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 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.
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: | 10 |
DrugPatentWatch® Estimated Generic Entry Opportunity Date for 209394
*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: 209394
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: | RX | Dosage: | TABLET;ORAL | Strength | 100MG;40MG | ||||
| Approval Date: | Aug 3, 2017 | 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: | 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: | Apr 10, 2023 | ||||||||
| Regulatory Exclusivity Use: | INFORMATION ADDED TO THE LABELING REGARDING SAFETY AND EFFICACY IN SUBJECTS WITH HCV SUBTYPE 3B INFECTION | ||||||||
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