Generated: December 18, 2017
DrugPatentWatch Database Preview
Details for New Drug Application (NDA): 205382
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describes INCRUSE ELLIPTA
, which is a drug marketed by Glaxo Grp England and is included in one NDA. It is available from one supplier. There are ten patents protecting this drug. Additional details are available on the INCRUSE ELLIPTA profile page.
The generic ingredient in INCRUSE ELLIPTA is umeclidinium bromide. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the umeclidinium bromide profile page.
Summary for 205382
Pharmacology for NDA: 205382
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Summary for product number 001
|Active Rx/OTC/Discontinued:||RX||Dosage:||POWDER;INHALATION||Strength||EQ 62.5MCG BASE/INH|
|Approval Date:||Apr 30, 2014||TE:||RLD:||Yes|
|Regulatory Exclusivity Expiration:||Dec 18, 2018
|Regulatory Exclusivity Use:||NEW CHEMICAL ENTITY|
|Regulatory Exclusivity Expiration:||Feb 24, 2019
|Regulatory Exclusivity Use:||UPDATES TO THE CLINICAL TRIALS SECTION OF THE LABELING TO INCLUDE RESULTS OF STUDIES PERFORMED TO EVALUATE THE BENEFIT OF ADDING INCRUSE ELLIPTA TO PATIENTS WHO ARE ON BACKGROUND THERAPY WITH BREO ELLIPTA AND ADVAIR DISKUS|
|Patent:||► Subscribe||Patent Expiration:||Dec 18, 2027||Product Flag?||Y||Substance Flag?||Y||Delist Request?|
Expired Orange Book Patents for NDA: 205382
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