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Serving hundreds of leading biopharmaceutical companies globally:

Medtronic
Federal Trade Commission
Queensland Health
Moodys
Accenture
Mallinckrodt
UBS
US Department of Justice
Express Scripts

Generated: July 18, 2018

DrugPatentWatch Database Preview

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 eight 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-seven 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:8
Therapeutic Class:Respiratory Tract Agents
Formulation / Manufacturing:see details
Generic Entry Opportunity Date for 205625
Generic Entry Date for 205625*:
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: 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 N 0173-0874-10
ARNUITY ELLIPTA fluticasone furoate POWDER;INHALATION 205625 NDA GlaxoSmithKline LLC 0173-0874 N 0173-0874-14

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:POWDER;INHALATIONStrength0.1MG/INH
Approval Date:Aug 20, 2014TE:RLD:Yes
Regulatory Exclusivity Expiration:May 17, 2021
Regulatory Exclusivity Use:NEW PATIENT POPULATION
Patent:➤ Try a Free TrialPatent Expiration:Aug 3, 2021Product Flag?YSubstance Flag?YDelist Request?
Patented Use:INDICATED FOR THE ONCE-DAILY MAINTENANCE TREATMENT OF ASTHMA AS PROPHYLACTIC THERAPY IN PATIENTS AGED 12 YEARS OF AGE AND OLDER
Patent:➤ Try a Free TrialPatent Expiration:Aug 3, 2021Product Flag?YSubstance Flag?Delist Request?

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 205625-001 Aug 20, 2014 ➤ Try a Free Trial ➤ Try a Free Trial
Glaxosmithkline ARNUITY ELLIPTA fluticasone furoate POWDER;INHALATION 205625-002 Aug 20, 2014 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

Harvard Business School
Argus Health
Medtronic
Colorcon
Healthtrust
Fuji
Dow
Fish and Richardson
Federal Trade Commission

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