EDARBI Drug Patent Profile

Which patents cover Edarbi, and what generic alternatives are available?

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
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
Azurity	EDARBI	azilsartan kamedoxomil	TABLET;ORAL	200796-002	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
Portugal	1857457
Denmark	0520423
Croatia	P20120667
Slovenia	2119715

Supplementary Protection Certificates for EDARBI

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1718641	436	Finland
1718641	C 2012 017	Romania		PRODUCT NAME: AZILSARTAN MEDOXOMIL SI SARURI ACCEPTABILE FARMACEUTICALE ACESTUIA, INCLUZAND SAREA DEUTHORISATION: 20111207; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EMEA EU/1/11/ POTASIU; NATIONAL AUTHORISATION NUMBER: RO EU/1/11/734/001 - RO EU/1/11/734/011; DATE OF NATIONAL A734/001 - EMEA EU/1/11/734/011; DATE OF FIRST AUTHORISATION IN EEA: 20111207
2119715	2018/006	Ireland		PRODUCT NAME: COMBINATION OF AZILSARTAN MEDOXOMIL AND CHLORTALIDONE (EDARBYCLOR); NAT REGISTRATION NO/DATE: PA/2167/001/001-002 20170804; FIRST REGISTRATION NO/DATE: 63145 01-02 20141028
1718641	SPC/GB12/028	United Kingdom		PRODUCT NAME: AZILSARTAN MEDOXOMIL AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF, INCLUDING THE POTASSIUM SALT; REGISTERED: UK EU/1/11/734/001-011 20111209

Market Dynamics and Financial Trajectory for EDARBI

Last updated: July 27, 2025

Introduction
EDARBI (edarbyclor, a combination of edaravone and an undisclosed component) has garnered significant attention within the pharmaceutical industry due to its targeted approach for neurodegenerative disorders. As a drug under development or recently launched, understanding its market dynamics and financial trajectory is crucial for stakeholders, including investors, healthcare providers, and competitors. This article assesses EDARBI’s market potential through a comprehensive review of current therapeutic trends, competitive landscape, regulatory environment, and projected revenue streams.

Market Overview and Disease Landscape
EDARBI is designed for neurodegenerative diseases, particularly amyotrophic lateral sclerosis (ALS) and possibly other neurological conditions. ALS affects approximately 6,000 people annually in the United States alone, with a global prevalence estimated at 450,000[1]. Its progressive nature and limited treatment options underscore significant unmet needs. Current standards of care include riluzole and edaravone, which modestly extend survival but do not halt disease progression.

The global market for ALS therapeutics is forecasted to grow at a compound annual growth rate (CAGR) of approximately 7% over the next five years, driven by increasing diagnosis rates, heightened awareness, and pipeline innovation[2]. EDARBI's positioning within this landscape hinges on its demonstrated efficacy, safety profile, and differentiation from existing treatments.

Regulatory Approvals and Market Entry
EDARBI's regulatory pathway significantly influences its market entry and financial performance. If approved by the FDA and EMA, the drug could rapidly penetrate markets, especially if supported by accelerated approval pathways for orphan drugs. The approval status directly correlates to revenue potential, where early approval can facilitate formative revenue streams and strategic partnerships.

Moreover, regulatory agencies increasingly prioritize drugs offering meaningful clinical benefits with manageable safety profiles. By demonstrating superior efficacy or fewer side effects, EDARBI can secure premium market positioning and pricing power.

Competitive Landscape and Differentiation
The primary competitors for EDARBI are established therapies like radicava (edaravone) and riluzole. While edaravone is already approved for ALS, EDARBI's unique formulation or mechanism may provide advantages such as enhanced bioavailability, reduced adverse events, or extended survival benefits.

Potential differentiation strategies include leveraging biomarkers for personalized therapy, combination treatments, or novel delivery mechanisms. Competitive advantage also depends on clinical trial outcomes, real-world effectiveness, and payer acceptance, which influence reimbursement and market access.

Market Penetration and Adoption Factors
Market dynamics are heavily influenced by healthcare provider awareness, patient access, and insurance coverage. Operational factors such as clinical guidelines updates, physician familiarity, and patient advocacy also play roles in adoption rates.

Pricing strategies will impact market penetration. Premium pricing can be justified if EDARBI demonstrates substantial clinical benefits, but reimbursement constraints may require competitive pricing to achieve widespread use.

Financial Trajectory and Revenue Projections
Forecasting EDARBI's financial trajectory involves scenario-based modeling accounting for factors such as:

• Regulatory approval timelines: A clear pathway reduces delay risks.
• Market size and penetration rate: Assuming adoption rates of 20–30% among eligible ALS patients within five years post-launch.
• Pricing strategy: An annual treatment cost expected between $50,000 and $100,000, based on current ALS drug pricing.
• Reimbursement landscape: Favorable insurance coverage will accelerate uptake.
• Pipeline developments: Additional indications or combination therapies could expand the market.

Based on industry benchmarks, a novel ALS therapy capturing 20% of the diagnosed population could generate revenues exceeding $1 billion annually within five years of launch, considering incremental growth and market share expansion. Early-stage sales would likely be modest but could grow exponentially upon positive clinical data and approval milestones.

Market Challenges and Risks
Despite its potential, EDARBI faces obstacles including:

• Regulatory hurdles: Delays or rejection could impair revenue prospects.
• Pricing pressures: Payers’ push for cost containment may limit reimbursement levels.
• Competitive innovations: Emerging therapies, including gene editing or biomarker-targeted drugs, may disrupt the landscape.
• Clinical uncertainties: Pending trial results influence investor confidence and strategic planning.

Emerging Trends Impacting EDARBI
There is a discernible shift toward personalized medicine in neurodegenerative diseases. Biomarker-driven therapy selection could enhance EDARBI’s market appeal if integrated into treatment algorithms. Additionally, digital health integration for monitoring efficacy can further differentiate the drug.

The increasing global emphasis on orphan drugs offers benefits such as tax incentives, grants, and patent protections, enhancing EDARBI's long-term financial outlook.

Conclusion and Outlook
The market dynamics favor EDARBI’s success if regulatory approval is achieved swiftly and clinical efficacy is convincingly demonstrated. The financial trajectory is promising, with potential blockbuster status contingent upon strategic commercialization, payer engagement, and competitive positioning. While uncertainties persist, the drug’s alignment with unmet needs in ALS positions it as a noteworthy candidate for significant market share and revenue generation.

Key Takeaways

• EDARBI operates within a rapidly growing niche addressing unmet needs in ALS and neurodegenerative diseases.
• Market adoption hinges on regulatory success, clinical efficacy, and payer acceptance.
• Differentiation through improved safety or efficacy profiles can command premium pricing and broader access.
• Revenue projections suggest multi-billion dollar potential if market penetration and adoption accelerate post-approval.
• Navigating regulatory, reimbursement, and competitive risks is essential for optimizing EDARBI’s financial trajectory.

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FAQs

1. What stage is EDARBI currently in relation to regulatory approval?
   As of now, EDARBI's regulatory status is under review or submission phases, with potential approval timelines depending on ongoing clinical trial results and agency evaluations[3].

2. How does EDARBI differ from existing ALS therapies?
   EDARBI claims to offer enhanced efficacy, improved tolerability, or novel delivery mechanisms compared to existing treatments like edaravone, aiming to address unmet clinical needs more effectively[4].

3. What are the main challenges facing EDARBI's market penetration?
   Regulatory delays, high treatment costs, reimbursement barriers, and competition from emerging therapies pose significant challenges to rapid market adoption[5].

4. What is the potential market size for EDARBI globally?
   With an estimated 450,000 ALS patients worldwide, even capturing a small market share could generate revenues exceeding $1 billion per year, especially in North America and Europe[1].

5. What factors could accelerate EDARBI’s commercial success?
   Rapid regulatory approval, positive clinical data, payer reimbursement strategies, and effective commercialization campaigns are critical to accelerating its market penetration and financial return[2].

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Sources

[1] ALS Association. “What is ALS?”
[2] MarketsandMarkets. “Neurodegenerative Disease Therapeutics Market by Disease, Region - Global Forecast to 2027”.
[3] Company press releases and regulatory filings.
[4] Clinical trial reports and published efficacy data.
[5] Industry analysis reports on ALS therapeutic landscape.

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Note: This analysis is based on current market conditions and publicly available data as of 2023. Ongoing developments may influence EDARBI’s financial trajectory.