Incruse Ellipta is a drug owned by Glaxo Group Ltd England Dba Glaxosmithkline. It is protected by 11 US drug patents filed from 2014 to 2016. Out of these, 10 drug patents are active and 1 has expired. Incruse 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 Oct 11, 2030. Details of Incruse 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 |
| US7498440 | Muscarinic acetylcholine receptor antagonists |
Apr, 2025
(3 months from now) | Active |
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US8746242 | Medicament dispenser |
Oct, 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 | 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 |
| US8183257 | Muscarinic acetylcholine receptor antagonists |
Jul, 2025
(6 months from now) | Active |
| US8309572 | Muscarinic acetylcholine receptor antagonists |
Apr, 2025
(3 months from now) | Active |
| 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 Incruse Ellipta's patents.
Latest Legal Activities on Incruse Ellipta's Patents
Given below is the list of recent legal activities going on the following patents of Incruse Ellipta.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 12th Year, Large Entity | 19 Apr, 2024 | US8309572 |
| 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 | 19 Oct, 2023 | US8183257 |
| 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, 8th Year, Large Entity | 28 Sep, 2020 | US8534281 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 13 Aug, 2020 | US7498440 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 14 Jul, 2020 | US7488827 |
FDA has granted several exclusivities to Incruse Ellipta. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Incruse 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 Incruse Ellipta.
Exclusivity Information
Incruse Ellipta holds 3 exclusivities. All of its exclusivities have expired in 2022. Details of Incruse Ellipta's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Dec 18, 2018 |
| M(M-172) | Feb 24, 2019 |
| M(M-245) | Jun 09, 2022 |
Several oppositions have been filed on Incruse 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 Incruse Ellipta's generic, the next section provides detailed information on ongoing and past EP oppositions related to Incruse Ellipta patents.
Incruse Ellipta's Oppositions Filed in EPO
Incruse 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 Incruse 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 Incruse Ellipta's family patents as well as insights into ongoing legal events on those patents.
Incruse Ellipta's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Incruse Ellipta's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Oct 11, 2030 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Incruse Ellipta Generics:
There are no approved generic versions for Incruse Ellipta as of now.
Alternative Brands for Incruse Ellipta
Incruse Ellipta which is used for managing airflow obstruction in patients with COPD., has several other brand drugs in the same treatment category and using the same active ingredient (Umeclidinium Bromide). 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 | Treatment Area | ||
|---|---|---|---|---|
| Glaxosmithkline |
| |||
Apart from drugs working in same treatment category, there are also some brand drugs where treatment area is different, but the active ingredient used is same i.e. Umeclidinium Bromide. Given below is the list of those drugs and companies owning them.
| Drug Owner | Drug Name | |
|---|---|---|
| Glaxosmithkline |
|
About Incruse Ellipta
Incruse Ellipta is a drug owned by Glaxo Group Ltd England Dba Glaxosmithkline. It is used for managing airflow obstruction in patients with COPD. Incruse Ellipta uses Umeclidinium Bromide as an active ingredient. Incruse Ellipta was launched by Glaxo Grp England in 2014.
Approval Date:
Incruse Ellipta was approved by FDA for market use on 30 April, 2014.
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 Incruse Ellipta is 30 April, 2014, its NCE-1 date is estimated to be 18 December, 2017.
Active Ingredient:
Incruse Ellipta uses Umeclidinium Bromide as the active ingredient. Check out other Drugs and Companies using Umeclidinium Bromide ingredient
Treatment:
Incruse Ellipta is used for managing airflow obstruction in patients with COPD.
Dosage:
Incruse Ellipta is available in powder form for inhalation use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 0.0625MG BASE/INH | POWDER | Prescription | INHALATION |