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.
Latest 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 |
---|---|---|
![]() | ||
Payment of Maintenance Fee, 12th Year, Large Entity | 21 Apr, 2022 | US7832351 |
Expire Patent Critical | 14 Feb, 2022 | US9861771 |
Maintenance Fee Reminder Mailed Critical | 30 Aug, 2021 | US9861771 |
Payment of Maintenance Fee, 12th Year, Large Entity | 13 Aug, 2020 | US7500444 |
Expire Patent Critical | 04 May, 2020 | US7350676 |
Maintenance Fee Reminder Mailed Critical | 18 Nov, 2019 | US7350676 |
Expire Patent Critical | 07 Jan, 2019 | US7143908 |
Maintenance Fee Reminder Mailed Critical | 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.
Patent | Proceeding Filing Date | Status | Respondent | Petitioner |
---|---|---|---|---|
![]() | ||||
US6743413 | September, 2015 |
Terminated-Settled
(18 Nov, 2016) | 3M Company | Mylan Pharmaceuticals Inc. |
US6596260 | July, 2001 |
Decision
(25 Sep, 2002) | BRUGGER et al |
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
![Family Patents](/_nuxt/img/family_patents.217b832.png)
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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.
Drug Owner | Drug Name | |||||||
---|---|---|---|---|---|---|---|---|
Fougera Pharms |
| |||||||
Glaxo Grp Ltd |
| |||||||
Mylan Speciality Lp |
| |||||||
Optinose Us Inc |
| |||||||
Teva Pharm |
|
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 |