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Last Updated: March 18, 2024

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INCRUSE ELLIPTA Drug Patent Profile


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Which patents cover Incruse Ellipta, and what generic alternatives are available?

Incruse Ellipta is a drug marketed by Glaxo Grp England and is included in one NDA. There are ten patents protecting this drug.

This drug has one hundred and seventy-seven patent family members in thirty-nine countries.

The generic ingredient in INCRUSE ELLIPTA is umeclidinium bromide. 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 profile page.

DrugPatentWatch® Generic Entry Outlook for Incruse Ellipta

Incruse Ellipta was eligible for patent challenges on December 18, 2017.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be December 18, 2027. 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 INCRUSE ELLIPTA
Drug Prices for INCRUSE ELLIPTA

See drug prices for INCRUSE ELLIPTA

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for INCRUSE ELLIPTA
Generic Entry Date for INCRUSE 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.

Pharmacology for INCRUSE ELLIPTA
Drug ClassAnticholinergic
Mechanism of ActionCholinergic Antagonists

US Patents and Regulatory Information for INCRUSE ELLIPTA

INCRUSE ELLIPTA is protected by ten US patents.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of INCRUSE 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 INCRUSE ELLIPTA

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

Counter for use with a medicament dispenser
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.

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.

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

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Glaxo Grp England INCRUSE ELLIPTA umeclidinium bromide POWDER;INHALATION 205382-001 Apr 30, 2014 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Glaxo Grp England INCRUSE ELLIPTA umeclidinium bromide POWDER;INHALATION 205382-001 Apr 30, 2014 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Glaxo Grp England INCRUSE ELLIPTA umeclidinium bromide POWDER;INHALATION 205382-001 Apr 30, 2014 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y Y ⤷  Try a Trial
Glaxo Grp England INCRUSE ELLIPTA umeclidinium bromide POWDER;INHALATION 205382-001 Apr 30, 2014 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y Y ⤷  Try a Trial
Glaxo Grp England INCRUSE ELLIPTA umeclidinium bromide POWDER;INHALATION 205382-001 Apr 30, 2014 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Glaxo Grp England INCRUSE ELLIPTA umeclidinium bromide POWDER;INHALATION 205382-001 Apr 30, 2014 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

EU/EMA Drug Approvals for INCRUSE ELLIPTA

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
GlaxoSmithKline (Ireland) Limited Incruse Ellipta (previously Incruse) umeclidinium bromide EMEA/H/C/002809
Indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).,
Authorised no no no 2014-04-28
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for INCRUSE ELLIPTA

When does loss-of-exclusivity occur for INCRUSE ELLIPTA?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

African Regional IP Organization (ARIPO)

Patent: 13
Estimated Expiration: ⤷  Try a Trial

Argentina

Patent: 0902
Estimated Expiration: ⤷  Try a Trial

Australia

Patent: 05237576
Estimated Expiration: ⤷  Try a Trial

Brazil

Patent: 0510170
Estimated Expiration: ⤷  Try a Trial

Canada

Patent: 64742
Estimated Expiration: ⤷  Try a Trial

Patent: 55954
Estimated Expiration: ⤷  Try a Trial

China

Patent: 76701
Estimated Expiration: ⤷  Try a Trial

Patent: 2040602
Estimated Expiration: ⤷  Try a Trial

Croatia

Patent: 0120832
Estimated Expiration: ⤷  Try a Trial

Patent: 0161385
Estimated Expiration: ⤷  Try a Trial

Cyprus

Patent: 13196
Estimated Expiration: ⤷  Try a Trial

Patent: 18082
Estimated Expiration: ⤷  Try a Trial

Denmark

Patent: 40177
Estimated Expiration: ⤷  Try a Trial

Patent: 70128
Estimated Expiration: ⤷  Try a Trial

Ecuador

Patent: 066940
Estimated Expiration: ⤷  Try a Trial

Eurasian Patent Organization

Patent: 5033
Estimated Expiration: ⤷  Try a Trial

Patent: 1994
Estimated Expiration: ⤷  Try a Trial

Patent: 0601991
Estimated Expiration: ⤷  Try a Trial

Patent: 1100019
Estimated Expiration: ⤷  Try a Trial

European Patent Office

Patent: 40177
Estimated Expiration: ⤷  Try a Trial

Patent: 70128
Estimated Expiration: ⤷  Try a Trial

Patent: 11936
Estimated Expiration: ⤷  Try a Trial

Hong Kong

Patent: 02423
Estimated Expiration: ⤷  Try a Trial

Hungary

Patent: 31304
Estimated Expiration: ⤷  Try a Trial

Patent: 400053
Estimated Expiration: ⤷  Try a Trial

Israel

Patent: 8152
Patent: 4-[HYDROXY(DIPHENYL)METHYL]-1-{2-[PHENYLMETHYL)OXY]ETHYL}-1-AZONIABICYCLO[2.2.2] OCTANE BROMIDE USEFUL FOR TREATING MUSCARINIC ACETYLCHOLINE RECEPTOR MEDIATED DISEASES, AND PHARMACEUTICAL COMPOSITIONS COMPRISING IT
Estimated Expiration: ⤷  Try a Trial

Japan

Patent: 14121
Estimated Expiration: ⤷  Try a Trial

Patent: 98871
Estimated Expiration: ⤷  Try a Trial

Patent: 07534769
Estimated Expiration: ⤷  Try a Trial

Patent: 12162559
Estimated Expiration: ⤷  Try a Trial

Lithuania

Patent: 70128
Estimated Expiration: ⤷  Try a Trial

Luxembourg

Patent: 565
Estimated Expiration: ⤷  Try a Trial

Malaysia

Patent: 4753
Estimated Expiration: ⤷  Try a Trial

Mexico

Patent: 06012405
Estimated Expiration: ⤷  Try a Trial

Morocco

Patent: 631
Estimated Expiration: ⤷  Try a Trial

Netherlands

Patent: 0694
Estimated Expiration: ⤷  Try a Trial

New Zealand

Patent: 9997
Estimated Expiration: ⤷  Try a Trial

Norway

Patent: 8959
Estimated Expiration: ⤷  Try a Trial

Patent: 17017
Estimated Expiration: ⤷  Try a Trial

Patent: 17018
Estimated Expiration: ⤷  Try a Trial

Patent: 065417
Estimated Expiration: ⤷  Try a Trial

Peru

Patent: 060259
Estimated Expiration: ⤷  Try a Trial

Poland

Patent: 40177
Estimated Expiration: ⤷  Try a Trial

Patent: 70128
Estimated Expiration: ⤷  Try a Trial

Portugal

Patent: 40177
Estimated Expiration: ⤷  Try a Trial

Patent: 70128
Estimated Expiration: ⤷  Try a Trial

Singapore

Patent: 6597
Estimated Expiration: ⤷  Try a Trial

Slovenia

Patent: 40177
Estimated Expiration: ⤷  Try a Trial

Patent: 70128
Estimated Expiration: ⤷  Try a Trial

South Africa

Patent: 0608565
Estimated Expiration: ⤷  Try a Trial

South Korea

Patent: 1037026
Estimated Expiration: ⤷  Try a Trial

Patent: 1152032
Estimated Expiration: ⤷  Try a Trial

Patent: 070015412
Estimated Expiration: ⤷  Try a Trial

Patent: 110010841
Estimated Expiration: ⤷  Try a Trial

Spain

Patent: 92848
Estimated Expiration: ⤷  Try a Trial

Patent: 00405
Estimated Expiration: ⤷  Try a Trial

Taiwan

Patent: 63759
Estimated Expiration: ⤷  Try a Trial

Patent: 0605887
Estimated Expiration: ⤷  Try a Trial

Ukraine

Patent: 768
Estimated Expiration: ⤷  Try a Trial

Uruguay

Patent: 871
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 INCRUSE ELLIPTA around the world.

Country Patent Number Title Estimated Expiration
Peru 20060259 COMPUESTOS DE QUINUCLIDINA COMO ANTAGONISTAS DEL RECEPTOR DE ACETILCOLINA MUSCARINICO ⤷  Try a Trial
Israel 97396 ⤷  Try a Trial
South Africa 200608565 MUSCARINIC ACETYLCHOLINE RECEPTOR ANTAGONISTS ⤷  Try a Trial
Norway 20082701 ⤷  Try a Trial
Malaysia 144753 MUSCARINIC ACETYLCHOLINE RECEPTOR ANTAGONISTS ⤷  Try a Trial
Poland 1907037 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for INCRUSE ELLIPTA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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
2506844 1890025-8 Sweden ⤷  Try a Trial PRODUCT NAME: COMBINATION OF A PHARMACEUTICALLY ACCEPTABLE SALT OF UMECLIDINIUM (E.G. UMECLIDINIUM BROMIDE), VILANTEROL OR A PHARMACEUTICALLY ACCEPTABLE SALT THEROF (E.G. VILANTEROL TRIFENATATE) AND FLUTICASONE FUROATE.; REG. NO/DATE: EU/1/17/1236 20171117
1740177 PA2014038,C1740177 Lithuania ⤷  Try a Trial PRODUCT NAME: UMEKLIDINO BROMIDAS; REGISTRATION NO/DATE: EU/1/14/922 20140428
1740177 2014/057 Ireland ⤷  Try a Trial PRODUCT NAME: UMECLIDINIUM BROMIDE; REGISTRATION NO/DATE: EU/1/14/922/001-003 20140428
1740177 92565 Luxembourg ⤷  Try a Trial PRODUCT NAME: BROMURE D'UMECLIDINUM; FIRST REGISTRATION DATE: 20140428
1740177 CR 2014 00052 Denmark ⤷  Try a Trial PRODUCT NAME: UMECLIDINIUMBROMID; REG. NO/DATE: EU/1/14/922/001-003 20140430
>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.