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  1. pharmadog
  2. ›drugs
  3. ›PIRFENIDONE
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PIRFENIDONE

Marketedupdated 3mo ago
by Aizant Drug Research Solutions Pvt Ltd
Approved
community read0 votes

🐶 often sniffed alongside

top 3
  • tagApproval2 co-mentions · 1 sources
  • companyAurobindo Pharma Ltd1 co-mentions · 1 sources
  • tagSmall Molecule1 co-mentions · 1 sources

indications

investigational
Pulmonary Fibrosis

all catalysts(1)

approval · 1
Apr 20, 2026
approval
4mo ago
PIRFENIDONE — FDA approval
PIRFENIDONE
→

Trials studying PIRFENIDONE

  • phase2A Study in People With Idiopathic Pulmonary Fibrosis to Test Whether Pirfenidone Influences the Amount of BI 1015550 in the Bloodactive not recruitingn=20
  • phase3Trial to Evaluate the Efficacy and Safety of LYT-100 (Deupirfenidone) Compared to Pirfenidone in Adults With Idiopathic Pulmonary Fibrosis (IPF)recruitingn=1,100
  • phase1A Study to Evaluate Pharmacokinetics and Drug-drug Interactions of ENV-101 (Taladegib) in Healthy Participantsrecruitingn=57
  • phase1Study on the Drug Interactions of HRS-9813, Pirfenidone and Nintedanib in Healthy Subjectsrecruitingn=20
  • phase3Pirfenidone Capsules in the Treatment of Radiation-induced Lung Injury With or Without Immune Pneumoniarecruitingn=298
  • phase2Phase ll Study of HEC585 in Patients With IPFactive not recruitingn=270
  • phase3Confirmatory Clinical Study of HEC585 Tablets in Patients With IPFrecruitingn=472
  • —Real-life-persistence to Antifibrotic Treatmentscompletedn=10,646
more trials →

Patent cliff

source: FDA Orange Book
first barrier falls
Sep 22, 2026
32 days

Earliest of all listed patents + FDA exclusivities. Generic / biosimilar entry typically only becomes possible AFTER both patent and exclusivity barriers expire.

patents (67)

  • Mar 28, 2037formulationUS 10188637
  • Mar 28, 2037formulationUS 10188637
  • Mar 28, 2037formulationUS 10188637
  • Aug 30, 2033method-of-use (U-2045)US 8778947
  • Aug 30, 2033method-of-use (U-1613)US 8778947
  • Aug 30, 2033method-of-use (U-2045)US 8778947
  • Aug 30, 2033method-of-use (U-2045)US 8778947
  • Jan 8, 2030method-of-use (U-1603)US 78163833.4y
  • Jan 8, 2030method-of-use (U-2042)US 78163833.4y
  • Jan 8, 2030method-of-use (U-2042)US 78163833.4y
  • Jan 8, 2030method-of-use (U-2050)US 78163833.4y
  • Jan 8, 2030method-of-use (U-2049)US 79106103.4y
  • Jan 8, 2030method-of-use (U-2048)US 79106103.4y
  • Jan 8, 2030method-of-use (U-2049)US 79106103.4y
  • Jan 8, 2030method-of-use (U-1604)US 79106103.4y
  • Jan 8, 2030method-of-use (U-2082)US 80130023.4y
  • Jan 8, 2030method-of-use (U-1603)US 80130023.4y
  • Jan 8, 2030method-of-use (U-2082)US 80130023.4y
  • Jan 8, 2030method-of-use (U-2047)US 80130023.4y
  • Jan 8, 2030method-of-use (U-2054)US 80844753.4y
  • Jan 8, 2030method-of-use (U-2054)US 80844753.4y
  • Jan 8, 2030method-of-use (U-2054)US 80844753.4y
  • Jan 8, 2030method-of-use (U-1605)US 80844753.4y
  • Jan 8, 2030method-of-use (U-2081)US 83187803.4y
  • Jan 8, 2030method-of-use (U-2081)US 83187803.4y
  • Jan 8, 2030method-of-use (U-2046)US 83187803.4y
  • Jan 8, 2030method-of-use (U-1606)US 83187803.4y
  • Jan 8, 2030method-of-use (U-1611)US 86480983.4y
  • Jan 8, 2030method-of-use (U-2052)US 86480983.4y
  • Jan 8, 2030method-of-use (U-2051)US 86480983.4y
  • Jan 8, 2030method-of-use (U-2051)US 86480983.4y
  • Jan 8, 2030method-of-use (U-1612)US 87541093.4y
  • Jan 8, 2030method-of-use (U-2053)US 87541093.4y
  • Jan 8, 2030method-of-use (U-2053)US 87541093.4y
  • Jan 8, 2030method-of-use (U-2053)US 87541093.4y
  • Apr 22, 2029method-of-use (U-1600)US 75667292.7y
  • Apr 22, 2029method-of-use (U-2270)US 75667292.7y
  • Apr 22, 2029method-of-use (U-2077)US 75667292.7y
  • Apr 22, 2029method-of-use (U-2077)US 75667292.7y
  • Apr 22, 2029method-of-use (U-2073)US 76357072.7y
  • Apr 22, 2029method-of-use (U-2074)US 76357072.7y
  • Apr 22, 2029method-of-use (U-2076)US 76357072.7y
  • Apr 22, 2029method-of-use (U-1609)US 76357072.7y
  • Apr 22, 2029method-of-use (U-2060)US 85924622.7y
  • Apr 22, 2029method-of-use (U-2062)US 85924622.7y
  • Apr 22, 2029method-of-use (U-2059)US 85924622.7y
  • Apr 22, 2029method-of-use (U-1609)US 85924622.7y
  • Apr 22, 2029method-of-use (U-2066)US 86097012.7y
  • Apr 22, 2029method-of-use (U-2070)US 86097012.7y
  • Apr 22, 2029method-of-use (U-1610)US 86097012.7y
  • Apr 22, 2029method-of-use (U-2064)US 86097012.7y
  • May 10, 2028formulationUS 83831501.7y
  • May 10, 2028formulationUS 83831501.7y
  • May 10, 2028formulationUS 83831501.7y
  • May 10, 2028formulationUS 83831501.7y
  • Dec 18, 2027method-of-use (U-1601)US 76962361.3y
  • Dec 18, 2027method-of-use (U-2080)US 77677001.3y
  • Dec 18, 2027method-of-use (U-2080)US 77677001.3y
  • Dec 18, 2027method-of-use (U-2080)US 77677001.3y
  • Dec 18, 2027method-of-use (U-1601)US 77677001.3y
  • Dec 18, 2027method-of-use (U-2079)US 84206741.3y
  • Dec 18, 2027formulationUS 84206741.3y
  • Dec 18, 2027method-of-use (U-2079)US 84206741.3y
  • Dec 18, 2027method-of-use (U-2079)US 84206741.3y
  • Sep 22, 2026formulationUS 776722532d
  • Sep 22, 2026formulationUS 798899432d
  • Sep 22, 2026formulationUS 875367932d

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brand
PIRFENIDONE
generic
PIRFENIDONE
indication
Idiopathic Pulmonary Fibrosis
phase
marketed
Data sources
openFDA · ClinicalTrials.gov
last refreshed 34m ago
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