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Last Updated: October 1, 2022

ESBRIET Drug Patent Profile


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

Esbriet is a drug marketed by Genentech Inc and is included in two NDAs. There are twenty-one patents protecting this drug and two Paragraph IV challenges.

This drug has two hundred and seventy-two patent family members in forty-five countries.

The generic ingredient in ESBRIET is pirfenidone. There are twenty-three drug master file entries for this compound. Ten 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 3rd, 2022.

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Drug patent expirations by year for ESBRIET
Drug Prices for ESBRIET

See drug prices for ESBRIET

Recent Clinical Trials for ESBRIET

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

SponsorPhase
Excalibur Pharmaceuticals, Inc.Phase 1
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Phase 2
University of California, San DiegoPhase 2

See all ESBRIET clinical trials

Pharmacology for ESBRIET
Drug ClassPyridone
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-five US patents.

Patents protecting ESBRIET

Granulate formulation of 5-methyl-1-phenyl-2-(1H)-pyridone and method of making the same
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Modifying pirfenidone treatment for patients with atypical liver function
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: DOSAGE MODIFICATION FOLLOWING ELEVATED LIVER ENZYMES IN TREATMENT OF IDIOPATHIC PULMONARY FIBROSIS

Modifying pirfenidone treatment for patients with atypical liver function
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: DOSAGE MODIFICATION FOLLOWING GRADE 2 ABNORMALITY IN LIVER FUNCTION BIOMARKER AFTER PIRFENIDONE ADMINISTRATION, BY DISCONTINUING PIRFENIDONE UNTIL BIOMARKERS ARE WITHIN LIMITS, THEN SUB-2400MG/DAY DOSE, THEN FULL DAILY DOSE IN TREATMENT OF IPF

Modifying pirfenidone treatment for patients with atypical liver function
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: DOSAGE MODIFICATION FOLLOWING GRADE 2 ABNORMALITY IN LIVER FUNCTION BIOMARKER AFTER PIRFENIDONE ADMINISTRATION, BY ADMINISTERING SUB-2400 MG/DAY DOSE THEN FULL DAY DAILY DOSE IN TREATMENT OF IPF

Modifying pirfenidone treatment for patients with atypical liver function
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: DOSAGE MODIFICATION FOLLOWING GRADE 2 ABNORMALITY IN LIVER FUNCTION BIOMARKER AFTER PIRFENIDONE ADMINISTRATION, BY ADMINISTERING SUB-2400MG/DAY DOSE THEN FULL DAILY DOSE IN TREATMENT OF IPF

Modifying pirfenidone treatment for patients with atypical liver function
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: DOSAGE MODIFICATION FOLLOWING GRADE 2 ABNORMALITY IN LIVER FUNCTION BIOMARKER AFTER PIRFENIDONE ADMINISTRATION, BY DISCONTINUING PIRFENIDONE UNTIL BIOMARKERS ARE WITHIN NORMAL LIMITS, THEN SUB-2400MG/DAY DOSE, THEN FULL DAILY DOSE IN TREATMENT OF IPF

Pirfenidone treatment for patients with atypical liver function
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: CONTINUED DOSING OR DOSAGE MODIFICATION FOLLOWING ELEVATED LIVER ENZYMES IN TREATMENT OF IDIOPATHIC PULMONARY FIBROSIS

Pirfenidone treatment for patients with atypical liver function
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: DOSAGE MODIFICATION FOLLOWING GRADE 2 ABNORMALITY IN LIVER FUNCTION BIOMARKER AFTER PIRFENIDONE ADMINISTRATION, BY DISCONTINUING PIRFENIDONE UNTIL BIOMARKERS ARE WITHIN NORMAL LIMITS, FOLLOWED BY 801 MG/DAY, DOSE, THEN 1602 MG/DAY IN TREATMENT OF IPF

Pirfenidone treatment for patients with atypical liver function
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: DOSING 1602 MG/DAY PIRFENIDONE FOLLOWING GRADE 2 ABNORMALITY IN LIVER FUNCTION BIOMARKER AFTER PIRFENIDONE ADMINISTRATION IN TREATMENT OF IPF

Pirfenidone treatment for patients with atypical liver function
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: FULL DAILY DOSING FOLLOWING GRADE 2 ABNORMALITY IN LIVER FUNCTION BIOMARKER AFTER PIRFENIDONE ADMINISTRATION IN TREATMENT OF IPF

Pirfenidone treatment for patients with atypical liver function
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: DOSAGE MODIFICATION FOLLOWING GRADE 2 ABNORMALITY IN LIVER FUNCTION BIOMARKER AFTER PIRFENIDONE ADMINISTRATION, BY DISCONTINUING PIRFENIDONE UNTIL BIOMARKERS ARE WITHIN NORMAL LIMITS FOLLOWED BY ADMINISTERING 1602 MG/DAY IN TREATMENT OF IPF

Pirfenidone treatment for patients with atypical liver function
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: DOSAGE MODIFICATION FOLLOWING GRADE 2 ABNORMALITY IN LIVER FUNCTION BIOMARKER AFTER PIRFENIDONE ADMINISTRATION, BY ADMINISTERING 801 MG/DAY FOLLOWED BY ADMINISTERING 1602 MG/DAY IN TREATMENT OF IPF

Pirfenidone treatment for patients with atypical liver function
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: DOSAGE MODIFICATION FOLLOWING GRADE 2 ABNORMALITY IN LIVER FUNCTION BIOMARKER AFTER PIRFENIDONE ADMINISTRATION, BY DISCONTINUING PIRFENIDONE UNTIL BIOMARKERS ARE WITHIN NORMAL LIMITS, FOLLOWED BY ADMINISTERING FULL DAILY DOSE IN TREATMENT OF IPF

Method of providing pirfenidone therapy to a patient
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: DOSE ESCALATION OVER 14 DAYS FOR TREATMENT OF IDIOPATHIC PULMONARY FIBROSIS

Capsule formulation of pirfenidone and pharmaceutically acceptable excipients
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD OF ADMINISTERING PIRFENIDONE CAPSULES TO TREAT A FIBROTIC CONDITION

Method of providing pirfenidone therapy to a patient
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: DOSE ESCALATION OVER 14 DAYS FOR TREATMENT OF IDIOPATHIC PULMONARY FIBROSIS

Method of providing pirfenidone therapy to a patient
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: PIRFENIDONE DOSE ESCALATION REGIMEN FOR TREATMENT OF IPF AS 801 MG/DAY FOR DAYS 1-7 OF THE REGIMEN, 1602 MG/DAY FOR DAYS 8-14 OF THE REGIMEN, AND 2403 MG/DAY FOR AT LEAST DAY 15 OF THE REGIMEN

Methods of administering pirfenidone therapy
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD FOR ADMINISTERING PIRFENIDONE TO REDUCE DRUG INTERACTIONS WITH FLUVOXAMINE

Methods of administering pirfenidone therapy
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: DISCONTINUING ADMINISTRATION OF FLUVOXAMINE TO AVOID DRUG INTERACTIONS WITH PIRFENIDONE AND THEN ADMINISTERING PIRFENIDONE

Methods of administering pirfenidone therapy
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: ADMINISTERING PIRFENIDONE WHILE AVOIDING CO-ADMINISTRATION OF FLUVOXAMINE TO AVOID DRUG INTERACTIONS WITH PIRFENIDONE

Methods of administering pirfenidone therapy
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD FOR ADMINISTERING PIRFENIDONE TO REDUCE DRUG INTERACTIONS WITH A STRONG INHIBITOR OF CYP1A2

Methods of administering pirfenidone therapy
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: DISCONTINUING ADMINISTRATION OF A STRONG CYP1A2 INHIBITOR TO AVOID DRUG INTERACTIONS WITH PIRFENIDONE AND THEN ADMINISTERING PIRFENIDONE

Methods of administering pirfenidone therapy
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: ADMINISTERING PIRFENIDONE WHILE AVOIDING CO-ADMINISTRATION OF A STRONG CYP1A2 INHIBITOR TO AVOID DRUG INTERACTIONS WITH PIRFENIDONE

Capsule formulation of pirfenidone and pharmaceutically acceptable excipients
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD OF ADMINISTERING PIRFENIDONE CAPSULES TO TREAT A FIBROTIC CONDITION

Methods of administering pirfenidone therapy
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD FOR ADMINISTERING PIRFENIDONE TO REDUCE DRUG INTERACTIONS WITH FLUVOXAMINE

Methods of administering pirfenidone therapy
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: ADMINISTERING PIRFENIDONE CONCURRENTLY WITH FLUVOXAMINE, THE PIRFENIDONE AT A DOSE OF ABOUT 801 MG/DAY TO REDUCE DRUG INTERACTIONS WITH FLUVOXAMINE

Methods of administering pirfenidone therapy
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: MODIFYING PIRFENIDONE ADMINISTRATION FROM A DOSE OF ABOUT 2400 MG/DAY DOWNWARD BY ABOUT 1600 MG/DAY WHILE CO-ADMINISTERING FLUVOXAMINE TO REDUCE DRUG INTERACTIONS WITH FLUVOXAMINE

Pirfenidone therapy and inducers of cytochrome P450
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD FOR ADMINISTERING PIRFENIDONE TO AVOID REDUCED EFFICACY BY DISCONTINUING SMOKING OR BY DISCONTINUING OR AVOIDING ANOTHER STRONG CYP1A2 INDUCER

Pirfenidone therapy and inducers of cytochrome P450
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: DISCONTINUING ADMINISTRATION OF A STRONG CYP1A2 INDUCER TO AVOID REDUCED PIRFENIDONE EFFICACY AND THEN ADMINISTERING PIRFENIDONE

Pirfenidone therapy and inducers of cytochrome P450
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: ADMINISTERING PIRFENIDONE WHILE AVOIDING CONCOMITANT ADMINISTRATION OF A STRONG INDUCER OF CYP1A2 TO AVOID REDUCED PIRFENIDONE EFFICACY

Pirfenidone therapy and inducers of cytochrome P450
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: DISCONTINUING A STRONG CYP1A2 INDUCER TO AVOID REDUCED PIRFENIDONE EFFICACY AND THEN ADMINISTERING PIRFENIDONE

Methods of administering pirfenidone therapy
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD FOR ADMINISTERING PIRFENIDONE WHILE AVOIDING OR DISCONTINUING CONCOMITANT USE OF A MODERATE TO STRONG INHIBITOR OF BOTH CYP1A2 AND ANOTHER CYP ENZYME INVOLVED IN PIRFENIDONE METABOLISM

Methods of administering pirfenidone therapy
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: ADMINISTERING PIRFENIDONE WHILE AVOIDING CONCOMITANT USE OF A CYP1A2 INHIBITOR THAT IS A MODERATE TO STRONG INHIBITOR OF BOTH CYP1A2 AND ANOTHER CYP ENZYME SELECTED FROM CYP2C9, CYP2C19, AND CYP2D6

Methods of administering pirfenidone therapy
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: DISCONTINUING USE OF A CYP1A2 INHIBITOR THAT IS A MODERATE TO STRONG INHIBITOR OF BOTH CYP1A2 AND ANOTHER CYP ENZYME SELECTED FROM CYP2C9, CYP2C19, AND CYP2D6 AND THEN ADMINISTERING PIRFENIDONE

Granulate formulation of pirfenidone and pharmaceutically acceptable excipients
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD OF ADMINISTERING A GRANULATE FORMULATION OF 5-METHYL-1-PHENYL-2-(1H)-PYRIDONE AS RECITED IN CLAIM 1, TO TREAT IDIOPATHIC PULMONARY FIBROSIS

Method of providing pirfenidone therapy to a patient
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: DOSE ESCALATION OVER 14 DAYS FOR TREATMENT OF A FIBROSIS CONDITION

Method of providing pirfenidone therapy to a patient
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: PIRFENIDONE DOSE ESCALATION REGIMEN FOR TREATMENT OF FIBROSIS AS 801 MG/DAY FOR DAYS 1-7 OF THE REGIMEN, 1602 MG/DAY FOR DAYS 8-14 OF THE REGIMEN, AND 2403 MG/DAY FOR AT LEAST DAY 15 OF THE REGIMEN

Pirfenidone treatment for patients with atypical liver function
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: CONTINUED DOSING OR DOSAGE MODIFICATION FOLLOWING ELEVATED LIVER ENZYMES IN TREATMENT OF IDIOPATHIC PULMONARY FIBROSIS

Pirfenidone treatment for patients with atypical liver function
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: DOSAGE MODIFICATION FOLLOWING GRADE 2 ABNORMALITY IN BIOMARKER AST AND/OR ALT AFTER PIRFENIDONE ADMINISTRATION, BY DISCONTINUING PIRFENIDONE UNTIL BIOMARKERS OF LIVER FUNCTION ARE WITHIN NORMAL LIMITS, THEN AT LEAST 1600MG/DAY IN TREATMENT OF IPF

Pirfenidone treatment for patients with atypical liver function
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: DOSAGE MODIFICATION FOLLOWING GRADE 2 ABNORMALITY IN LIVER FUNCTION BIOMARKER AFTER PIRFENIDONE ADMINISTRATION, BY DISCONTINUING PIRFENIDONE UNTIL BIOMARKERS ARE WITHIN NORMAL LIMITS, FOLLOWED BY ADMINISTERING AT LEAST 1600 MG/DAY IN TREATMENT OF IPF

Pirfenidone treatment for patients with atypical liver function
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: DOSAGE MODIFICATION FOLLOWING GRADE 2 ABNORMALITY IN BIOMARKER AST AND/OR ALT AFTER PIRFENIDONE ADMINISTRATION, BY ADMINISTERING SUB-1600 MG/DAY, FOLLOWING BY ADMINISTERING AT LEAST 1600 MG/DAY IN TREATMENT OF IPF

Pirfenidone treatment for patients with atypical liver function
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: DOSAGE MODIFICATION FOLLOWING GRADE 2 ABNORMALITY IN BIOMARKER AST AND/OR ALT AFTER PIRFENIDONE ADMINISTRATION, BY ADMINISTERING SUB-2400MG/DAY DOSE, FOLLOWED BY ADMINISTERING 2403MG/DAY IN TREATMENT OF IPF

Pirfenidone treatment for patients with atypical liver function
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: DOSING 2403 MG/DAY PIRFENIDONE FOLLOWING GRADE 2 ABNORMALITY IN BIOMARKER AST AND/OR ALT AFTER PIRFENIDONE ADMINISTRATION IN TREATMENT OF IPF

Pirfenidone treatment for patients with atypical liver function
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: DOSAGE MODIFICATION FOLLOWING GRADE 2 ABNORMALITY IN BIOMARKER AST AND/OR ALT AFTER PIRFENIDONE ADMINISTRATION, BY DISCONTINUING PIRFENIDONE UNTIL BIOMARKERS OF LIVER FUNCTION ARE WITHIN NORMAL LIMITS, FOLLOWED BY FULL DAILY DOSE IN TREATMENT OF IPF

Pirfenidone treatment for patients with atypical liver function
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: DOSING OF AT LEAST 1600 MG/DAY FOLLOWING GRADE 2 ABNORMALITY IN LIVER FUNCTION BIOMARKER AFTER PIRFENIDONE ADMINISTRATION IN TREATMENT OF IPF

Pirfenidone treatment for patients with atypical liver function
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: DOSING OF AT LEAST 1600 MG/DAY FOLLOWING GRADE 2 LIVER ABNORMALITY IN BIOMARKER AST AND/OR ALT AFTER PIRFENIDONE ADMINISTRATION IN TREATMENT OF IPF

Pirfenidone treatment for patients with atypical liver function
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: DOSAGE MODIFICATION FOLLOWING GRADE 2 ABNORMALITY IN LIVER FUNCTION BIOMARKER AFTER PIRFENIDONE ADMINISTRATION, BY ADMINISTERING SUB-1600 MG/DAY DOSE, FOLLOWED BY ADMINISTERING AT LEAST 1600 MG/DAY DOSE IN TREATMENT OF IPF

Pirfenidone treatment for patients with atypical liver function
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: CONTINUED DOSING OR DOSAGE MODIFICATION FOLLOWING ELVATED LIVER ENZYMES IN USE OF PIRFENIDONE

Pirfenidone treatment for patients with atypical liver function
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: FULL DAILY DOSING FOLLOWING GRADE 2 ABNORMALITY IN LIVER FUNCTION BIOMARKER ALT OR AST AFTER PIRFENIDONE ADMINISTRATION

Pirfenidone treatment for patients with atypical liver function
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: DOSAGE MODIFICATION FOLLOWING GRADE 2 ABNORMALITY IN LIVER FUNCTION BIOMARKER ALT OR AST AFTER PIRFENIDONE ADMINISTRATION, BY ADMINISTERING A SUB-1600 MG/DAY DOSE, FOLLOWED BY ADMINISTERING AT LEAST 1602 MG/DAY

Pirfenidone treatment for patients with atypical liver function
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: DOSAGE MODIFICATION FOLLOWING GRADE 2 ABNORMALITY IN LIVER FUNCTION BIOMARKER ALT OR AST AFTER PIRFENIDONE ADMINISTRATION, BY ADMINISTERING SUB-2400 MG/DAY DOSE, FOLLOWED BY FULL DAILY DOSE

Pirfenidone treatment for patients with atypical liver function
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: DOSAGE MODIFICATION FOLLOWING GRADE 2 ABNORMALITY IN LIVER FUNCTION BIOMARKER ALT OR AST AFTER PIRFENIDONE ADMINISTRATION, BY DISCONTINUING PIRFENIDONE, FOLLOWED BY ADMINISTERING AT LEAST 1602 MG/DAY

Pirfenidone treatment for patients with atypical liver function
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: DOSAGE MODIFICATION FOLLOWING GRADE 2 ABNORMALITY IN LIVER FUNCTION BIOMARKER ALT OR AST AFTER PIRFENIDONE ADMINISTRATION, BY DISCONTINUING PIRFENIDONE UNTIL BIOMARKERS OF LIVER FUNCTION ARE WITHIN NORMAL LIMITS, FOLLOWED BY FULL DAILY DOSE

Pirfenidone treatment for patients with atypical liver function
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: DOSAGE MODIFICATION FOLLOWING GRADE 2 ABNORMALITY IN BIOMARKER ALT OR AST AFTER PIRFENIDONE ADMINISTRATION, BY DISCONTINUING PIRFENIDONE UNTIL BIOMARKERS OF LIVER FUNCTION ARE WITHIN NORMAL LIMITS, THEN SUB-1600 MG/DAY, THEN AT LEAST 1602 MG/DAY

Pirfenidone treatment for patients with atypical liver function
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: DOSING AT LEAST 1602 MG/DAY FOLLOWING GRADE 2 ABNORMALITY IN LIVER FUNCTION BIOMARKER ALT OR AST AFTER PIRFENIDONE ADMINISTRATION

Pirfenidone therapy and inducers of cytochrome P450
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD FOR ADMINISTERING PIRFENIDONE TO AVOID REDUCED EFFICACY BY DISCONTINUING SMOKING OR BY DISCONTINUING A STRONG CYP1A2 INDUCER

Pirfenidone therapy and inducers of cytochrome P450
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: DISCONTINUING SMOKING TO AVOID REDUCED PIRFENIDONE EFFICACY AND THEN ADMINISTERING PIRFENIDONE

Pirfenidone therapy and inducers of cytochrome P450
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: DISCONTINUING ADMINISTRATION OF A STRONG CYP1A2 INDUCER TO AVOID REDUCED PIRFENIDONE EFFICACY AND THEN ADMINISTERING PIRFENIDONE

Capsule formulation of pirfenidone and pharmaceutically acceptable excipients
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD OF ADMINISTERING PIRFENIDONE CAPSULES TO TREAT A FIBROTIC CONDITION

Pirfenidone therapy and inducers of cytochrome P450
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD FOR ADMINISTERING PIRFENIDONE TO AVOID REDUCED EFFICACY BY AVOIDING SMOKING OR BY AVOIDING ANOTHER STRONG CYP1A2 INDUCER

Pirfenidone therapy and inducers of cytochrome P450
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: ADMINISTERING PIRFENIDONE WHILE AVOIDING CONCOMITANT ADMINISTRATION OF A STRONG INDUCER OF CYP1A2, INCLUDING CIGARETTE SMOKE, TO AVOID REDUCED PIRFENIDONE EFFICACY

Methods of administering pirfenidone therapy
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: DOSAGE MODIFICATION IN TREATMENT WITH PIRFENIDONE TO REDUCE DRUG INTERACTIONS WITH CIPROFLOXACIN

Methods of administering pirfenidone therapy
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: DOSE REDUCTION OF PIRFENIDONE BY ABOUT ONE HALF DURING CONCURRENT ADMINISTRATION OF CIPROFLOXACIN AT A DOSE OF 750 MG TWICE DAILY (1500 MG/DAY) TO REDUCE DRUG INTERACTIONS IN TREATMENT OF A FIBROTIC, INFLAMMATORY, OR AUTOIMMUNE DISORDER

Methods of administering pirfenidone therapy
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: ADMINISTRATION OF PIRFENIDONE AND AVOIDING CONCURRENT ADMINISTRATION OF CIPROFLOXACIN AT A DOSE OF 750 MG TO REDUCE DRUG INTERACTIONS IN TREATMENT OF A FIBROTIC, INFLAMMATORY, OR AUTOIMMUNE DISORDER

Pharmaceutical composition containing as an active ingredient 5-methyl-1-phenyl-2-(1H)-pyridone
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

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 208780-001 Jan 11, 2017 AB RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Genentech Inc ESBRIET pirfenidone TABLET;ORAL 208780-002 Jan 11, 2017 DISCN Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Genentech Inc ESBRIET pirfenidone TABLET;ORAL 208780-003 Jan 11, 2017 AB RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Genentech Inc ESBRIET pirfenidone TABLET;ORAL 208780-003 Jan 11, 2017 AB RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Genentech Inc ESBRIET pirfenidone TABLET;ORAL 208780-003 Jan 11, 2017 AB RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for ESBRIET

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

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/002154
Esbriet is indicated in adults for the treatment of mild to moderate idiopathic pulmonary fibrosis.,
Authorised no no no 2011-02-27
Alfred E. Tiefenbacher (GmbH & Co. KG) 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
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

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)

Patent: 55
Estimated Expiration: See Plans and Pricing

Argentina

Patent: 7990
Estimated Expiration: See Plans and Pricing

Australia

Patent: 06295440
Estimated Expiration: See Plans and Pricing

Patent: 11201520
Estimated Expiration: See Plans and Pricing

Patent: 13201986
Estimated Expiration: See Plans and Pricing

Patent: 14240300
Estimated Expiration: See Plans and Pricing

Patent: 17241530
Estimated Expiration: See Plans and Pricing

Brazil

Patent: 0616324
Estimated Expiration: See Plans and Pricing

Canada

Patent: 20380
Estimated Expiration: See Plans and Pricing

Patent: 62013
Estimated Expiration: See Plans and Pricing

Patent: 37365
Estimated Expiration: See Plans and Pricing

China

Patent: 1267810
Estimated Expiration: See Plans and Pricing

Patent: 3393607
Estimated Expiration: See Plans and Pricing

Patent: 3735530
Estimated Expiration: See Plans and Pricing

Patent: 8883072
Estimated Expiration: See Plans and Pricing

Patent: 4533688
Estimated Expiration: See Plans and Pricing

Cuba

Patent: 080043
Estimated Expiration: See Plans and Pricing

Cyprus

Patent: 15544
Estimated Expiration: See Plans and Pricing

Denmark

Patent: 40364
Estimated Expiration: See Plans and Pricing

Ecuador

Patent: 088394
Estimated Expiration: See Plans and Pricing

Eurasian Patent Organization

Patent: 0093
Estimated Expiration: See Plans and Pricing

Patent: 0800881
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 40364
Estimated Expiration: See Plans and Pricing

Patent: 31025
Estimated Expiration: See Plans and Pricing

Patent: 35985
Estimated Expiration: See Plans and Pricing

Patent: 95696
Estimated Expiration: See Plans and Pricing

Georgia, Republic of

Patent: 0115303
Estimated Expiration: See Plans and Pricing

Hong Kong

Patent: 17762
Estimated Expiration: See Plans and Pricing

Israel

Patent: 9273
Estimated Expiration: See Plans and Pricing

Patent: 9868
Estimated Expiration: See Plans and Pricing

Patent: 1745
Estimated Expiration: See Plans and Pricing

Japan

Patent: 15101
Estimated Expiration: See Plans and Pricing

Patent: 37732
Estimated Expiration: See Plans and Pricing

Patent: 09509962
Estimated Expiration: See Plans and Pricing

Patent: 12224641
Estimated Expiration: See Plans and Pricing

Patent: 14169341
Estimated Expiration: See Plans and Pricing

Patent: 19513145
Estimated Expiration: See Plans and Pricing

Patent: 22087115
Estimated Expiration: See Plans and Pricing

Mexico

Patent: 08003882
Estimated Expiration: See Plans and Pricing

Patent: 18011819
Estimated Expiration: See Plans and Pricing

Morocco

Patent: 875
Estimated Expiration: See Plans and Pricing

New Zealand

Patent: 5957
Estimated Expiration: See Plans and Pricing

Patent: 1443
Estimated Expiration: See Plans and Pricing

Patent: 0129
Estimated Expiration: See Plans and Pricing

Norway

Patent: 5131
Estimated Expiration: See Plans and Pricing

Patent: 080759
Estimated Expiration: See Plans and Pricing

Poland

Patent: 40364
Estimated Expiration: See Plans and Pricing

Patent: 35985
Estimated Expiration: See Plans and Pricing

Portugal

Patent: 40364
Estimated Expiration: See Plans and Pricing

Slovenia

Patent: 40364
Estimated Expiration: See Plans and Pricing

South Africa

Patent: 0802237
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 1645069
Estimated Expiration: See Plans and Pricing

Patent: 1675651
Estimated Expiration: See Plans and Pricing

Patent: 080046673
Estimated Expiration: See Plans and Pricing

Patent: 130100381
Estimated Expiration: See Plans and Pricing

Patent: 140029554
Estimated Expiration: See Plans and Pricing

Patent: 180123067
Estimated Expiration: See Plans and Pricing

Spain

Patent: 96144
Estimated Expiration: See Plans and Pricing

Patent: 83595
Estimated Expiration: See Plans and Pricing

Tunisia

Patent: 08136
Estimated Expiration: See Plans and Pricing

Ukraine

Patent: 433
Estimated Expiration: See Plans and Pricing

Patent: 5861
Estimated Expiration: See Plans and Pricing

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
China 104780762 Methods of administering pirfenidone therapy See Plans and Pricing
Ukraine 99433 ЛЕКАРСТВЕННАЯ ФОРМА ПИРФЕНИДОНА В ВИДЕ КАПСУЛ С ФАРМАЦЕВТИЧЕСКИ ПРИЕМЛЕМЫМИ ЭКСЦИПИЕНТАМИ;ЛІКАРСЬКА ФОРМА ПІРФЕНІДОНУ У ВИГЛЯДІ КАПСУЛ З ФАРМАЦЕВТИЧНО ПРИЙНЯТНИМИ ЕКСЦИПІЄНТАМИ (CAPSULE FORMULATION OF PIRFENIDONE AND PHARMACEUTICALLY ACCEPTABLE EXCIPIENTS) See Plans and Pricing
Slovenia 1940364 See Plans and Pricing
Japan 5715101 See Plans and Pricing
Spain 2395159 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

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Serving leading biopharmaceutical companies globally:

Colorcon
Baxter
Mallinckrodt
Boehringer Ingelheim
Merck
Medtronic

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.