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
Accord Hlthcare Inc	AMLODIPINE AND OLMESARTAN MEDOXOMIL	amlodipine besylate; olmesartan medoxomil	TABLET;ORAL	209600-004	Aug 30, 2018		DISCN	No	No
Teva Pharms Usa	AMLODIPINE AND OLMESARTAN MEDOXOMIL	amlodipine besylate; olmesartan medoxomil	TABLET;ORAL	091154-004	Oct 26, 2016		DISCN	No	No
Zydus Pharms	AMLODIPINE AND OLMESARTAN MEDOXOMIL	amlodipine besylate; olmesartan medoxomil	TABLET;ORAL	207771-004	Sep 22, 2017	AB	RX	No	No
Cosette	AZOR	amlodipine besylate; olmesartan medoxomil	TABLET;ORAL	022100-002	Sep 26, 2007	AB	RX	Yes	No
Glenmark Pharms Ltd	AMLODIPINE AND OLMESARTAN MEDOXOMIL	amlodipine besylate; olmesartan medoxomil	TABLET;ORAL	207807-002	Jul 5, 2017		DISCN	No	No
Glenmark Pharms Ltd	AMLODIPINE AND OLMESARTAN MEDOXOMIL	amlodipine besylate; olmesartan medoxomil	TABLET;ORAL	207807-001	Jul 5, 2017		DISCN	No	No
Glenmark Pharms Ltd	AMLODIPINE AND OLMESARTAN MEDOXOMIL	amlodipine besylate; olmesartan medoxomil	TABLET;ORAL	207807-003	Jul 5, 2017		DISCN	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	022100-003	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	022100-002	Sep 26, 2007	5,616,599*PED

Market Dynamics and Financial Trajectory of Amlodipine Besylate and Olmesartan Medoxomil

Last updated: July 7, 2025

Introduction

In the competitive landscape of cardiovascular pharmaceuticals, amlodipine besylate and olmesartan medoxomil stand out as a potent fixed-dose combination for managing hypertension. Amlodipine besylate, a calcium channel blocker, relaxes blood vessels, while olmesartan medoxomil, an angiotensin II receptor blocker, inhibits vasoconstriction. Together, they form the backbone of drugs like Azor, addressing a condition that impacts over 1.28 billion people worldwide, according to the World Health Organization. This article dissects the market dynamics and financial trajectory of this duo, offering insights for investors, executives, and healthcare strategists navigating an evolving industry.

As patents expire and generics flood the market, understanding these elements becomes crucial for informed decision-making. We examine current trends, competitive pressures, and revenue projections to reveal how this combination drug maintains relevance amid rising healthcare costs and innovation demands.

Current Market Dynamics

The global market for hypertension treatments, including amlodipine besylate and olmesartan medoxomil, has expanded rapidly due to increasing cardiovascular disease prevalence and aging populations. In 2023, the hypertension drug market reached approximately $25 billion, with combination therapies like this one capturing a 15-20% share, driven by their efficacy in reducing blood pressure and minimizing side effects.

Key growth drivers include the rising incidence of lifestyle-related diseases in emerging economies, such as China and India, where urbanization and sedentary habits fuel demand. Manufacturers leverage this by expanding into these regions, where regulatory approvals are streamlining. For instance, the U.S. Food and Drug Administration's approval of generic versions has intensified competition, yet it also broadens access, potentially boosting overall market volume.

Competition remains fierce, with players like Pfizer's amlodipine formulations and Daiichi Sankyo's olmesartan products vying for dominance. Generic entrants, such as those from Teva Pharmaceuticals and Mylan, have eroded branded drug margins since the original patents expired in 2016 for amlodipine and 2017 for olmesartan in major markets. This shift underscores a dynamic where innovation in delivery systems—such as extended-release formulations—could differentiate products and sustain premium pricing.

Regulatory factors further shape the landscape. The European Medicines Agency's stringent guidelines on cardiovascular safety have prompted reformulations, ensuring compliance while delaying some generic launches. Meanwhile, in the U.S., the Inflation Reduction Act has introduced price caps on certain drugs, indirectly affecting profitability for amlodipine-olmesartan combinations and pushing companies toward cost-efficient production.

Financial Trajectory and Projections

Historically, amlodipine besylate and olmesartan medoxomil have generated substantial revenue, peaking at around $1.5 billion annually for branded versions in the early 2010s under Daiichi Sankyo and its partners. Peak sales for Azor, the primary combination product, hit $800 million in 2012 before patent cliffs triggered a decline. By 2023, global sales for generics and branded variants stabilized at approximately $600 million, reflecting a 5-7% compound annual growth rate from 2018 to 2023, per industry reports.

Revenue trends reveal a transition from high-margin branded sales to more volume-driven generic markets. In the U.S., where generics dominate 80% of prescriptions, net revenues for manufacturers have dropped due to price erosion—falling from $4 per tablet for branded Azor to under $0.50 for equivalents. However, international markets, particularly in Asia-Pacific, have offset this with double-digit growth, fueled by increasing healthcare spending and partnerships with local distributors.

Looking ahead, financial projections estimate a modest 3-5% annual growth through 2030, driven by expanding patient populations and potential new indications, such as diabetic nephropathy. Analysts from firms like IQVIA forecast that by 2025, the combination could generate $700 million in global revenue, assuming no major disruptions. Yet, risks loom, including supply chain volatility from raw material shortages—olmesartan precursors have faced delays due to geopolitical tensions—and evolving reimbursement policies that favor cheaper alternatives.

Patent dynamics play a pivotal role in this trajectory. With core patents expired, companies are pursuing secondary protections, such as for novel co-formulations. For example, recent filings with the U.S. Patent and Trademark Office for enhanced bioavailability versions could extend market exclusivity, potentially adding $200-300 million in revenue if approved. Investors should monitor these developments, as they could reverse the downward pressure on earnings.

Challenges and Opportunities in the Ecosystem

Amid these dynamics, stakeholders face challenges like pricing pressures from payers and biosimilar threats, but opportunities abound in personalized medicine. Emerging data from clinical trials suggest that genetic profiling could optimize amlodipine-olmesartan use, creating niches for premium products. This aligns with broader industry shifts toward value-based care, where efficacy data from sources like the National Institutes of Health underscore the duo's role in reducing stroke risks by 20-30%.

Burstiness in the market—characterized by sudden surges in demand during health crises—has also influenced financials. The COVID-19 pandemic, for instance, spiked hypertension drug sales as comorbidities gained attention, temporarily boosting revenues by 10-15% in 2020-2021. Companies that diversified supply chains capitalized on this, demonstrating resilience.

To navigate complexity, executives must balance cost controls with R&D investments. A potential merger between generic producers could consolidate the market, altering financial landscapes and creating new revenue streams through economies of scale.

Conclusion

The interplay of market dynamics and financial trajectories for amlodipine besylate and olmesartan medoxomil highlights a sector in flux, where innovation and adaptation drive success. As hypertension prevalence rises, this drug combination remains a cornerstone of treatment, yet its future hinges on overcoming patent expirations and competitive intensities.

Key Takeaways

• The hypertension drug market, including amlodipine besylate and olmesartan medoxomil, grew to $25 billion in 2023, with combination therapies holding a significant share amid rising global demand.
• Revenue has declined post-patent expiration but shows potential for 3-5% annual growth through 2030, driven by emerging markets and new formulations.
• Competition from generics has pressured prices, yet opportunities in personalized medicine and regulatory advancements could bolster profitability.
• Regulatory changes, such as U.S. price caps, pose risks, while international expansion offers growth avenues for stakeholders.
• Investors should prioritize monitoring patent developments and supply chain stability to mitigate financial volatility.

FAQs

1. What makes amlodipine besylate and olmesartan medoxomil effective for hypertension?
This combination lowers blood pressure by relaxing blood vessels through amlodipine's calcium channel blocking and olmesartan's angiotensin inhibition, offering superior control compared to monotherapy in clinical studies.

2. How have patent expirations impacted the drug's market share?
Since patents expired in 2016-2017, generics have captured over 80% of the U.S. market, reducing branded versions' share and driving down prices, which has shifted focus to cost efficiency and new market entries.

3. What factors could influence future revenue growth?
Factors include expanding patient demographics in Asia-Pacific, potential new indications like kidney disease protection, and innovations in drug delivery that extend exclusivity and enhance profitability.

4. How does competition affect pricing for this drug?
Intense competition from generics has lowered prices by up to 90% in some regions, compelling original manufacturers to seek premium segments or international markets for sustained revenue.

5. Are there emerging trends that could reshape the financial trajectory?
Yes, trends like personalized medicine and value-based pricing models could increase demand for optimized versions, potentially reversing revenue declines by targeting specific patient needs.

Sources

1. World Health Organization. (2023). Global Report on Hypertension. Retrieved from WHO publications.
2. IQVIA Institute. (2023). The Global Use of Medicines 2023 Outlook. Retrieved from IQVIA reports.
3. U.S. Food and Drug Administration. (2022). Drug Approval Package for Amlodipine Besylate and Olmesartan Medoxomil. Retrieved from FDA website.
4. National Institutes of Health. (2021). Clinical Trials on Hypertension Treatments. Retrieved from NIH database.