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Generated: September 18, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 209394

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NDA 209394 describes MAVYRET, which is a drug marketed by Abbvie Inc and is included in one NDA. It is available from one supplier. There are six patents protecting this drug. Additional details are available on the MAVYRET profile page.

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.
Summary for 209394
Tradename:MAVYRET
Applicant:Abbvie Inc
Ingredient:glecaprevir; pibrentasvir
Patents:6
Generic Entry Opportunity Date for 209394
Generic Entry Date for 209394*:
Constraining patent/regulatory exclusivity:
Dosage:
TABLET;ORAL

*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.

Suppliers and Packaging for NDA: 209394
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MAVYRET glecaprevir; pibrentasvir TABLET;ORAL 209394 NDA AbbVie Inc. 0074-2625 0074-2625-01 1 DOSE PACK in 1 CARTON (0074-2625-01) > 3 TABLET, FILM COATED in 1 DOSE PACK
MAVYRET glecaprevir; pibrentasvir TABLET;ORAL 209394 NDA AbbVie Inc. 0074-2625 0074-2625-28 4 CARTON in 1 CARTON (0074-2625-28) > 7 DOSE PACK in 1 CARTON > 3 TABLET, FILM COATED in 1 DOSE PACK

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength100MG;40MG
Approval Date:Aug 3, 2017TE:RLD:Yes
Regulatory Exclusivity Expiration:Aug 3, 2022
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Regulatory Exclusivity Expiration:Aug 6, 2021
Regulatory Exclusivity Use:REVISIONS TO THE GLECAPREVIR/PIBRENTASVIR COMBINATION PRODUCT PRESCRIBING INFORMATION TO INCLUDE SAFETY AND EFFICACY DATA FROM THE HCV/HIV-1 COINFECTION STUDY M14-730 AND FROM THE LIVER AND RENAL TRANSPLANT STUDY M13-596
Patent:➤ Try a Free TrialPatent Expiration:Jun 10, 2030Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF CHRONIC HEPATITIS C VIRUS (HCV) GENOTYPE 1, 2, 3, 4, 5, OR 6

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