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Generated: December 18, 2017

DrugPatentWatch Database Preview

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 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

Tradename:1
Applicant:1
Ingredient:1
Patents:10

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

Summary 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:► SubscribePatent Expiration:Dec 18, 2027Product Flag?YSubstance Flag?YDelist Request?

Expired Orange Book Patents for NDA: 205382

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Glaxo Grp EnglandINCRUSE ELLIPTA umeclidinium bromidePOWDER;INHALATION205382-001Apr 30, 2014► Subscribe► Subscribe
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Serving leading biopharmaceutical companies globally:

Cerilliant
Express Scripts
Cipla
Cantor Fitzgerald
Healthtrust
Daiichi Sankyo
Julphar
Citi
Merck
Mallinckrodt

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