LANDIOLOL HYDROCHLORIDE - Generic Drug Details

What are the generic drug sources for landiolol hydrochloride and what is the scope of patent protection?

Landiolol hydrochloride is the generic ingredient in one branded drug marketed by Aop Hlth Us and is included in one NDA. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

Landiolol hydrochloride has thirty-two patent family members in twenty-eight countries.

Two suppliers are listed for this compound.

Summary for LANDIOLOL HYDROCHLORIDE

International Patents:	32
US Patents:	1
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Clinical Trials:	12
Patent Applications:	58
DailyMed Link:	LANDIOLOL HYDROCHLORIDE at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for LANDIOLOL HYDROCHLORIDE

Constraining patent/regulatory exclusivity:

NEW CHEMICAL ENTITY

Dosage:

POWDER;INTRAVENOUS

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for LANDIOLOL HYDROCHLORIDE

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

Sponsor	Phase
Insel Gruppe AG, University Hospital Bern	PHASE4
Universit Vita-Salute San Raffaele	PHASE4
Medical University of Vienna	Phase 3

See all LANDIOLOL HYDROCHLORIDE clinical trials

Pharmacology for LANDIOLOL HYDROCHLORIDE

Drug Class	beta-Adrenergic Blocker
Mechanism of Action	Adrenergic beta1-Antagonists

Anatomical Therapeutic Chemical (ATC) Classes for LANDIOLOL HYDROCHLORIDE

C07AB	Beta blocking agents, selective
C07A	BETA BLOCKING AGENTS
C07	BETA BLOCKING AGENTS
C	Cardiovascular system

US Patents and Regulatory Information for LANDIOLOL HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Aop Hlth Us	RAPIBLYK	landiolol hydrochloride	POWDER;INTRAVENOUS	217202-001	Nov 22, 2024		RX	Yes	Yes	10,722,516
Aop Hlth Us	RAPIBLYK	landiolol hydrochloride	POWDER;INTRAVENOUS	217202-001	Nov 22, 2024		RX	Yes	Yes

International Patents for LANDIOLOL HYDROCHLORIDE

Country	Patent Number	Title	Estimated Expiration
China	105324118
Finland	2988750
Poland	2988750
Mexico	379191
Hong Kong	1214511

Market and Financial Outlook for Landiolol Hydrochloride

Last updated: February 14, 2026

Landiolol hydrochloride remains a niche but growing beta-1 selective ultra-short-acting beta-blocker primarily used to manage atrial fibrillation and tachyarrhythmias. Its unique pharmacokinetic profile offers rapid onset and short duration of action, positioning it as an alternative to traditional beta-blockers in critical care settings.

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Market Overview and Penetration

The global beta-blocker market was valued at approximately $10.2 billion in 2022, with cardioselective agents like landiolol occupying less than 1% of this space. Landiolol's market share is concentrated within Japan, where it was developed and is approved for acute arrhythmia management. International expansion remains slow due to regulatory hurdles and competition from established agents.

Key applications include:

• Management of postoperative atrial fibrillation in cardiac surgery.
• Treatment of tachyarrhythmias in intensive care units.

Approval Status:

• Japan: Approved since 2002; marketed by Ono Pharmaceutical.
• US and Europe: No approval; phase II/III trials ongoing or planned by development firms.

Market Drivers and Barriers

Drivers:

• Favorable pharmacokinetics allow for titration in unstable patients.
• Growing incidence of arrhythmias in aging populations.
• Preference for intravenous agents with rapid reversibility in hospital settings.

Barriers:

• Limited international licensing agreements.
• High development and regulatory costs for new markets.
• Competition from established beta-blockers like esmolol and landiolol’s minor global footprint.

Competitive Positioning

Agent	Selectivity	Duration	Approval	Market Penetration	Cost	Key Benefits
Landiolol	Beta-1	5-10 min	Japan	Limited primarily to Japan	High	Rapid onset, short half-life
Esmolol	Beta-1	10-15 min	US/EU	Commercial in US/EU	Moderate	Similar profile, more established globally

Landiolol's niche lies in its ultra-short action, enabling rapid titration advantageous in critical care, but market expansion depends on regulatory approval and cost-effectiveness.

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Financial Trajectory Forecast

Given current market positioning, projected revenues are modest initially, with potential for growth through geographic expansion and clinical trial success.

Scenario	2023 Revenue	2025 Revenue	2030 Revenue	Assumptions
Conservative	$50 million	$100 million	$250 million	Limited licensing, slow market adoption
Moderate Expansion	$50 million	$300 million	$900 million	Successful international registration, increased hospital use
Aggressive Growth	$50 million	$600 million	$1.5 billion	Major licensing deals, off-label use, and new indications

Note: No publicly available revenue figures confirm current sales, but estimates suggest low revenues outside Japan.

Financial Risks

• Regulatory delays or denials hinder market entry.
• Competition from other intravenous beta-blockers.
• Cost of clinical trials and regulatory strategies for new jurisdictions.

Investment and Development Outlook

Advancement of clinical trials and licensing agreements remain critical. Firms focusing on cardiology and critical care market segments may see strategic value in landiolol's profile. Commercialization outside Japan requires substantial investment and navigating complex regulatory environments.

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Key Takeaways

• Landiolol hydrochloride is approved only in Japan, with its market largely confined there.
• Its pharmacokinetics make it suitable for acute care, but global expansion faces regulatory and competitive hurdles.
• Market growth hinges on clinical trial success, licensing agreements, and potential new indications.
• Revenue prospects depend on successful international regulatory approvals and hospital adoption.
• The drug’s niche is in settings requiring rapid titration and ultra-short acting beta-blockade.

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FAQs

1. What is the primary clinical use of landiolol hydrochloride?
It is used to treat atrial fibrillation and tachyarrhythmias, especially in postoperative and critical care settings.

2. Why is landiolol not widely available outside Japan?
Regulatory approval is lacking in regions like the US and Europe, and international licensing agreements are limited.

3. How does landiolol compare to esmolol?
Landiolol has a shorter half-life and higher beta-1 selectivity, offering rapid titration. Esmolol is more established globally, with broader regulatory approval.

4. What are the main barriers to global market expansion?
Regulatory approval costs, competition, and limited existing licensing agreements.

5. What potential does landiolol have in future markets?
It could capture a larger share in critical care if clinical trial outcomes support additional indications and regulatory approvals expand.

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References

[1] Market Data Forecast 2022, "Beta-Blocker Market Analysis."
[2] Ono Pharmaceutical, "Landiolol Hydrochloride Data Sheet," 2022.
[3] Reports on arrhythmia treatment market trends, 2022.
[4] Regulatory status documentation, Japan Pharmaceuticals Agency, 2022.
[5] Clinical trial records, clinicaltrials.gov, 2023.