➤ Get the DrugPatentWatch Daily Briefing

Get Daily Updates on Generic Entry, Litigation, Biosimilars, and more …

Serving leading biopharmaceutical companies globally:

Colorcon
Boehringer Ingelheim
Harvard Business School
McKesson
Johnson and Johnson
Moodys

Last Updated: October 27, 2021

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021433


Email this page to a colleague

« Back to Dashboard

NDA 021433 describes FLOVENT HFA, which is a drug marketed by Glaxo Grp Ltd and is included in one NDA. It is available from four suppliers. There are three patents protecting this drug. Additional details are available on the FLOVENT HFA profile page.

The generic ingredient in FLOVENT HFA is fluticasone propionate. There are twenty-nine drug master file entries for this compound. Seventy suppliers are listed for this compound. Additional details are available on the fluticasone propionate profile page.
Summary for 021433
Tradename:FLOVENT HFA
Applicant:Glaxo Grp Ltd
Ingredient:fluticasone propionate
Patents:3
Formulation / Manufacturing:see details
Pharmacology for NDA: 021433
Suppliers and Packaging for NDA: 021433
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FLOVENT HFA fluticasone propionate AEROSOL, METERED;INHALATION 021433 NDA GlaxoSmithKline LLC 0173-0718 0173-0718-20 1 INHALER in 1 CARTON (0173-0718-20) > 120 AEROSOL, METERED in 1 INHALER
FLOVENT HFA fluticasone propionate AEROSOL, METERED;INHALATION 021433 NDA GlaxoSmithKline LLC 0173-0719 0173-0719-20 1 INHALER in 1 CARTON (0173-0719-20) > 120 AEROSOL, METERED in 1 INHALER
Paragraph IV (Patent) Challenges for 021433
Tradename Dosage Ingredient NDA Submissiondate
FLOVENT HFA AEROSOL, METERED;INHALATION fluticasone propionate 021433 2016-12-23

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:AEROSOL, METERED;INHALATIONStrength0.22MG/INH
Approval Date:May 14, 2004TE:RLD:Yes
Patent:⤷  Try it FreePatent Expiration:Aug 26, 2026Product Flag?Substance Flag?Delist Request?Y
Patent:⤷  Try it FreePatent Expiration:Dec 19, 2023Product Flag?Substance Flag?Delist Request?Y

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:AEROSOL, METERED;INHALATIONStrength0.11MG/INH
Approval Date:May 14, 2004TE:RLD:Yes
Patent:⤷  Try it FreePatent Expiration:Dec 1, 2021Product Flag?Substance Flag?Delist Request?Y

Expired US Patents for NDA 021433

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Glaxo Grp Ltd FLOVENT HFA fluticasone propionate AEROSOL, METERED;INHALATION 021433-001 May 14, 2004 ⤷  Try it Free ⤷  Try it Free
Glaxo Grp Ltd FLOVENT HFA fluticasone propionate AEROSOL, METERED;INHALATION 021433-001 May 14, 2004 ⤷  Try it Free ⤷  Try it Free
Glaxo Grp Ltd FLOVENT HFA fluticasone propionate AEROSOL, METERED;INHALATION 021433-002 May 14, 2004 ⤷  Try it Free ⤷  Try it Free
Glaxo Grp Ltd FLOVENT HFA fluticasone propionate AEROSOL, METERED;INHALATION 021433-001 May 14, 2004 ⤷  Try it Free ⤷  Try it Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Complete Access Available with Subscription

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

Serving leading biopharmaceutical companies globally:

AstraZeneca
Dow
McKesson
McKinsey
Merck
Boehringer Ingelheim

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.