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Last Updated: May 28, 2022

TRELEGY ELLIPTA Drug Patent Profile


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When do Trelegy Ellipta patents expire, and what generic alternatives are available?

Trelegy 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 TRELEGY ELLIPTA is fluticasone furoate; umeclidinium bromide; vilanterol trifenatate. There are twenty-nine drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the fluticasone furoate; umeclidinium bromide; vilanterol trifenatate profile page.

DrugPatentWatch® Generic Entry Outlook for Trelegy Ellipta

Trelegy 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 has been one patent litigation case 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 TRELEGY ELLIPTA
Drug Prices for TRELEGY ELLIPTA

See drug prices for TRELEGY ELLIPTA

DrugPatentWatch® Estimated Generic Entry Opportunity Date for TRELEGY ELLIPTA
Generic Entry Date for TRELEGY 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 TRELEGY ELLIPTA

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Baylor Research InstitutePhase 4
GlaxoSmithKlinePhase 4

See all TRELEGY ELLIPTA clinical trials

US Patents and Regulatory Information for TRELEGY ELLIPTA

TRELEGY ELLIPTA is protected by eighteen US patents and two FDA Regulatory Exclusivities.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of TRELEGY 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 TRELEGY 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 CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD) COMPRISING THE ONCE PER DAY ADMINISTRATION OF TRELEGY ELLIPTA, 100 MCG FLUTICASONE FUROATE/62.5 MCG UMECLIDINIUM/25 MCG VILANTEROL

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 PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD), INCLUDING CHRONIC BRONCHITIS AND/OR EMPHYSEMA

Phenethanolamine derivatives for treatment of respiratory diseases
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: MAINTENANCE TREATMENT OF ASTHMA IN PATIENTS 18 YRS AND OLDER, OR 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: METHOD OF INHIBITING THE BINDING OF ACETYLCHOLINE TO AN ACETYLCHOLINE RECEPTOR IN THE RESPIRATORY TRACT OF A HUMAN, COMPRISING CONTACTING THE RECEPTOR WITH AN EFFECTIVE AMOUNT OF UMECLIDINIUM, VIA INHALATION

Muscarinic acetylcholine receptor antagonists
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD OF INHIBITING THE BINDING OF ACETYLCHOLINE TO AN ACETYLCHOLINE RECEPTOR IN THE RESPIRATORY TRACT OF A HUMAN, COMPRISING CONTACTING THE RECEPTOR WITH AN EFFECTIVE AMOUNT OF UMECLIDINIUM, VIA TOPICAL APPLICATION

Muscarinic acetylcholine receptor antagonists
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD OF INHIBITING THE BINDING OF ACETYLCHOLINE TO AN ACETYLCHOLINE RECEPTOR IN THE RESPIRATORY TRACT OF A HUMAN, COMPRISING CONTACTING THE RECEPTOR WITH AN EFFECTIVE AMOUNT OF UMECLIDINIUM, VIA TOPICAL APPLICATION

Medicament dispenser
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD OF DISPENSING A COMBINATION MEDICAMENT PRODUCT FROM CLAIMED DELIVERY DEVICE, FOR EXAMPLE FOR THE TREATMENT OF ASTHMA OR COPD

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 PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD), INCLUDING CHRONIC BRONCHITIS AND/OR EMPHYSEMA

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 PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD), INCLUDING CHRONIC BRONCHITIS AND/OR EMPHYSEMA; AND ASTHMA

FDA Regulatory Exclusivity protecting TRELEGY ELLIPTA

MAINTENANCE TREATMENT OF ASTHMA IN PATIENTS AGED 18 YEARS AND OLDER
Exclusivity Expiration: See Plans and Pricing

NEW STRENGTH
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 TRELEGY ELLIPTA fluticasone furoate; umeclidinium bromide; vilanterol trifenatate POWDER;INHALATION 209482-002 Sep 9, 2020 RX Yes Yes See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Glaxosmithkline TRELEGY ELLIPTA fluticasone furoate; umeclidinium bromide; vilanterol trifenatate POWDER;INHALATION 209482-002 Sep 9, 2020 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Glaxosmithkline TRELEGY ELLIPTA fluticasone furoate; umeclidinium bromide; vilanterol trifenatate POWDER;INHALATION 209482-002 Sep 9, 2020 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Glaxosmithkline TRELEGY ELLIPTA fluticasone furoate; umeclidinium bromide; vilanterol trifenatate POWDER;INHALATION 209482-002 Sep 9, 2020 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Glaxosmithkline TRELEGY ELLIPTA fluticasone furoate; umeclidinium bromide; vilanterol trifenatate POWDER;INHALATION 209482-001 Sep 18, 2017 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Glaxosmithkline TRELEGY ELLIPTA fluticasone furoate; umeclidinium bromide; vilanterol trifenatate POWDER;INHALATION 209482-001 Sep 18, 2017 RX Yes Yes See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Glaxosmithkline TRELEGY ELLIPTA fluticasone furoate; umeclidinium bromide; vilanterol trifenatate POWDER;INHALATION 209482-002 Sep 9, 2020 RX Yes Yes See Plans and Pricing See Plans and Pricing Y 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 TRELEGY ELLIPTA

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Glaxosmithkline TRELEGY ELLIPTA fluticasone furoate; umeclidinium bromide; vilanterol trifenatate POWDER;INHALATION 209482-001 Sep 18, 2017 See Plans and Pricing See Plans and Pricing
Glaxosmithkline TRELEGY ELLIPTA fluticasone furoate; umeclidinium bromide; vilanterol trifenatate POWDER;INHALATION 209482-001 Sep 18, 2017 See Plans and Pricing See Plans and Pricing
Glaxosmithkline TRELEGY ELLIPTA fluticasone furoate; umeclidinium bromide; vilanterol trifenatate POWDER;INHALATION 209482-002 Sep 9, 2020 See Plans and Pricing See Plans and Pricing
Glaxosmithkline TRELEGY ELLIPTA fluticasone furoate; umeclidinium bromide; vilanterol trifenatate POWDER;INHALATION 209482-002 Sep 9, 2020 See Plans and Pricing See Plans and Pricing
Glaxosmithkline TRELEGY ELLIPTA fluticasone furoate; umeclidinium bromide; vilanterol trifenatate POWDER;INHALATION 209482-002 Sep 9, 2020 See Plans and Pricing See Plans and Pricing
Glaxosmithkline TRELEGY ELLIPTA fluticasone furoate; umeclidinium bromide; vilanterol trifenatate POWDER;INHALATION 209482-001 Sep 18, 2017 See Plans and Pricing See Plans and Pricing
Glaxosmithkline TRELEGY ELLIPTA fluticasone furoate; umeclidinium bromide; vilanterol trifenatate POWDER;INHALATION 209482-002 Sep 9, 2020 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for TRELEGY ELLIPTA

When does loss-of-exclusivity occur for TRELEGY 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 TRELEGY ELLIPTA around the world.

Country Patent Number Title Estimated Expiration
Norway 2017018 See Plans and Pricing
Japan 2005533583 See Plans and Pricing
Japan 2005523267 See Plans and Pricing
China 1294142 See Plans and Pricing
China 1829547 Medicament dispenser See Plans and Pricing
Australia 2003236835 See Plans and Pricing
Spain 2524370 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for TRELEGY ELLIPTA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1740177 C300694 Netherlands See Plans and Pricing PRODUCT NAME: UMECLIDINIUMBROMIDE; REGISTRATION NO/DATE: EU/1/14/922/001-003 20140428
1740177 1490060-9 Sweden See Plans and Pricing MARKETING AUTHORIZATION NUMBER AND DATE OF GRANT/NOTIFICATION: EU/1/14/922, 2014-04-30; PERIOD OF VALIDITY (FROM - UNTIL): 20250428 - 20240429
2506844 CA 2018 00023 Denmark See Plans and Pricing PRODUCT NAME: FARMACEUTISK KOMBINATIONSPRODUKT OMFATTENDE ET FARMACEUTISK ACCEPTABELT SALT AF UMECLIDINIUM (F.EKS. UMECLIDINIUMBROMID), VILANTEROL ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF (F.EKS. VILANTEROLTRIFENATAT) OG FLUTICASONFUROAT; REG. NO/DATE: EU/1/17/1236 20171117
1740177 2014/057 Ireland See Plans and Pricing PRODUCT NAME: UMECLIDINIUM BROMIDE; REGISTRATION NO/DATE: EU/1/14/922/001-003 20140428
1305329 C01305329/01 Switzerland See Plans and Pricing PRODUCT NAME: FLUTICASON FUROAT; REGISTRATION NUMBER/DATE: SWISSMEDIC 57968 19.12.2007
2506844 PA2018011 Lithuania See Plans and Pricing PRODUCT NAME: UMEKLIDINAS + VILANTEROLIS + FLUTIKAZONO FUROATAS; REGISTRATION NO/DATE: EU/1/17/1236 20171115
2506844 132018000000341 Italy See Plans and Pricing 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

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Serving leading biopharmaceutical companies globally:

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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.