ANORO ELLIPTA Drug Patent Profile
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When do Anoro Ellipta patents expire, and what generic alternatives are available?
Anoro Ellipta is a drug marketed by Glaxosmithkline and is included in one NDA. There are fifteen patents protecting this drug.
This drug has three hundred and forty patent family members in forty-seven 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.
Indicators of Generic Entry
Summary for ANORO ELLIPTA
| International Patents: | 340 |
| US Patents: | 15 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 1 |
| Clinical Trials: | 45 |
| Patent Applications: | 202 |
| Drug Prices: | Drug price information for ANORO ELLIPTA |
| What excipients (inactive ingredients) are in ANORO ELLIPTA? | ANORO ELLIPTA excipients list |
| DailyMed Link: | ANORO ELLIPTA at DailyMed |
DrugPatentWatch® Estimated Generic Entry Opportunity 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 fifteen US patents and one FDA Regulatory Exclusivity.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of ANORO 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 ANORO ELLIPTA
Combinations of a muscarinic receptor antagonist and a beta-2 adrenoreceptor agonist
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: MAINTENANCE TREATMENT OF PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)
Phenethanolamine derivatives for treatment of respiratory diseases
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Muscarinic acetylcholine receptor antagonists
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Inhalation devices for delivering phenethanolamine derivatives for the treatment of respiratory diseases
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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
Muscarinic acetylcholine receptor antagonists
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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.
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
Combinations of a muscarinic receptor antagonist and a beta-2 adrenoreceptor agonist
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Phenethanolamine derivatives for treatment of respiratory diseases
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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.
FDA Regulatory Exclusivity protecting ANORO ELLIPTA
ADDITIONAL INFORMATION ADDED TO THE LABELING BASED ON SAFETY AND EFFICACY DATA FROM THE IMPACT TRIAL
Exclusivity 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 | ANORO ELLIPTA | umeclidinium bromide; vilanterol trifenatate | POWDER;INHALATION | 203975-001 | Dec 18, 2013 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | ||||
| Glaxosmithkline | ANORO ELLIPTA | umeclidinium bromide; vilanterol trifenatate | POWDER;INHALATION | 203975-001 | Dec 18, 2013 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | Y | See Plans and Pricing | |||
| Glaxosmithkline | ANORO ELLIPTA | umeclidinium bromide; vilanterol trifenatate | POWDER;INHALATION | 203975-001 | Dec 18, 2013 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | 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 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 | See Plans and Pricing | See Plans and Pricing |
| >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: See Plans and Pricing
Patent: 14204459
Estimated Expiration: See Plans and Pricing
Patent: 16262698
Estimated Expiration: See Plans and Pricing
Patent: 18282427
Estimated Expiration: See Plans and Pricing
Patent: 21204302
Estimated Expiration: See Plans and Pricing
Brazil
Patent: 2012012925
Estimated Expiration: See Plans and Pricing
Canada
Patent: 81487
Estimated Expiration: See Plans and Pricing
Chile
Patent: 12001432
Estimated Expiration: See Plans and Pricing
China
Patent: 2724974
Estimated Expiration: See Plans and Pricing
Patent: 7412229
Estimated Expiration: See Plans and Pricing
Colombia
Patent: 41613
Estimated Expiration: See Plans and Pricing
Costa Rica
Patent: 120265
Estimated Expiration: See Plans and Pricing
Croatia
Patent: 0180312
Estimated Expiration: See Plans and Pricing
Cyprus
Patent: 20058
Estimated Expiration: See Plans and Pricing
Denmark
Patent: 06844
Estimated Expiration: See Plans and Pricing
Dominican Republic
Patent: 012000148
Estimated Expiration: See Plans and Pricing
Eurasian Patent Organization
Patent: 3839
Estimated Expiration: See Plans and Pricing
Patent: 1290266
Estimated Expiration: See Plans and Pricing
European Patent Office
Patent: 06844
Estimated Expiration: See Plans and Pricing
Patent: 35707
Estimated Expiration: See Plans and Pricing
Hong Kong
Patent: 49407
Estimated Expiration: See Plans and Pricing
Hungary
Patent: 36216
Estimated Expiration: See Plans and Pricing
Patent: 800027
Estimated Expiration: See Plans and Pricing
Israel
Patent: 9893
Estimated Expiration: See Plans and Pricing
Japan
Patent: 16631
Estimated Expiration: See Plans and Pricing
Patent: 13512270
Estimated Expiration: See Plans and Pricing
Lithuania
Patent: 2018011
Estimated Expiration: See Plans and Pricing
Patent: 06844
Estimated Expiration: See Plans and Pricing
Luxembourg
Patent: 0077
Estimated Expiration: See Plans and Pricing
Mexico
Patent: 1290
Estimated Expiration: See Plans and Pricing
Patent: 12006310
Estimated Expiration: See Plans and Pricing
Montenegro
Patent: 965
Estimated Expiration: See Plans and Pricing
Morocco
Patent: 853
Estimated Expiration: See Plans and Pricing
New Zealand
Patent: 0026
Estimated Expiration: See Plans and Pricing
Norway
Patent: 06844
Estimated Expiration: See Plans and Pricing
Peru
Patent: 130042
Estimated Expiration: See Plans and Pricing
Patent: 170915
Estimated Expiration: See Plans and Pricing
Poland
Patent: 06844
Estimated Expiration: See Plans and Pricing
Portugal
Patent: 06844
Estimated Expiration: See Plans and Pricing
Serbia
Patent: 848
Estimated Expiration: See Plans and Pricing
Singapore
Patent: 1087
Estimated Expiration: See Plans and Pricing
Patent: 201407864U
Estimated Expiration: See Plans and Pricing
Slovenia
Patent: 06844
Estimated Expiration: See Plans and Pricing
South Africa
Patent: 1203890
Estimated Expiration: See Plans and Pricing
South Korea
Patent: 1742140
Estimated Expiration: See Plans and Pricing
Patent: 1830728
Estimated Expiration: See Plans and Pricing
Patent: 120092163
Estimated Expiration: See Plans and Pricing
Patent: 170061719
Estimated Expiration: See Plans and Pricing
Spain
Patent: 59330
Estimated Expiration: See Plans and Pricing
Turkey
Patent: 1802921
Estimated Expiration: See Plans and Pricing
Ukraine
Patent: 6775
Estimated Expiration: See Plans and Pricing
United Kingdom
Patent: 21075
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 ANORO ELLIPTA around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Czech Republic | 9601807 | See Plans and Pricing | |
| South Korea | 100912324 | See Plans and Pricing | |
| Singapore | 150525 | COUNTER FOR USE WITH A MEDICAMENT DISPENSER | See Plans and Pricing |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for ANORO ELLIPTA
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1425001 | PA2014019 | Lithuania | See Plans and Pricing | PRODUCT NAME: VILANTEROLUM; REGISTRATION NO/DATE: EU/1/13/886/001-006 20131113 |
| 1425001 | 14C0028 | France | See Plans and Pricing | PRODUCT NAME: VILANTEROL OU UN SEL OU UN SOLVATE DE CELUI-CI,EN PARTICULIER LE TRIFENATATE DE VILANTEROL.; REGISTRATION NO/DATE: EU/1/13/886/001-006 20131113 |
| 2506844 | 18C1022 | France | See Plans and Pricing | PRODUCT NAME: COMBINAISON COMPRENANT UN SEL PHARMACEUTIQUEMENT ACCEPTABLE D'UMECLIDINIUM (EN PARTICULIER LE BROMURE D'UMECLIDINIUM), DU VILANTEROL OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI (EN PARTICULIER LE TRIFENATATE DE VILANTEROL), ET DU FUROATE DE FLUTICASONE; REGISTRATION NO/DATE: EU/1/17/1236 20171117 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Make Better Decisions: Try a trial or see plans & pricing
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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