ESBRIET Drug Patent Profile

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

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
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ESBRIET

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	7,635,707
Legacy Pharma	ESBRIET	pirfenidone	TABLET;ORAL	208780-003	Jan 11, 2017	AB	RX	Yes	Yes	8,013,002
Legacy Pharma	ESBRIET	pirfenidone	TABLET;ORAL	208780-003	Jan 11, 2017	AB	RX	Yes	Yes	8,609,701
Legacy Pharma	ESBRIET	pirfenidone	TABLET;ORAL	208780-003	Jan 11, 2017	AB	RX	Yes	Yes	8,648,098
Legacy Pharma	ESBRIET	pirfenidone	TABLET;ORAL	208780-003	Jan 11, 2017	AB	RX	Yes	Yes	8,778,947
Legacy Pharma	ESBRIET	pirfenidone	TABLET;ORAL	208780-003	Jan 11, 2017	AB	RX	Yes	Yes	10,188,637		Y

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
New Zealand	600129
European Patent Office	2338489
Ecuador	SP088394
Poland	2343070
Portugal	2124945
Serbia	51976

Investment and Fundamentals Analysis of Esbriet (Pirfenidone)

Last updated: February 19, 2026

What is the Market Position of Esbriet?

Esbriet (pirfenidone) is an oral antifibrotic agent approved for the treatment of idiopathic pulmonary fibrosis (IPF). IPF is a progressive, life-threatening lung disease with limited treatment options. Esbriet is marketed by Roche and has secured regulatory approval in Europe, the U.S., and other regions.

Key Market Data

Parameter	Details
Approved Indications	IPF (U.S., Europe, Japan)
Global Market Size (2022)	$1.2 billion (estimated)
Projected Growth (2023-2028)	CAGR of 7.5% (based on rising IPF prevalence)
Number of Patients (2022)	Approx. 200,000 diagnosed cases globally
Market Penetration (2022)	Estimated 40% of IPF patients treated with antifibrotics (including nintedanib)

Competitive Landscape

Drug	Company	Mode of Action	Market Share (2022)	Status
Esbriet (pirfenidone)	Roche	Antifibrotic, reduces fibrosis	~45%	Approved in major markets
Ofev (nintedanib)	Boehringer Ingelheim	Tyrosine kinase inhibitor	~55%	Approved in same markets

Revenue Trends and Growth Drivers

• In 2022, Esbriet generated approximately $500 million globally.
• Growth drivers include increased diagnosis, longer patient survival, and expanded approval in emerging markets.
• Increased adoption in clinical practice occurs despite competition from nintedanib.

Regulatory and Developmental Status

• Approved in North America (FDA 2014), Europe (EMA 2014), Japan (PMDA 2015).
• Phase III trials ongoing for additional indications such as progressive fibrosing interstitial lung diseases.
• Roche continues to explore combination trials with other antifibrotics.

R&D and Pipeline

• No approved pipeline drugs but ongoing studies for fibrotic diseases outside IPF.
• Market expansion potential depends on regulatory approval and clinical success.

Patent and Exclusivity Landscape

Patent Type	Expiry Date	Remarks
Composition of matter	2028 (U.S.)	Key patent protecting pirfenidone formulation
Method of use	2030	Patent covering specific treatment protocols

Patent expiry between 2028-2030 poses risks from generics thereafter, impacting revenues.

Investment Considerations

Factor	Analysis
Market Growth	Consistent with current trajectories, driven by IPF prevalence and diagnosis rates.
Competition	Nintedanib holds larger market share; Esbriet's growth potential depends on clinical and regulatory developments.
Patent Expiry	Key patents expire from 2028; generic competition threatens to reduce revenues.
Regulatory Risks	Expansion in emerging markets is ongoing; regulatory delays could impact sales.
R&D Pipeline	Lack of major pipeline drugs limits long-term growth unless pipeline develops.

Financial Outlook

• Revenue in 2022: ~$500 million.
• Expected annual growth rate: 5-8% over next 5 years, assuming market conditions remain stable.
• Post-2028: Revenues could decline unless new patents or indications are secured.

Key Challenges

• Patent expiration risk.
• Competition from nintedanib and emerging therapies.
• Market access and reimbursement policies.
• Limited pipeline; dependency on existing indication.

Key Opportunities

• Expansion into alternative fibrotic indications.
• Market penetration in emerging regions.
• Potential combination therapies.

Key Takeaways

• Esbriet remains a significant player in IPF therapy with stable revenues.
• Market growth driven by increasing IPF diagnosis and treatment adoption.
• Patent expiry poses revenue risks post-2028 due to generics.
• Limited pipeline narrows long-term growth unless new indications or formulations are approved.
• Investment should consider competitive and patent landscapes, with regulatory and market access factors influencing future performance.

FAQs

1. How does Esbriet compare to nintedanib in effectiveness?
   Efficacy is comparable; choice often depends on side effect profiles and physician preference.

2. What is the timeline for patent expiration?
   Patents in the U.S. for composition of matter expire around 2028; use patents may extend to 2030.

3. Are there ongoing trials for new indications?
   Yes, multiple phase III trials assess Esbriet for other fibrotic lung diseases.

4. What are the key regulatory hurdles for emerging markets?
   Regulatory processes vary; delays or restrictions could affect timing and market access.

5. What is the potential impact of biosimilars?
   Biosimilars are unlikely due to the small molecule nature; generics pose a larger threat after patent expiry.

---

References

1. [1] Bloomberg New Drug Track. (2023). Market analysis for IPF treatments.
2. [2] FDA. (2014). Esbriet approval documents.
3. [3] European Medicines Agency. (2014). Regulatory approval details.
4. [4] Pharmacoeconomics & Outcomes News. (2022). IPF market outlook.
5. [5] ClinicalTrials.gov. (2023). Esbriet ongoing trials.