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The generic ingredient in ESBRIET is pirfenidone. There are twenty-two drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the pirfenidone profile page.
Generic Entry Opportunity Date for 208780
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Pharmacology for NDA: 208780
Suppliers and Packaging for NDA: 208780
Profile for product number 001
|Approval Date:||Jan 11, 2017||TE:||RLD:||Yes|
|Regulatory Exclusivity Expiration:||Oct 15, 2019|
|Regulatory Exclusivity Use:||NEW CHEMICAL ENTITY|
|Regulatory Exclusivity Expiration:||Oct 15, 2021|
|Regulatory Exclusivity Use:||TREATMENT OF IDIOPATHIC PULMONARY FIBROSIS|
|Patent:||➤ Sign Up||Patent Expiration:||Apr 22, 2029||Product Flag?||Substance Flag?||Delist Request?|
|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|
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