ARNUITY ELLIPTA Drug Patent Profile
✉ Email this page to a colleague
Which patents cover Arnuity Ellipta, and what generic alternatives are available?
Arnuity Ellipta is a drug marketed by Glaxosmithkline and is included in one NDA. There are six patents protecting this drug.
This drug has one hundred and seventeen patent family members in twenty-seven countries.
The generic ingredient in ARNUITY ELLIPTA is fluticasone furoate. There are twenty-nine drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the fluticasone furoate profile page.
DrugPatentWatch® Generic Entry Outlook for Arnuity Ellipta
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be March 1, 2026. This may change due to patent challenges or generic licensing.
There have been two patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.
Indicators of Generic Entry
Summary for ARNUITY ELLIPTA
International Patents: | 117 |
US Patents: | 6 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 41 |
Clinical Trials: | 2 |
Patent Applications: | 1,426 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for ARNUITY ELLIPTA |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for ARNUITY ELLIPTA |
What excipients (inactive ingredients) are in ARNUITY ELLIPTA? | ARNUITY ELLIPTA excipients list |
DailyMed Link: | ARNUITY ELLIPTA at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for ARNUITY ELLIPTA
Generic Entry Date for ARNUITY ELLIPTA*:
Constraining patent/regulatory exclusivity:
INFORMATION ADDED TO SECTION 8.4 OF THE LABELING TO INCLUDE THE RESULT OF STUDY HZA114971 NDA:
Dosage:
POWDER;INHALATION |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Recent Clinical Trials for ARNUITY ELLIPTA
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
University of Virginia | Phase 2 |
GlaxoSmithKline | Phase 3 |
Pharmacology for ARNUITY ELLIPTA
Drug Class | Corticosteroid |
Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Anatomical Therapeutic Chemical (ATC) Classes for ARNUITY ELLIPTA
US Patents and Regulatory Information for ARNUITY ELLIPTA
ARNUITY ELLIPTA is protected by six US patents and one FDA Regulatory Exclusivity.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of ARNUITY ELLIPTA is ⤷ Try a Trial.
This potential generic entry date is based on INFORMATION ADDED TO SECTION 8.4 OF THE LABELING TO INCLUDE THE RESULT OF STUDY HZA114971.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
Patents protecting ARNUITY ELLIPTA
Counter for use with a medicament dispenser
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Medicament dispenser
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Medicament dispenser
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Manifold for use in medicament dispenser
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Medicament dispenser
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Medicament dispenser
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
FDA Regulatory Exclusivity protecting ARNUITY ELLIPTA
INFORMATION ADDED TO SECTION 8.4 OF THE LABELING TO INCLUDE THE RESULT OF STUDY HZA114971
Exclusivity Expiration: ⤷ Try a Trial
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Glaxosmithkline | ARNUITY ELLIPTA | fluticasone furoate | POWDER;INHALATION | 205625-003 | May 17, 2018 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Glaxosmithkline | ARNUITY ELLIPTA | fluticasone furoate | POWDER;INHALATION | 205625-003 | May 17, 2018 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Glaxosmithkline | ARNUITY ELLIPTA | fluticasone furoate | POWDER;INHALATION | 205625-003 | May 17, 2018 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Expired US Patents for ARNUITY ELLIPTA
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Glaxosmithkline | ARNUITY ELLIPTA | fluticasone furoate | POWDER;INHALATION | 205625-001 | Aug 20, 2014 | ⤷ Try a Trial | ⤷ Try a Trial |
Glaxosmithkline | ARNUITY ELLIPTA | fluticasone furoate | POWDER;INHALATION | 205625-001 | Aug 20, 2014 | ⤷ Try a Trial | ⤷ Try a Trial |
Glaxosmithkline | ARNUITY ELLIPTA | fluticasone furoate | POWDER;INHALATION | 205625-003 | May 17, 2018 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
EU/EMA Drug Approvals for ARNUITY ELLIPTA
Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
---|---|---|---|---|---|---|---|---|---|
GlaxoSmithKline (Ireland) Limited | Avamys | fluticasone furoate | EMEA/H/C/000770 Adults, adolescents (12 years and over) and children (6-11 years). Avamys is indicated for the treatment of the symptoms of allergic rhinitis. |
Authorised | no | no | no | 2008-01-11 | |
Glaxo Group Ltd. | Alisade | fluticasone furoate | EMEA/H/C/001019 Adults, adolescents (12 years and over) and children (6 - 11 years). Alisade is indicated for the treatment of the symptoms of allergic rhinitis. |
Withdrawn | no | no | no | 2008-10-06 | |
>Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
International Patents for ARNUITY ELLIPTA
When does loss-of-exclusivity occur for ARNUITY ELLIPTA?
Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:
Australia
Patent: 05274296
Estimated Expiration: ⤷ Try a Trial
Brazil
Patent: 0514346
Estimated Expiration: ⤷ Try a Trial
Canada
Patent: 77248
Estimated Expiration: ⤷ Try a Trial
China
Patent: 0528256
Estimated Expiration: ⤷ Try a Trial
Patent: 1084030
Estimated Expiration: ⤷ Try a Trial
Cyprus
Patent: 17205
Estimated Expiration: ⤷ Try a Trial
Denmark
Patent: 86498
Estimated Expiration: ⤷ Try a Trial
European Patent Office
Patent: 86498
Estimated Expiration: ⤷ Try a Trial
Hong Kong
Patent: 06169
Estimated Expiration: ⤷ Try a Trial
Hungary
Patent: 28513
Estimated Expiration: ⤷ Try a Trial
Japan
Patent: 60868
Estimated Expiration: ⤷ Try a Trial
Patent: 08509766
Estimated Expiration: ⤷ Try a Trial
Mexico
Patent: 07001956
Estimated Expiration: ⤷ Try a Trial
Poland
Patent: 86498
Estimated Expiration: ⤷ Try a Trial
Portugal
Patent: 86498
Estimated Expiration: ⤷ Try a Trial
South Africa
Patent: 0700851
Estimated Expiration: ⤷ Try a Trial
Spain
Patent: 61421
Estimated Expiration: ⤷ Try a Trial
United Kingdom
Patent: 18278
Estimated Expiration: ⤷ Try a Trial
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
See the table below for additional patents covering ARNUITY ELLIPTA around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
European Patent Office | 1907037 | DISTRIBUTEUR DE MÉDICAMENTS (MEDICAMENT DISPENSER) | ⤷ Try a Trial |
South Africa | 200300929 | 17.Beta.-carbothioate 17.Alpha.-arylcarbonyloxyloxy androstane derivative as anti-inflammatory agents. | ⤷ Try a Trial |
Germany | 60321311 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for ARNUITY ELLIPTA
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1519731 | 13C0067 | France | ⤷ Try a Trial | PRODUCT NAME: AZELASTINE OU SES SELS PHARMACEUTIQUEMENT ACCEPTABLES ET UN ESTER PHARMACEUTIQUEMENT ACCEPTABLE DE FLUTICASONE; NAT. REGISTRATION NO/DATE: NL41755 20130925; FIRST REGISTRATION: SK - 24/0055/13-S 20130215 |
1305329 | 300343 | Netherlands | ⤷ Try a Trial | 300343, 20210803, EXPIRES: 20230110 |
2506844 | 132018000000341 | Italy | ⤷ Try a Trial | PRODUCT NAME: UN PRODOTTO DI COMBINAZIONE FARMACEUTICA COMPRENDENTE UN SALE FARMACEUTICAMENTE ACCETTABILE DI UMECLIDINIO (AD ESEMPIO BROMURO DI UMECLIDINIO), VILANTEROLO O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE (AD ESEMPIO VILANTEROLO TRIFENATATO) E UN FUROATO(TRELEGY ELLIPTA - FLUTICASONE FUROATO/UMECLIDINIO/VILANTEROLO); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/17/1236, 20171117 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |