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The generic ingredient in MAVYRET is glecaprevir; pibrentasvir. One supplier is listed for this compound. Additional details are available on the glecaprevir; pibrentasvir profile page.
DrugPatentWatch® Estimated Generic Entry Opportunity Date for 215110
*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: 215110
Profile for product number 001
|Approval Date:||Jun 10, 2021||TE:||RLD:||Yes|
|Regulatory Exclusivity Expiration:||Sep 26, 2022|
|Regulatory Exclusivity Use:||EIGHT-WEEK DOSING REGIMEN FOR THE TREATMENT OF GENOTYPES 1, 2, 3, 4, 5, AND 6, CHRONIC HEPATITIS C VIRUS INFECTION IN TREATMENT-NAIVE SUBJECTS WITH COMPENSATED CIRRHOSIS BASED ON THE RESULTS FROM THE EXPEDITION-8 STUDY|
|Regulatory Exclusivity Expiration:||Apr 10, 2023|
|Regulatory Exclusivity Use:||INFORMATION ADDED TO THE LABELING REGARDING SAFETY AND EFFICACY IN SUBJECTS WITH HCV SUBTYPE 3B INFECTION|
|Regulatory Exclusivity Expiration:||Aug 3, 2022|
|Regulatory Exclusivity Use:||NEW CHEMICAL ENTITY|
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