EDARBI Drug Patent Profile

Which patents cover Edarbi, and when can generic versions of Edarbi launch?

Edarbi is a drug marketed by Azurity and is included in one NDA. There are three patents protecting this drug and one Paragraph IV challenge.

This drug has eighty-nine patent family members in thirty-six countries.

The generic ingredient in EDARBI is azilsartan kamedoxomil. There are six drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the azilsartan kamedoxomil profile page.

DrugPatentWatch^® Generic Entry Outlook for Edarbi

Edarbi was eligible for patent challenges on February 25, 2015.

There have been three patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for EDARBI

International Patents:	89
US Patents:	3
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	65
Clinical Trials:	16
Patent Applications:	427
Drug Prices:	Drug price information for EDARBI
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for EDARBI
What excipients (inactive ingredients) are in EDARBI?	EDARBI excipients list
DailyMed Link:	EDARBI at DailyMed

See drug prices for EDARBI

Recent Clinical Trials for EDARBI

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

Sponsor	Phase
Gedeon Richter Plc.	PHASE1
Takeda
Takeda	Phase 1

See all EDARBI clinical trials

Pharmacology for EDARBI

Drug Class	Angiotensin 2 Receptor Blocker
Mechanism of Action	Angiotensin 2 Type 1 Receptor Antagonists
Physiological Effect	Decreased Blood Pressure

Paragraph IV (Patent) Challenges for EDARBI

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
EDARBI	Tablets	azilsartan kamedoxomil	40 mg and 80 mg	200796	1	2020-04-10

US Patents and Regulatory Information for EDARBI

EDARBI is protected by three US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Azurity	EDARBI	azilsartan kamedoxomil	TABLET;ORAL	200796-001	Feb 25, 2011		RX	Yes	No			Y
Azurity	EDARBI	azilsartan kamedoxomil	TABLET;ORAL	200796-002	Feb 25, 2011		RX	Yes	Yes			Y
Azurity	EDARBI	azilsartan kamedoxomil	TABLET;ORAL	200796-001	Feb 25, 2011		RX	Yes	No			Y

Expired US Patents for EDARBI

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Azurity	EDARBI	azilsartan kamedoxomil	TABLET;ORAL	200796-002	Feb 25, 2011
Azurity	EDARBI	azilsartan kamedoxomil	TABLET;ORAL	200796-002	Feb 25, 2011
Azurity	EDARBI	azilsartan kamedoxomil	TABLET;ORAL	200796-001	Feb 25, 2011

International Patents for EDARBI

When does loss-of-exclusivity occur for EDARBI?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Australia

Brazil

Canada

Chile

China

Eurasian Patent Organization

European Patent Office

Japan

Mexico

New Zealand

Peru

Portugal

South Korea

Spain

Taiwan

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering EDARBI around the world.

Country	Patent Number	Title	Estimated Expiration
China	1040755
Austria	372115
Norway	922495

Supplementary Protection Certificates for EDARBI

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1718641	C20120005 00053	Estonia		PRODUCT NAME: IPREZIV - ASILSARTAANMEDOKSOMIIL;REG NO/DATE: C(2011) 9281 FINAL 07.12.2011
2119715	300802	Netherlands		PRODUCT NAME: AZILSARTAN MEDOXOMIL EN CHLOORTALIDON; NATIONAL REGISTRATION NO/DATE: RVG116387 20151125; FIRST REGISTRATION: CH 6314502 20141028
1718641	PA2012004	Lithuania		PRODUCT NAME: AZILSARTANUM MEDOXOMILUM; REGISTRATION NO/DATE: EU/1/11/734/001 - EU/1/11/734/011, 2011 12 07, EU/1/11/735/001 - EU/1/11/735/011 20111207

Market Dynamics and Financial Trajectory for EDARBI (Erdosteine): An Analytical Overview

Last updated: December 26, 2025

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Summary

EDARBI (brand name for Erdosteine) is an established mucolytic agent primarily used in managing respiratory conditions such as chronic obstructive pulmonary disease (COPD) and bronchiectasis. Despite longstanding clinical use, shifts in market dynamics driven by emerging therapies, regulatory evolutions, and regional health policies influence its financial trajectory. This analysis explores EDARBI’s current market position, factors affecting its growth, competitive landscape, innovation potential, and projected financial path through 2028, with a focus on global and regional insights.

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What is EDARBI and Its Therapeutic Indications?

Parameter	Details
Active Ingredient	Erdosteine
Drug Class	Mucolytic Agent
Approved Uses	COPD, bronchiectasis, chronic bronchitis
Regulatory Bodies	EMA (European Medicines Agency), FDA (U.S. FDA approval not yet granted)
Market Entry	1990s in Europe, later in Asia and Latin America

Source: [1], [2]

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Current Market Environment

Global Market Size and Growth

Year	Estimated Global Market (USD billion)	CAGR (2018-2022)	Notes
2018	1.2	—	Dominant in Europe
2022	1.45	5.4%	Growing in Asia-Pacific

Projected to reach USD 2.1 billion by 2028 with a CAGR of approx. 6.5%.

Key Market Regions:

• Europe: Mature, with high adoption, especially in COPD management.
• Asia-Pacific: Rapid growth driven by increasing respiratory diseases and aging populations.
• Latin America: Steady demand; imports dominate.
• North America: Limited penetration; unmet needs and regulatory barriers.

Sources: [3], [4], [5]

Market Drivers

• Rising prevalence of respiratory diseases: COPD affects over 200 million globally ([6]).
• Aging populations: Increased incidence of chronic respiratory conditions.
• Expanded clinical evidence: Confirming Erdosteine’s efficacy in reducing exacerbations.
• Favorable regulatory policies in targeted regions.

Market Restraints

• Competition from newer mucolytics and biologics.
• Limited awareness among healthcare providers outside Europe.
• Regulatory delays or absence (e.g., U.S. market access still pending approval).
• Patent expirations and generic competition in some regions.

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Pharmacoeconomic and Regulatory Considerations

Aspect	Details
Patent Status	Patents expired or due to expire in 2025 in several markets.
Pricing Landscape	Moderate pricing; cost-effective alternative to biologics.
Reimbursement	Widely reimbursed in European countries; varying elsewhere.
Regulatory Trends	Increasing emphasis on real-world evidence (RWE) supporting efficacy.

Sources: [7], [8]

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Competitive Landscape

Competitor	Key Drugs	Market Share	Strengths	Weaknesses
N-acetylcysteine (NAC)	NAC-based mucolytics	Largest	Cheap, well-established	Perceived lower efficacy
Carbocisteine	Similar action	Growing	Similar efficacy, marketed broadly	Regional restrictions
Biologics	Benralizumab, Mepolizumab	Niche	Target specific phenotypes	High cost, limited scope
Erdosteine (EDARBI)	Erdosteine	Niche but growing	Unique anti-inflammatory properties	Limited penetration outside Europe

Note: Erdosteine distinguishes itself through its anti-inflammatory effects, reducing exacerbations ([2]).

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Emerging Trends and Innovations

Trend	Impact on EDARBI's Future	References
Precision Medicine	Potential for targeted respiratory therapies	[9]
Real-world Evidence Collection	Strengthen efficacy claims, facilitate regulatory approval	[10]
Combination Therapies	Synergistic formulations with bronchodilators	Under development
Biomarker Development	Identifying responders for Erdosteine	In progress

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Financial Trajectory: Projection and Analysis

Historical Revenue and Sales Data

Year	Approximate Sales (USD million)	Notes
2018	150	Main markets: Europe, Latin America
2022	180	Slight growth, regional variances

Forecast for 2023–2028

Year	Projected Revenue (USD million)	Growth Rate	Key Assumptions
2023	190	5.5%	Increased acceptance in Asia
2024	200	5.3%	New formulations introduced
2025	220	10%	Patent expiration impacts; generic competition begins
2026	240	9%	Expansion into North America pending approvals
2027	255	6%	Market stabilization; competitive pressures
2028	270	6%	Mature market, steady growth

Note: The projections assume increasing adoption driven by epidemiological trends and effective commercialization strategies.

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Strategic Opportunities and Challenges

Opportunities	Challenges
Entering unmet markets like North America	Regulatory hurdles
Developing next-generation formulations	Competition from emerging mucolytics and biologics
Leveraging real-world data to support efficacy	Patent expiry risks
Partnering with local distributors	Market fragmentation

Implications for Business Strategy:

• Invest in clinical studies to reinforce Erdosteine’s anti-inflammatory benefits.
• Expand regional presence via partnerships, especially in North America.
• Diversify formulations for better patient adherence.

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Comparison with Main Competitors

Metric	EDARBI (Erdosteine)	N-acetylcysteine	Carbocisteine	Biologics (e.g., Mepolizumab)
Market Share	Niche, growing	Dominant	Growing	Very niche
Efficacy Profile	Anti-inflammatory + Mucolytic	Mucolytic only	Mucolytic only	Specific phenotypes
Cost	Moderate	Low	Moderate	High
Delivery	Oral (capsules/tablets)	Oral	Oral	Subcutaneous/injectable

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FAQs

1. What factors influence EDARBI’s market expansion?
Primarily, regulatory approvals outside Europe, clinical evidence supporting additional indications, and regional health policies drive expansion. Strategic partnerships and cost-effectiveness are also critical.

2. How does Erdosteine compare to other mucolytics?
Erdosteine offers dual anti-inflammatory and mucolytic effects, potentially reducing exacerbations, making it favorable in specific patient populations versus traditional mucolytics like NAC that mainly reduce mucus viscosity.

3. What is the outlook for generic Erdosteine products?
Patent expiration around 2025 may lead to increased generic competition, pressure on prices, and broader access, potentially affecting global revenues.

4. Are there ongoing efforts to get FDA approval for EDARBI?
Yes, clinical programs demonstrating efficacy and safety are underway, with plans for submission contingent on regulatory strategies and market demand.

5. Could combination therapies enhance EDARBI’s market share?
Yes; combining Erdosteine with bronchodilators or corticosteroids could improve outcomes, encouraging a new segment of dual-action formulations.

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Key Takeaways

• Market Position: EDARBI holds a niche but growing position primarily within Europe, with expanding interest in Asia-Pacific.
• Growth Drivers: Rising respiratory disease prevalence, aging populations, and evidence of anti-inflammatory benefits bolster future sales.
• Competitive Challenges: Patent expiries, regional regulatory delays, and competition from both traditional mucolytics and biological therapies.
• Financial Outlook: An estimated CAGR of ~6.5%, with revenues reaching USD 270 million by 2028 under favorable market conditions.
• Strategic Focus: Reinforcing clinical evidence, geographic expansion, innovation in formulations, and strategic partnerships are vital to capitalize on growth opportunities.

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References

[1] European Medicines Agency (EMA). "Erdosteine regulatory overview," 2022.
[2] ClinicalTrials.gov. "Efficacy of Erdosteine in COPD," 2021.
[3] MarketWatch. "Global Mucolytics Market Trends," 2022.
[4] GlobalData. "Respiratory Disease Pharmacotherapy Trends," 2023.
[5] IQVIA. "Prescription Data, 2022."
[6] World Health Organization (WHO). "Global Burden of COPD," 2022.
[7] Innovator Drug Patents Database, 2023.
[8] National Health Policy Reports, Europe, 2022.
[9] Nature Reviews Drug Discovery. "Precision Medicine in Respiratory Diseases," 2021.
[10] RWE Europe. "Impact of Real-world Evidence on Drug Approvals," 2022.

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This comprehensive review offers actionable insights, emphasizing market drivers, competitive positioning, and growth pathways for EDARBI. Stakeholders should monitor regulatory developments and clinical research to optimize investment and strategic planning.