Flovent Hfa Patent Expiration

Flovent Hfa is a drug owned by Glaxo Group Ltd Dba Glaxosmithkline. It is protected by 39 US drug patents filed from 2013 to 2018. Out of these, 2 drug patents are active and 37 have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Aug 26, 2026. Details of Flovent Hfa's patents and their expiration are given in the table below.

Drug Patent Number Drug Patent Title Drug Patent Expiry Status
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US6251368 Pharmaceutical aerosol formulation containing a particulate medicament, a propellant and substantially free of a surfactant
Dec, 2012

(11 years ago)

Expired
US6251368

(Pediatric)

Pharmaceutical aerosol formulation containing a particulate medicament, a propellant and substantially free of a surfactant
Jun, 2013

(11 years ago)

Expired
US6596260 Aerosol container and a method for storage and administration of a predetermined amount of a pharmaceutically active aerosol
Aug, 2014

(10 years ago)

Expired
US5658549 Aerosol formulations containing propellant 134a and fluticasone propionate
Aug, 2014

(10 years ago)

Expired
US5674472 Canisters containing aerosol formulations containing P134a and fluticasone propionate
Oct, 2014

(9 years ago)

Expired
US6596260

(Pediatric)

Aerosol container and a method for storage and administration of a predetermined amount of a pharmaceutically active aerosol
Feb, 2015

(9 years ago)

Expired
US5658549

(Pediatric)

Aerosol formulations containing propellant 134a and fluticasone propionate
Feb, 2015

(9 years ago)

Expired
US5674472

(Pediatric)

Canisters containing aerosol formulations containing P134a and fluticasone propionate
Apr, 2015

(9 years ago)

Expired
US6315173 Valve for aerosol container
Dec, 2017

(6 years ago)

Expired
US6966467 Valve for aerosol container
Dec, 2017

(6 years ago)

Expired
US6170717 Valve for aerosol container
Dec, 2017

(6 years ago)

Expired
US6510969 Valve for aerosol container
Dec, 2017

(6 years ago)

Expired
US6161724 Indicating device
Jan, 2018

(6 years ago)

Expired
US6435372 Delivery system for a medicament and method for the assembly thereof
Jan, 2018

(6 years ago)

Expired
US6938796 Indicating device
Jan, 2018

(6 years ago)

Expired
US7143908 Indicating device
Jan, 2018

(6 years ago)

Expired
US6997349 Indicating device
Jan, 2018

(6 years ago)

Expired
US7107986 Dispenser with doses' counter
Jun, 2018

(6 years ago)

Expired
US6431168 Dispenser with doses′ counter
Jun, 2018

(6 years ago)

Expired
US6315173

(Pediatric)

Valve for aerosol container
Jun, 2018

(6 years ago)

Expired
US6966467

(Pediatric)

Valve for aerosol container
Jun, 2018

(6 years ago)

Expired
US6510969

(Pediatric)

Valve for aerosol container
Jun, 2018

(6 years ago)

Expired
US6170717

(Pediatric)

Valve for aerosol container
Jun, 2018

(6 years ago)

Expired
US6997349

(Pediatric)

Indicating device
Jul, 2018

(6 years ago)

Expired
US6435372

(Pediatric)

Delivery system for a medicament and method for the assembly thereof
Jul, 2018

(6 years ago)

Expired
US7143908

(Pediatric)

Indicating device
Jul, 2018

(6 years ago)

Expired
US6161724

(Pediatric)

Indicating device
Jul, 2018

(6 years ago)

Expired
US6938796

(Pediatric)

Indicating device
Jul, 2018

(6 years ago)

Expired
US7350676 Valve for aerosol container
Aug, 2018

(6 years ago)

Expired
US6431168

(Pediatric)

Dispenser with doses′ counter
Dec, 2018

(5 years ago)

Expired
US7350676

(Pediatric)

Valve for aerosol container
Feb, 2019

(5 years ago)

Expired
US7107986

(Pediatric)

Dispenser with doses' counter
Dec, 2019

(4 years ago)

Expired
US9861771 Device housing for an aerosol container
Oct, 2020

(3 years ago)

Expired
US6743413 Suspension aerosol formulations
Jun, 2021

(3 years ago)

Expired
US6743413

(Pediatric)

Suspension aerosol formulations
Dec, 2021

(2 years ago)

Expired
US7832351 Actuation indicator for a dispensing device
Jun, 2023

(1 year, 2 months ago)

Expired
US7832351

(Pediatric)

Actuation indicator for a dispensing device
Dec, 2023

(8 months ago)

Expired
US7500444 Actuation indicator for a dispensing device
Feb, 2026

(1 year, 5 months from now)

Active
US7500444

(Pediatric)

Actuation indicator for a dispensing device
Aug, 2026

(1 year, 11 months from now)

Active


A patent's expiry date may change depending upon legal activities going on that patent. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. Tracking these ongoing activities on a patent application helps to keep an eye on the latest developments in the patent process of the drug which can give an idea of how early a drug's generic could be available. The next section provides a list of recent legal activities on Flovent Hfa's patents.

Given below is the list of recent legal activities going on the following patents of Flovent Hfa.

Activity Date Patent Number
Patent litigations
Payment of Maintenance Fee, 12th Year, Large Entity 21 Apr, 2022 US7832351
Expire Patent 14 Feb, 2022 US9861771
Maintenance Fee Reminder Mailed 30 Aug, 2021 US9861771
Payment of Maintenance Fee, 12th Year, Large Entity 13 Aug, 2020 US7500444
Expire Patent 04 May, 2020 US7350676
Maintenance Fee Reminder Mailed 18 Nov, 2019 US7350676
Expire Patent 07 Jan, 2019 US7143908
Maintenance Fee Reminder Mailed 16 Jul, 2018 US7143908
Payment of Maintenance Fee, 8th Year, Large Entity 13 Apr, 2018 US7832351
Payment of Maintenance Fee, 12th Year, Large Entity 14 Feb, 2018 US7107986


While patent expiration is one way of estimating the generic date of a drug, if a patent gets invalidated somehow, the generic of the drug may arrive early. Being aware of all relevant patents can help in avoiding legal pitfalls. Given below are details of the litigation history of Flovent Hfa and ongoing litigations to help you estimate the early arrival of Flovent Hfa generic.

Flovent Hfa's Litigations

Flovent Hfa has been subject to various legal proceedings, including patent litigations. The earliest legal proceeding was initiated on Jul 26, 2001, against patent number US6596260. The petitioner , challenged the validity of this patent, with BRUGGER et al as the respondent. Click below to track the latest information on how companies are challenging Flovent Hfa's patents.

Last updated on September 3, 2024
Patent Proceeding Filing Date Status Respondent Petitioner
Patent litigations
US6743413 September, 2015 Terminated-Settled
(18 Nov, 2016)
3M Company Mylan Pharmaceuticals Inc.
US6596260 July, 2001 Decision
(25 Sep, 2002)
BRUGGER et al

Stay ahead of others in designing the generic launch strategy of these 5 blockbuster drugs expiring in next 5 years.

Get the exclusive patent insights now. Don't be the last to know.

US patents provide insights into the exclusivity only within the United States, but Flovent Hfa is protected by patents in multiple countries. Understanding the full scope of patent protection is crucial in strategizing market entry. By looking at the broader patent landscape, you can identify markets with weaker patent protection which could be ideal generic entry points. The following section offers details on Flovent Hfa's family patents as well as insights into ongoing legal events on those patents.

Flovent Hfa's Family Patents

Flovent Hfa has patent protection in a total of 17 countries. It's US patent count contributes only to 7.1% of its total global patent coverage. 5 countries have all of their patents expired or invalidated which has opened up potential generic launch opportunities in these countries. Click below to unlock the full patent family tree for Flovent Hfa.

Family Patents



Generic Launch

Generic Release Date:

Flovent Hfa's generic launch date based on the expiry of its last outstanding patent is estimated to be Aug 26, 2026 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)

Flovent Hfa Generics:

Fluticasone Propionate is the generic name for the brand Flovent Hfa. 13 different companies have already filed for the generic of Flovent Hfa, with Hikma having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Flovent Hfa's generic

How can I launch a generic of Flovent Hfa before its drug patent expiration? :

You can seek FDA approval to launch a generic drug before the expiration of Flovent Hfa's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Flovent Hfa's sponsor is invalid, unenforceable, or will not be infringed by your generic product.

Given below are the details of the already filed Para IV certificates on Flovent Hfa -

Strength Submission Date ANDA(s) Filed First applicant approval Last patent expiry 180 day status
0.11 mcg/inh 23 Dec, 2016 1 26 Feb, 2026
0.22 mcg/inh 29 Oct, 2021 1 26 Feb, 2026

Flovent Hfa Competitors

Understanding your competition is essential for market success. Flovent Hfa which is used for treating respiratory disorders such as asthma through inhalation of a pharmaceutical formulation., has several other brand drugs using the same active ingredient (Fluticasone Propionate). Given below is the list of those companies and their brand drugs, to help you identify new opportunities, assess competitors, and plan your market strategies more effectively.


Apart from brand drugs containing the same ingredient, some generics have also been filed for Fluticasone Propionate, Flovent Hfa's active ingredient. Check the complete list of approved generic manufacturers for Flovent Hfa





About Flovent Hfa

Flovent Hfa is a drug owned by Glaxo Group Ltd Dba Glaxosmithkline. It is used for treating respiratory disorders such as asthma through inhalation of a pharmaceutical formulation. Flovent Hfa uses Fluticasone Propionate as an active ingredient. Flovent Hfa was launched by Glaxo Grp Ltd in 2004.

Approval Date:

Flovent Hfa was approved by FDA for market use on 14 May, 2004.

Active Ingredient:

Flovent Hfa uses Fluticasone Propionate as the active ingredient. Check out other Drugs and Companies using Fluticasone Propionate ingredient

Treatment:

Flovent Hfa is used for treating respiratory disorders such as asthma through inhalation of a pharmaceutical formulation.

Dosage:

Flovent Hfa is available in aerosol, metered form for inhalation use. Given below is detailed information on Dosage -

Strength Dosage Form Availability Application Pathway
0.22MG/INH AEROSOL, METERED Prescription INHALATION
0.044MG/INH AEROSOL, METERED Prescription INHALATION
0.11MG/INH AEROSOL, METERED Prescription INHALATION