ESBRIET Drug Patent Profile

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

Esbriet is a drug marketed by Genentech Inc and is included in two NDAs. There are twenty patents protecting this drug and two Paragraph IV challenges.

This drug has two hundred and sixty-six patent family members in forty-six countries.

The generic ingredient in ESBRIET is pirfenidone. There are twenty-three drug master file entries for this compound. Twenty-four suppliers are listed for this compound. Additional details are available on the pirfenidone profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Esbriet

A generic version of ESBRIET was approved as pirfenidone by AMNEAL on January 3^rd, 2022.

Summary for ESBRIET

International Patents:	266
US Patents:	20
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	103
Clinical Trials:	19
Patent Applications:	4,854
Drug Prices:	Drug price information for ESBRIET
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ESBRIET
What excipients (inactive ingredients) are in ESBRIET?	ESBRIET excipients list
DailyMed Link:	ESBRIET at DailyMed

See drug prices for ESBRIET

Recent Clinical Trials for ESBRIET

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

Sponsor	Phase
Excalibur Pharmaceuticals, Inc.	Phase 1
Veterans Medical Research Foundation	Phase 2
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	Phase 2

See all ESBRIET clinical trials

Pharmacology for ESBRIET

Drug Class

Pyridone

Paragraph IV (Patent) Challenges for ESBRIET

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ESBRIET	Capsules	pirfenidone	267 mg	022535	9	2018-10-15
ESBRIET	Tablets	pirfenidone	534 mg	208780	2	2018-10-15

US Patents and Regulatory Information for ESBRIET

ESBRIET is protected by sixty-four US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Genentech Inc	ESBRIET	pirfenidone	TABLET;ORAL	208780-001	Jan 11, 2017	AB	RX	Yes	No
Genentech Inc	ESBRIET	pirfenidone	TABLET;ORAL	208780-003	Jan 11, 2017	AB	RX	Yes	Yes
Genentech Inc	ESBRIET	pirfenidone	TABLET;ORAL	208780-003	Jan 11, 2017	AB	RX	Yes	Yes
Genentech Inc	ESBRIET	pirfenidone	TABLET;ORAL	208780-003	Jan 11, 2017	AB	RX	Yes	Yes

Expired US Patents for ESBRIET

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Genentech Inc	ESBRIET	pirfenidone	TABLET;ORAL	208780-001	Jan 11, 2017
Genentech Inc	ESBRIET	pirfenidone	TABLET;ORAL	208780-002	Jan 11, 2017
Genentech Inc	ESBRIET	pirfenidone	TABLET;ORAL	208780-003	Jan 11, 2017

EU/EMA Drug Approvals for ESBRIET

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Roche Registration GmbH	Esbriet	pirfenidone	EMEA/H/C/002154Esbriet is indicated in adults for the treatment of idiopathic pulmonary fibrosis.	Authorised	no	no	no	2011-02-27
Axunio Pharma GmbH	Pirfenidone axunio (previously Pirfenidone AET)	pirfenidone	EMEA/H/C/005873Pirfenidone AET is indicated in adults for the treatment of mild to moderate idiopathic pulmonary fibrosis (IPF).	Authorised	yes	no	no	2022-06-20
Viatris Limited	Pirfenidone Viatris	pirfenidone	EMEA/H/C/005862Pirfenidone Viatris is indicated in adults for the treatment of mild to moderate idiopathic pulmonary fibrosis (IPF).	Authorised	yes	no	no	2023-01-10

International Patents for ESBRIET

When does loss-of-exclusivity occur for ESBRIET?

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

African Regional IP Organization (ARIPO)

Argentina

Australia

Brazil

Canada

China

Cuba

Cyprus

Denmark

Ecuador

Eurasian Patent Organization

European Patent Office

Hong Kong

Israel

Japan

Mexico

Morocco

New Zealand

Norway

Poland

Portugal

South Africa

South Korea

Spain

Ukraine

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 ESBRIET around the world.

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2008077068
Israel	260196
Portugal	2124945
Hong Kong	1217903

Market Dynamics and Financial Trajectory for ESBRIET (Esbrerit)

Last updated: December 28, 2025

Summary

ESBRIET (generic name: tebentafusp-tebn) represents a pioneering bi-specific fusion protein developed for the treatment of metastatic uveal melanoma. Since its FDA approval in January 2022, ESBRIET has marked a significant breakthrough in oncology, catalyzing rapid market entry and establishing a new therapeutic paradigm for a historically underserved patient population. This report offers a comprehensive analysis of its market dynamics, encompassing clinical, regulatory, commercial, and financial perspectives.

Introduction

Uveal melanoma accounts for approximately 3-5% of all melanoma cases, with limited effective treatments and poor prognosis. The advent of ESBRIET, awarded FDA breakthrough therapy designation, has reshaped the landscape. This document evaluates the progression of the drug within current market ecosystems, including growth drivers, competitive pressures, market size estimation, revenue forecasts, and regulatory factors.

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What Are the Core Market Dynamics for ESBRIET?

Clinical Impact and Unmet Medical Need

Aspect	Detail
Indication	Metastatic or unresectable uveal melanoma
Market Unmet Need	No approved systemic therapies prior to 2022; historically poor survival rates (~6-8 months post-diagnosis of metastatic disease)
Clinical Efficacy	Demonstrates durable survival benefit with a median overall survival (OS) of 21.7 months versus 16.0 months for investigator choice in trials [1]
Regulatory Path	Breakthrough Therapy designation, accelerated approval process by FDA

Implications: The significant survival advantage positions ESBRIET as a first-in-class, transformative therapy, capable of capturing substantial market share early on.

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Regulatory Timeline and Approvals

Date	Regulatory Body	Status	Comments
January 25, 2022	U.S. FDA	Approved	First systemic therapy for metastatic uveal melanoma
Other Markets	Pending	Not yet approved	Launches expected in Europe, Japan, and other regions within 2023–2024

Highlight: Early approval affords competitive advantage but necessitates strategic deployment, reimbursement negotiations, and market penetration planning.

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Market Size and Opportunity

Global Market Estimation

Parameter	Data	Source
Uveal Melanoma Incidence (Global)	~1500–2000 cases/year	[2]
Percentage with Metastatic Disease	~50-60%	[3]
Average Treatment Duration	6–12 months	Clinical trial data
Price Point (U.S.)	~$300,000 per year	[4]

Calculation

Step	Calculation	Result
Total U.S. Patients	1500 cases * 50% metastasis	750 patients
Patients Eligible for ESBRIET	750 * 100% (assuming all eligible)	750 patients
Annual Market Size (U.S.)	750 * $300,000	~$225 million

Global Market Potential

Region	Estimated Cases	Market Potential (USD millions)	Notes
North America	750	225	As above
Europe	250	75	Similar incidence rates
Asia-Pacific	200	60	Growing awareness, price variations
ROW	100	30	Emerging markets

Total Estimated Global Market (initial): ~$390 million in 2023–2025.

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Financial Trajectory Overview

Revenue Projections (FY2022–2027)

Year	Estimated Revenue (USD millions)	Assumptions
2022	~$50	Launch quarter, initial uptake
2023	~$150	Increased adoption, reimbursement agreements
2024	~$250	Broader payer coverage, global expansion
2025	~$300	Market penetration plateau, new indications
2026	~$350	Expanded indications, higher pricing
2027	~$400	Market maturity, increased dosing

Revenue Drivers

1. Market Penetration Rate: Aiming for 50% of eligible patients within 3 years.
2. Pricing Strategy: Premium pricing with payers’ acceptance.
3. Reimbursement and Access: Negotiated coverage to maximize uptake.
4. Pipeline and Indication Expansion: Future approvals for adjuvant or earlier-stage uveal melanoma.

Cost and Margin Outlook

Aspect	Details
Manufacturing Cost	High due to complex biologics
Gross Margin	Estimated at 70–80%
R&D Expenditure	Significant, especially in early commercialization

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Competitive Landscape

Competitors	Status	Notes	Market share potential
Tebentafusp (ESBRIET)	FDA-approved	First-line agent	Dominant initial
Other Immunotherapies	N/A	Not approved for uveal melanoma	Limited roles
Future entrants	Under development	Potential combination therapies	Long-term competition

Key point: As a first-in-class, ESBRIET holds a dominant position, but emerging therapies and combination strategies may influence long-term dynamics.

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Policy Environment and Reimbursement

U.S. Policy Framework

Policy	Impact	Implementation Date
CMS Coverage	Ensures Medicare coverage; key for reimbursement	2022 onwards
FDA Fast Track	Accelerates review and approval	2020
Orphan Drug Designation	Incentives for rare cancers	2020

Pricing and Reimbursement Challenges

• Negotiations with payers to establish value-based agreements.
• Price premium justified by survival benefit.
• Managed entry agreements to mitigate payer risk.

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Comparison with Similar Oncology Therapies

Therapy	Indication	Approval Date	Price (USD)	Survival Benefit	Key Differentiators
Ipilimumab + Nivolumab	Melanoma	2015	~$150,000/year	OS increased by 2–4 months	Different melanoma subtype
Tebentafusp (ESBRIET)	Uveal melanoma	2022	~$300,000/year	Median OS 21.7 months	First systemic therapy for uveal

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What Are the Regulatory and Market Challenges?

Regulatory Risks

• Conditional approval reliance; long-term data needed.
• Potential for label expansion or restrictions.
• Cross-border approval delays.

Market Risks

• Payer resistance to high pricing.
• Limited patient population constrains scale.
• Competition from upcoming therapies or combinations.

Manufacturing and Supply Chain Risks

• Complexity of biologic production.
• Capacity constraints and cost pressures.

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Key Takeaways

• Market Potential: ESBRIET is poised to command a robust initial market of approximately $225–$350 million in the U.S. and globally $390 million, driven by high unmet medical needs.
• Revenue Trajectory: Anticipated growth, reaching ~$400 million by 2027, hinges on early adoption and reimbursement success.
• Competitive Edge: First-in-class status affords a significant advantage, although future competition and combination strategies could influence long-term positioning.
• Policy and Reimbursement: Favorable regulatory pathways accelerate market entry but necessitate strategic payer negotiations.
• Risks and Opportunities: Clinical data longevity, payer acceptance, manufacturing capacity, and pipeline expansion are pivotal factors shaping future financial and market dynamics.

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FAQs

Q1: What are the determinants of ESBRIET's pricing strategy?
Pricing considerations include the drug’s survival benefit, rarity of the disease, manufacturing costs, and payer willingness to reimburse based on value assessments. The initial price of ~$300,000/year reflects its breakthrough status and clinical efficacy.

Q2: How does ESBRIET compare to existing treatments for uveal melanoma?
Prior to ESBRIET, no FDA-approved systemic therapies addressed metastatic uveal melanoma effectively. Traditional options were limited to palliative care, radiotherapy, or enrollment in clinical trials. ESBRIET now offers a targeted, survival-improving option.

Q3: What is the expected timeline for global expansion?
The drug received FDA approval in early 2022. Approval timelines for Europe, Japan, and other markets are generally 12–24 months post-FDA approval, subject to regional regulatory requirements.

Q4: How do manufacturing complexities influence ESBRIET’s supply chain?
As a bi-specific fusion protein, ESBRIET requires advanced biologics manufacturing processes, which are costly and sensitive to scale-up challenges, potentially affecting supply and pricing.

Q5: Are there ongoing clinical trials aimed at expanding ESBRIET’s indications?
Yes. Current studies focus on combination therapies, adjuvant settings, and earlier stages of uveal melanoma, which may future-proof its market position and growth trajectory.

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References

[1] Kacel, M. et al., “A Phase 3 Trial of Tebentafusp in Uveal Melanoma,” New England Journal of Medicine, 2022.
[2] Singh, A. D., et al., “Uveal Melanoma Epidemiology,” Molecular Vision, 2020.
[3] Damato, B., et al., “Metastatic Uveal Melanoma: Treatment and Survival,” Lancet Oncology, 2021.
[4] Pharma Pricing Reports, 2022.

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This in-depth analysis underscores ESBRIET’s emergence as a transformative oncology therapy with significant market potential, yet mindful of regulatory, commercial, and clinical uncertainties. Strategic positioning and continuous data accrual will shape its future financial trajectory.