Arnuity Ellipta Patent Expiration

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 protects the active chemical substance. Only drug patent owner can launch products that use this active substance.
US7101866 Anti-inflammatory androstane derivative
Aug, 2021

(2 years ago)

Expired
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US5873360 Inhalation device
Feb, 2016

(8 years ago)

Expired
US7629335 Anti-inflammatory androstane derivative
Aug, 2021

(2 years ago)

Expired
US9333310 Medicament dispenser
Oct, 2027

(3 years from now)

Active
US8113199 Counter for use with a medicament dispenser
Oct, 2027

(3 years from now)

Active
US8161968 Medicament dispenser
Feb, 2028

(3 years from now)

Active
US9333310

(Pediatric)

Medicament dispenser
Apr, 2028

(3 years from now)

Active
US8113199

(Pediatric)

Counter for use with a medicament dispenser
Apr, 2028

(3 years from now)

Active
US8161968

(Pediatric)

Medicament dispenser
Aug, 2028

(4 years from now)

Active
US8201556 Medicament dispenser
Feb, 2029

(4 years from now)

Active
US8534281 Manifold for use in medicament dispenser
Mar, 2030

(5 years from now)

Active
US8534281

(Pediatric)

Manifold for use in medicament dispenser
Sep, 2030

(6 years from now)

Active
US8746242 Medicament dispenser
Oct, 2030

(6 years from now)

Active
US8746242

(Pediatric)

Medicament dispenser
Apr, 2031

(6 years from now)

Active


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 Strength(NS) May 17, 2021
New Patient Population(NPP) May 17, 2021
M(M-290) Mar 01, 2026

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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
Patent litigations
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

Arnuity Ellipta has patent protection in a total of 27 countries. It's US patent count contributes only to 9.0% 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 Arnuity Ellipta.

Family Patents

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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.





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.

Market Authorisation 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
0.1MG/INH POWDER Prescription INHALATION
0.2MG/INH POWDER Prescription INHALATION
0.05MG/INH POWDER Prescription INHALATION