ESBRIET Drug Patent Profile

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

Esbriet is a drug marketed by Legacy 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:	7,087
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
Legacy	ESBRIET	pirfenidone	TABLET;ORAL	208780-001	Jan 11, 2017	AB	RX	Yes	No
Legacy	ESBRIET	pirfenidone	TABLET;ORAL	208780-003	Jan 11, 2017	AB	RX	Yes	Yes
Legacy	ESBRIET	pirfenidone	TABLET;ORAL	208780-003	Jan 11, 2017	AB	RX	Yes	Yes
Legacy	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
Legacy	ESBRIET	pirfenidone	TABLET;ORAL	208780-003	Jan 11, 2017
Legacy	ESBRIET	pirfenidone	TABLET;ORAL	208780-001	Jan 11, 2017
Legacy	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
Austria	E503480
Australia	2009313302
Australia	2010212371
Australia	2011200385

Last updated: July 23, 2026

Esbriet (Pirfenidone) Market Dynamics and Financial Trajectory: Exclusivity, Competition, Pricing, and Revenue Outlook

Esbriet (pirfenidone) is the branded, oral antifibrotic for idiopathic pulmonary fibrosis (IPF). In market terms, its financial trajectory is shaped by (1) patent and regulatory exclusivity, (2) uptake of competing antifibrotics (notably nintedanib-based regimens and subsequent line extensions), (3) payer behavior tied to formulary placement and copay assistance, and (4) the durability of real-world adherence given Esbriet’s gastrointestinal and fatigue adverse-event burden. Net sales depend on US and major ex-US geographies where pirfenidone brands face generic and/or authorized generic entry pressure.

What is Esbriet (pirfenidone) used for, and how does its indication scope shape demand?

Esbriet is prescribed for IPF. Demand mechanics for IPF antifibrotics are driven by:

• Diagnosis incidence and referral patterns for interstitial lung disease (ILD) centers.
• Stage of disease at treatment initiation, which influences adherence and persistence.
• Physician prescribing preference for efficacy and tolerability profiles.

How do payer rules and ICD coding affect Esbriet’s addressable market?

• Coverage is typically anchored to confirmed IPF diagnosis and treatment criteria.
• Prior authorization and step therapy practices can narrow “real” access versus headline prevalence.

What drives treatment persistence in pirfenidone?

• Dose titration and management of GI side effects influence early discontinuation.
• Real-world persistence often determines “effective” market value beyond prescription counts.

How strong is Esbriet’s patent and exclusivity position versus generic erosion risk?

Branded antifibrotics in IPF face two recurring financial threats:

1. US and EU patent expiry that enable generic competition.
2. Regulatory and litigation outcomes that determine whether “at-risk” entry occurs.

Exclusivity and patent estate: what matters for the revenue curve

The revenue curve steepens once exclusivity barriers lift because pirfenidone is chemically simple enough that generic manufacturing and bioequivalence are feasible once legal/regulatory timelines allow entry.

When does exclusivity lose force and competition accelerate?

Competition acceleration typically coincides with:

• Final expiration of formulation and method-of-use protections covering dose regimens and specific crystalline/polymorphic forms.
• Court outcomes on listed patents and/or settlement terms that define “design-around” ability and entry dates.

What does the Orange Book status of Esbriet imply for US generic launch scenarios?

For oral small-molecule brands, Orange Book listings act as the operational map for generic entry risk:

• Number and scope of listed patents on the reference listed drug.
• Whether patents are composition, method-of-use, or manufacturing/formulation-related.
• Whether Paragraph IV challenges are likely based on patent aging and legal strength.

What patents typically appear on pirfenidone brand listings that matter to generics?

• Composition-of-matter and salt/form polymorph disclosures
• Dosing regimen or method-of-use for IPF
• Formulation and manufacturing method patents (often later-expiring)

How does patent density affect launch timing?

More listed patents, even if some are weaker, can delay the first valid Paragraph IV ANDA approvals via litigation stay structures and repeated appeal cycles.

What Paragraph IV challenges and patent litigation dynamics affect Esbriet’s financial trajectory?

For Esbriet, litigation dynamics affect revenue in two ways:

• Time-to-generic entry: stays and appeals delay substitution.
• Settlement terms: settlements can include “carve-outs” for certain strengths or authorized generics.

How do settlements change pricing power?

If generic entry occurs via authorized partners or early-launch settlements, payer switching can happen faster, compressing branded gross-to-net and pharmacy margins even before the market reaches full penetration.

What litigation timing patterns are most revenue-relevant?

• Appeals outcomes that end stays
• District court rulings followed by Federal Circuit affirmations
• Consent judgments that set entry dates

How does Esbriet compete commercially with nintedanib and other IPF antifibrotic strategies?

Esbriet’s competitive set in IPF includes nintedanib (OFEV and authorized generics elsewhere) and real-world sequencing patterns:

• Some clinicians start with the agent with perceived tolerability.
• Combination and switching patterns occur, but practice varies by guideline interpretation and insurance coverage.

What is the competitive “battlefront” for IPF antifibrotics?

• Payer formulary placement between pirfenidone and nintedanib
• Copay support availability and utilization
• Side-effect management protocols
• Real-world efficacy perceptions shaped by subgroup outcomes and adherence

How does tolerability shape market share?

• Pirfenidone adherence may be more sensitive to GI and fatigue management.
• Nintedanib has a different toxicity profile, often affecting dose modifications and discontinuation.

What pricing and gross-to-net dynamics typically determine Esbriet profitability?

Branded IPF medicines usually face:

• Heightened rebate intensity after generic threats appear.
• Rising copay assistance costs as net pricing pressure increases.
• Patient out-of-pocket management to preserve persistence when alternative generics are near.

How does the ramp of generic competition change net pricing?

• Early periods show “partial substitution” in specific channels.
• Once multiple generics are available, pharmacy and PBM incentives increase switching.

What are the main levers in gross-to-net compression risk?

• PBM contract terms
• Formulary tier shifts
• Increased rebate demands tied to budget impact

What are the key manufacturing and supply chain issues that influence Esbriet market performance?

For oral small molecules, supply risks can still affect revenues through:

• Lot-level quality events
• Manufacturing capacity constraints
• Regulatory inspections and changes in production sites

How do supply events translate into financial impact?

• In-year revenue volatility from backorders or delayed shipments
• Temporary loss of share if competing antifibrotics are prioritized

Which geographies drive Esbriet’s financial trajectory, and how does competition differ by region?

Revenue exposure depends on:

• US share under payer constraints
• EU and UK market structures, where generics may have entered earlier or later depending on patent outcomes
• Specialty pharmacy distribution patterns

What region-level factors alter generic substitution speed?

• Local patent enforcement and injunction standards
• Government reimbursement timelines
• PBM equivalents and tendering behavior in public systems

How do financial metrics typically behave as Esbriet approaches and passes generic entry?

For branded antifibrotics with oral dosing:

• Prescription volume often drops first after generic approvals.
• Net sales can decline more slowly if patients remain on branded via persistence.
• Gross-to-net worsens before unit volume drops fully, due to rebate and payer renegotiation.

What trajectory is most consistent with IPF antifibrotic market history?

• Stable sales through near-term competitive threats
• Gradual decline during litigation and late-stage exclusivity
• Stepwise decline around first generic availability and accelerated erosion after second/third generic entries

How big is Esbriet’s revenue exposure to channel shift and formulary decisions?

Revenue exposure is high because IPF is a chronic therapy requiring long persistence. The largest financial swings come from:

• PBM formulary placement changes
• Step-therapy introduction
• Designation as non-preferred in commercial plans

Where does Esbriet gain share despite competitive threats?

• When plans include it as preferred due to negotiated pricing
• When copay support offsets patient cost and reduces discontinuation

Key Takeaways

• Esbriet’s financial trajectory is primarily driven by exclusivity timelines, patent litigation outcomes, and whether US and major ex-US geographies face earlier generic or authorized-generic erosion.
• Commercial performance depends on payer formulary status and persistence, which in turn are linked to real-world tolerability management for pirfenidone.
• Competitive dynamics with nintedanib-based strategies determine whether pirfenidone retains meaningful share under pressure from switching and rebate-based channel incentives.
• The revenue curve typically worsens in advance of generic entry due to gross-to-net compression, then accelerates when multiple generic options are available.

FAQs

1) Will Esbriet lose sales first to generics or to switching toward nintedanib?

Switching can start before full generic entry if payers narrow access. Generic substitution accelerates later when cost-driven incentives align.

2) What formulation or dosing changes could protect Esbriet from direct generic substitution?

Formulation, polymorph, or method-of-use dosing regimens can delay substitution if they remain protected and are tied to the FDA-approved labeling and Orange Book listed patents.

3) Do biosimilar dynamics apply to Esbriet?

No. Esbriet is a small-molecule drug, so the competitive framework is generics and authorized generics, not biosimilars.

4) How do patent settlements typically affect market entry timing for pirfenidone generics?

Settlements often establish entry dates, product-specific carve-outs, and non-adjudicated patent constraints that govern when ANDAs can launch.

5) What payer levers most influence Esbriet’s net sales?

PBM rebate intensity, formulary tier placement, prior authorization requirements, and copay support eligibility are the primary drivers.

References

1. FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. U.S. Food and Drug Administration.
2. FDA. Prescribing information for Esbriet (pirfenidone). U.S. Food and Drug Administration.
3. European Medicines Agency (EMA). Public assessment information and product information for pirfenidone-containing products. European Medicines Agency.

DrugChatter Q&A for ESBRIET

Esbriet loss of exclusivity europe?
Registration trials of esbriet europe?
When do esbriet drug patents expire?
Esbriet pirfenidone patent dispute?
How much does esbriet cost?