Flovent Diskus 100 Patent Expiration

Flovent Diskus 100 is a drug owned by Glaxo Group Ltd England Dba Glaxosmithkline. It is protected by 2 US drug patents filed in 2013 out of which all have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Aug 23, 2016. Details of Flovent Diskus 100's patents and their expiration are given in the table below.

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Drug Patent Number Drug Patent Title Drug Patent Expiry Status
These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US5873360

(Pediatric)

Inhalation device
Aug, 2016

(10 years ago)

Expired
US5873360 Inhalation device
Feb, 2016

(10 years ago)

Expired

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US patents provide insights into the exclusivity only within the United States, but Flovent Diskus 100 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 Diskus 100's family patents as well as insights into ongoing legal events on those patents.

Flovent Diskus 100's Family Patents


Family Patents

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Clinical Trials

Recent Clinical Trials on Flovent Diskus 100:

Sometimes companies keep conducting clinical trials even after the drug's approval to discover new formulations, methods of use, or new treatment indications, so they could file for additional patents or receive regulatory exclusivity extensions, such as pediatric exclusivity, potentially delaying generic competition. Based on these recent clinical trials, generic companies need to consider the potential for new intellectual property or regulatory hurdles. These strategic moves by the drug owner might delay generic substitution or lead to additional sales of the brand drug, even after patent expiry.

Title Lead Sponsor Collaborators Status Phases
Clinical Trials
Efficacy and Safety of 186 mcg of OPN-375 Nasal Spray Twice a Day (BID) in Adolescents With Chronic Rhinosinusitis Without Nasal Polyps Optinose US Inc. NA RECRUITING
(Sep 1, 2026)
PHASE3
Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Glycopyrronium (Bromide) in Children (6 to Less Than 12 Years) With Asthma Novartis Pharmaceuticals NA RECRUITING
(Aug 1, 2026)
PHASE2
Functional Respiratory Imaging Study (DARWiIN) Chiesi Farmaceutici S.p.A. NA COMPLETED
(Mar 1, 2026)
PHASE3
A Trial to Evaluate EP-104GI in Adults With Eosinophilic Esophagitis (EoE). Eupraxia Pharmaceuticals Inc. NA RECRUITING
(Mar 1, 2026)
PHASE1, PHASE2




Generic Launch

Generic Release Date:

Flovent Diskus 100's generic launch date based on the expiry of its last outstanding patent is estimated to be Aug 23, 2016 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)

Flovent Diskus 100 Generic API suppliers:

Fluticasone Propionate is the generic name for the brand Flovent Diskus 100. 14 different companies have already filed for the generic of Flovent Diskus 100, with Hikma having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Flovent Diskus 100's generic

Alternative Brands for Flovent Diskus 100

There are several other brand drugs using the same active ingredient (Fluticasone Propionate) as Flovent Diskus 100. 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 Diskus 100's active ingredient. Check the complete list of approved generic manufacturers for Flovent Diskus 100





About Flovent Diskus 100

Flovent Diskus 100 is a drug owned by Glaxo Group Ltd England Dba Glaxosmithkline. Flovent Diskus 100 uses Fluticasone Propionate as an active ingredient. Flovent Diskus 100 was launched by Glaxo in 2000.

Approval Date:

Flovent Diskus 100 was approved by FDA for market use on 29 September, 2000.

Active Ingredient:

Flovent Diskus 100 uses Fluticasone Propionate as the active ingredient. Check out other Drugs and Companies using Fluticasone Propionate ingredient

Dosage:

Flovent Diskus 100 is available in powder form for inhalation use. Given below is detailed information on Dosage -

Strength Dosage Form Availability Application Pathway
0.1MG/INH POWDER Prescription INHALATION