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Last Updated: May 21, 2024

Details for New Drug Application (NDA): 205625


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NDA 205625 describes ARNUITY ELLIPTA, which is a drug marketed by Glaxosmithkline and is included in one NDA. It is available from one supplier. There are three patents protecting this drug. Additional details are available on the ARNUITY ELLIPTA profile page.

The generic ingredient in ARNUITY ELLIPTA is fluticasone furoate. There are twenty-nine drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the fluticasone furoate profile page.
Summary for 205625
Tradename:ARNUITY ELLIPTA
Applicant:Glaxosmithkline
Ingredient:fluticasone furoate
Patents:3
Formulation / Manufacturing:see details
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 205625
Generic Entry Date for 205625*:
Constraining patent/regulatory exclusivity:
INFORMATION ADDED TO SECTION 8.4 OF THE LABELING TO INCLUDE THE RESULT OF STUDY HZA114971
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: 205625
Suppliers and Packaging for NDA: 205625
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ARNUITY ELLIPTA fluticasone furoate POWDER;INHALATION 205625 NDA GlaxoSmithKline LLC 0173-0874 0173-0874-10 1 INHALER in 1 CARTON (0173-0874-10) / 30 POWDER in 1 INHALER
ARNUITY ELLIPTA fluticasone furoate POWDER;INHALATION 205625 NDA GlaxoSmithKline LLC 0173-0874 0173-0874-14 1 INHALER in 1 CARTON (0173-0874-14) / 14 POWDER in 1 INHALER

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:POWDER;INHALATIONStrength0.1MG/INH
Approval Date:Aug 20, 2014TE:RLD:Yes
Patent:⤷  Try a TrialPatent Expiration:Feb 5, 2029Product Flag?YSubstance Flag?Delist Request?
Patent:⤷  Try a TrialPatent Expiration:Apr 11, 2031Product Flag?Substance Flag?Delist Request?Y
Patent:⤷  Try a TrialPatent Expiration:Apr 2, 2028Product Flag?Substance Flag?Delist Request?Y

Expired US Patents for NDA 205625

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Glaxosmithkline ARNUITY ELLIPTA fluticasone furoate POWDER;INHALATION 205625-003 May 17, 2018 ⤷  Try a Trial ⤷  Try a Trial
Glaxosmithkline ARNUITY ELLIPTA fluticasone furoate POWDER;INHALATION 205625-002 Aug 20, 2014 ⤷  Try a Trial ⤷  Try a Trial
Glaxosmithkline ARNUITY ELLIPTA fluticasone furoate POWDER;INHALATION 205625-002 Aug 20, 2014 ⤷  Try a Trial ⤷  Try a Trial
Glaxosmithkline ARNUITY ELLIPTA fluticasone furoate POWDER;INHALATION 205625-001 Aug 20, 2014 ⤷  Try a Trial ⤷  Try a 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 verification 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.