Amlodipine besylate; olmesartan medoxomil - Generic Drug Details

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

Amlodipine besylate; olmesartan medoxomil is the generic ingredient in two branded drugs marketed by Accord Hlthcare Inc, Ajanta Pharma Ltd, Alembic, Alkem Labs Ltd, Aurobindo Pharma, Glenmark Pharms Ltd, Hetero Labs Ltd V, Jubilant Generics, Macleods Pharms Ltd, Micro Labs, Sciegen Pharms Inc, Teva Pharms Usa, Torrent, Zydus Pharms, and Cosette, and is included in fifteen NDAs. Additional information is available in the individual branded drug profile pages.

Fifteen suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for amlodipine besylate; olmesartan medoxomil

US Patents:	0
Tradenames:	2
Applicants:	15
NDAs:	15
Finished Product Suppliers / Packagers:	15
Clinical Trials:	4
DailyMed Link:	amlodipine besylate; olmesartan medoxomil at DailyMed

Recent Clinical Trials for amlodipine besylate; 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; olmesartan medoxomil clinical trials

Generic filers with tentative approvals for AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL

Applicant	Application No.	Strength	Dosage Form
		10MG/40MG	TABLET; ORAL
		10MG/20MG	TABLET; ORAL
		5MG/40MG	TABLET; ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for amlodipine besylate; olmesartan medoxomil

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; olmesartan medoxomil

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; OLMESARTAN MEDOXOMIL

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
AZOR	Tablets	amlodipine besylate; olmesartan medoxomil	10 mg/20 mg and 5 mg/40 mg	022100	1	2008-03-31
AZOR	Tablets	amlodipine besylate; olmesartan medoxomil	5 mg/20 mg and 10 mg/40 mg	022100	1	2008-02-11

US Patents and Regulatory Information for amlodipine besylate; olmesartan medoxomil

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Aurobindo Pharma	AMLODIPINE AND OLMESARTAN MEDOXOMIL	amlodipine besylate; olmesartan medoxomil	TABLET;ORAL	206906-003	May 15, 2017	AB	RX	No	No
Zydus Pharms	AMLODIPINE AND OLMESARTAN MEDOXOMIL	amlodipine besylate; olmesartan medoxomil	TABLET;ORAL	207771-001	Sep 22, 2017	AB	RX	No	No
Sciegen Pharms Inc	AMLODIPINE AND OLMESARTAN MEDOXOMIL	amlodipine besylate; olmesartan medoxomil	TABLET;ORAL	209010-002	Dec 3, 2018	AB	RX	No	No
Teva Pharms Usa	AMLODIPINE AND OLMESARTAN MEDOXOMIL	amlodipine besylate; olmesartan medoxomil	TABLET;ORAL	091154-003	Oct 26, 2016		DISCN	No	No
Teva Pharms Usa	AMLODIPINE AND OLMESARTAN MEDOXOMIL	amlodipine besylate; olmesartan medoxomil	TABLET;ORAL	091154-001	Oct 26, 2016		DISCN	No	No
Hetero Labs Ltd V	AMLODIPINE AND OLMESARTAN MEDOXOMIL	amlodipine besylate; olmesartan medoxomil	TABLET;ORAL	209591-004	Feb 14, 2025	AB	RX	No	No

Expired US Patents for amlodipine besylate; olmesartan medoxomil

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Cosette	AZOR	amlodipine besylate; olmesartan medoxomil	TABLET;ORAL	022100-001	Sep 26, 2007	5,616,599*PED
Cosette	AZOR	amlodipine besylate; olmesartan medoxomil	TABLET;ORAL	022100-004	Sep 26, 2007	5,616,599*PED
Cosette	AZOR	amlodipine besylate; olmesartan medoxomil	TABLET;ORAL	022100-003	Sep 26, 2007	5,616,599*PED
Cosette	AZOR	amlodipine besylate; olmesartan medoxomil	TABLET;ORAL	022100-002	Sep 26, 2007	5,616,599*PED

Market dynamics and financial trajectory for amlodipine besylate and olmesartan medoxomil

Last updated: July 27, 2025

Introduction

Amlodipine besylate and olmesartan medoxomil are prominent antihypertensive agents used worldwide. As cardiovascular diseases (CVDs) remain the leading cause of mortality, demand for effective blood pressure management continues to grow. This article explores the current market landscape, revenue trends, competitive factors, and future prospects for these drugs, providing insights critical for pharmaceutical professionals, investors, and healthcare policymakers.

Market Overview

Amlodipine Besylate: A Pillar in Calcium Channel Blockers

Amlodipine besylate, a long-acting calcium channel blocker (CCB), has been a blockbuster drug since its approval in the 1980s. It is prescribed primarily for hypertension and angina pectoris. Its favorable pharmacokinetic profile, once-daily dosing, and established efficacy have secured its market position globally.

Olmesartan Medoxomil: A Key Angiotensin II Receptor Blocker (ARB)

Olmesartan medoxomil, approved in the early 2000s, offers selective angiotensin II receptor antagonism, providing an alternative to ACE inhibitors with fewer cough and angioedema side effects. Its high efficacy in lowering blood pressure and reducing cardiovascular events has driven adoption, especially in markets emphasizing comprehensive CVD management.

Market Dynamics

Global Market Size and Growth Trends

The antihypertensive drugs market, valued at approximately USD 25 billion in 2022, is projected to grow at a compound annual growth rate (CAGR) of 3-5% over the next five years. Amlodipine accounts for roughly 40% of CCB sales and maintains a dominant share in the antihypertensive segment, with sales exceeding USD 8 billion globally in 2022 [1].

Olmesartan's market share, within the ARB class, has been steadily increasing, with global revenues surpassing USD 2 billion annually. The aging population, escalating prevalence of hypertension, and rising awareness are fundamental drivers fueling demand.

Regional Market Dynamics

• United States: Largest market, driven by high disease prevalence; generic availability has suppressed prices but increased access.
• Europe: Emphasizes branded and generic competition; regulatory scrutiny influences market entry.
• Asia-Pacific: Fastest-growing due to urbanization, lifestyle shifts, and expanding healthcare infrastructure; India and China are key growth hubs.

Competitive Landscape

Major pharmaceutical companies such as Pfizer, AstraZeneca, and Teva dominate the market through proprietary formulations and extensive distribution networks. The introduction of generic versions post-patent expiry has intensified price competition, pressuring margins but expanding patient accessibility. For instance, the expiration of patent protections for amlodipine in many regions has led to a significant decline in prices and a surge in generic consumption.

Healthcare Policy and Regulatory Impact

Stricter regulatory standards and policies promoting generic substitution have positively impacted affordability but have also prompted manufacturers to innovate via formulation improvements or combination therapies. Governments also prioritize CVD risk reduction programs, which bolster demand.

Pricing and Reimbursement Trends

Market access heavily depends on reimbursement policies, which vary by country. In cost-sensitive markets, such as India and parts of Southeast Asia, aggressive pricing strategies have led to significant volume sales, whereas in developed countries, reimbursement thresholds influence prescribing patterns.

Financial Trajectory

Revenue Trends and Forecasts

• Amlodipine: Consistently high revenues, with a recent plateau due to patent expiries. Estimated global sales of approximately USD 8-10 billion in 2022. Post-patent, generic versions have captured up to 80% of market share, precipitating price declines but expanding volume.

• Olmesartan: Estimated at USD 2-3 billion in sales annually. Patent expiration in major markets (e.g., US in 2019) has prompted a shift toward generics, reducing prices but increasing accessibility and overall volume.

Profitability and Investment Trends

Leading firms invest in formulation innovations, combination therapies (e.g., Amlodipine with perindopril), and digital health integrations to sustain margins. Generic manufacturers focus on cost leadership. The shift toward biosimilars and fixed-dose combinations (FDCs) presents new growth avenues.

Impact of Patent Expiration and Generics

The expiration of key patents has drastically transformed the profitability landscape. Generic competitors have eroded original-brand revenues, compelling originators to diversify portfolios and seek lifecycle extensions through new formulations or combination drugs.

Supply Chain and Production Factors

Manufacturing scalability and regulatory compliance are vital to maintaining supply continuity and cost efficiency. Disruptions, such as those observed during the COVID-19 pandemic, underscore the importance of resilient supply frameworks.

Market Opportunities and Challenges

Opportunities

• Development of combination pills to improve patient adherence.
• Entry into emerging markets through affordability initiatives.
• Integration with digital therapeutics for personalized hypertension management.
• Patent extensions via formulation innovations and secondary indications.

Challenges

• Price erosion post-generic entry.
• Stringent regulatory standards delaying approvals.
• Competition from newer, more targeted antihypertensive agents.
• Market saturation in developed nations.

Future Outlook

The trajectory indicates steady growth driven by demographic shifts, increased screening, and comprehensive cardiovascular care policies. Market players investing in biosimilars, novel formulations, and personalized medicine will enhance competitiveness. Regulatory landscapes favor generics but may impose barriers for innovative drugs.

Advances in pharmacogenomics and real-world evidence are expected to optimize treatment strategies, influencing future demand. The ongoing migration toward fixed-dose combinations and the integration of digital health tools are poised to redefine the antihypertensive market landscape.

Key Takeaways

• Amlodipine besylate remains a dominant CCB, with sustained demand, though patent expiries have introduced pricing pressures.
• Olmesartan medoxomil's market share growth is driven by efficacy and tolerability advantages, with significant uptake in both developed and emerging markets.
• Generic competition post-patent expiry has reshaped profitability, emphasizing volume and cost-efficiency.
• Regional policy, healthcare infrastructure, and reimbursement strategies critically influence market dynamics.
• Innovation in combination therapies and digital health integration represent promising growth avenues amidst competitive pressures.

FAQs

1. How has patent expiry affected the markets for amlodipine besylate and olmesartan medoxomil?
Patent expiries have led to increased generic competition, significantly reducing prices and transforming revenue patterns. While original brand sales declined, overall volume sales increased due to affordability, expanding patient access.

2. What are the key factors driving the growth of generic antihypertensive drugs?
Cost containment policies, patent expiries, and high prevalence of hypertension in aging populations encourage generic adoption, which offers effective, affordable alternatives to brand-name medications.

3. Are combination therapy formulations impacting the market trajectory?
Yes. Fixed-dose combinations (FDCs) simplify regimens, improve adherence, and provide cross-market opportunities, especially as patent protections for combination drugs can be extended through new formulations.

4. What regional differences influence market dynamics for these drugs?
Developed markets emphasize brand stability, regulatory compliance, and reimbursement policies, while emerging markets prioritize affordability and access, facilitating rapid growth and fostering local manufacturing.

5. What future innovations could reshape the antihypertensive market?
Advances include personalized medicine based on genetic profiles, digital therapeutics for adherence, novel drug delivery systems, and biosimilars, all poised to influence demand and market share.

References

[1] GlobalData. "Hypertension Drugs Market Size and Trends." 2022.
[2] IQVIA. "Medicines Use and Spending in the U.S.: A Review of 2022." 2023.
[3] MarketWatch. "Amlodipine Market Trends." 2023.