Get our Free Patent Expiration Newsletter

Serving leading biopharmaceutical companies globally:

Moodys
McKinsey
Johnson and Johnson
Harvard Business School
AstraZeneca
Express Scripts

Last Updated: October 22, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 209482

See Plans and Pricing

« Back to Dashboard

NDA 209482 describes TRELEGY ELLIPTA, which is a drug marketed by Glaxosmithkline and is included in one NDA. It is available from one supplier. There are nineteen patents protecting this drug. Additional details are available on the TRELEGY ELLIPTA profile page.

The generic ingredient in TRELEGY ELLIPTA is fluticasone furoate; umeclidinium bromide; vilanterol trifenatate. There are twenty-nine drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the fluticasone furoate; umeclidinium bromide; vilanterol trifenatate profile page.
Summary for 209482
Generic Entry Opportunity Date for 209482
Generic Entry Date for 209482*:
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.

Suppliers and Packaging for NDA: 209482
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TRELEGY ELLIPTA fluticasone furoate; umeclidinium bromide; vilanterol trifenatate POWDER;INHALATION 209482 NDA GlaxoSmithKline LLC 0173-0887 0173-0887-10 1 TRAY in 1 CARTON (0173-0887-10) > 1 INHALER in 1 TRAY > 30 POWDER in 1 INHALER
TRELEGY ELLIPTA fluticasone furoate; umeclidinium bromide; vilanterol trifenatate POWDER;INHALATION 209482 NDA GlaxoSmithKline LLC 0173-0887 0173-0887-14 1 TRAY in 1 CARTON (0173-0887-14) > 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 0.0625MG BASE/INH;EQ 0.025MG BASE/INH
Approval Date:Sep 18, 2017TE:RLD:Yes
Regulatory Exclusivity Expiration:Apr 24, 2021
Regulatory Exclusivity Use:REVISED INDICATION FOR FIXED-DOSE COMBINATION OF FLUTICASONE FUROATE, UMECLIDINIUM, AND VILANTEROL TO TREAT AIRFLOW OBSTRUCTION IN CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD) AND TO REDUCE COPD EXACERBATIONS IN PTS WITH HISTORY OF EXACERBATIONS
Patent:  Start TrialPatent Expiration:Aug 3, 2021Product Flag?YSubstance Flag?Delist Request?
Patented Use:THE TREATMENT OF AN INFLAMMATORY DISORDER OF THE RESPIRATORY TRACT BY ONCE-PER-DAY ADMINISTRATION OF A PHARMACEUTICAL FORMULATION COMPRISING FLUTICASONE FUROATE AND A LONG-ACTING BETA2 ADRENORECEPTOR AGONIST
Patent:  Start TrialPatent Expiration:Aug 3, 2021Product Flag?YSubstance Flag?Delist Request?
Patented Use:THE TREATMENT OF AN INFLAMMATORY DISORDER OF THE RESPIRATORY TRACT BY ONCE-PER-DAY ADMINISTRATION OF A PHARMACEUTICAL FORMULATION COMPRISING FLUTICASONE FUROATE AND A LONG-ACTING BETA2 ADRENORECEPTOR AGONIST

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Harvard Business School
Medtronic
Moodys
Colorcon
McKesson

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.