ARNUITY ELLIPTA Drug Patent Profile
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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 sixteen 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 October 2, 2027. This may change due to patent challenges or generic licensing.
Indicators of Generic Entry
Summary for ARNUITY ELLIPTA
International Patents: | 116 |
US Patents: | 6 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 36 |
Clinical Trials: | 2 |
Patent Applications: | 1,856 |
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 Generic Entry Opportunity Date for ARNUITY ELLIPTA
Generic Entry Date for ARNUITY ELLIPTA*:
Constraining patent/regulatory exclusivity:
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.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of ARNUITY ELLIPTA is See Plans and Pricing.
This potential generic entry date is based on patent See Plans and Pricing.
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Medicament dispenser
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Medicament dispenser
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Manifold for use in medicament dispenser
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Medicament dispenser
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Medicament dispenser
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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 | See Plans and Pricing | See Plans and Pricing | Y | See Plans and Pricing | |||
Glaxosmithkline | ARNUITY ELLIPTA | fluticasone furoate | POWDER;INHALATION | 205625-002 | Aug 20, 2014 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | Y | See Plans and Pricing | |||
Glaxosmithkline | ARNUITY ELLIPTA | fluticasone furoate | POWDER;INHALATION | 205625-001 | Aug 20, 2014 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | Y | See Plans and Pricing | |||
Glaxosmithkline | ARNUITY ELLIPTA | fluticasone furoate | POWDER;INHALATION | 205625-003 | May 17, 2018 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | Y | See Plans and Pricing | |||
>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 | 205625-003 | May 17, 2018 | See Plans and Pricing | See Plans and Pricing |
Glaxosmithkline | ARNUITY ELLIPTA | fluticasone furoate | POWDER;INHALATION | 205625-001 | Aug 20, 2014 | See Plans and Pricing | See Plans and Pricing |
Glaxosmithkline | ARNUITY ELLIPTA | fluticasone furoate | POWDER;INHALATION | 205625-002 | Aug 20, 2014 | See Plans and Pricing | See Plans and Pricing |
Glaxosmithkline | ARNUITY ELLIPTA | fluticasone furoate | POWDER;INHALATION | 205625-002 | Aug 20, 2014 | See Plans and Pricing | See Plans and Pricing |
>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: See Plans and Pricing
Brazil
Patent: 0514346
Estimated Expiration: See Plans and Pricing
Canada
Patent: 77248
Estimated Expiration: See Plans and Pricing
China
Patent: 0528256
Estimated Expiration: See Plans and Pricing
Patent: 1084030
Estimated Expiration: See Plans and Pricing
Cyprus
Patent: 17205
Estimated Expiration: See Plans and Pricing
Denmark
Patent: 86498
Estimated Expiration: See Plans and Pricing
European Patent Office
Patent: 86498
Estimated Expiration: See Plans and Pricing
Hong Kong
Patent: 06169
Estimated Expiration: See Plans and Pricing
Hungary
Patent: 28513
Estimated Expiration: See Plans and Pricing
Japan
Patent: 60868
Estimated Expiration: See Plans and Pricing
Patent: 08509766
Estimated Expiration: See Plans and Pricing
Mexico
Patent: 07001956
Estimated Expiration: See Plans and Pricing
Poland
Patent: 86498
Estimated Expiration: See Plans and Pricing
Portugal
Patent: 86498
Estimated Expiration: See Plans and Pricing
South Africa
Patent: 0700851
Estimated Expiration: See Plans and Pricing
Spain
Patent: 61421
Estimated Expiration: See Plans and Pricing
United Kingdom
Patent: 18278
Estimated Expiration: See Plans and Pricing
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 |
---|---|---|---|
South Korea | 20080080636 | MANIFOLD FOR USE IN MEDICAMENT DISPENSER | See Plans and Pricing |
Spain | 2745602 | See Plans and Pricing | |
European Patent Office | 1478340 | Formulation pharmaceutique comprenant une suspension aqueuse d'un dérivé d'androstane pour le traitement d'états inflammatoires et allergiques (Pharmaceutical formulation comprising an aqueous suspension of an androstane derivative for the treatment of inflammatory and allergic conditions) | See Plans and Pricing |
Denmark | 37991 | See Plans and Pricing | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for ARNUITY ELLIPTA
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1305329 | SZ 12/2008 | Austria | See Plans and Pricing | PRODUCT NAME: FLUTICASON FUROAT UND DESSEN SOLVATE |
1305329 | C01305329/01 | Switzerland | See Plans and Pricing | PRODUCT NAME: FLUTICASON FUROAT; REGISTRATION NUMBER/DATE: SWISSMEDIC 57968 19.12.2007 |
1305329 | CA 2008 00022 | Denmark | See Plans and Pricing | |
2506844 | 2018C/022 | Belgium | See Plans and Pricing | PRODUCT NAME: EEN FARMACEUTISCH COMBINATIEPRODUCT DAT EEN FARMACEUTISCH AANVAARDBAAR ZOUT VAN UMECLIDINIUM (BV. UMECLIDINIUMBROMIDE), VILANTEROL OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN (BV. VILANTEROLTRIFENATAAT) EN FLUTICASONEFUROAAT OMVAT; AUTHORISATION NUMBER AND DATE: EU/1/17/1236 20171117 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |