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Generated: September 25, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 204275

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NDA 204275 describes BREO ELLIPTA, which is a drug marketed by Glaxo Grp Ltd 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 BREO ELLIPTA profile page.

The generic ingredient in BREO ELLIPTA is fluticasone furoate; vilanterol trifenatate. There are twenty-seven drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the fluticasone furoate; vilanterol trifenatate profile page.
Summary for 204275
Tradename:BREO ELLIPTA
Applicant:Glaxo Grp Ltd
Ingredient:fluticasone furoate; vilanterol trifenatate
Patents:14
Generic Entry Opportunity Date for 204275
Generic Entry Date for 204275*:
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: 204275
Suppliers and Packaging for NDA: 204275
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BREO ELLIPTA fluticasone furoate; vilanterol trifenatate POWDER;INHALATION 204275 NDA GlaxoSmithKline LLC 0173-0859 0173-0859-10 1 TRAY in 1 CARTON (0173-0859-10) > 1 INHALER in 1 TRAY > 30 POWDER in 1 INHALER
BREO ELLIPTA fluticasone furoate; vilanterol trifenatate POWDER;INHALATION 204275 NDA GlaxoSmithKline LLC 0173-0859 0173-0859-14 1 TRAY in 1 CARTON (0173-0859-14) > 1 INHALER in 1 TRAY > 14 POWDER in 1 INHALER

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:POWDER;INHALATIONStrength0.1MG/INH;EQ 0.025MG BASE/INH
Approval Date:May 10, 2013TE:RLD:Yes
Regulatory Exclusivity Expiration:Apr 30, 2018
Regulatory Exclusivity Use:DAILY TREATMENT OF ASTHMA IN PATIENTS AGED 18 YEARS AND OLDER
Regulatory Exclusivity Expiration:May 15, 2020
Regulatory Exclusivity Use:INCLUSION OF DATA FROM THE SUMMIT STUDY FOR BREO ELLIPTA (FLUTICASONE FUROATE/VILANTEROL TRIFENATATE) INHALATION POWDER IN THE PACKAGE INSERT.
Regulatory Exclusivity Expiration:May 10, 2018
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY

Expired US Patents for NDA 204275

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Glaxo Grp Ltd BREO ELLIPTA fluticasone furoate; vilanterol trifenatate POWDER;INHALATION 204275-001 May 10, 2013 ➤ Sign Up ➤ Sign Up
Glaxo Grp Ltd BREO ELLIPTA fluticasone furoate; vilanterol trifenatate POWDER;INHALATION 204275-002 Apr 30, 2015 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Daiichi Sankyo
Fuji
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Covington
Chinese Patent Office

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