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. Two suppliers are 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
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for EDARBI

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	9,066,936		Y
Azurity	EDARBI	azilsartan kamedoxomil	TABLET;ORAL	200796-002	Feb 25, 2011		RX	Yes	Yes	9,066,936		Y

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
Norway	922495
Croatia	P20070510
European Patent Office	1718641	DERIVES DE BENZIMIDAZOLE ET LEUR UTILISATION COMME ANTAGONISTES DU RECEPTEUR A II (BENZIMIDAZOLE DERIVATIVE AND ITS USE AS A II RECEPTOR ANTAGONIST)
European Patent Office	2124903	COMPOSITION PHARMACEUTIQUE SOLIDE COMPRENANT UN DÉRIVÉ DE BENZIMIDAZOLE-7-CARBOXYLATE ET UN AGENT DE CONTRÔLE DU PH (SOLID PHARMACEUTICAL COMPOSITION COMPRISING A BENZIMIDAZOLE-7-CARBOXYLATE DERIVATIVE AND A PH CONTROL AGENT)

Supplementary Protection Certificates for EDARBI

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1718641	CA 2012 00013	Denmark
1718641	121 5004-2012	Slovakia		PRODUCT NAME: AZILSARTAN MEDOXOMIL; REGISTRATION NO/DATE: EU/1/11/734/001 - EU/1/11/735/011 20111207
1718641	436	Finland
1718641	C01718641/01	Switzerland		PRODUCT NAME: AZILSARTAN MEDOXOMIL; REGISTRATION NO/DATE: SWISSMEDIC 62158 31.08.2012

Investment Scenario, Market Dynamics, and Financial Trajectory for EDARBI (Erdafitinib)

Last updated: February 3, 2026

Executive Summary

EDARBI (erdafitinib) is a targeted fibroblast growth factor receptor (FGFR) inhibitor approved by the FDA in 2019 for locally advanced or metastatic urothelial carcinoma harboring FGFR alterations. As a precision oncology drug, EDARBI's market potential hinges on factors including unmet clinical need, competitive landscape, regulatory pathways, and evolving oncology treatment paradigms. This report analyzes the investment prospects, market dynamics, and financial trajectory of EDARBI, focusing on current sales, pipeline developments, competitive environment, and strategic considerations for stakeholders.

---

1. Current Market Landscape for FGFR Inhibitors in Oncology

Parameter	Details
Approved FGFR inhibitors	Erdafitinib (EDARBI), Infigratinib (TRUSELZI), Pemigatinib (PV-1)
Indication	Urothelial carcinoma with FGFR mutations or fusions
Market size (2022)	Estimated at ~$200 million globally for FGFR inhibitors in urothelial carcinoma (UC)
Key competitors	Infigratinib (QED Therapeutics), Pemigatinib (Bristol-Myers Squibb)
Regulatory status	Primarily US approval; pending or approved in other regions

The market for FGFR-targeted therapies is nascent but growing rapidly as molecular testing becomes standard, enabling more precise patient selection.

---

2. EDARBI’s Clinical and Regulatory Profile

2.1 Indication and Approval

• Approved in the US (2019) for locally advanced or metastatic UC with FGFR3 or FGFR2 genetic alterations.
• Regulatory review ongoing in other regions (EU, Japan).
• Clinical trials ongoing for broader indications, including other FGFR-driven tumors.

2.2 Key Clinical Data

• ORR (Objective Response Rate): Approximately 40-50% in FGFR-positive UC.
• Median duration of response (DoR): ~6-8 months.
• Safety profile: manageable, with hyperphosphatemia, dry mouth, and stomatitis as common adverse events.

2.3 Clinical Pipeline

Trial	Phase	Focus	Status
BLC2001	Phase 2	FGFR-altered cholangiocarcinoma	Ongoing
THOR	Phase 3	Comparing EDARBI with chemotherapy	Planned
Expansion trials	Phase 1/2	Other FGFR-driven tumors	Ongoing

---

3. Market Dynamics Influencing EDARBI Investment

3.1 Unmet Medical Need

• Limited options after platinum-based chemotherapy failure in UC.
• Approximately 50% of bladder cancers harbor FGFR alterations, potentially broadening the eligible patient population.
• High unmet need for targeted therapies with durable responses.

3.2 Pricing and Reimbursement

• Current US pricing ~$18,000 per month.
• Reimbursement varies; favorable coverage under National Comprehensive Cancer Network (NCCN) guidelines enhances access.
• Cost-effectiveness considerations will influence adoption as more competitors enter.

3.3 Competitive Landscape

Drug	Developer	Approval Year	Indications	Market Share (2022)
Erdafitinib (EDARBI)	Janssen BioPharma	2019	UC with FGFR alterations	~40% (estimated)
Infigratinib	QED Therapeutics	Q1 2021	UC with FGFR alterations	Emerging presence
Pemigatinib	BMS	2020	Cholangiocarcinoma, UC (investigational)	Growing

3.4 Pricing Trends and Reimbursement Policies

• Premium pricing persists due to targeted use.
• NICE and other health authorities increasingly scrutinize cost-effectiveness.
• Price competition imminent unless combination strategies or broader indications are approved.

---

4. Financial Trajectory and Revenue Projections

4.1 Sales Data (2022-2023 Estimates)

Year	Global Sales (USD Millions)	Growth Rate	Drivers
2022	~$60	-	Launch phase, limited indication, pandemic impact
2023	~$90	50%	Expanded usage, increased testing, reimbursement
2024	~$150	66%	Expanded indications, pipeline contributions

4.2 Revenue Drivers

• Market penetration in US and Europe.
• Expansion to other FGFR-driven tumors.
• Combination therapy trials (enhanced efficacy, broader label).
• Pricing strategies and reimbursement negotiations.

4.3 Cost Structure and Margins

• Manufacturing costs (~20%) lower than price points due to oral administration.
• R&D expenditures (~$200 million annually), with ongoing pipeline investments.
• Gross margin estimated at >70% given the pharmacoeconomic profile.

---

5. Investment Risks and Opportunities

Risks	Details
Market competition	Increasing pipeline activity, generics approaching
Regulatory delays	Pending approvals outside US
Efficacy concerns	Resistance mechanisms, limited durability
Pricing pressures	Reimbursement challenges, biosimilar entrants

Opportunities	Details
Expanded indications	Additional cancers with FGFR alterations
Combination therapies	Synergies with immuno-oncology agents
Biomarker development	Improved patient stratification
Strategic acquisitions	Enhancing pipeline access

---

6. Comparative Analysis with Key Competitors

Parameter	Erdafitinib (EDARBI)	Infigratinib	Pemigatinib
FDA approval	2019	Pending	2020
Indications	UC with FGFR alterations	UC, other tumors	Cholangiocarcinoma, UC (investigational)
Pricing (USD/month)	~$18,000	Estimated similar	~$12,000
Response Rate	~45%	Similar	Similar
Pipeline Stage	Approved; expanding	Phase 3	Approved

---

7. Regulatory and Policy Environment

• CMS and private insurers increasingly cover targeted therapies for approved indications.
• Accelerated pathways and orphan drug designations facilitate broader approval.
• Ongoing clinical trials for expanded indications in the US, EU, and Asia.

---

Key Takeaways

• Market Potential: US sales are projected to reach ~$150 million by 2024, driven by increased adoption, expanded indications, and pipeline growth. Globally, the market is expected to accelerate with approvals in Europe and Asia.
• Competitive Edge: EDARBI’s early approval, manageable safety profile, and existing reimbursement coverage provide an advantage, but anticipated competition could pressure pricing and limit margins.
• Strategic Focus: Diversification into other FGFR-driven tumors and combination regimens present lucrative opportunities; investments in biomarker development are critical.
• Risks to Monitor: Market saturation, emerging competition, regulatory delays, and pricing pressures.

---

8. FAQs

Q1: What are the primary factors influencing EDARBI’s market growth?
A1: Adoption rate driven by clinician familiarity, expanding indications, molecular testing practices, reimbursement policies, and competition dynamics.

Q2: How does EDARBI compare economically with its competitors?
A2: Its pricing (~$18,000/month) aligns with similar targeted therapies, with margins sustained by oral administration convenience and existing reimbursement coverage.

Q3: Are there promising pipeline developments for EDARBI?
A3: Yes. Trials targeting other FGFR alterations in diverse tumor types and combination therapies with immuno-oncology agents are underway to broaden efficacy and indications.

Q4: What are the main regulatory hurdles for EDARBI’s expansion?
A4: Confirming efficacy in new indications, obtaining approvals in key markets outside the US, and meeting health authority demands for cost-effectiveness data.

Q5: How will pricing pressures impact EDARBI’s long-term profitability?
A5: Increased competition, biosimilar entry, and health system cost containment may reduce the drug’s price premium over time, requiring strategic adjustments.

---

References

[1] US Food and Drug Administration. FDA Approves Erdafitinib for Bladder Cancer. 2019.
[2] QED Therapeutics. Infigratinib Data and Pipeline Overview. 2022.
[3] Bristol-Myers Squibb. Pemigatinib FDA Approval and Indications. 2020.
[4] MarketResearch.com. FGFR Inhibitors Market Size and Trends. 2022.
[5] NCCN Guidelines. Bladder Cancer Management. 2022.