Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Last Updated: October 21, 2019

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 two suppliers. 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-nine 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 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: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.
Patent:  Start TrialPatent Expiration:Aug 3, 2021Product Flag?YSubstance Flag?Delist Request?
Patented Use:INDICATED FOR LONG-TERM, ONCE-DAILY MAINTENANCE TREATMENT OF AIRFLOW OBSTRUCTION IN PTS WITH COPD, INCLUDING CHRONIC BRONCHITIS AND/OR EMPHYSEMA, ALSO TO REDUCE EXACERBATIONS OF COPD IN PTS WITH A HISTORY OF EXACERBATIONS
Patent:  Start TrialPatent Expiration:Aug 3, 2021Product Flag?YSubstance Flag?Delist Request?
Patented Use:INDICATED FOR THE ONCE-DAILY INHALED TREATMENT FOR ASTHMA IN ADULTS AGED 18 YEARS AND OLDER

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   Start Trial   Start Trial
Glaxo Grp Ltd BREO ELLIPTA fluticasone furoate; vilanterol trifenatate POWDER;INHALATION 204275-002 Apr 30, 2015   Start Trial   Start 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.