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Last Updated: May 19, 2024

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ANORO ELLIPTA Drug Patent Profile


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Which patents cover Anoro Ellipta, and when can generic versions of Anoro Ellipta launch?

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

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Drug patent expirations by year for ANORO ELLIPTA
Drug Prices for ANORO ELLIPTA

See drug prices for ANORO ELLIPTA

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

SponsorPhase
Baylor Research InstitutePhase 4
Chiesi Farmaceutici S.p.A.Phase 4
Luis Puente MaestuPhase 4

See all ANORO ELLIPTA clinical trials

Pharmacology 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 ⤷  Try a Trial.

This potential generic entry date is based on patent ⤷  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.

Patents protecting ANORO ELLIPTA

Combinations of a muscarinic receptor antagonist and a beta-2 adrenoreceptor agonist
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: MAINTENANCE TREATMENT OF PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)

Phenethanolamine derivatives for treatment of respiratory diseases
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Muscarinic acetylcholine receptor antagonists
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Muscarinic acetylcholine receptor antagonists
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Medicament dispenser
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Muscarinic acetylcholine receptor antagonists
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
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: ⤷  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

Combinations of a muscarinic receptor antagonist and a beta-2 adrenoreceptor agonist
Patent Number: ⤷  Try a Trial
Patent 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 ANORO ELLIPTA umeclidinium bromide; vilanterol trifenatate POWDER;INHALATION 203975-001 Dec 18, 2013 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Glaxosmithkline ANORO ELLIPTA umeclidinium bromide; vilanterol trifenatate POWDER;INHALATION 203975-001 Dec 18, 2013 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Glaxosmithkline ANORO ELLIPTA umeclidinium bromide; vilanterol trifenatate POWDER;INHALATION 203975-001 Dec 18, 2013 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Glaxosmithkline ANORO ELLIPTA umeclidinium bromide; vilanterol trifenatate POWDER;INHALATION 203975-001 Dec 18, 2013 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Glaxosmithkline ANORO ELLIPTA umeclidinium bromide; vilanterol trifenatate POWDER;INHALATION 203975-001 Dec 18, 2013 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 ANORO ELLIPTA

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: ⤷  Try a Trial

Patent: 14204459
Estimated Expiration: ⤷  Try a Trial

Patent: 16262698
Estimated Expiration: ⤷  Try a Trial

Patent: 17238392
Estimated Expiration: ⤷  Try a Trial

Patent: 18282427
Estimated Expiration: ⤷  Try a Trial

Patent: 21204302
Estimated Expiration: ⤷  Try a Trial

Patent: 23219901
Estimated Expiration: ⤷  Try a Trial

Brazil

Patent: 2012012925
Estimated Expiration: ⤷  Try a Trial

Patent: 2018069147
Estimated Expiration: ⤷  Try a Trial

Canada

Patent: 81487
Estimated Expiration: ⤷  Try a Trial

Patent: 18345
Estimated Expiration: ⤷  Try a Trial

Chile

Patent: 12001432
Estimated Expiration: ⤷  Try a Trial

China

Patent: 2724974
Estimated Expiration: ⤷  Try a Trial

Patent: 7412229
Estimated Expiration: ⤷  Try a Trial

Patent: 8778288
Estimated Expiration: ⤷  Try a Trial

Colombia

Patent: 41613
Estimated Expiration: ⤷  Try a Trial

Costa Rica

Patent: 120265
Estimated Expiration: ⤷  Try a Trial

Croatia

Patent: 0180312
Estimated Expiration: ⤷  Try a Trial

Cyprus

Patent: 20058
Estimated Expiration: ⤷  Try a Trial

Denmark

Patent: 06844
Estimated Expiration: ⤷  Try a Trial

Dominican Republic

Patent: 012000148
Estimated Expiration: ⤷  Try a Trial

Eurasian Patent Organization

Patent: 3839
Estimated Expiration: ⤷  Try a Trial

Patent: 1290266
Estimated Expiration: ⤷  Try a Trial

European Patent Office

Patent: 06844
Estimated Expiration: ⤷  Try a Trial

Patent: 35707
Estimated Expiration: ⤷  Try a Trial

Patent: 32892
Estimated Expiration: ⤷  Try a Trial

France

Patent: C1022
Estimated Expiration: ⤷  Try a Trial

Hong Kong

Patent: 49407
Estimated Expiration: ⤷  Try a Trial

Hungary

Patent: 36216
Estimated Expiration: ⤷  Try a Trial

Patent: 800027
Estimated Expiration: ⤷  Try a Trial

Israel

Patent: 9893
Estimated Expiration: ⤷  Try a Trial

Japan

Patent: 16631
Estimated Expiration: ⤷  Try a Trial

Patent: 13512270
Estimated Expiration: ⤷  Try a Trial

Patent: 19509315
Estimated Expiration: ⤷  Try a Trial

Lithuania

Patent: 506844
Estimated Expiration: ⤷  Try a Trial

Patent: 2018011
Estimated Expiration: ⤷  Try a Trial

Patent: 06844
Estimated Expiration: ⤷  Try a Trial

Luxembourg

Patent: 0077
Estimated Expiration: ⤷  Try a Trial

Malaysia

Patent: 4864
Estimated Expiration: ⤷  Try a Trial

Mexico

Patent: 1290
Estimated Expiration: ⤷  Try a Trial

Patent: 12006310
Estimated Expiration: ⤷  Try a Trial

Montenegro

Patent: 965
Estimated Expiration: ⤷  Try a Trial

Morocco

Patent: 853
Estimated Expiration: ⤷  Try a Trial

New Zealand

Patent: 0026
Estimated Expiration: ⤷  Try a Trial

Norway

Patent: 06844
Estimated Expiration: ⤷  Try a Trial

Peru

Patent: 130042
Estimated Expiration: ⤷  Try a Trial

Patent: 170915
Estimated Expiration: ⤷  Try a Trial

Poland

Patent: 06844
Estimated Expiration: ⤷  Try a Trial

Portugal

Patent: 06844
Estimated Expiration: ⤷  Try a Trial

Russian Federation

Patent: 18131440
Estimated Expiration: ⤷  Try a Trial

Serbia

Patent: 848
Estimated Expiration: ⤷  Try a Trial

Singapore

Patent: 1087
Estimated Expiration: ⤷  Try a Trial

Patent: 201407864U
Estimated Expiration: ⤷  Try a Trial

Slovenia

Patent: 06844
Estimated Expiration: ⤷  Try a Trial

South Africa

Patent: 1203890
Estimated Expiration: ⤷  Try a Trial

South Korea

Patent: 1742140
Estimated Expiration: ⤷  Try a Trial

Patent: 1830728
Estimated Expiration: ⤷  Try a Trial

Patent: 120092163
Estimated Expiration: ⤷  Try a Trial

Patent: 170061719
Estimated Expiration: ⤷  Try a Trial

Patent: 180128937
Estimated Expiration: ⤷  Try a Trial

Spain

Patent: 59330
Estimated Expiration: ⤷  Try a Trial

Turkey

Patent: 1802921
Estimated Expiration: ⤷  Try a Trial

Ukraine

Patent: 6775
Estimated Expiration: ⤷  Try a Trial

United Kingdom

Patent: 21075
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 ANORO ELLIPTA around the world.

Country Patent Number Title Estimated Expiration
Australia 2017238392 Mannose-derived antagonists of FimH useful for treating disease ⤷  Try a Trial
Hungary S1400053 ⤷  Try a Trial
Canada 2616193 DISTRIBUTEUR DE MEDICAMENTS (MEDICAMENT DISPENSER) ⤷  Try a Trial
European Patent Office 3335707 COMBINAISONS D'UN ANTAGONISTE DE RÉCEPTEUR MUSCARINIQUE ET D'UN AGONISTE DU RÉCEPTEUR BÊTA-2 ADRÉNERGIQUE (COMBINATIONS OF A MUSCARINIC RECEPTOR ANTAGONIST AND A BETA-2 ADRENORECEPTOR AGONIST) ⤷  Try a Trial
Hong Kong 1066479 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for ANORO ELLIPTA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1740177 1490060-9 Sweden ⤷  Try a Trial MARKETING AUTHORIZATION NUMBER AND DATE OF GRANT/NOTIFICATION: EU/1/14/922, 2014-04-30; PERIOD OF VALIDITY (FROM - UNTIL): 20250428 - 20240429
2506844 300942 Netherlands ⤷  Try a Trial 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
1425001 C 2014 016 Romania ⤷  Try a Trial PRODUCT NAME: VILANTEROL SAU O SARE SAU SOLVAT AL ACESTUIA; NATIONAL AUTHORISATION NUMBER: EU/1/13/886/001, EU/1/13/886/002, EU/1/13/886/003, EU/1/13/886/004, EU/1/13/886/005, EU/1/13/886/006; DATE OF NATIONAL AUTHORISATION: 20131113; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/13/886/001, EU/1/13/886/002, EU/1/13/886/003, EU/1/13/886/004, EU/1/13/886/005, EU/1/13/886/006; DATE OF FIRST AUTHORISATION IN EEA: 20131113
2506844 122018000060 Germany ⤷  Try a Trial PRODUCT NAME: PHARMAZEUTISCHES KOMBINATIONSPRODUKT UMFASSEND EIN PHARMAZEUTISCH ANNEHMBARES SALZ VON UMECLIDINIUM (EINSCHLIESSLICH UMECLIDINIUMBROMID), VILANTEROL ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON (EINSCHLIESSLICH VILANTEROLTRIFENATAT) UND FLUTICASONFUROAT.; REGISTRATION NO/DATE: EU/1/17/1236 20171115
1425001 C20140013 00103 Estonia ⤷  Try a Trial PRODUCT NAME: VILANTEROOLTRIFENATAAT;REG NO/DATE: K(2013)8089 (LOPLIK) 13.11.2013
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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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.