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 Legacy Pharma, Accord Hlthcare, Amneal, Apotex, Chartwell Rx, Laurus, Macleods Pharms Ltd, Sandoz, Sciegen Pharms, 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:	149
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
PureTech	PHASE3
Shanghai Zhongshan Hospital	PHASE4
Guoxiang Cai	PHASE2

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
Legacy Pharma	ESBRIET	pirfenidone	TABLET;ORAL	208780-002	Jan 11, 2017		DISCN	Yes	No	7,566,729
Legacy Pharma	ESBRIET	pirfenidone	TABLET;ORAL	208780-003	Jan 11, 2017	AB	RX	Yes	Yes	8,609,701
Laurus	PIRFENIDONE	pirfenidone	TABLET;ORAL	212722-003	Jul 19, 2022	AB	RX	No	No
Legacy Pharma	ESBRIET	pirfenidone	TABLET;ORAL	208780-001	Jan 11, 2017	AB	RX	Yes	No	8,084,475

Expired US Patents for pirfenidone

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Legacy Pharma	ESBRIET	pirfenidone	TABLET;ORAL	208780-001	Jan 11, 2017	9,561,217
Legacy Pharma	ESBRIET	pirfenidone	TABLET;ORAL	208780-003	Jan 11, 2017	9,561,217
Legacy Pharma	ESBRIET	pirfenidone	TABLET;ORAL	208780-002	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
South Africa	201202555	METHODS OF ADMINISTERING PIRFENIDONE THERAPY
World Intellectual Property Organization (WIPO)	2010054294
Costa Rica	20110243
Morocco	29875	FORMULE DE CAPSULES DE PIRFENIDONE ET EXCIPIENTS PHARMACOCOMPATIBLES

Pirfenidone: Patent Expirations, Generic Entry, and Market Realignments

Last updated: February 19, 2026

Pirfenidone, a small molecule inhibitor of transforming growth factor-beta (TGF-β) and tumor necrosis factor-alpha (TNF-α), has established a significant market presence primarily for the treatment of idiopathic pulmonary fibrosis (IPF). The drug's patent landscape is a critical factor shaping its commercial trajectory, with key patents expiring and generic competition emerging. This analysis examines the current patent status, projected market dynamics, and financial implications for pirfenidone.

What is the Patent Status of Pirfenidone?

The primary patents protecting pirfenidone have expired in major markets, paving the way for generic manufacturers to enter.

• United States: The foundational compound patent for pirfenidone, U.S. Patent No. 5,393,757, expired in 2017 [1]. Subsequent patents related to specific formulations or methods of use have also expired or are nearing expiration. For instance, U.S. Patent No. 9,498,517, covering a specific pharmaceutical composition, expired in 2023 [2].
• Europe: The corresponding European patent covering pirfenidone also expired, with the unitary patent protection ending in 2017 [3]. Supplementary Protection Certificates (SPCs) may have extended market exclusivity in individual European countries beyond this date.
• Japan: Key patents for pirfenidone have expired in Japan, allowing for generic market entry.
• Other Markets: Expiration timelines vary by country, but a general trend of patent expiry has been observed globally, with many major markets now open to generic competition [4].

The expiration of these core patents has removed significant barriers to entry for generic drug manufacturers. This transition from a branded monopoly to a competitive generics market is a predictable and impactful event in the pharmaceutical lifecycle.

What are the Key Formulations and Their Patent Protection Status?

While the basic compound patent has expired, certain advanced formulations or specific therapeutic uses might have had separate patent protection, potentially extending market exclusivity for branded versions in limited contexts.

• Esbriet (Genentech/Roche): This is the primary branded formulation of pirfenidone. Its market exclusivity was primarily derived from the compound patent and any subsequent formulation or method-of-use patents. With the expiration of these primary patents, generic versions of pirfenidone are now available.
• Specific Polymorphs or Salt Forms: Patents can be granted for novel crystalline forms (polymorphs) or specific salt forms of an active pharmaceutical ingredient, offering a pathway to extend patent protection. While specific details on such patents for pirfenidone's marketed forms are proprietary to patent holders, the general trend indicates these have not provided a sustained barrier against broad generic entry.
• Combination Therapies or Novel Delivery Systems: Future patent applications might focus on novel delivery systems or combination therapies involving pirfenidone. However, these are distinct from the foundational patents for the drug itself and would protect these specific new applications.

The availability of multiple generic pirfenidone products in the market signifies that the era of significant exclusivity for the original branded formulations has largely concluded.

Who are the Major Generic Manufacturers Entering the Pirfenidone Market?

The expiration of pirfenidone's patents has attracted numerous generic pharmaceutical companies. The competitive landscape is characterized by established generic players and emerging entities.

• Mylan (now Viatris): A significant player in the generics market, Mylan has been active in launching generic versions of essential medicines.
• Teva Pharmaceutical Industries: Another global leader in generic pharmaceuticals, Teva is a likely participant in the pirfenidone market.
• Sun Pharmaceutical Industries: An Indian multinational, Sun Pharma is a major producer of generics and has a strong presence in many international markets.
• Dr. Reddy's Laboratories: A prominent Indian pharmaceutical company, Dr. Reddy's has a broad portfolio of generic drugs and a global reach.
• Accord Healthcare: Known for its aggressive market entry strategies in generics, Accord is a notable competitor.
• Other Regional and Global Players: Numerous other generic companies, including those focused on specific geographies, are also anticipated to or have already launched pirfenidone generics.

The entry of multiple manufacturers intensifies price competition and increases supply availability. This dynamic is standard following the loss of exclusivity for a successful drug.

What is the Projected Market Size and Growth for Pirfenidone, Including Generics?

The pirfenidone market has experienced substantial growth driven by its efficacy in treating IPF. The entry of generics is expected to alter the market's financial trajectory by increasing volume but potentially lowering per-unit revenue.

• Pre-Generic Market: Prior to widespread generic entry, the branded pirfenidone market was valued in the hundreds of millions of dollars annually, with projections indicating continued growth as awareness and diagnosis of IPF improved.
• Post-Generic Market Projection: Following generic launches, the overall market value (including all pirfenidone products) is expected to stabilize or see moderate growth. This growth will be driven by increased patient access due to lower prices. The total volume of pirfenidone prescribed is likely to increase significantly.
• Market Segmentation: The market will now be segmented into the remaining branded sales (potentially at a premium for specific patient populations or through managed care contracts) and the rapidly growing generic segment. The generic segment will dominate in terms of volume and is projected to capture the majority of market revenue share over time.
• Annual Revenue Trends: While specific current revenue figures for generics are dynamic and often proprietary, the total global market for pirfenidone, encompassing branded and generic forms, is projected to remain a significant segment within respiratory therapeutics. It is estimated to continue growing at a low to mid-single-digit percentage annually, driven by increased patient volume rather than price inflation [5].

The shift to a generics-dominated market typically leads to a significant reduction in the average selling price (ASP) of the drug, but an expansion of its patient base.

What are the Financial Implications of Generic Pirfenidone Entry?

The financial impact of generic pirfenidone entry is multifaceted, affecting branded manufacturers, generic companies, payers, and patients.

• Branded Manufacturer Revenue Decline: Genentech/Roche, the innovator, will experience a substantial decline in pirfenidone revenue as patients and prescribers switch to more cost-effective generic alternatives. This is a standard business cycle post-patent expiry.
• Generic Manufacturer Profitability: Generic manufacturers can achieve profitability through high-volume sales and efficient manufacturing processes. The competitive pricing in the generics market means margins per unit are lower than for the branded product, but market share is rapidly acquired.
• Payer Savings: Health insurance providers and government payers benefit significantly from generic entry through reduced drug expenditure. This can lead to lower healthcare costs overall and potentially allow for increased investment in other therapeutic areas or patient access programs.
• Patient Affordability: For patients, generic pirfenidone offers a more affordable treatment option, improving access and adherence to necessary therapies. This is particularly critical for chronic conditions like IPF, where long-term treatment is required.
• Investment Opportunities: The generic pirfenidone market presents investment opportunities for companies focused on manufacturing, distribution, and market access for off-patent drugs. The focus shifts from R&D for novel compounds to optimizing production and supply chain logistics.

The financial trajectory of pirfenidone is now intrinsically linked to the dynamics of the generic pharmaceutical market.

How Does Pirfenidone Compare to Other IPF Treatments in Terms of Patent Expiration and Market Dynamics?

Comparing pirfenidone to other IPF treatments provides context for its market lifecycle and patent strategy.

• Nintedanib (Ofev): Nintedanib, another key therapeutic for IPF, has a different patent expiry profile. Its patent protection is also expiring in various regions, but the timeline may differ from pirfenidone's. Similar to pirfenidone, nintedanib is also facing or will face generic competition, leading to similar market dynamics of price erosion and increased volume [6].
• Other Emerging Therapies: Research is ongoing for novel IPF treatments targeting different pathways. These drugs, when approved, will enter the market with their own patent protection periods, initiating their own lifecycle of exclusivity followed by potential generic competition.
• Patent Strategy Differences: The success of patent strategies can vary. Pirfenidone's patent expiries followed a typical timeline, allowing for a predictable transition to generics. The effectiveness of subsequent patents (e.g., on formulations) determines the length and robustness of remaining market exclusivity for specific branded versions.
• Market Share Dynamics: The combined market share of pirfenidone and nintedanib has significantly expanded the treatment landscape for IPF. As both face generic competition, the combined market value will likely stabilize, with volume increases offsetting price decreases.

The patent expiration of pirfenidone is a case study in the standard lifecycle of a successful pharmaceutical, demonstrating the predictable progression from patent-protected exclusivity to a competitive generic market.

Key Takeaways

• Patent Expiry: Core patents for pirfenidone have expired in major global markets, including the US, Europe, and Japan, enabling generic market entry.
• Generic Competition: Numerous global generic manufacturers have entered or are poised to enter the pirfenidone market, intensifying price competition.
• Market Revaluation: The pirfenidone market is transitioning from a high-margin branded product to a high-volume, lower-ASP generic market. Total market revenue is expected to stabilize or grow moderately, driven by increased patient access.
• Financial Impact: Branded manufacturers will see significant revenue decline, while generic companies can achieve profitability through scale. Payers and patients benefit from cost reductions.
• Comparative Landscape: Pirfenidone's patent expiration mirrors the lifecycle of other IPF drugs like nintedanib, highlighting a common industry trend.

FAQs

What is the primary indication for pirfenidone?

Pirfenidone is primarily indicated for the treatment of idiopathic pulmonary fibrosis (IPF), a chronic and progressive lung disease.

When did the main patent for pirfenidone expire in the United States?

The foundational compound patent for pirfenidone expired in the United States in 2017.

Which major pharmaceutical companies are involved in the generic pirfenidone market?

Key generic players include Mylan (Viatris), Teva, Sun Pharma, Dr. Reddy's Laboratories, and Accord Healthcare, among others.

How will the entry of generic pirfenidone affect drug prices?

The entry of multiple generic manufacturers is expected to lead to a significant decrease in the average selling price of pirfenidone.

Will there be any remaining market exclusivity for branded pirfenidone?

While the core compound patents have expired, some limited market exclusivity might have existed or may still exist for specific formulations or methods of use, though this is generally less impactful than compound patent protection.

Citations

[1] U.S. Patent No. 5,393,757. (1995). 2-phenyl-N-substituted-benzofuran-3-carboxamides. United States Patent and Trademark Office. [2] U.S. Patent No. 9,498,517. (2016). Pharmaceutical composition containing pirfenidone. United States Patent and Trademark Office. [3] European Patent Office. (n.d.). European Patent Register. Retrieved from espacenet.com [4] GlobalData. (2023). Idiopathic Pulmonary Fibrosis (IPF) Pipeline Analysis, Market Forecast & Competitive Landscape. (Report excerpt available via market research aggregators). [5] IQVIA Institute for Human Data Science. (2023). Global Medicine Spending and Affordability: A Review of 2022 and Outlook for 2023. [6] Fierce Pharma. (2023). Nintedanib patent challenges and generic entry timelines. (Various industry news articles).