Arnuity Ellipta is a drug owned by Glaxosmithkline Intellectual Property Development Ltd England. It is protected by 14 US drug patents filed from 2014 to 2023. Out of these, 11 drug patents are active and 3 have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Apr 11, 2031. Details of Arnuity Ellipta's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents protect the active ingredient(API) of the drug. Only drug patent owner can launch products that use this active ingredient until these patents expire. | |||
| US7101866 | Anti-inflammatory androstane derivative |
Aug, 2021
(3 years ago) |
Expired
|
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
|
US8746242 (Pediatric) | Medicament dispenser |
Apr, 2031
(6 years from now) | Active |
| US8746242 | Medicament dispenser |
Oct, 2030
(5 years from now) | Active |
|
US8534281 (Pediatric) | Manifold for use in medicament dispenser |
Sep, 2030
(5 years from now) | Active |
| US8534281 | Manifold for use in medicament dispenser |
Mar, 2030
(5 years from now) | Active |
| US8201556 | Medicament dispenser |
Feb, 2029
(4 years from now) | Active |
|
US8161968 (Pediatric) | Medicament dispenser |
Aug, 2028
(3 years from now) | Active |
|
US8113199 (Pediatric) | Counter for use with a medicament dispenser |
Apr, 2028
(3 years from now) | Active |
|
US9333310 (Pediatric) | Medicament dispenser |
Apr, 2028
(3 years from now) | Active |
| US8161968 | Medicament dispenser |
Feb, 2028
(3 years from now) | Active |
| US8113199 | Counter for use with a medicament dispenser |
Oct, 2027
(2 years from now) | Active |
| US9333310 | Medicament dispenser |
Oct, 2027
(2 years from now) | Active |
| US7629335 | Anti-inflammatory androstane derivative |
Aug, 2021
(3 years ago) |
Expired
|
| US5873360 | Inhalation device |
Feb, 2016
(8 years ago) |
Expired
|
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 Arnuity Ellipta's patents.
Latest Legal Activities on Arnuity Ellipta's Patents
Given below is the list of recent legal activities going on the following patents of Arnuity Ellipta.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 12th Year, Large Entity | 21 Nov, 2023 | US8201556 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 20 Oct, 2023 | US9333310 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 21 Sep, 2023 | US8161968 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 21 Jul, 2023 | US8113199 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 17 Nov, 2021 | US8746242 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 20 May, 2021 | US7629335 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 28 Sep, 2020 | US8534281 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 18 Nov, 2019 | US8201556 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 22 Oct, 2019 | US9333310 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 16 Sep, 2019 | US8161968 |
FDA has granted several exclusivities to Arnuity Ellipta. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Arnuity Ellipta, regardless of the status of it's patents. These exclusivities hence play a crucial role in delaying the generic launch. Given below are details of the exclusivities granted to Arnuity Ellipta.
Exclusivity Information
Arnuity Ellipta holds 4 exclusivities out of which 3 have expired. Its last outstanding exclusivity is set to expire in 2026. Details of Arnuity Ellipta's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Product(NP) | Aug 20, 2017 |
| New Patient Population(NPP) | May 17, 2021 |
| New Strength(NS) | May 17, 2021 |
| M(M-290) | Mar 01, 2026 |
Several oppositions have been filed on Arnuity Ellipta's European patents. EP oppositions can significantly impact the timeline for the generic launch of drugs. If an opposition results in the revocation or amendment of a patent, it can shorten the exclusivity period of the original drug. This can lead to an earlier entry of generic versions into the market. To help you estimate the potential early arrival of Arnuity Ellipta's generic, the next section provides detailed information on ongoing and past EP oppositions related to Arnuity Ellipta patents.
Arnuity Ellipta's Oppositions Filed in EPO
Arnuity Ellipta has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Apr 17, 2020, by Elkington And Fife Llp. This opposition was filed on patent number EP06765149A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
 | |||
| EP06765149A | Apr, 2020 | ELKINGTON AND FIFE LLP | Patent maintained as amended |
US patents provide insights into the exclusivity only within the United States, but Arnuity Ellipta 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 Arnuity Ellipta's family patents as well as insights into ongoing legal events on those patents.
Arnuity Ellipta's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Arnuity Ellipta's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Apr 11, 2031 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Arnuity Ellipta Generics:
There are no approved generic versions for Arnuity Ellipta as of now.
Alternative Brands for Arnuity Ellipta
Arnuity Ellipta which is used for once-daily maintenance treatment of asthma in patients aged 5 years and older., has several other brand drugs using the same active ingredient (Fluticasone Furoate). 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 | ||
|---|---|---|---|
| Glaxo Grp Ltd |
| ||
| Glaxosmithkline |
| ||
| Haleon Us Holdings |
|
About Arnuity Ellipta
Arnuity Ellipta is a drug owned by Glaxosmithkline Intellectual Property Development Ltd England. It is used for once-daily maintenance treatment of asthma in patients aged 5 years and older. Arnuity Ellipta uses Fluticasone Furoate as an active ingredient. Arnuity Ellipta was launched by Glaxosmithkline in 2018.
Approval Date:
Arnuity Ellipta was approved by FDA for market use on 17 May, 2018.
Active Ingredient:
Arnuity Ellipta uses Fluticasone Furoate as the active ingredient. Check out other Drugs and Companies using Fluticasone Furoate ingredient
Treatment:
Arnuity Ellipta is used for once-daily maintenance treatment of asthma in patients aged 5 years and older.
Dosage:
Arnuity Ellipta is available in powder form for inhalation use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 0.2MG/INH | POWDER | Prescription | INHALATION |
| 0.05MG/INH | POWDER | Prescription | INHALATION |
| 0.1MG/INH | POWDER | Prescription | INHALATION |