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-three patent family members in forty-five countries.

The generic ingredient in ESBRIET is pirfenidone. There are twenty-three drug master file entries for this compound. Twenty-one 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:	263
US Patents:	20
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	142
Clinical Trials:	19
Patent Applications:	5,268
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
University of California, San Diego	Phase 2
San Diego Veterans Healthcare System	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

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/002154 Esbriet 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/005873 Pirfenidone 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/005862 Pirfenidone 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

Georgia, Republic of

Hong Kong

Israel

Japan

Mexico

Morocco

New Zealand

Norway

Poland

Portugal

Slovenia

South Africa

South Korea

Spain

Tunisia

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
South Korea	20030072608
European Patent Office	2441455	Procédés d'administration d'une thérapie par pirfénidone (Methods of administering pirfenidone therapy)
Eurasian Patent Organization	030093	ЛЕКАРСТВЕННАЯ ФОРМА ПИРФЕНИДОНА В ВИДЕ КАПСУЛ С ФАРМАЦЕВТИЧЕСКИ ПРИЕМЛЕМЫМИ ЭКСЦИПИЕНТАМИ (CAPSULE FORMULATION OF PIRFENIDONE AND PHARMACEUTICALLY ACCEPTABLE EXCIPIENTS)
Georgia, Republic of	P20166426	PIRFENIDONE THERAPY AND INDUCERS OF CYTOCHROME P450
Taiwan	201020232	Modifying pirfenidone treatment for patients with atypical liver function
Japan	2015526528	ピルフェニドン療法の投与方法

ESBRIET Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Esbriet (Pirfenidone)

Introduction

Esbriet (pirfenidone) is an oral anti-fibrotic medication approved for the treatment of idiopathic pulmonary fibrosis (IPF), a chronic and progressive lung disease. Here, we delve into the market dynamics and financial trajectory of Esbriet, highlighting its current status, market forecasts, and the factors influencing its market position.

Market Overview

Esbriet has been approved in several major markets, including the United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan, since its initial approval in Europe in 2011 and in the US in 2014[3].

Clinical Benefits and Market Impact

Clinical studies have demonstrated the efficacy of Esbriet in improving patient outcomes. A pooled analysis from the ASCEND and CAPACITY Phase III studies showed a 38% reduction in the risk of death in IPF patients treated with Esbriet for up to two years[4]. Long-term treatment with Esbriet has also been associated with slower lung function decline, improved exercise tolerance, and increased overall survival rates compared to no-antifibrotic therapies[2].

Market Forecast

The market for Esbriet is expected to undergo significant changes due to several factors:

• Extensive Research: Ongoing research in IPF treatment and the development of novel therapies are likely to impact the market scenario. New therapies under development could challenge Esbriet's dominance[1][3].
• Healthcare Spending: Incremental healthcare spending globally is anticipated to expand the market size, allowing drug manufacturers to penetrate deeper into the market[1][3].
• Market Competitors: Other approved products for IPF, such as nintedanib, are providing market competition to Esbriet. The launch of late-stage emerging therapies will also significantly impact the market[1][3].

Sales Data and Market Size

Historical and forecasted sales data indicate that Esbriet's market size has been substantial but is facing challenges. For instance, sales of Esbriet plummeted by more than 70% to 202 million Swiss francs ($229 million) in 2023 due to competition from cheaper generics[5].

Regulatory Milestones and Development Activities

Esbriet has several regulatory milestones, including its approval in multiple countries. The drug's development activities are closely monitored, with ongoing clinical trials and pharmacological studies. However, the patent details and regulatory status are critical in determining its market longevity[3].

SWOT Analysis

• Strengths: Esbriet's proven clinical benefits, including reduced mortality and slowed disease progression, are significant strengths. Its availability in over 40 countries also adds to its market reach[4][5].
• Weaknesses: The decline in sales due to generic competition and the emergence of new therapies are major weaknesses. The mechanism of action, though beneficial, is not fully understood, which could lead to further research and competition[5].
• Opportunities: The increasing healthcare spending and the need for effective IPF treatments present opportunities for Esbriet. Continuing research and development could also lead to new indications or improved formulations[1][3].
• Threats: The launch of late-stage emerging therapies and the potential sale of Esbriet by Roche due to declining sales are significant threats to its market position[1][5].

Competitive Landscape

The competitive landscape for Esbriet includes other anti-fibrotic drugs like nintedanib. The market is highly competitive, with multiple players vying for market share. The emergence of new therapies and the potential entry of generics further intensify the competition[1][3].

Financial Performance

The financial performance of Esbriet has been impacted by several factors, including competition from generics and the emergence of new therapies. Despite its clinical benefits, the sales of Esbriet have declined significantly, prompting Roche to consider selling the drug[5].

Potential Sale by Roche

Roche is currently evaluating options for Esbriet, including a potential sale, due to declining sales and increased competition. This decision is part of Roche's strategy to prune its portfolio and focus on growth areas[5].

Market Projections 2017-2030

Market projections indicate that while Esbriet will continue to be a significant player in the IPF treatment market, its sales are expected to be impacted by the launch of new therapies and generic competition. Detailed market assessments, including SWOT analysis and analyst views, suggest that the market size for Esbriet will evolve based on these factors[1][3].

Key Findings and Market Assessment

• Seven Major Markets: The report provides a detailed market assessment of Esbriet in the United States, EU5, and Japan, highlighting historical and forecasted sales data from 2017 to 2030[1][3].
• Clinical Trials and Development: Ongoing clinical trials and development activities are crucial in assessing the current and future market scenario of Esbriet[3].

Conclusion

Esbriet's market dynamics are complex, influenced by its clinical benefits, market competition, and financial performance. While it has demonstrated significant benefits in treating IPF, the emergence of new therapies and generic competition pose significant challenges. The potential sale by Roche further complicates its market trajectory.

Key Takeaways

• Esbriet has proven clinical benefits in treating IPF, including reduced mortality and slowed disease progression.
• The market for Esbriet is highly competitive, with new therapies and generics impacting its sales.
• Roche is considering selling Esbriet due to declining sales and increased competition.
• Market projections indicate a changing market scenario for Esbriet from 2017 to 2030.
• Ongoing research and development are critical in determining Esbriet's future market position.

Frequently Asked Questions (FAQs)

Q: What is Esbriet used for? A: Esbriet (pirfenidone) is used for the treatment of idiopathic pulmonary fibrosis (IPF), a chronic and progressive lung disease.

Q: What are the clinical benefits of Esbriet? A: Esbriet has been shown to reduce the risk of death, slow lung function decline, and improve exercise tolerance in IPF patients.

Q: Why are sales of Esbriet declining? A: Sales of Esbriet are declining due to competition from cheaper generics and the emergence of new therapies.

Q: Is Roche considering selling Esbriet? A: Yes, Roche is evaluating options for Esbriet, including a potential sale, due to declining sales and increased competition.

Q: What is the market forecast for Esbriet from 2017 to 2030? A: The market forecast indicates that while Esbriet will remain a significant player, its sales will be impacted by new therapies and generic competition.

Cited Sources:

1. ResearchAndMarkets.com - Esbriet (Pirfenidone) - Drug Insight and Market Forecast - 2030
2. ILD Collaborative - Esbriet Extends Long-term Survival, Slows IPF Progression, Real-life Study Reveals
3. BusinessWire - Global Esbriet (Pirfenidone) Drug Insight and Market Forecast Report 2020-2030
4. European Pharmaceutical Review - Esbriet data show benefits of long-term treatment in IPF
5. Bloomberg via SwissInfo - Roche Explores Selling Lung Disease Drug Amid Buyer Interest