Pirfenidone - Generic Drug Details

What are the generic sources for pirfenidone and what is the scope of freedom to operate?

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, Hetero Labs Ltd V, Micro Labs, MSN, and Teva Pharms Usa, and is included in twenty-three 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-four patent family members in forty-six countries.

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

Summary for pirfenidone

International Patents:	264
US Patents:	20
Tradenames:	2
Applicants:	15
NDAs:	23
Drug Master File Entries:	23
Finished Product Suppliers / Packagers:	23
Raw Ingredient (Bulk) Api Vendors:	143
Clinical Trials:	122
Patent Applications:	6,548
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
Nanfang Hospital, Southern Medical University	Phase 2
Boehringer Ingelheim	Phase 1
Modern Biosciences Ltd	Phase 2

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
Laurus	PIRFENIDONE	pirfenidone	TABLET;ORAL	212722-003	Jul 19, 2022	AB	RX	No	No
Genentech Inc	ESBRIET	pirfenidone	CAPSULE;ORAL	022535-001	Oct 15, 2014	AB	RX	Yes	Yes			Y
Genentech Inc	ESBRIET	pirfenidone	TABLET;ORAL	208780-003	Jan 11, 2017	AB	RX	Yes	Yes

Expired US Patents for pirfenidone

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

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/002154 Esbriet 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/005873 Pirfenidone 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/005862 Pirfenidone 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
European Patent Office	2124945	PROCÉDÉ PERMETTANT D'ADMINISTRER UNE THÉRAPIE PAR LE PIRFENIDONE À UN PATIENT (METHOD OF PROVIDING PIRFENIDONE THERAPY TO A PATIENT)
European Patent Office	3895696	PRÉPARATION DE GRANULÉS DE 5-MÉTHYL-1-PHÉNYL-2(1H)-PYRIDONE ET SON PROCÉDÉ DE FABRICATION (GRANULATE FORMULATION OF 5-METHYL-1-PHENYL-2(1H)-PYRIDONE AND METHOD OF MAKING THE SAME)
Spain	2525543

Market Dynamics and Financial Trajectory for Pirfenidone

Introduction to Pirfenidone

Pirfenidone, marketed under the brand name Esbriet, is an antifibrotic agent approved by the FDA in October 2014 for the treatment of idiopathic pulmonary fibrosis (IPF). It has been shown to slow the rate of lung damage in patients with IPF, although it does not cure the disease or reverse existing lung damage[5].

Market Size and Growth

The global idiopathic pulmonary fibrosis (IPF) treatment market, in which pirfenidone plays a significant role, is projected to grow substantially. By 2031, the global IPF market is estimated to reach $11.7 billion, growing at a CAGR of 7.3% over the forecast period. This growth is largely driven by the US market, which is expected to account for more than 85% of the sales during this period due to high prevalence and increasing drug prices[1].

Segment Contribution

In the IPF management market, pirfenidone is a major contributor. The drug class segment, which includes pirfenidone, nintedanib, and other drugs, shows that pirfenidone accounts for a significant share. This is attributed to its unique combination of anti-fibrotic, antioxidant, and anti-inflammatory properties, as well as its proven efficiency in clinical trials[3].

Clinical Trial Data and Efficacy

Clinical trials, such as the ASCEND study, have demonstrated that pirfenidone slows down the average level of lung damage in patients with IPF. The study showed that treatment with pirfenidone reduced the decline in forced vital capacity (FVC) compared to the placebo group. However, it did not improve symptoms such as breathlessness, cough, or fatigue[5].

Side Effects and Patient Compliance

Pirfenidone is associated with several side effects, including gastrointestinal intolerance, liver enzymes derangement, and cutaneous disorders. These side effects can lead to dose reduction or treatment suspension, affecting patient compliance. For instance, about 34.4% of patients experienced treatment suspension due to side effects[2].

Distribution Channels

The distribution of pirfenidone is primarily through hospital pharmacies, which have witnessed rapid growth. Retail pharmacies and other distribution channels also play a role, but hospital pharmacies remain the dominant segment[3].

Geographic Market

The US market is the largest and most lucrative for pirfenidone due to the high prevalence of IPF and the high costs of treatment. In contrast, markets in Japan and the five major EU countries are expected to remain relatively stable due to lower prevalence and lower treatment costs[1].

Financial Projections

The IPF management market, which includes pirfenidone, was valued at $3,113.5 million in 2023 and is predicted to reach $3,429.6 million by 2031, growing at a CAGR of 1.28% from 2024 to 2031. The increasing drug prices and market penetration, especially in the US, will drive the financial growth of pirfenidone[3].

Competitive Landscape

Pirfenidone competes primarily with nintedanib (Ofev) in the IPF treatment market. Both drugs have been shown to slow the progression of lung damage, but they have different side effect profiles and patient responses. The competitive landscape is also influenced by ongoing research and development of novel treatments, which could potentially alter market dynamics in the future[4].

Research and Development

Continuous research and development initiatives are crucial for the growth of pirfenidone in the market. Long-term follow-up studies have shown benefits of continued treatment with pirfenidone, reinforcing its value in the healthcare sector. These initiatives help in maintaining and expanding its market share[5].

Regulatory Environment

The FDA approval of pirfenidone in 2014 marked a significant milestone in the treatment of IPF. Regulatory approvals and guidelines play a critical role in the market dynamics, ensuring that the drug meets safety and efficacy standards. Compliance with regulatory requirements is essential for maintaining market presence[5].

Patient Journey and Treatment Adherence

For patients with IPF, adherence to pirfenidone treatment is crucial despite the lack of immediate symptomatic relief. It is important for patients to be honest with their doctors about side effects to manage them effectively. Treatment adherence can be influenced by patient education and support programs, which are vital for maximizing the benefits of pirfenidone[5].

Market Challenges

Despite its growth potential, the pirfenidone market faces challenges such as lower prevalence and lower treatment costs in certain regions, which restrict sales. Additionally, the side effect profile and the need for continuous monitoring can impact patient compliance and overall market growth[1][3].

Future Outlook

The future outlook for pirfenidone is positive, driven by increasing market penetration, high drug prices, and ongoing research and development. However, the market will need to navigate challenges such as competition from new treatments and regional variations in prevalence and treatment costs.

"Pirfenidone is expected to hold a major share of the global Idiopathic Pulmonary Fibrosis Management market in 2023. This is attributed to providing a unique combination of anti-fibrotic, antioxidant, and anti-inflammatory properties"[3].

Key Takeaways

• Market Growth: The global IPF treatment market, driven by pirfenidone, is expected to reach $11.7 billion by 2031.
• US Market Dominance: The US market accounts for over 85% of the sales due to high prevalence and increasing drug prices.
• Clinical Efficacy: Pirfenidone slows down lung damage but does not cure IPF or improve symptoms like breathlessness.
• Side Effects: Common side effects include gastrointestinal intolerance and liver enzymes derangement.
• Distribution: Hospital pharmacies are the primary distribution channel.
• Financial Projections: The IPF management market is valued at $3,113.5 million in 2023 and is predicted to grow at a CAGR of 1.28% from 2024 to 2031.

FAQs

Q: What is pirfenidone used for? A: Pirfenidone is used for the treatment of idiopathic pulmonary fibrosis (IPF), slowing down the rate of lung damage.

Q: How effective is pirfenidone in treating IPF? A: Pirfenidone has been shown to slow the decline in lung function but does not cure IPF or reverse existing lung damage.

Q: What are the common side effects of pirfenidone? A: Common side effects include gastrointestinal intolerance, liver enzymes derangement, and cutaneous disorders.

Q: Which market dominates the sales of pirfenidone? A: The US market dominates the sales of pirfenidone, accounting for over 85% of the sales.

Q: What is the projected market size for the global IPF treatment market by 2031? A: The global IPF treatment market is projected to reach $11.7 billion by 2031.

Sources

1. Global Idiopathic Pulmonary Fibrosis Market $11.7 Billion by 2031 - iHealthcareAnalyst
2. Pirfenidone in Idiopathic Pulmonary Fibrosis: Real-World ... - MDPI
3. Idiopathic Pulmonary Fibrosis Management Market Share and Size ... - InsightAce Analytic
4. Global Idiopathic Pulmonary Fibrosis (IPF) Market Analysis Report ... - BusinessWire
5. Pharmacologic Treatments | - ILD Collaborative - ILD Collaborative