Pirfenidone Patent Expiration

Pirfenidone is used for treating idiopathic pulmonary fibrosis. It was first introduced by Legacy Pharma Inc Sezc in its drug Esbriet on Oct 15, 2014. 16 different companies have introduced drugs containing Pirfenidone.


Pirfenidone Patents

Given below is the list of patents protecting Pirfenidone, along with the drug name that holds that patent and the company name owning that drug.

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Drug Used in Drug Patent Number Drug Patent Title Drug Patent Expiry Drug Owner
Esbriet US10188637 Granulate formulation of 5-methyl-1-phenyl-2-(1H)-pyridone and method of making the same Mar 28, 2037 Legacy
Esbriet US8778947 Methods of administering pirfenidone therapy Aug 30, 2033 Legacy
Esbriet US7816383 Methods of administering pirfenidone therapy Jan 08, 2030 Legacy
Esbriet US7910610 Methods of administering pirfenidone therapy Jan 08, 2030 Legacy
Esbriet US8013002 Methods of administering pirfenidone therapy Jan 08, 2030 Legacy
Esbriet US8084475 Pirfenidone therapy and inducers of cytochrome P450 Jan 08, 2030 Legacy
Esbriet US8318780 Methods of administering pirfenidone therapy Jan 08, 2030 Legacy
Esbriet US8648098 Pirfenidone therapy and inducers of cytochrome P450 Jan 08, 2030 Legacy
Esbriet US8754109 Pirfenidone therapy and inducers of cytochrome P450 Jan 08, 2030 Legacy
Esbriet US7566729 Modifying pirfenidone treatment for patients with atypical liver function Apr 22, 2029 Legacy
Esbriet US7635707 Pirfenidone treatment for patients with atypical liver function Apr 22, 2029 Legacy
Esbriet US8592462 Pirfenidone treatment for patients with atypical liver function Apr 22, 2029 Legacy
Esbriet US8609701 Pirfenidone treatment for patients with atypical liver function Apr 22, 2029 Legacy
Esbriet US8383150 Granulate formulation of pirfenidone and pharmaceutically acceptable excipients May 10, 2028 Legacy
Esbriet US7696236 Method of providing pirfenidone therapy to a patient Dec 18, 2027 Legacy
Esbriet US7696326 Multiple antigen glycopeptide carbohydrate, vaccine comprising the same and use thereof Dec 18, 2027 Legacy
Esbriet US7767700 Method of providing pirfenidone therapy to a patient Dec 18, 2027 Legacy
Esbriet US8420674 Method of providing pirfenidone therapy to a patient Dec 18, 2027 Legacy
Esbriet US7767225 Capsule formulation of pirfenidone and pharmaceutically acceptable excipients Sep 22, 2026

(Expired)

Legacy
Esbriet US7988994 Capsule formulation of pirfenidone and pharmaceutically acceptable excipients Sep 22, 2026

(Expired)

Legacy
Esbriet US8753679 Capsule formulation of pirfenidone and pharmaceutically acceptable excipients Sep 22, 2026

(Expired)

Legacy
Esbriet US9561217 Pharmaceutical composition containing as an active ingredient 5-methyl-1-phenyl-2-(1H)-pyridone Jan 25, 2022

(Expired)

Legacy



Pirfenidone's Family Patents

Family Patents

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Clinical Trials

Recent Clinical Trials on Pirfenidone:

Sometimes companies keep conducting clinical trials even after the drug's approval to discover new formulations, methods of use, or new treatment indications, so they could file for additional patents or receive regulatory exclusivity extensions, such as pediatric exclusivity, potentially delaying generic competition. Based on these recent clinical trials, generic companies need to consider the potential for new intellectual property or regulatory hurdles. These strategic moves by the drug owner might delay generic substitution or lead to additional sales of the brand drug, even after patent expiry.

Title Lead Sponsor Collaborators Status Phases
Clinical Trials
Pifenidone Prophylactic Therapy for Radiation Lung Injury in Patients Who Have Previously Received Immune Checkpoint Inhibitors Hubei Cancer Hospital NA COMPLETED
(Sep 1, 2026)
PHASE2
Study on the Drug Interactions of HRS-9813, Pirfenidone and Nintedanib in Healthy Subjects Guangdong Hengrui Pharmaceutical Co., Ltd NA COMPLETED
(Sep 1, 2026)
PHASE1
Trial to Evaluate the Efficacy and Safety of LYT-100 (Deupirfenidone) Compared to Pirfenidone in Adults With Idiopathic Pulmonary Fibrosis (IPF) PureTech NA RECRUITING
(Sep 1, 2026)
PHASE3
A Study in People With Idiopathic Pulmonary Fibrosis to Test Whether Pirfenidone Influences the Amount of BI 1015550 in the Blood Boehringer Ingelheim NA COMPLETED
(Aug 1, 2026)
PHASE2
A Trial to Evaluate Efficacy and Safety of Buloxibutid in People With Idiopathic Pulmonary Fibrosis. Vicore Pharma AB NA ACTIVE NOT RECRUITING
(Aug 1, 2026)
PHASE2
Study to Determine Potential for Drug-drug Interactions When Co-administering Deupirfenidone (LYT-100) and Nintedanib PureTech NA COMPLETED
(Aug 1, 2026)
PHASE1
Pirfenidone as Treatment of Chronic Pancreatitis Vikas Dudeja NA NOT YET RECRUITING
(Aug 1, 2026)
PHASE2
Evaluation of Pirfenidone as a Novel Therapeutic Strategy Against Recurrent Acute Pancreatitis. University of Alabama at Birmingham NA RECRUITING
(Jul 1, 2026)
PHASE2
A Phase 3 Study of Efficacy and Safety of AK3280 in Patients With Idiopathic Pulmonary Fibrosis Shanghai Ark Biopharmaceutical Co., Ltd. NA NOT YET RECRUITING
(Jul 1, 2026)
PHASE3
Randomized, Double-blind Study of Efficacy and Safety of Bexotegrast (PLN-74809) for Idiopathic Pulmonary Fibrosis Pliant Therapeutics, Inc. NA TERMINATED
(Jun 1, 2026)
PHASE2
A Study Evaluating the Safety and Efficacy of Inhaled AP01 in Participants With Progressive Pulmonary Fibrosis Avalyn Pharma Inc. NA ACTIVE NOT RECRUITING
(Jun 1, 2026)
PHASE2
A Phase I Evaluation of the Safety and Tolerability of Pirfenidone in Idiopathic Subglottic Stenosis London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's NA NOT YET RECRUITING
(Jun 1, 2026)
PHASE1
Pirfenidone to Prevent Fibrosis in Ards. Università Vita-Salute San Raffaele NA RECRUITING
(May 1, 2026)
PHASE3
Senicapoc in Patients With Worsening Fibrotic Interstitial Lung Disease Vejle Hospital NA RECRUITING
(May 1, 2026)
PHASE2
A Study to Evaluate Pharmacokinetics and Drug-drug Interactions of ENV-101 (Taladegib) in Healthy Participants Endeavor Biomedicines, Inc. NA RECRUITING
(May 1, 2026)
PHASE1
Exploratory Study on the Efficacy and Safety of Nebulized hUC-MSC-Derived Exosomes for Non-Acute CIP Zhou Chengzhi NA NOT YET RECRUITING
(May 1, 2026)
PHASE1, PHASE2
Phase ll Study of HEC585 in Patients With IPF Sunshine Lake Pharma Co., Ltd. NA ACTIVE NOT RECRUITING
(Apr 1, 2026)
PHASE2
Study of Oral Epigallocatechin-3-gallate (EGCG) in IPF Patients Hal Chapman NA COMPLETED
(Apr 1, 2026)
PHASE1
A Phase 2 Study of CAL101 in Patients With Idiopathic Pulmonary Fibrosis Calluna Pharma AS NA ACTIVE NOT RECRUITING
(Apr 1, 2026)
PHASE2
Confirmatory Clinical Study of HEC585 Tablets in Patients With IPF Sunshine Lake Pharma Co., Ltd. NA RECRUITING
(Apr 1, 2026)
PHASE3
Pirfenidone Capsules in the Treatment of Radiation-induced Lung Injury With or Without Immune Pneumonia Beijing Continent Pharmaceutical Co, Ltd. NA RECRUITING
(Apr 1, 2026)
PHASE2, PHASE3
A Phase 2 Study of LTI-03 in Patients With Idiopathic Pulmonary Fibrosis Rein Therapeutics NA RECRUITING
(Mar 1, 2026)
PHASE2
PK of Deupirfenidone Versus Pirfenidone in Older Healthy Subjects PureTech NA COMPLETED
(Mar 1, 2026)
PHASE1
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase III Study to Evaluate the Efficacy and Safety of HSK44459 Tablets in Patients With Idiopathic Pulmonary Fibrosis Haisco Pharmaceutical Group Co., Ltd. NA NOT YET RECRUITING
(Mar 1, 2026)
PHASE3


Pirfenidone Generic API Manufacturers

Several generic applications have been filed for Pirfenidone. The first generic version for Pirfenidone was by Amneal Eu Ltd and was approved on Jan 3, 2022. And the latest generic version is by Aurobindo Pharma Ltd and was approved on Apr 20, 2026.

Given below is the list of companies who have filed for Pirfenidone generic, along with the locations of their manufacturing plants worldwide.