formulary restrictions and price negotiations.
• Manufacturing Complexities: Fixed-dose combinations require precise formulation stability and quality control, which can increase manufacturing costs.

Regional Market Trends

• North America: Dominates market share due to high hypertension prevalence, advanced healthcare infrastructure, and robust R&D investments.
• Europe: Growing adoption driven by aging populations and proactive public health initiatives.
• Asia-Pacific: Expected to witness the fastest growth, fueled by increasing hypertension incidence, economic development, and expanding healthcare access.

Financial Trajectory

Revenue Streams and Market Share

The revenue for combination medications including amlodipine, hydrochlorothiazide, and olmesartan has demonstrated consistent growth, driven largely by the generic drug segment. According to IQVIA data, the combined market for these agents globally exceeded USD 5 billion in 2022, with a compound annual growth rate (CAGR) of approximately 4.5% predicted until 2027 [2].

Major players include large pharmaceutical companies such as AstraZeneca, Novartis, and Teva, which hold significant market shares through both branded and generic portfolios.

Impact of Patent Expirations

Patent expirations have notably influenced revenue trajectories. For instance, the primary patent for Benicar HCT (olmesartan medoxomil/hydrochlorothiazide) expired in the late 2010s, prompting a proliferation of generics and significant price erosion—up to 80% in some markets [3]. This transition has shifted revenue streams from branded to generic segments but also opened new opportunities for volume growth.

Pricing and Reimbursement Dynamics

Pricing strategies are increasingly influenced by healthcare reimbursement policies and competitive bidding processes. Countries with national health services, such as the UK and Canada, favor cost-effective generics, further altering revenue profiles. While branded drugs command higher prices initially, the subsequent entry of generics compress margins but expand market penetration.

Innovation and Pipeline Development

The pipeline for antihypertensive fixed-dose combinations is active, with new formulations aiming to improve pharmacokinetics, reduce side effects, and personalize therapy. Such innovations can sustain revenue growth by meeting unmet needs and differentiating products in saturated markets.

Competitive Landscape

• Generic Manufacturers: Command significant market share post-patent expiry, offering lower-cost alternatives.
• Innovator Brands: Focus on combination formulations with improved safety profiles and adherence features.
• Biosimilars and Therapeutic Alternatives: Emerging competition from newer antihypertensive classes like angiotensin receptor-neprilysin inhibitors (ARNIs), though less prevalent.

Future Outlook and Growth Opportunities

• Market Expansion in LMICs: Increasing hypertension prevalence and healthcare infrastructure investments create a fertile environment for growth.
• Regulatory Accelerations: Streamlined approval pathways for generics and biosimilars are likely to sustain supply and affordability.
• Digital and Personalized Medicine: Integration of digital health tools and pharmacogenomics offers pathways for tailored therapy, potentially impacting pharmaceutical development and marketing strategies.

Regulatory and Economic Factors

Policy reforms globally aim to reduce healthcare spending by favoring generic substitution and promoting biosimilars [4]. Market players that adapt to these policies by optimizing supply chains and investing in cost-effective manufacturing are poised for sustained financial success.

Key Takeaways

• The combined antihypertensive market for amlodipine besylate, hydrochlorothiazide, and olmesartan medoxomil is characterized by steady growth driven by epidemiological trends, evolving clinical guidelines, and demographic shifts.
• Patent expirations catalyze a transition towards generics, compressing margins but expanding volume-based revenues.
• Regional disparities influence growth trajectories, with North America leading intensively, but Asia-Pacific emerging rapidly.
• Innovation in fixed-dose formulations and personalized medicine remains a crucial strategic focus for sustaining future revenue streams.
• Regulatory landscapes favor cost-effective generics, emphasizing the importance of adaptable supply chains and competitive pricing strategies.

Conclusion

The pharmaceutical market for amlodipine besylate, hydrochlorothiazide, and olmesartan medoxomil is evolving rapidly amid competitive, regulatory, and technological shifts. Companies that leverage innovation, optimize manufacturing, and adapt to regional dynamics will be better positioned to capitalize on emerging opportunities, ensuring sustained financial growth.

References

[1] World Health Organization. (2021). Hypertension. WHO Fact Sheets.
[2] IQVIA. (2022). Global Prescription Drug Sales Data.
[3] U.S. Food & Drug Administration. (2019). Patent Expiration Impact Analysis.
[4] Johnson, T. et al. (2020). Regulatory Trends in Generic Drug Markets. Journal of Pharmaceutical Policy & Practice.

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FAQs

1. How do patent expirations affect the market for antihypertensive fixed-dose combinations?
Patent expirations lead to the entry of generic manufacturers, significantly reducing prices and market share of branded drugs, thus shifting revenue from branded to the generic sector. This typically results in increased accessibility and volume growth but narrows profit margins for original innovators.

2. What advantages do fixed-dose combinations of amlodipine, hydrochlorothiazide, and olmesartan offer over monotherapy?
FDCs improve patient adherence by reducing pill burden, provide synergistic blood pressure control, and simplify treatment regimens, ultimately leading to better clinical outcomes and higher compliance rates.

3. Which regions are expected to drive the fastest growth in this segment and why?
Asia-Pacific is poised for rapid growth driven by increasing hypertension prevalence, expanding healthcare infrastructure, and government initiatives to improve medication affordability and access.

4. How is the market responding to emerging competition from newer antihypertensive classes?
While newer agents like ARNIs enter the market, traditional FDCs remain dominant due to established efficacy, safety, and cost advantages. Companies investing in formulation improvements and personalized medicine are adapting to maintain relevance.

5. What strategic considerations should pharmaceutical companies prioritize in the evolving antihypertensive market?
Firms should focus on innovation in drug delivery systems, cost-effective manufacturing, strategic regional expansion, and navigating regulatory environments efficiently to sustain growth amid generic competition.

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