Breo Ellipta is a drug owned by Glaxo Group Ltd England Dba Glaxosmithkline. It is protected by 25 US drug patents filed from 2013 to 2023. Out of these, 16 drug patents are active and 9 have expired. Breo Ellipta's patents will be open to challenges from 13 November, 2025. Based on its patents and exclusivities, its generic launch date is estimated to be Apr 11, 2031. Details of Breo 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. | |||
| US7439393 | Phenethanolamine derivatives for treatment of respiratory diseases |
May, 2025
(6 months from now) | Active |
| USRE44874 | Phenethanolamine derivatives for treatment of respiratory diseases |
Mar, 2023
(1 year, 7 months ago) |
Expired
|
| 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 |
|
US11116721 (Pediatric) | Pharmaceutical formulations comprising 4-{(1R)-2-[(6-{2-[(2,6-dichlorobenzyl)oxy]ethoxy}hexyl)amino]-1-hydroxyethyl}-2-(hydroxymethyl) phenol |
Aug, 2029
(4 years from now) | Active |
| US11116721 | Pharmaceutical formulations comprising 4-{(1R)-2-[(6-{2-[(2,6-dichlorobenzyl)oxy]ethoxy}hexyl)amino]-1-hydroxyethyl}-2-(hydroxymethyl) phenol |
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 |
|
US8511304 (Pediatric) | Medicament dispenser |
Dec, 2027
(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 |
| US8511304 | Medicament dispenser |
Jun, 2027
(2 years from now) | Active |
|
US7439393 (Pediatric) | Phenethanolamine derivatives for treatment of respiratory diseases |
Nov, 2025
(1 year, 27 days from now) | Active |
| US7361787 | Phenethanolamine derivatives for treatment of respiratory diseases |
Mar, 2023
(1 year, 7 months ago) |
Expired
|
| US7776895 | Inhalation devices for delivering phenethanolamine derivatives for the treatment of respiratory diseases |
Sep, 2022
(2 years ago) |
Expired
|
| US6878698 | Anti-inflammatory androstane derivatives |
Aug, 2021
(3 years ago) |
Expired
|
| US7629335 | Anti-inflammatory androstane derivative |
Aug, 2021
(3 years ago) |
Expired
|
| US6537983 | Anti-inflammatory androstane derivatives |
Aug, 2021
(3 years ago) |
Expired
|
| US7101866 | Anti-inflammatory androstane derivative |
Aug, 2021
(3 years ago) |
Expired
|
| US6759398 | 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 Breo Ellipta's patents.
Latest Legal Activities on Breo Ellipta's Patents
Given below is the list of recent legal activities going on the following patents of Breo Ellipta.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| 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, 12th Year, Large Entity | 20 Jan, 2022 | US7776895 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 17 Nov, 2021 | US8746242 |
| Patent Issue Date Used in PTA Calculation Critical | 14 Sep, 2021 | US11116721 |
| Recordation of Patent Grant Mailed Critical | 14 Sep, 2021 | US11116721 |
| Email Notification Critical | 26 Aug, 2021 | US11116721 |
| Issue Notification Mailed Critical | 25 Aug, 2021 | US11116721 |
| Dispatch to FDC | 12 Aug, 2021 | US11116721 |
FDA has granted several exclusivities to Breo Ellipta. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Breo 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 Breo Ellipta.
Exclusivity Information
Breo Ellipta holds 7 exclusivities out of which 4 have expired. Its last outstanding exclusivity is set to expire in 2026. Details of Breo Ellipta's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Product(NP) | Apr 30, 2018 |
| New Indication(I-708) | Apr 30, 2018 |
| New Chemical Entity Exclusivity(NCE) | May 10, 2018 |
| M(M-202) | May 15, 2020 |
| New Patient Population(NPP) | May 13, 2026 |
| New Strength(NS) | May 13, 2026 |
| Pediatric Exclusivity(PED) | Nov 13, 2026 |
Several oppositions have been filed on Breo 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 Breo Ellipta's generic, the next section provides detailed information on ongoing and past EP oppositions related to Breo Ellipta patents.
Breo Ellipta's Oppositions Filed in EPO
Breo Ellipta has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on May 08, 2014, by Vossius & Partner. This opposition was filed on patent number EP03731693A. 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 |
| EP09779096A | Feb, 2020 | SANDOZ AG | Granted and Under Opposition |
| EP09779096A | Feb, 2020 | N.V. Nederlandsch Octrooibureau | Granted and Under Opposition |
| EP09779096A | Feb, 2020 | Teva UK Limited | Granted and Under Opposition |
| EP09779096A | Feb, 2020 | HGF Limited | Granted and Under Opposition |
| EP09779096A | Feb, 2020 | Aera A/S | Granted and Under Opposition |
| EP09779096A | Feb, 2020 | Gill Jennings & Every LLP | Granted and Under Opposition |
| EP09779096A | Feb, 2020 | Dehns Ltd | Granted and Under Opposition |
| EP09779096A | Feb, 2020 | Arven Ilac Sanayi Ve Ticaret A.S. | Granted and Under Opposition |
| EP10178947A | Jun, 2015 | Teva UK Limited | Revoked |
| EP03731693A | May, 2014 | Teva UK Limited | Opposition rejected |
| EP03731693A | May, 2014 | Vossius & Partner | Opposition rejected |
US patents provide insights into the exclusivity only within the United States, but Breo 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 Breo Ellipta's family patents as well as insights into ongoing legal events on those patents.
Breo Ellipta's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Breo 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)
Breo Ellipta Generics:
There are no approved generic versions for Breo Ellipta as of now.
About Breo Ellipta
Breo Ellipta is a drug owned by Glaxo Group Ltd England Dba Glaxosmithkline. It is used for the long-term maintenance treatment of airflow obstruction in patients with COPD and asthma, including chronic bronchitis and emphysema, to reduce exacerbations. Breo Ellipta uses Fluticasone Furoate; Vilanterol Trifenatate as an active ingredient. Breo Ellipta was launched by Glaxo Grp Ltd in 2023.
Approval Date:
Breo Ellipta was approved by FDA for market use on 12 May, 2023.
NCE-1 date:
NCE-1 date also known as the four year date occurs four years after the original drug approval and marks the first opportunity for a generic manufacturer to file an ANDA with a Paragraph IV certification. This is the earliest point when generic competition might begin, provided the challenge is successful. Since the approval date for Breo Ellipta is 12 May, 2023, its NCE-1 date is estimated to be 13 November, 2025.
Active Ingredient:
Breo Ellipta uses Fluticasone Furoate; Vilanterol Trifenatate as the active ingredient. Check out other Drugs and Companies using Fluticasone Furoate; Vilanterol Trifenatate ingredient
Treatment:
Breo Ellipta is used for the long-term maintenance treatment of airflow obstruction in patients with COPD and asthma, including chronic bronchitis and emphysema, to reduce exacerbations.
Dosage:
Breo Ellipta is available in powder form for inhalation use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 0.1MG/INH;EQ 0.025MG BASE/INH | POWDER | Prescription | INHALATION |
| 0.05MG/INH;EQ 0.025MG BASE/INH | POWDER | Prescription | INHALATION |
| 0.2MG/INH;EQ 0.025MG BASE/INH | POWDER | Prescription | INHALATION |