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Generated: November 15, 2018

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Details for New Drug Application (NDA): 205382

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NDA 205382 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 are two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the umeclidinium bromide profile page.
Summary for 205382
Tradename:INCRUSE ELLIPTA
Applicant:Glaxo Grp England
Ingredient:umeclidinium bromide
Patents:10
Generic Entry Opportunity Date for 205382
Generic Entry Date for 205382*:
Constraining patent/regulatory exclusivity:
Dosage:
POWDER;INHALATION

*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: 205382
Mechanism of ActionCholinergic Antagonists
Suppliers and Packaging for NDA: 205382
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
INCRUSE ELLIPTA umeclidinium bromide POWDER;INHALATION 205382 NDA GlaxoSmithKline LLC 0173-0873 0173-0873-06 1 TRAY in 1 CARTON (0173-0873-06) > 1 INHALER in 1 TRAY > 7 AEROSOL, POWDER in 1 INHALER
INCRUSE ELLIPTA umeclidinium bromide POWDER;INHALATION 205382 NDA GlaxoSmithKline LLC 0173-0873 0173-0873-10 1 TRAY in 1 CARTON (0173-0873-10) > 1 INHALER in 1 TRAY > 30 AEROSOL, POWDER in 1 INHALER

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:POWDER;INHALATIONStrengthEQ 62.5MCG BASE/INH
Approval Date:Apr 30, 2014TE: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:➤ Try a Free TrialPatent Expiration:Dec 18, 2027Product Flag?YSubstance Flag?YDelist Request?

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