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Generated: December 15, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 203975

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NDA 203975 describes ANORO ELLIPTA, which is a drug marketed by Glaxosmithkline and is included in one NDA. It is available from one supplier. There are fourteen patents protecting this drug. Additional details are available on the ANORO ELLIPTA profile page.

The generic ingredient in ANORO ELLIPTA is umeclidinium bromide; vilanterol trifenatate. 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; vilanterol trifenatate profile page.

Summary for 203975

Tradename:1
Applicant:1
Ingredient:1
Patents:14

Pharmacology for NDA: 203975

Suppliers and Packaging for NDA: 203975

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ANORO ELLIPTA umeclidinium bromide; vilanterol trifenatate POWDER;INHALATION 203975 NDA GlaxoSmithKline LLC 0173-0869 0173-0869-06 1 TRAY in 1 CARTON (0173-0869-06) > 1 INHALER in 1 TRAY > 7 POWDER in 1 INHALER
ANORO ELLIPTA umeclidinium bromide; vilanterol trifenatate POWDER;INHALATION 203975 NDA GlaxoSmithKline LLC 0173-0869 0173-0869-10 1 TRAY in 1 CARTON (0173-0869-10) > 1 INHALER in 1 TRAY > 30 POWDER in 1 INHALER

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:POWDER;INHALATIONStrengthEQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH
Approval Date:Dec 18, 2013TE:RLD:Yes
Regulatory Exclusivity Expiration:Dec 18, 2018
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Regulatory Exclusivity Expiration:May 10, 2018
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Regulatory Exclusivity Expiration:Dec 18, 2016
Regulatory Exclusivity Use:NEW PRODUCT

Expired Orange Book Patents for NDA: 203975

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
GlaxosmithklineANORO ELLIPTAumeclidinium bromide; vilanterol trifenatatePOWDER;INHALATION203975-001Dec 18, 2013► Subscribe► Subscribe
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Serving leading biopharmaceutical companies globally:

Queensland Health
Teva
AstraZeneca
Dow
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Johnson and Johnson
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Daiichi Sankyo
Federal Trade Commission

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