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Generated: June 20, 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-six 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
Formulation / Manufacturing:	see details

Pharmacology for NDA: 204275

Mechanism of Action	Adrenergic beta2-Agonists Corticosteroid Hormone Receptor Agonists

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	N	0173-0859-10
BREO ELLIPTA	fluticasone furoate; vilanterol trifenatate	POWDER;INHALATION	204275	NDA	GlaxoSmithKline LLC	0173-0859	N	0173-0859-14

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	POWDER;INHALATION			Strength	0.1MG/INH;EQ 0.025MG BASE/INH
Approval Date:	May 10, 2013	TE:		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

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

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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.