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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 two suppliers. There are fifteen 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-two drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the fluticasone furoate; vilanterol trifenatate profile page.

Summary for NDA: 204275

Tradename:
BREO ELLIPTA
Applicant:
Glaxo Grp Ltd
Ingredient:
fluticasone furoate; vilanterol trifenatate
Patents:15
Formulation / Manufacturing:see details

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

Summary 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
Patent:5,873,360Patent Expiration:Feb 23, 2016Product Flag?YSubstance Flag?Delist Request?
Patent:7,629,335Patent Expiration:Aug 3, 2021Product Flag?YSubstance Flag?Delist Request?
Patent:7,776,895Patent Expiration:Sep 11, 2022Product Flag?YSubstance Flag?Delist Request?

Expired Orange Book Patents for NDA: 204275

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Glaxo Grp Ltd
BREO ELLIPTA
fluticasone furoate; vilanterol trifenatate
POWDER;INHALATION204275-001May 10, 20135,873,360► subscribe
Glaxo Grp Ltd
BREO ELLIPTA
fluticasone furoate; vilanterol trifenatate
POWDER;INHALATION204275-002Apr 30, 20155,873,360► subscribe
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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