Trelegy Ellipta is a drug owned by Glaxosmithkline Intellectual Property Development Ltd England. It is protected by 27 US drug patents filed from 2018 to 2023. Out of these, 18 drug patents are active and 9 have expired. Trelegy Ellipta's patents have been open to challenges since 18 December, 2017. Based on its patents and exclusivities, its generic launch date is estimated to be Apr 11, 2031. Details of Trelegy 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. | |||
| US7488827 | Muscarinic acetylcholine receptor antagonists |
Dec, 2027
(2 years from now) | Active |
| US7439393 | Phenethanolamine derivatives for treatment of respiratory diseases |
May, 2025
(7 days from now) | Active |
| US7498440 | Muscarinic acetylcholine receptor antagonists |
Apr, 2025
(16 days ago) |
Expired
|
| USRE44874 | Phenethanolamine derivatives for treatment of respiratory diseases |
Mar, 2023
(2 years 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
(5 years from now) | Active |
| US11090294 | Combinations of a muscarinic receptor antagonist and a beta-2 adrenoreceptor agonist |
Nov, 2030
(5 years from now) | Active |
| US9750726 | Combinations of a muscarinic receptor antagonist and a beta-2 adrenoreceptor agonist |
Nov, 2030
(5 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
(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
(2 years from now) | Active |
|
US9333310 (Pediatric) | Medicament dispenser |
Apr, 2028
(2 years from now) | Active |
| US8161968 | Medicament dispenser |
Feb, 2028
(2 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
(6 months from now) | Active |
| US8183257 | Muscarinic acetylcholine receptor antagonists |
Jul, 2025
(2 months from now) | Active |
| US8309572 | Muscarinic acetylcholine receptor antagonists |
Apr, 2025
(16 days ago) |
Expired
|
| US7776895 | Inhalation devices for delivering phenethanolamine derivatives for the treatment of respiratory diseases |
Sep, 2022
(2 years ago) |
Expired
|
| US7629335 | Anti-inflammatory androstane derivative |
Aug, 2021
(3 years ago) |
Expired
|
| US6759398 | Anti-inflammatory androstane derivative |
Aug, 2021
(3 years ago) |
Expired
|
| US6878698 | Anti-inflammatory androstane derivatives |
Aug, 2021
(3 years ago) |
Expired
|
| US6537983 | Anti-inflammatory androstane derivatives |
Aug, 2021
(3 years ago) |
Expired
|
FDA has granted several exclusivities to Trelegy Ellipta. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Trelegy 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 Trelegy Ellipta.
Exclusivity Information
Trelegy Ellipta holds 4 exclusivities. All of its exclusivities have expired in 2023. Details of Trelegy Ellipta's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Dec 18, 2018 |
| New Indication(I-775) | Apr 24, 2021 |
| New Indication(I-843) | Sep 09, 2023 |
| New Strength(NS) | Sep 09, 2023 |
Several oppositions have been filed on Trelegy 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 Trelegy Ellipta's generic, the next section provides detailed information on ongoing and past EP oppositions related to Trelegy Ellipta patents.
Trelegy Ellipta's Oppositions Filed in EPO
Trelegy 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 |
| EP10781527A | Sep, 2018 | Sima Patent ve Lisanslama Hizmetleri Ltd.Sti. | Granted and Under Opposition |
| EP10781527A | Sep, 2018 | Breuer, Markus | Granted and Under Opposition |
| EP10781527A | Sep, 2018 | Teva UK Limited | 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 Trelegy 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 Trelegy Ellipta's family patents as well as insights into ongoing legal events on those patents.
Trelegy Ellipta's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Trelegy 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)
Trelegy Ellipta Generics:
There are no approved generic versions for Trelegy Ellipta as of now.
About Trelegy Ellipta
Trelegy Ellipta is a drug owned by Glaxosmithkline Intellectual Property Development Ltd England. It is used for maintenance treatment of chronic obstructive pulmonary disease (COPD) and asthma. Trelegy Ellipta uses Fluticasone Furoate; Umeclidinium Bromide; Vilanterol Trifenatate as an active ingredient. Trelegy Ellipta was launched by Glaxosmithkline in 2017.
Approval Date:
Trelegy Ellipta was approved by FDA for market use on 18 September, 2017.
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 Trelegy Ellipta is 18 September, 2017, its NCE-1 date is estimated to be 18 December, 2017.
Active Ingredient:
Trelegy Ellipta uses Fluticasone Furoate; Umeclidinium Bromide; Vilanterol Trifenatate as the active ingredient. Check out other Drugs and Companies using Fluticasone Furoate; Umeclidinium Bromide; Vilanterol Trifenatate ingredient
Treatment:
Trelegy Ellipta is used for maintenance treatment of chronic obstructive pulmonary disease (COPD) and asthma.
Dosage:
Trelegy 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 0.0625MG BASE/INH;EQ 0.025MG BASE/INH | POWDER | Prescription | INHALATION |
| 0.2MG/INH;EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH | POWDER | Prescription | INHALATION |