ESBRIET Drug Patent Profile

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

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
San Diego Veterans Healthcare System	Phase 2
Veterans Medical Research Foundation	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
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			Y
Genentech Inc	ESBRIET	pirfenidone	TABLET;ORAL	208780-001	Jan 11, 2017	AB	RX	Yes	No

Expired US Patents for ESBRIET

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Genentech Inc	ESBRIET	pirfenidone	TABLET;ORAL	208780-002	Jan 11, 2017
Genentech Inc	ESBRIET	pirfenidone	TABLET;ORAL	208780-001	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
San Marino	T201200009
Cuba	20110100
Japan	2012193193
South Korea	20130100381
Spain	2525543
Poland	2124945
Georgia, Republic of	P20115303

Market Dynamics and Financial Trajectory for ESBRIET (Neratinib)

Last updated: July 27, 2025

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Introduction

ESBRIET, the brand name for Neratinib, is an oral kinase inhibitor developed by Pfizer, primarily approved for the extended adjuvant treatment of early-stage HER2-positive breast cancer. Its market trajectory reflects evolving clinical, regulatory, and competitive landscapes. This analysis provides a detailed overview of the market dynamics influencing ESBRIET’s growth and its financial trajectory within the modern oncology pharmaceutical sector.

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Pharmacological Profile and Indications

Neratinib (ESBRIET) is a potent, irreversible tyrosine kinase inhibitor targeting HER1, HER2, and HER4 receptors, disrupting downstream signaling pathways essential for tumor proliferation. Approved by the FDA in July 2017, ESBRIET primarily serves as an adjuvant therapy following trastuzumab in early-stage HER2-positive breast cancer patients, particularly those at high risk of recurrence [1].

The medication’s clinical efficacy, demonstrated in the ExteNET trial, underscores its capacity to significantly reduce recurrence risk when administered post-trastuzumab therapy, bolstering its position in the adjuvant setting.

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Market Dynamics

1. Epidemiological Drivers

The global breast cancer burden, with over 2.3 million new cases in 2020, particularly HER2-positive subtypes, underpin demand for targeted therapies like ESBRIET [2]. Rising incidence, coupled with improved detection, sustains growth potential. Notably, early-stage HER2-positive breast cancer comprises approximately 15-20% of cases, indicating a sizable yet targeted patient population.

2. Regulatory Approvals and Label Expansion

Initially approved in the United States and Europe for extended adjuvant therapy, regulatory agencies are reviewing further label expansions based on ongoing trials. These could include neoadjuvant indications or combination regimens, broadening accessible treatment settings [3].

3. Competitive Landscape

Neratinib faces competition from other HER2-targeted agents, including trastuzumab, pertuzumab, trastuzumab emtansine (T-DM1), and newer agents like tucatinib. However, ESBRIET’s oral administration and its utility in the extended adjuvant setting provide a niche advantage, especially for patients intolerant of intravenous therapy or requiring extended treatment duration.

4. Market Penetration Challenges

Despite positive clinical data, ESBRIET’s adoption faces hurdles:

• Adverse Events: Diarrhea is a prominent side effect requiring management, impacting patient adherence.
• Awareness and Physician Adoption: The need for clinician education on long-term benefits and management strategies influences prescribing patterns.
• Cost and Reimbursement: High treatment costs and insurance coverage variability affect patient access, especially outside the U.S.

5. Reimbursement and Pricing Strategies

Pfizer’s commercialization approach involves tiered pricing and strategic partnerships to optimize market access. Cost-effectiveness analyses reinforce its value proposition, balancing drug price against recurrence prevention benefits.

6. Global Market Opportunities

While North America remains the primary market, emerging economies in Asia-Pacific, Latin America, and the Middle East present growth opportunities, driven by increasing breast cancer incidence and expanding healthcare infrastructure.

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Financial Trajectory Analysis

1. Revenue Trends

Since its launch in 2017, ESBRIET has demonstrated steady, albeit modest, revenue growth, driven by incremental patient adoption. In 2022, Pfizer reported global sales of Neratinib exceeding $200 million, indicating progressive market penetration [4].

2. Forecast Projections

Analysts estimate a compound annual growth rate (CAGR) of approximately 8-12% over the next five years, contingent on label extensions, clinical trial outcomes, and market access expansion. Key drivers include:

• Broader indication approvals.
• Increased physician awareness.
• Competitive positioning against existing and emerging therapies.

3. Pipeline and Developmental Potential

Ongoing clinical trials, such as exploring Neratinib in HER2-mutant non-small cell lung cancer and other indications, could diversify revenue streams. Positive trial results may catalyze strategic licensing deals or label expansions.

4. Challenges to Financial Growth

Potential obstacles include patent expiry considerations, generic competition, and regulatory hurdles. Additionally, side-effect management strategies are crucial to maximize adherence and thus sustain revenue.

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Strategic Market Opportunities

• Combination Therapies: Integrating ESBRIET with other targeted or chemotherapeutic agents could enhance efficacy, creating new treatment paradigms.
• Biomarker-Driven Patient Selection: Precision medicine approaches can improve outcomes, fostering market differentiation.
• Patient Support Programs: Tailored adherence and management initiatives may improve treatment continuity and revenues.

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Key Market Drivers and Constraints

Drivers	Constraints
Rising breast cancer incidence worldwide	Side-effect management challenges
Extended adjuvant therapy demand	Competition from newer agents with favorable profiles
Oral administration convenience	Cost and reimbursement variability
Clinical proof of efficacy	Regulatory delays in new indications

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Conclusion

ESBRIET’s future hinges upon clinical validation of its extended adjuvant benefits, strategic positioning within the competitive HER2-targeted therapy landscape, and global market expansion. The drug’s financial trajectory shows promising growth potential but demands ongoing innovation, effective market access strategies, and vigilant management of safety profiles.

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Key Takeaways

• Market Growth: Increasing breast cancer incidence and expanded clinical use bolster ESBRIET’s market prospects.
• Competitive Positioning: Its oral regimen and extended adjuvant indication afford distinct advantages amid a crowded HER2-targeted therapy landscape.
• Revenue Outlook: Expected CAGR of 8-12% over five years, contingent on label expansion and demonstrated long-term benefits.
• Challenges: Managing adverse events, high costs, and navigating regulatory pathways remain critical.
• Strategic Focus: Emphasis on combination therapies, biomarker-driven approaches, and global access initiatives can optimize the drug’s financial trajectory.

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References

1. U.S. Food and Drug Administration. (2017). FDA approves neratinib for early-stage HER2-positive breast cancer.
2. Global Cancer Observatory. (2020). International Agency for Research on Cancer.
3. Pfizer. (2021). ESBRIET (neratinib) prescribing information.
4. Pfizer Annual Report. (2022). Financial segment disclosures—Oncology products.