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McKesson
Fuji
QuintilesIMS
Argus Health
Farmers Insurance
Federal Trade Commission
Merck
Baxter
Julphar

Generated: April 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 206038

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NDA 206038 describes ORKAMBI, which is a drug marketed by Vertex Pharms Inc and is included in one NDA. It is available from one supplier. There are fifteen patents protecting this drug. Additional details are available on the ORKAMBI profile page.

The generic ingredient in ORKAMBI is ivacaftor; lumacaftor. There are three drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the ivacaftor; lumacaftor profile page.
Summary for 206038
Tradename:ORKAMBI
Applicant:Vertex Pharms Inc
Ingredient:ivacaftor; lumacaftor
Patents:15
Suppliers and Packaging for NDA: 206038
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ORKAMBI ivacaftor; lumacaftor TABLET;ORAL 206038 NDA Vertex Pharmaceuticals Incorporated 51167-700 N 51167-700-02
ORKAMBI ivacaftor; lumacaftor TABLET;ORAL 206038 NDA Vertex Pharmaceuticals Incorporated 51167-809 N 51167-809-01

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength125MG;200MG
Approval Date:Jul 2, 2015TE:RLD:Yes
Regulatory Exclusivity Expiration:Jan 25, 2021
Regulatory Exclusivity Use:ADDITIONAL INFORMATION ADDED TO THE PEDIATRIC USE SECTION OF THE LABELING REGARDING A NEW CLINICAL TRIAL IN PATIENTS AGED 6 THROUGH 11 YEARS (TRIAL 4)
Regulatory Exclusivity Expiration:Jul 2, 2020
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Regulatory Exclusivity Expiration:Sep 28, 2023
Regulatory Exclusivity Use:TREATMENT OF CYSTIC FIBROSIS (CF) IN PATIENTS AGE 6-11 YEAR OLD WHO ARE HOMOZYGOUS FOR THE F508DEL MUTATION IN THE CFTR GENE

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AstraZeneca
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