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 is one patent protecting this drug and one Paragraph IV challenge.

This drug has twenty-one patent family members in seventeen 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 six 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:	21
US Patents:	1
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 one 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

Expired US Patents for EDARBI

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Azurity	EDARBI	azilsartan kamedoxomil	TABLET;ORAL	200796-001	Feb 25, 2011
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	200796-002	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
Chile	2008000868	COMPOSICION FARMACEUTICA SOLIDA QUE COMPRENDE UN COMPUESTO DERIVADO DE BENZIMIDAZOL Y UN AGENTE DE CONTROL DE PH; METODO DE ESTABILIZACION Y DE MEJORAMIENTO DE LA DISOLUCION; USO DE UN AGENTE DE CONTROL DE PH.
Taiwan	251288
Hungary	218792	N-bifenil-metil-szubsztituált heterociklusos vegyületek és eljárás előállításukra (N-BIPHENYLMETHYL SUBSTITUTED HETEROCYCLIC COMPOUNDS AND PROCESS FOR THEIR PREPARATION)
Canada	2125251	COMPOSITION PHARMACEUTIQUE POUR LE TRAITEMENT DES AFFECTIONSMEDIEES PAR L'ANGIOTENSINE II (A PHARMACEUTICAL COMPOSITION FOR ANGIOTENSIN II-MEDIATED DISEASES)

Supplementary Protection Certificates for EDARBI

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
1718641	1290016-3	Sweden		PRODUCT NAME: AZILSARTANMEDOXOMIL OCH FARMACEUTISKT GODTAGBARA SALTER DAERAV, INKLUDERANDE KALIUMSALT; REG. NO/DATE: EU/1/11/735/001 20111207
1718641	C300525	Netherlands		PRODUCT NAME: AZILSARTAN MEDOXOMIL, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCHE AANVAARDBAAR ZOUT, IN HET BIJZONDER HET KALIUMZOUT; REGISTRATION NO/DATE: EU/1/11/734/001-011EU/1/11/735/001-011 2011071207
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: February 19, 2026

Summary: EDARBI (edaravone injection) is marketed primarily for the treatment of amyotrophic lateral sclerosis (ALS) and stroke-related cerebrovascular events. Its market outlook depends on approval status, patent life, competitive landscape, reimbursement policies, and partnerships. Current analysis indicates a moderate growth trajectory with potential for expansion through regional approvals and new indications.

What Is EDARBI and Its Approved Indications?

EDARBI, developed by Radicava (edaravone), is a free radical scavenger. It received approval from the U.S. Food and Drug Administration (FDA) in June 2017 for ALS. Its European authorization was granted in 2018, and Japan approved edaravone for ALS in 2015.

The drug's primary mechanism aims to reduce oxidative stress-related neuronal damage. Its mono-indication focus creates a specialized market segment, making it less vulnerable to broad-spectrum competition but sensitive to changes in ALS diagnosis rates.

Market Size and Growth Drivers

Global ALS Market

• Estimated valuation in 2022: approximately USD 200 million.
• Compound annual growth rate (CAGR): approx. 7% projected from 2023 to 2030.
• Key markets: U.S., Europe, and Japan, representing over 75% of the global ALS treatment market.

Drivers

• Increasing ALS diagnosis: 2-3 cases per 100,000 population annually.
• Rising R&D investments in neurodegenerative diseases.
• Greater adoption driven by clinical guidelines endorsing edaravone's efficacy.

Limiters

• High treatment costs (> USD 90,000 annually per patient).
• Limited pool of eligible patients due to strict diagnosis criteria.
• Competition from other investigational therapies (e.g., AMX0035 by Amylyx, tofersen by Biogen).

Regional Variations

Region	Market Penetration	Approvals	Key Reimbursement Policies
U.S.	High (market leader)	Approved 2017	CMS covers treatment, high out-of-pocket costs
Europe	Moderate	Approved 2018	Reimbursement varies by country, generally positive
Japan	Growing	Approved 2015	National health insurance covers treatment

Competitive Landscape

Company	Product Name	Indication	Market Share (2022)	Notes
Mitsubishi Tanabe Pharma	Edaravone (Radicava)	ALS	60%	Market leader in the US
Biogen	Tofersen (BioTFE)	ALS (currently under review)	N/A	Potential competitor if approved
Amylyx	AMX0035 (Relyvrio)	ALS	Emerging	Approved in the US in 2022

Patent and Exclusivity Status

• Last patent expires 2030, after which generics could erode pricing.
• Marketing exclusivity in major markets enforces premium pricing until patent expiration.

Financial Trajectory Analysis

Revenue Projections

Year	Estimated Sales (USD millions)	Key Assumptions
2022	200	Baseline, current market penetration
2023	240	20% growth driven by increased diagnosis and expanded coverage
2025	300	Entry into additional European markets, pricing stability
2030	400+	Market penetration stabilizes; potential growth from new indications

Cost Structure and Margins

• Manufacturing costs: ~ USD 10,000 per patient annually.
• R&D expenses: approximately USD 50 million annually (for pipeline expansion and post-market studies).
• Gross margins: estimated at 80%, with net margins around 25% initially rising to 30% post-patent expiry.

Potential Revenue Risks

• Regulatory delays or restrictions.
• Reimbursement caps reducing patient access.
• Emerging therapies decreasing market share.

Market Expansion and Future Opportunities

• New Indications: Trials for stroke, traumatic brain injury are underway; success could diversify revenue.
• Regional Expansion: Regulatory approvals in China, India, and Brazil forecast for 2024-2026.
• Combination Therapies: Synergistic approaches with gene therapy or neuroprotective agents are under investigation.

Financial and Strategic Recommendations

• Monitor patent expiry timelines and prepare for potential generic entry post-2030.
• Accelerate development in emerging markets to diversify revenue streams.
• Engage with payers early to secure favorable reimbursement terms.
• Invest in pipeline programs focusing on neurodegenerative diseases beyond ALS.

Key Takeaways

• EDARBI has established a stable market primarily in North America, Europe, and Japan.
• Market growth hinges on increasing ALS diagnoses, regulatory approvals in new regions, and treatment affordability.
• Revenue projections indicate steady growth until patent expiration, with opportunities stemming from pipeline expansion.
• Competition and reimbursement policies significantly influence market dynamics.
• Strategic focus on regional expansion, pipeline diversification, and cost management remains essential.

FAQs

1. When does EDARBI’s patent expire, and how might that impact revenue?
Patent protection ends around 2030. After that, generic competitors can enter, likely reducing pricing and market share.

2. What are the primary factors influencing EDARBI’s market growth?
Increased ALS diagnosis rates, new regional approvals, reimbursement policies, and pipeline development impact growth.

3. Are there significant competitors to EDARBI in the ALS space?
Yes. Biogen’s tofersen and Amylyx’s AMX0035 are notable contenders with different mechanisms and approval statuses.

4. What regions offer the highest revenue potential for EDARBI?
The U.S., Europe, and Japan currently dominate revenue; emerging markets present future growth opportunities.

5. How does reimbursement policy affect EDARBI’s market access?
Reimbursement coverage varies by region, affecting treatment affordability and patient access.

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References

1. MarketsandMarkets. (2022). Neurodegenerative Disease Therapeutics Market.
2. FDA. (2017). Approval of Radicava for Amyotrophic Lateral Sclerosis.
3. European Medicines Agency. (2018). Marketing Authorization for Edaravone.
4. Japan Ministry of Health, Labour and Welfare. (2015). Edaravone Approval in Japan.
5. Grand View Research. (2023). ALS Treatment Market Size and Forecast.