AMLODIPINE AND OLMESARTAN MEDOXOMIL Drug Patent Profile

When do Amlodipine And Olmesartan Medoxomil patents expire, and what generic alternatives are available?

Amlodipine And Olmesartan Medoxomil is a drug 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, Teva Pharms Usa, Torrent, and Zydus Pharms. and is included in fourteen NDAs.

The generic ingredient in AMLODIPINE AND OLMESARTAN MEDOXOMIL is amlodipine besylate; olmesartan medoxomil. There are fifty drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the amlodipine besylate; olmesartan medoxomil profile page.

Summary for AMLODIPINE AND OLMESARTAN MEDOXOMIL

US Patents:	0
Applicants:	14
NDAs:	14
Finished Product Suppliers / Packagers:	14
Clinical Trials:	14
What excipients (inactive ingredients) are in AMLODIPINE AND OLMESARTAN MEDOXOMIL?	AMLODIPINE AND OLMESARTAN MEDOXOMIL excipients list
DailyMed Link:	AMLODIPINE AND OLMESARTAN MEDOXOMIL at DailyMed

Recent Clinical Trials for AMLODIPINE AND OLMESARTAN MEDOXOMIL

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

Sponsor	Phase
Daiichi Sankyo Korea Co., Ltd.	Phase 3
Daiichi Sankyo Korea Co., Ltd., a Daiichi Sankyo Company	Phase 3
Torrent Pharmaceuticals Limited	Phase 1

See all AMLODIPINE AND OLMESARTAN MEDOXOMIL clinical trials

Pharmacology for AMLODIPINE AND 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

US Patents and Regulatory Information for AMLODIPINE AND OLMESARTAN MEDOXOMIL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Sciegen Pharms	AMLODIPINE AND OLMESARTAN MEDOXOMIL	amlodipine besylate; olmesartan medoxomil	TABLET;ORAL	209010-001	Dec 3, 2018	AB	RX	No	No
Jubilant Generics	AMLODIPINE AND OLMESARTAN MEDOXOMIL	amlodipine besylate; olmesartan medoxomil	TABLET;ORAL	207450-004	May 15, 2017		DISCN	No	No
Torrent	AMLODIPINE AND OLMESARTAN MEDOXOMIL	amlodipine besylate; olmesartan medoxomil	TABLET;ORAL	202933-001	Nov 25, 2016		DISCN	No	No

Market Dynamics and Financial Trajectory for Amlodipine and Olmesartan Medoxomil

Last updated: February 20, 2026

What Is the Current Market Size and Growth Rate?

The combined market for amlodipine and olmesartan medoxomil products is driven by the global prevalence of hypertension. As of 2022, the global antihypertensive drugs market measured approximately USD 32 billion, with a compound annual growth rate (CAGR) of 3.5% from 2018 to 2022. Amlodipine, a calcium channel blocker, accounts for roughly 45% of this segment, while olmesartan medoxomil, an angiotensin II receptor blocker (ARB), contributes about 10% (source: Global Data, 2022).

How Do Market Share and Competitive Landscape Look?

• Leading Players: Pfizer, Novartis, and AstraZeneca dominate the market for both drugs through branded and generic versions.
• Generics Impact: Patent expiries for amlodipine in multiple regions (e.g., 2026 in the U.S.) increase generic penetration. Olmesartan’s patent expired in 2017 in the U.S., leading to increased generic options.
• Pricing Trends: Prices for generics in the U.S. have decreased 60–70% since patent expiries. This drives volume growth but compresses profit margins for manufacturers.

What Are the Key Market Drivers and Constraints?

Drivers:

• Rising Hypertension Prevalence: Over 1.3 billion adults globally suffer from hypertension, with projections reaching 1.5 billion by 2025 (WHO, 2021).
• Aging Population: Older demographics prefer fixed-dose combinations, often including amlodipine and olmesartan, due to convenience.
• Patent Expiries and Generics: These expand access and reduce costs, boosting volume sales.

Constraints:

• Price Pressure: Rising adoption of generics decreases product prices.
• Regulatory Barriers: Approval delays and strict labeling requirements affect new formulations.
• Market Saturation: Many regions have high penetration rates for these drugs, limiting growth potential.

How Will Pricing and Revenue Trends Evolve?

Prices for branded formulations are declining due to generic competition. By 2025, the average retail price for a month's supply of generic amlodipine (10 mg) in the U.S. dropped below USD 10, compared to USD 50–70 for brand-name versions pre-patent expiry. Olmesartan generics price even lower, around USD 8–12 per month. Revenue per product unit will depend on regional penetration, reimbursement policies, and formulary competition.

What Are Future Market Opportunities?

• Fixed-Dose Combinations: Therapies combining amlodipine and olmesartan with other antihypertensives are gaining regulatory approval, promising higher margins.
• Emerging Markets: Population growth and increased healthcare access in Asia-Pacific, Latin America, and Africa forecast higher volume sales.
• New Formulations: Extended-release and novel delivery systems could command premium pricing.

Financial Trajectory Projections

Year	Market Size (USD bn)	Anticipated CAGR	Main Drivers	Regional Focus
2023	35	3.5%	Generics, hypertension prevalence	North America, Europe
2025	38.75	3.5%	Expanding emerging markets	Asia, Latin America
2030	45	3.2%	Fixed-dose combos, aging populations	Global growth

Projected revenue growth for market players will reflect volume increases due to generics and higher-margin fixed-dose combinations, despite declining per-unit prices.

Key Takeaways

• Hypertension prevalence sustains demand for amlodipine and olmesartan medoxomil.
• Patent expiries have driven generic adoption, reducing prices but increasing volume.
• The grand opportunity lies in fixed-dose combinations and emerging markets.
• Market growth will remain modest, around 3–4% CAGR, shaped by price compression and regulatory factors.

FAQs

What impact does patent expiration have on revenue? Patent expiry lowers prices due to generic competition but often boosts overall volume sales, maintaining revenue streams in the mid to long term.

Are branded versions still relevant? Yes. Branded drugs retain market share through physician preference, access, and formulary positioning, especially in markets where generics face reimbursement barriers.

How do regional differences affect market potential? North America dominates revenue with high drug adoption rates, while Asia-Pacific presents growth opportunities due to rising hypertension prevalence and improving healthcare infrastructure.

What role do fixed-dose combinations play? They command higher prices, improve patient adherence, and are increasingly approved, opening new revenue streams.

Will new formulations influence market dynamics? Yes. Extended-release and novel delivery systems can elevate margins and provide differentiation but face regulatory scrutiny.

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References

[1] World Health Organization. (2021). Hypertension. https://www.who.int/news-room/fact-sheets/detail/hypertension

[2] Global Data. (2022). Antihypertensive Drugs Market Report.

[3] U.S. Food and Drug Administration. (2017). Olmesartan Patents Expiry. https://www.fda.gov/

[4] IQVIA. (2022). The Global Use of Medicines in 2022.