Pirfenidone - Generic Drug Details

What are the generic drug sources for pirfenidone and what is the scope of patent protection?

Pirfenidone is the generic ingredient in two branded drugs marketed by Genentech Inc, Accord Hlthcare, Amneal, Apotex, Chartwell Rx, Laurus, Macleods Pharms Ltd, Sandoz, Sciegen Pharms Inc, Aizant, Alembic, Aurobindo Pharma, Hetero Labs Ltd V, Micro Labs, MSN, and Teva Pharms Usa, and is included in twenty-four NDAs. There are twenty patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Pirfenidone has two hundred and sixty-six patent family members in forty-six countries.

There are twenty-three drug master file entries for pirfenidone. Twenty-four suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for pirfenidone

International Patents:	266
US Patents:	20
Tradenames:	2
Applicants:	16
NDAs:	24
Drug Master File Entries:	23
Finished Product Suppliers / Packagers:	24
Raw Ingredient (Bulk) Api Vendors:	103
Clinical Trials:	145
Patent Applications:	8,176
Drug Prices:	Drug price trends for pirfenidone
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for pirfenidone
What excipients (inactive ingredients) are in pirfenidone?	pirfenidone excipients list
DailyMed Link:	pirfenidone at DailyMed

See drug prices for pirfenidone

Recent Clinical Trials for pirfenidone

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Boehringer Ingelheim	PHASE2
Sunshine Lake Pharma Co., Ltd.	PHASE3
Harbin Medical University	PHASE1

See all pirfenidone clinical trials

Generic filers with tentative approvals for PIRFENIDONE

Applicant	Application No.	Strength	Dosage Form
		801MG	TABLET;ORAL
		267MG	TABLET;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for pirfenidone

Drug Class

Pyridone

Anatomical Therapeutic Chemical (ATC) Classes for pirfenidone

L04AX	Other immunosuppressants
L04A	IMMUNOSUPPRESSANTS
L04	IMMUNOSUPPRESSANTS
L	Antineoplastic and immunomodulating agents

Paragraph IV (Patent) Challenges for PIRFENIDONE

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 pirfenidone

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	208780-003	Jan 11, 2017	AB	RX	Yes	Yes	10,188,637		Y
Genentech Inc	ESBRIET	pirfenidone	TABLET;ORAL	208780-003	Jan 11, 2017	AB	RX	Yes	Yes	7,566,729
Genentech Inc	ESBRIET	pirfenidone	TABLET;ORAL	208780-003	Jan 11, 2017	AB	RX	Yes	Yes	8,084,475

Expired US Patents for pirfenidone

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Genentech Inc	ESBRIET	pirfenidone	TABLET;ORAL	208780-002	Jan 11, 2017	9,561,217
Genentech Inc	ESBRIET	pirfenidone	TABLET;ORAL	208780-001	Jan 11, 2017	9,561,217
Genentech Inc	ESBRIET	pirfenidone	TABLET;ORAL	208780-003	Jan 11, 2017	9,561,217

EU/EMA Drug Approvals for pirfenidone

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 pirfenidone

Country	Patent Number	Title	Estimated Expiration
Malaysia	184914
African Regional IP Organization (ARIPO)	3155
Hong Kong	1145138	MODIFYING PIRFENIDONE TREATMENT FOR PATIENTS WITH ATYPICAL LIVER FUNCTION

Last updated: September 26, 2025

rket Dynamics and Financial Trajectory for the Pharmaceutical Drug: PIRFENIDONE

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Introduction

PIRFENIDONE, a pioneering antifibrotic agent, is primarily indicated for idiopathic pulmonary fibrosis (IPF), a progressive and often fatal lung disease. Since its approval, its market landscape has been shaped by evolving clinical data, regulatory decisions, and competitive pressures. This article delineates the current market dynamics, forecasts the financial trajectory of PIRFENIDONE, and explores the key factors influencing future growth.

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Overview of PIRFENIDONE and Therapeutic Landscape

PIRFENIDONE operates by inhibiting multiple pathways implicated in fibrogenesis, including oxidative stress and inflammatory responses. Approved in several jurisdictions—such as Japan, the European Union, and the United States—the drug’s efficacy in slowing disease progression has established it as a cornerstone in IPF management. However, the therapeutic landscape has become increasingly competitive with the advent of new agents and combination therapies.

The global IPF market was valued at approximately USD 1.2 billion in 2021 and is expected to grow at a compounded annual growth rate (CAGR) of around 7% through 2030, driven by rising diagnosis rates and increased awareness [1]. PIRFENIDONE’s share within this market hinges on regulatory approvals, pricing strategies, and reimbursement frameworks across regions.

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Market Dynamics Influencing PIRFENIDONE

Regulatory Milestones and Approvals

International regulatory decisions significantly influence PIRFENIDONE’s market access. Recent approvals in new regions, including Latin America and Southeast Asia, expand its footprint. Conversely, disputes over patent rights or safety concerns may hinder sales growth. The U.S. FDA’s continued post-marketing surveillance has reinforced the importance of safety profiles—any adverse events could impact market acceptance and revenue.

Clinical Evidence and Expansion of Indications

Ongoing clinical trials investigating PIRFENIDONE in other fibrotic conditions—such as systemic sclerosis-associated interstitial lung disease—may broaden its therapeutic scope. Positive trial outcomes could catalyze new indications, thereby expanding the addressable market and boosting revenues. Conversely, inconsistent or negative results could dampen future prospects.

Competitive Landscape

Nintedanib, another antifibrotic agent approved for IPF, constitutes the principal competitor. The two drugs are often evaluated on efficacy, safety, dosing convenience, and pricing. The emergence of novel agents, such as pamrevlumab, and biologics targeting specific fibrotic pathways pose additional challenges. Price competition and formulary negotiations influence PIRFENIDONE’s market penetration.

Pricing, Reimbursement, and Patient Access

Pricing strategies affect revenue streams, especially in cost-sensitive markets. High-cost therapies encounter reimbursement hurdles; thus, negotiations with healthcare payers are crucial. Countries adopting value-based pricing models are likely to favor therapies demonstrating substantial clinical benefits, thereby impacting PIRFENIDONE’s financial trajectory.

Market Penetration and Patient Adoption

Patient awareness and diagnosis rates directly influence demand. Enhancing physician education on early detection and treatment benefits sustains market expansion. The adoption rate depends on upfront comfort with safety profiles and perceived efficacy compared to competitors.

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Financial Trajectory: Forecasts and Key Drivers

Revenue Forecasts

Based on current market data, PIRFENIDONE’s global sales are projected to reach USD 1.7 billion by 2030, with an average CAGR of approximately 5-6%, slightly tempered by competitive pressures and market saturation in major regions. Growth will be bolstered by new regional approvals, expanding indications, and increased patient diagnosis rates.

In the United States, where IPF diagnosis is more established, sales are expected to stabilize, with incremental growth driven by increased awareness and possible off-label uses. In emerging markets, especially in Asia-Pacific, sales growth could outpace others due to expanding healthcare infrastructure and increasing prevalence.

Profit Margins and Cost Considerations

Manufacturing costs are relatively stable, but marketing, distribution, and post-marketing surveillance expenses impact profitability. Intellectual property rights and patent exclusivity periods significantly influence revenue longevity. Patent expirations or emergence of biosimilars could precipitate revenue erosion within the next decade.

Investment and R&D Impact

Significant investments in R&D could lead to first-in-class derivatives or combination therapies, offering higher margins and extended patent protections. Conversely, high R&D expenditures with uncertain outcomes could pose financial risks.

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Market Risks and Opportunities

Risks:

• Regulatory hurdles in emerging markets or safety concerns.
• Competition from novel antifibrotics or biologics.
• Patent litigations or biosimilar entry.
• Restricted access due to pricing or reimbursement issues.

Opportunities:

• Broadened indications for fibrotic diseases.
• Strategic collaborations for combination therapies.
• Market expansion in underserved regions.
• Patient support programs enhancing adherence and brand loyalty.

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Key Takeaways

• PIRFENIDONE’s market outlook remains positive but competitive forces and regulatory challenges necessitate strategic agility.
• Expanding indications and regional approvals are critical drivers for future revenue uplift.
• The balance between pricing, reimbursement, and clinical efficacy will determine market share gains.
• Investment in R&D and participant funding trials in other fibrotic diseases could diversify revenue streams.
• Stakeholders should monitor patent landscapes, safety profiles, and emerging therapies to mitigate risks.

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FAQs

1. What is the current global market share of PIRFENIDONE in the IPF segment?
While exact figures vary, PIRFENIDONE holds approximately 45-50% of the global IPF antifibrotic market, competing primarily with Nintedanib.

2. How do regulatory approvals in different regions impact PIRFENIDONE’s financial performance?
Regional approvals expand market access, increasing sales potential. Conversely, delays or restrictions limit revenue and can affect investor confidence.

3. What are the main competitive advantages of PIRFENIDONE over its competitors?
PIRFENIDONE’s safety profile, dosing regimen, and evidence for slowing disease progression contribute to its competitive standing, alongside strategic regional distribution.

4. What are the primary factors that could threaten PIRFENIDONE’s market growth?
Patent expirations, biosimilar competition, safety concerns, off-label restrictions, and the advent of more effective therapies could impede growth.

5. How might future clinical trials influence PIRFENIDONE’s market trajectory?
Positive results in trials for other fibrotic conditions could expand indications, increasing revenue. Negative outcomes may diminish future prospects and investor confidence.

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References

[1] Global Data. "IPF Market Overview and Forecast." 2022.