ANORO ELLIPTA Drug Patent Profile
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Which patents cover Anoro Ellipta, and what generic alternatives are available?
Anoro Ellipta is a drug marketed by Glaxosmithkline and is included in one NDA. There are twelve patents protecting this drug.
This drug has three hundred and twenty-nine patent family members in forty-eight countries.
The generic ingredient in ANORO ELLIPTA is umeclidinium bromide; vilanterol trifenatate. There are two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the umeclidinium bromide; vilanterol trifenatate profile page.
DrugPatentWatch® Generic Entry Outlook for Anoro Ellipta
Anoro Ellipta was eligible for patent challenges on May 10, 2017.
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be November 29, 2030. 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 ANORO ELLIPTA
International Patents: | 329 |
US Patents: | 12 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 57 |
Clinical Trials: | 47 |
Patent Applications: | 289 |
Drug Prices: | Drug price information for ANORO ELLIPTA |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for ANORO ELLIPTA |
What excipients (inactive ingredients) are in ANORO ELLIPTA? | ANORO ELLIPTA excipients list |
DailyMed Link: | ANORO ELLIPTA at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for ANORO ELLIPTA
Generic Entry Date for ANORO 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 ANORO ELLIPTA
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Baylor Research Institute | Phase 4 |
Chiesi Farmaceutici S.p.A. | Phase 4 |
Luis Puente Maestu | Phase 4 |
Pharmacology for ANORO ELLIPTA
Drug Class | Anticholinergic beta2-Adrenergic Agonist |
Mechanism of Action | Adrenergic beta2-Agonists Cholinergic Antagonists |
Anatomical Therapeutic Chemical (ATC) Classes for ANORO ELLIPTA
US Patents and Regulatory Information for ANORO ELLIPTA
ANORO ELLIPTA is protected by twelve US patents.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of ANORO ELLIPTA is ⤷ Sign Up.
This potential generic entry date is based on patent ⤷ Sign Up.
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 ANORO ELLIPTA
Combinations of a muscarinic receptor antagonist and a beta-2 adrenoreceptor agonist
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: MAINTENANCE TREATMENT OF PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)
Phenethanolamine derivatives for treatment of respiratory diseases
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Muscarinic acetylcholine receptor antagonists
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Muscarinic acetylcholine receptor antagonists
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Medicament dispenser
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Muscarinic acetylcholine receptor antagonists
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: INDICATED FOR THE LONG-TERM, ONCE-DAILY, MAINTENANCE TREATMENT OF AIRFLOW OBSTRUCTION IN PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD), INCLUDING CHRONIC BRONCHITIS AND/OR EMPHYSEMA.
Muscarinic acetylcholine receptor antagonists
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: INDICATED FOR THE LONG-TERM, ONCE-DAILY, MAINTENANCE TREATMENT OF AIRFLOW OBSTRUCTION IN PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD), INCLUDING CHRONIC BRONCHITIS AND/OR EMPHYSEMA.
Medicament dispenser
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Manifold for use in medicament dispenser
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Medicament dispenser
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Medicament dispenser
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Combinations of a muscarinic receptor antagonist and a beta-2 adrenoreceptor agonist
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Glaxosmithkline | ANORO ELLIPTA | umeclidinium bromide; vilanterol trifenatate | POWDER;INHALATION | 203975-001 | Dec 18, 2013 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Glaxosmithkline | ANORO ELLIPTA | umeclidinium bromide; vilanterol trifenatate | POWDER;INHALATION | 203975-001 | Dec 18, 2013 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Glaxosmithkline | ANORO ELLIPTA | umeclidinium bromide; vilanterol trifenatate | POWDER;INHALATION | 203975-001 | Dec 18, 2013 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
>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 ANORO ELLIPTA
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Glaxosmithkline | ANORO ELLIPTA | umeclidinium bromide; vilanterol trifenatate | POWDER;INHALATION | 203975-001 | Dec 18, 2013 | ⤷ Sign Up | ⤷ Sign Up |
Glaxosmithkline | ANORO ELLIPTA | umeclidinium bromide; vilanterol trifenatate | POWDER;INHALATION | 203975-001 | Dec 18, 2013 | ⤷ Sign Up | ⤷ Sign Up |
Glaxosmithkline | ANORO ELLIPTA | umeclidinium bromide; vilanterol trifenatate | POWDER;INHALATION | 203975-001 | Dec 18, 2013 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for ANORO ELLIPTA
When does loss-of-exclusivity occur for ANORO ELLIPTA?
Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:
Australia
Patent: 10326798
Estimated Expiration: ⤷ Sign Up
Patent: 14204459
Estimated Expiration: ⤷ Sign Up
Patent: 16262698
Estimated Expiration: ⤷ Sign Up
Patent: 17238392
Estimated Expiration: ⤷ Sign Up
Patent: 18282427
Estimated Expiration: ⤷ Sign Up
Patent: 21204302
Estimated Expiration: ⤷ Sign Up
Patent: 23219901
Estimated Expiration: ⤷ Sign Up
Brazil
Patent: 2012012925
Estimated Expiration: ⤷ Sign Up
Patent: 2018069147
Estimated Expiration: ⤷ Sign Up
Canada
Patent: 81487
Estimated Expiration: ⤷ Sign Up
Patent: 18345
Estimated Expiration: ⤷ Sign Up
Chile
Patent: 12001432
Estimated Expiration: ⤷ Sign Up
China
Patent: 2724974
Estimated Expiration: ⤷ Sign Up
Patent: 7412229
Estimated Expiration: ⤷ Sign Up
Patent: 8778288
Estimated Expiration: ⤷ Sign Up
Colombia
Patent: 41613
Estimated Expiration: ⤷ Sign Up
Costa Rica
Patent: 120265
Estimated Expiration: ⤷ Sign Up
Croatia
Patent: 0180312
Estimated Expiration: ⤷ Sign Up
Cyprus
Patent: 20058
Estimated Expiration: ⤷ Sign Up
Denmark
Patent: 06844
Estimated Expiration: ⤷ Sign Up
Dominican Republic
Patent: 012000148
Estimated Expiration: ⤷ Sign Up
Eurasian Patent Organization
Patent: 3839
Estimated Expiration: ⤷ Sign Up
Patent: 1290266
Estimated Expiration: ⤷ Sign Up
European Patent Office
Patent: 06844
Estimated Expiration: ⤷ Sign Up
Patent: 35707
Estimated Expiration: ⤷ Sign Up
Patent: 32892
Estimated Expiration: ⤷ Sign Up
France
Patent: C1022
Estimated Expiration: ⤷ Sign Up
Hong Kong
Patent: 49407
Estimated Expiration: ⤷ Sign Up
Hungary
Patent: 36216
Estimated Expiration: ⤷ Sign Up
Patent: 800027
Estimated Expiration: ⤷ Sign Up
Israel
Patent: 9893
Estimated Expiration: ⤷ Sign Up
Japan
Patent: 16631
Estimated Expiration: ⤷ Sign Up
Patent: 13512270
Estimated Expiration: ⤷ Sign Up
Patent: 19509315
Estimated Expiration: ⤷ Sign Up
Lithuania
Patent: 506844
Estimated Expiration: ⤷ Sign Up
Patent: 2018011
Estimated Expiration: ⤷ Sign Up
Patent: 06844
Estimated Expiration: ⤷ Sign Up
Luxembourg
Patent: 0077
Estimated Expiration: ⤷ Sign Up
Malaysia
Patent: 4864
Estimated Expiration: ⤷ Sign Up
Mexico
Patent: 1290
Estimated Expiration: ⤷ Sign Up
Patent: 12006310
Estimated Expiration: ⤷ Sign Up
Montenegro
Patent: 965
Estimated Expiration: ⤷ Sign Up
Morocco
Patent: 853
Estimated Expiration: ⤷ Sign Up
New Zealand
Patent: 0026
Estimated Expiration: ⤷ Sign Up
Norway
Patent: 06844
Estimated Expiration: ⤷ Sign Up
Peru
Patent: 130042
Estimated Expiration: ⤷ Sign Up
Patent: 170915
Estimated Expiration: ⤷ Sign Up
Poland
Patent: 06844
Estimated Expiration: ⤷ Sign Up
Portugal
Patent: 06844
Estimated Expiration: ⤷ Sign Up
Russian Federation
Patent: 18131440
Estimated Expiration: ⤷ Sign Up
Serbia
Patent: 848
Estimated Expiration: ⤷ Sign Up
Singapore
Patent: 1087
Estimated Expiration: ⤷ Sign Up
Patent: 201407864U
Estimated Expiration: ⤷ Sign Up
Slovenia
Patent: 06844
Estimated Expiration: ⤷ Sign Up
South Africa
Patent: 1203890
Estimated Expiration: ⤷ Sign Up
South Korea
Patent: 1742140
Estimated Expiration: ⤷ Sign Up
Patent: 1830728
Estimated Expiration: ⤷ Sign Up
Patent: 120092163
Estimated Expiration: ⤷ Sign Up
Patent: 170061719
Estimated Expiration: ⤷ Sign Up
Patent: 180128937
Estimated Expiration: ⤷ Sign Up
Spain
Patent: 59330
Estimated Expiration: ⤷ Sign Up
Turkey
Patent: 1802921
Estimated Expiration: ⤷ Sign Up
Ukraine
Patent: 6775
Estimated Expiration: ⤷ Sign Up
United Kingdom
Patent: 21075
Estimated Expiration: ⤷ Sign Up
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 ANORO ELLIPTA around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Japan | 4886509 | ⤷ Sign Up | |
Norway | 2506844 | ⤷ Sign Up | |
Spain | 2316599 | ⤷ Sign Up | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for ANORO ELLIPTA
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
2506844 | 300942 | Netherlands | ⤷ Sign Up | PRODUCT NAME: EEN FARMACEUTISCH COMBINATIEPRODUCT OMVATTENDE EEN FARMACEUTISCH AANVAARDBAAR ZOUT VAN UMECLIDINIUM (BIJVOORBEELD UMECLIDINIUMBROMIDE), VILANTEROL OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN (BIJVOORBEELD VILANTEROLTRIFENATAAT) EN FLUTICASONFUROAAT; REGISTRATION NO/DATE: EU/1/17/1236 20171117 |
1740177 | SPC/GB14/055 | United Kingdom | ⤷ Sign Up | PRODUCT NAME: UMECLIDINIUM BROMIDE (ALSO REFERRED TO AS 4-(HYDROXY(DIPHENYL)METHYL)-1-(2-((PHENYLMETHYL)OXY)ETHYL)-1-AZONIABICYCLO(2.2.2)OCTANE BROMIDE); REGISTERED: UK EU/1/14/922/001 20140430; UK EU/1/14/922/002 20140430; UK EU/1/14/922/003 20140430 |
1740177 | PA2014038,C1740177 | Lithuania | ⤷ Sign Up | PRODUCT NAME: UMEKLIDINO BROMIDAS; REGISTRATION NO/DATE: EU/1/14/922 20140428 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |