ESBRIET Drug Patent Profile

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

Esbriet is a drug marketed by Legacy Pharma 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
Legacy Pharma	ESBRIET	pirfenidone	TABLET;ORAL	208780-001	Jan 11, 2017	AB	RX	Yes	No
Legacy Pharma	ESBRIET	pirfenidone	TABLET;ORAL	208780-003	Jan 11, 2017	AB	RX	Yes	Yes
Legacy Pharma	ESBRIET	pirfenidone	TABLET;ORAL	208780-003	Jan 11, 2017	AB	RX	Yes	Yes
Legacy Pharma	ESBRIET	pirfenidone	TABLET;ORAL	208780-003	Jan 11, 2017	AB	RX	Yes	Yes
Legacy Pharma	ESBRIET	pirfenidone	TABLET;ORAL	208780-003	Jan 11, 2017	AB	RX	Yes	Yes
Legacy Pharma	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
Legacy Pharma	ESBRIET	pirfenidone	TABLET;ORAL	208780-001	Jan 11, 2017
Legacy Pharma	ESBRIET	pirfenidone	TABLET;ORAL	208780-003	Jan 11, 2017
Legacy Pharma	ESBRIET	pirfenidone	TABLET;ORAL	208780-002	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
South Korea	20120099772
Denmark	2124945
Israel	261745	פורמולציית גרגירים של 5-מתיל-1-פניל-2(h1)-פירידון ושיטה להכנתה (Granulate formulation of 5-methyl-1-phenyl-2(1h)-pyridone and method of making the same)
European Patent Office	2343070	Traitement avec le pirfenidone de patients avec fonctions hépatique atypique (Pirfenidone treatment for patients with atypical liver function)
South Korea	20080046673	CAPSULE FORMULATION OF PIRFENIDONE AND PHARMACEUTICALLY ACCEPTABLE EXCIPIENTS
Japan	2012509362

ESBRIET: Patent Landscape and Market Outlook

Last updated: February 19, 2026

ESBRIET (pirfenidone) is an orally administered small molecule approved for the treatment of idiopathic pulmonary fibrosis (IPF). Its market trajectory is shaped by patent expiration, generic competition, and evolving clinical utility. This analysis details ESBRIET's patent status, market performance, and projected future.

What is ESBRIET's Current Patent Status?

ESBRIET's primary composition of matter patent has expired in major markets.

• United States: The U.S. Patent No. 5,536,742, covering pirfenidone, expired on January 21, 2018. Subsequent patents related to specific formulations or methods of use may exist, but the core patent protection has lapsed.
• European Union: Similar to the U.S., the basic patent for pirfenidone has expired. Supplementary Protection Certificates (SPCs) may have extended market exclusivity in specific EU countries, but these are also largely concluded or nearing conclusion.
• Japan: The patent for pirfenidone expired in Japan in 2015.

The expiration of these foundational patents has opened the door for generic manufacturers.

How Has ESBRIET Performed Financially?

ESBRIET, originally developed by InterMune and later acquired by Roche, has demonstrated significant commercial success.

• 2015 (Acquisition Year): Roche acquired InterMune for approximately $8.3 billion, driven primarily by the potential of pirfenidone. At the time of acquisition, pirfenidone had projected peak sales exceeding $3 billion.
• 2016: ESBRIET generated $685 million in global sales. [1]
• 2017: Global sales reached $860 million. [1]
• 2018: Sales increased to $960 million. [1]
• 2019: ESBRIET achieved $1.08 billion in sales. [1]
• 2020: Global sales were $1.11 billion. [1]
• 2021: Sales totaled $1.07 billion. [1]
• 2022: Global sales declined slightly to $1.03 billion. [2]

The plateau and subsequent slight decline in sales from 2020 onwards are indicative of increasing generic competition and market maturation.

What is the Impact of Generic Entry?

The U.S. Food and Drug Administration (FDA) has approved multiple generic versions of pirfenidone.

• First Generic Approval: In late 2019, the FDA approved the first generic pirfenidone capsules. [3]
• Subsequent Approvals: Several other pharmaceutical companies have since received FDA approval for their generic pirfenidone products, including tablets and capsules. This has led to a significant increase in market competition.

The introduction of generics has a predictable impact on pricing and market share for the originator product.

• Price Erosion: Generic entry typically leads to substantial price reductions. Estimates suggest price decreases of 30-50% or more within the first year of robust generic competition.
• Market Share Shift: The originator's market share erodes as physicians and payers adopt lower-cost generic alternatives.

The specific sales figures for generic pirfenidone are fragmented, as they are reported by individual manufacturers and not aggregated in the same manner as branded drug sales. However, the presence of multiple approved generics indicates a highly competitive landscape.

What is the Competitive Landscape for Pirfenidone?

ESBRIET faces competition from other branded and generic therapies for IPF.

• Nintedanib (OFEV): Developed by Boehringer Ingelheim, nintedanib is another tyrosine kinase inhibitor approved for IPF. It has demonstrated comparable efficacy to pirfenidone in slowing disease progression.

  • 2020 Sales: OFEV generated €2.16 billion (approximately $2.5 billion USD at the time). [4]
  • 2021 Sales: OFEV sales reached €2.48 billion (approximately $2.9 billion USD). [4]
  • 2022 Sales: OFEV sales were €2.94 billion (approximately $3.1 billion USD). [4]
  • Patent Status: Nintedanib's primary patents are expected to expire later this decade, providing a longer period of market exclusivity compared to pirfenidone.

• Other IPF Treatments: While nintedanib is the most direct branded competitor, research continues into novel IPF therapies targeting different pathways. The availability of generic pirfenidone also increases the pressure on all IPF treatments to demonstrate superior value or efficacy.

What is the Future Outlook for ESBRIET?

The market outlook for ESBRIET is characterized by continued generic penetration and declining revenue for the branded product.

• Declining Branded Sales: Roche's reported sales for ESBRIET are expected to continue their downward trend as generic competition intensifies. The company's financial reports will likely reflect this shift, with sales figures for pirfenidone being consolidated or reported as part of a broader respiratory or anti-fibrotic portfolio.
• Sustained Generic Demand: Despite the decline in branded sales, the overall market for pirfenidone is expected to remain robust due to its established efficacy and the availability of cost-effective generic alternatives. The total market value, encompassing both branded and generic sales, may stabilize or even grow as access expands.
• Geographic Considerations: The pace of generic entry and its impact on sales can vary by region, depending on regulatory approval timelines, patent extensions (like SPCs), and reimbursement policies.

What are the Key Drivers of Future Pirfenidone Use?

• Clinical Guidelines: Inclusion in treatment guidelines by professional bodies like the American Thoracic Society (ATS) and the European Respiratory Society (ERS) solidifies pirfenidone's role in IPF management.
• Real-World Evidence: Ongoing studies and real-world data continue to inform clinical practice regarding pirfenidone's long-term benefits and patient outcomes.
• Cost-Effectiveness: The significant price reduction of generic pirfenidone makes it a more accessible treatment option for a broader patient population, particularly in healthcare systems with cost constraints.
• Combination Therapies: Research into the potential benefits of combining pirfenidone with other anti-fibrotic agents or novel therapies could influence its future use patterns.

Key Takeaways

• ESBRIET's core composition of matter patent has expired in major markets, leading to the introduction of generic pirfenidone.
• The drug achieved significant commercial success, with peak annual sales exceeding $1 billion for the branded product.
• Generic entry has resulted in substantial price erosion and a decline in branded sales for ESBRIET.
• Nintedanib (OFEV) remains the primary branded competitor, with a longer patent runway.
• The overall market for pirfenidone is expected to persist due to the availability of cost-effective generics and established clinical utility in IPF treatment.

Frequently Asked Questions

1. When did the primary patent for pirfenidone expire in the United States?

The U.S. Patent No. 5,536,742 for pirfenidone expired on January 21, 2018.

2. What was the approximate peak annual sales for branded ESBRIET?

Branded ESBRIET achieved peak annual sales of approximately $1.11 billion in 2020.

3. What is the main branded competitor to pirfenidone for IPF?

Nintedanib, marketed as OFEV by Boehringer Ingelheim, is the primary branded competitor.

4. What is the anticipated impact of generic pirfenidone on the market?

Generic pirfenidone is expected to lead to significant price reductions and a shift in market share away from the branded product.

5. What factors are expected to sustain the overall market for pirfenidone despite generic competition?

The sustained market is driven by clinical guidelines, growing real-world evidence, the cost-effectiveness of generics, and potential research into combination therapies.

Citations

[1] Roche. (2015-2022). Annual Reports. [Specific report dates can be found on Roche's Investor Relations website.]

[2] Roche. (2023). Annual Report 2022. Retrieved from [Roche Investor Relations website]

[3] U.S. Food and Drug Administration. (2019). FDA Approves First Generic Version of Pirfenidone Capsules. [Press Release - available via FDA website archives]

[4] Boehringer Ingelheim. (2020-2022). Annual Reports. [Specific report dates can be found on Boehringer Ingelheim's corporate website.]