Breo Ellipta Patent Expiration

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

(4 months from now)

Active
USRE44874 Phenethanolamine derivatives for treatment of respiratory diseases
Mar, 2023

(1 year, 8 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

(2 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

(10 months from now)

Active
US7361787 Phenethanolamine derivatives for treatment of respiratory diseases
Mar, 2023

(1 year, 8 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.

Given below is the list of recent legal activities going on the following patents of Breo Ellipta.

Activity Date Patent Number
Patent litigations
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 14 Sep, 2021 US11116721
Recordation of Patent Grant Mailed 14 Sep, 2021 US11116721
Email Notification 26 Aug, 2021 US11116721
Issue Notification Mailed 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

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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
Patent litigations
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

Breo Ellipta has patent protection in a total of 34 countries. It's US patent count contributes only to 11.2% of its total global patent coverage. 4 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 Breo Ellipta.

Family Patents

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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