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Last Updated: March 28, 2024

Details for New Drug Application (NDA): 215110


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NDA 215110 describes MAVYRET, which is a drug marketed by Abbvie and is included in two NDAs. It is available from one supplier. There are ten 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 215110
Tradename:MAVYRET
Applicant:Abbvie
Ingredient:glecaprevir; pibrentasvir
Patents:8
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 215110
Generic Entry Date for 215110*:
Constraining patent/regulatory exclusivity:
Dosage:
PELLETS;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: 215110
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MAVYRET glecaprevir; pibrentasvir PELLETS;ORAL 215110 NDA AbbVie Inc. 0074-2600 0074-2600-28 1 PACKET in 1 CARTON (0074-2600-28) / 28 PELLET in 1 PACKET

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:PELLETS;ORALStrength50MG;20MG/PACKET
Approval Date:Jun 10, 2021TE:RLD:Yes
Regulatory Exclusivity Expiration:Jun 10, 2028
Regulatory Exclusivity Use:FOR TREATMENT OF PEDIATRIC PATIENTS 3 YEARS OF AGE TO LESS THAN 12 YEARS OF AGE WEIGHING LESS THAN 45 KG WITH CHRONIC HEPATITIS C VIRUS (HCV) GENOTYPE 1, 2, 3, 4, 5 OR 6 INFECTION WITHOUT CIRRHOSIS OR WITH COMPENSATED CIRRHOSIS (CHILD-PUGH A); AND TREATMENT OF PEDIATRIC PATIENTS 3 YEARS OF AGE TO LESS THAN 12 YEARS OF AGE WEIGHING LESS THAN 45 KG WITH HCV GENOTYPE 1 INFECTION, WHO PREVIOUSLY HAVE BEEN TREATED WITH A REGIMEN CONTAINING AN HCV NS5A INHIBITOR OR AN NS3/4A PROTEASE INHIBITOR (PI), BUT NOT BOTH
Regulatory Exclusivity Expiration:Dec 10, 2028
Regulatory Exclusivity Use:PEDIATRIC EXCLUSIVITY
Patent:⤷  Try a TrialPatent Expiration:Dec 10, 2030Product Flag?Substance Flag?Delist Request?Y

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.