Pirfenidone Global Patent Coverage & Expiry Overview

Track protection status across key markets to assess launch feasibility.

It is formulated by 15 pharmaceutical companies such as GENENTECH INC, AMNEAL, ACCORD HLTHCARE and others. It is marketed under 2 brand names, including ESBRIET, PIRFENIDONE. Available in 3 different strengths, such as 267MG, 801MG, 534MG, and administered through 2 routes including CAPSULE;ORAL, TABLET;ORAL.

Strategic Dashboard

info

insightsStrategic Insights

Sourcing & Feasibility

check_circle API availability: autorenew Loading API feasibility...

groups Licensing: 15 potential partners

calendar_todayUS Launch window: autorenew Loading launch window...

timeline Key Patent Barrier & Expiry Timeline

autorenew Loading patent barriers...

factoryGeneric Manufacturer Snapshot

autorenew Loading manufacturers...

gavelRisk & Opportunity Summary

dangerous Risk: autorenew Loading risk analysis...
watch_later Watch: autorenew Loading watch analysis...
rocket_launch Opportunity: autorenew Loading opportunity analysis...
flag
gavel
calendar_today
calendar_today

Access Global Patent Data

Stay ahead with worldwide patent expiry and latest updates.

✓ Comprehensive global patent expiry timelines
✓ Full patent family details and status updates
Unlock Global Patents

Orange Book Drug Approval Timeline

FDA approval history for this ingredient

NDA (New Drug Application) ANDA (Generic Application)

Access Global Exclusivity and Patent Expiry Extensions

Stay ahead with worldwide patent expiry insights, exclusivity data, and latest updates.

✓ Comprehensive global patent expiry timelines
✓ Full patent family details and status updates
✓ Latest exclusivity data and extensions
Unlock Global Access

US Orange Book Patents Expiration Timeline

Key expiration dates for US patents covering this ingredient

View Global Patents Expiration Timeline

Stay ahead with worldwide patent expiry insights, market data, and research updates.

✓ Comprehensive global patent expiry timelines
✓ Full patent family details and status updates
Unlock Global Patent Timeline

Orange Book Drug Strengths

Latest drug strengths approved by FDA

Strength Route of Administration Companies Latest Approval Date

Orange Book Patents

Patents approved by the FDA for the ingredient

Patent Number Publication Date Legal Status Patent Expiry Date
{"application_id":"8033","ingredient":"PIRFENIDONE","trade_name":"ESBRIET","family_id":"6fe5e65550ee4c3789b6","publication_number":"US7988994B2","cleaned_patent_number":"7988994","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2026-09-22","publication_date":"2011-08-02","legal_status":"Granted"} US7988994B2 Formulation 02 Aug, 2011 Granted 22 Sep, 2026
{"application_id":"35265","ingredient":"PIRFENIDONE","trade_name":"ESBRIET","family_id":"6fe5e65550ee4c3789b6","publication_number":"US8753679B2","cleaned_patent_number":"8753679","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2026-09-22","publication_date":"2014-06-17","legal_status":"Patented case"} US8753679B2 Formulation 17 Jun, 2014 Patented case 22 Sep, 2026
{"application_id":"35263","ingredient":"PIRFENIDONE","trade_name":"ESBRIET","family_id":"6fe5e65550ee4c3789b6","publication_number":"US7767225B2","cleaned_patent_number":"7767225","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2026-09-22","publication_date":"2010-08-03","legal_status":"Granted"} US7767225B2 Formulation 03 Aug, 2010 Granted 22 Sep, 2026
{"application_id":"35126","ingredient":"PIRFENIDONE","trade_name":"ESBRIET","family_id":"7d187cb157d44c88850f","publication_number":"US7767700B2","cleaned_patent_number":"7767700","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2027-12-18","publication_date":"2010-08-03","legal_status":"Granted"} US7767700B2 03 Aug, 2010 Granted 18 Dec, 2027
{"application_id":"35127","ingredient":"PIRFENIDONE","trade_name":"ESBRIET","family_id":"7d187cb157d44c88850f","publication_number":"US8420674B2","cleaned_patent_number":"8420674","drug_product_flag":"-, Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2027-12-18","publication_date":"2013-04-16","legal_status":"Granted"} US8420674B2 16 Apr, 2013 Granted 18 Dec, 2027
{"application_id":"35125","ingredient":"PIRFENIDONE","trade_name":"ESBRIET","family_id":"7d187cb157d44c88850f","publication_number":"US7696236B2","cleaned_patent_number":"7696236","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2027-12-18","publication_date":"2010-04-13","legal_status":"Granted"} US7696236B2 13 Apr, 2010 Granted 18 Dec, 2027
{"application_id":"35264","ingredient":"PIRFENIDONE","trade_name":"ESBRIET","family_id":"6fe5e65550ee4c3789b6","publication_number":"US8383150B2","cleaned_patent_number":"8383150","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2028-05-10","publication_date":"2013-02-26","legal_status":"Patented case"} US8383150B2 Formulation 26 Feb, 2013 Patented case 10 May, 2028
{"application_id":"31810","ingredient":"PIRFENIDONE","trade_name":"ESBRIET","family_id":"d7a8db1ae30d4886992a","publication_number":"US8609701B2","cleaned_patent_number":"8609701","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2029-04-22","publication_date":"2013-12-17","legal_status":"Granted"} US8609701B2 17 Dec, 2013 Granted 22 Apr, 2029
{"application_id":"1467","ingredient":"PIRFENIDONE","trade_name":"ESBRIET","family_id":"d7a8db1ae30d4886992a","publication_number":"US7635707B1","cleaned_patent_number":"7635707","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2029-04-22","publication_date":"2009-12-22","legal_status":"Granted"} US7635707B2 22 Dec, 2009 Granted 22 Apr, 2029
{"application_id":"36400","ingredient":"PIRFENIDONE","trade_name":"ESBRIET","family_id":"d7a8db1ae30d4886992a","publication_number":"US8592462B2","cleaned_patent_number":"8592462","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2029-04-22","publication_date":"2013-11-26","legal_status":"Granted"} US8592462B2 26 Nov, 2013 Granted 22 Apr, 2029
{"application_id":"36398","ingredient":"PIRFENIDONE","trade_name":"ESBRIET","family_id":"d7a8db1ae30d4886992a","publication_number":"US7566729B1","cleaned_patent_number":"7566729","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2029-04-22","publication_date":"2009-07-28","legal_status":"Patented case"} US7566729B2 28 Jul, 2009 Patented case 22 Apr, 2029
{"application_id":"35966","ingredient":"PIRFENIDONE","trade_name":"ESBRIET","family_id":"e0c1db407fd14d0ba7ec","publication_number":"US8013002B2","cleaned_patent_number":"8013002","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2030-01-08","publication_date":"2011-09-06","legal_status":"Granted"} US8013002B2 06 Sep, 2011 Granted 08 Jan, 2030
{"application_id":"35968","ingredient":"PIRFENIDONE","trade_name":"ESBRIET","family_id":"e0c1db407fd14d0ba7ec","publication_number":"US7816383B1","cleaned_patent_number":"7816383","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2030-01-08","publication_date":"2010-10-19","legal_status":"Granted"} US7816383B2 19 Oct, 2010 Granted 08 Jan, 2030
{"application_id":"1477","ingredient":"PIRFENIDONE","trade_name":"ESBRIET","family_id":"e0c1db407fd14d0ba7ec","publication_number":"US7910610B1","cleaned_patent_number":"7910610","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2030-01-08","publication_date":"2011-03-22","legal_status":"Granted"} US7910610B2 22 Mar, 2011 Granted 08 Jan, 2030
{"application_id":"31321","ingredient":"PIRFENIDONE","trade_name":"ESBRIET","family_id":"0cb42b6125304f79afa1","publication_number":"US8754109B2","cleaned_patent_number":"8754109","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2030-01-08","publication_date":"2014-06-17","legal_status":"Granted"} US8754109B2 17 Jun, 2014 Granted 08 Jan, 2030
{"application_id":"36747","ingredient":"PIRFENIDONE","trade_name":"ESBRIET","family_id":"0cb42b6125304f79afa1","publication_number":"US8084475B2","cleaned_patent_number":"8084475","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2030-01-08","publication_date":"2011-12-27","legal_status":"Granted"} US8084475B2 27 Dec, 2011 Granted 08 Jan, 2030
{"application_id":"35969","ingredient":"PIRFENIDONE","trade_name":"ESBRIET","family_id":"e0c1db407fd14d0ba7ec","publication_number":"US8318780B2","cleaned_patent_number":"8318780","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2030-01-08","publication_date":"2012-11-27","legal_status":"Granted"} US8318780B2 27 Nov, 2012 Granted 08 Jan, 2030
{"application_id":"36746","ingredient":"PIRFENIDONE","trade_name":"ESBRIET","family_id":"0cb42b6125304f79afa1","publication_number":"US8648098B2","cleaned_patent_number":"8648098","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2030-01-08","publication_date":"2014-02-11","legal_status":"Granted"} US8648098B2 11 Feb, 2014 Granted 08 Jan, 2030
{"application_id":"34973","ingredient":"PIRFENIDONE","trade_name":"ESBRIET","family_id":"d595e5f5b7b54daea020","publication_number":"US8778947B2","cleaned_patent_number":"8778947","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2033-08-30","publication_date":"2014-07-15","legal_status":"Granted"} US8778947B2 15 Jul, 2014 Granted 30 Aug, 2033
{"application_id":"37184","ingredient":"PIRFENIDONE","trade_name":"ESBRIET","family_id":"e55bf983d8a042d7ad61","publication_number":"US10188637B2","cleaned_patent_number":"10188637","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2037-03-28","publication_date":"2019-01-29","legal_status":"Granted"} US10188637B2 Formulation 29 Jan, 2019 Granted 28 Mar, 2037

Recent Clinical Trials

Latest clinical trials and research studies for this ingredient

NCT ID Title Status Phase Conditions Start Date Completion Date

API Suppliers/Manufacturer (Branded/Generic companies)

Manufacturing Locations

View Complete Supplier List

Unlock access to all suppliers of Pirfenidone

✓ Access a comprehensive list of global suppliers
✓ Get information on each supplier
Unlock Suppliers

Note: Patent expirations and exclusivity timelines are dynamic and may shift based on litigation, regulatory extensions, and maintenance filings. Regular monitoring is advised.

GreyB © 2025 Elixir. All rights reserved.