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Last Updated: September 25, 2022

INCRUSE ELLIPTA Drug Patent Profile


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When do Incruse Ellipta patents expire, 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.

Indicators of Generic Entry

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Summary for INCRUSE ELLIPTA
International Patents:177
US Patents:10
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 54
Patent Applications: 602
Drug Prices: Drug price information for INCRUSE ELLIPTA
What excipients (inactive ingredients) are in INCRUSE ELLIPTA?INCRUSE ELLIPTA excipients list
DailyMed Link:INCRUSE ELLIPTA at DailyMed
Drug patent expirations by year for INCRUSE ELLIPTA
Drug Prices for INCRUSE ELLIPTA

See drug prices for INCRUSE ELLIPTA

DrugPatentWatch® Estimated Generic Entry Opportunity 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 Action Cholinergic Antagonists

US Patents and Regulatory Information for INCRUSE ELLIPTA

INCRUSE ELLIPTA is protected by ten US patents and one FDA Regulatory Exclusivity.

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

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

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.

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.

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

FDA Regulatory Exclusivity protecting INCRUSE 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
Glaxo Grp England INCRUSE ELLIPTA umeclidinium bromide POWDER;INHALATION 205382-001 Apr 30, 2014 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Glaxo Grp England INCRUSE ELLIPTA umeclidinium bromide POWDER;INHALATION 205382-001 Apr 30, 2014 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Glaxo Grp England INCRUSE ELLIPTA umeclidinium bromide POWDER;INHALATION 205382-001 Apr 30, 2014 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

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: See Plans and Pricing

Argentina

Patent: 0902
Estimated Expiration: See Plans and Pricing

Australia

Patent: 05237576
Estimated Expiration: See Plans and Pricing

Brazil

Patent: 0510170
Estimated Expiration: See Plans and Pricing

Canada

Patent: 64742
Estimated Expiration: See Plans and Pricing

Patent: 55954
Estimated Expiration: See Plans and Pricing

China

Patent: 76701
Estimated Expiration: See Plans and Pricing

Patent: 2040602
Estimated Expiration: See Plans and Pricing

Croatia

Patent: 0120832
Estimated Expiration: See Plans and Pricing

Patent: 0161385
Estimated Expiration: See Plans and Pricing

Cyprus

Patent: 13196
Estimated Expiration: See Plans and Pricing

Patent: 18082
Estimated Expiration: See Plans and Pricing

Denmark

Patent: 40177
Estimated Expiration: See Plans and Pricing

Patent: 70128
Estimated Expiration: See Plans and Pricing

Ecuador

Patent: 066940
Estimated Expiration: See Plans and Pricing

Eurasian Patent Organization

Patent: 5033
Estimated Expiration: See Plans and Pricing

Patent: 1994
Estimated Expiration: See Plans and Pricing

Patent: 0601991
Estimated Expiration: See Plans and Pricing

Patent: 1100019
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 40177
Estimated Expiration: See Plans and Pricing

Patent: 70128
Estimated Expiration: See Plans and Pricing

Patent: 11936
Estimated Expiration: See Plans and Pricing

Hong Kong

Patent: 02423
Estimated Expiration: See Plans and Pricing

Hungary

Patent: 31304
Estimated Expiration: See Plans and Pricing

Patent: 400053
Estimated Expiration: See Plans and Pricing

Israel

Patent: 8152
Estimated Expiration: See Plans and Pricing

Japan

Patent: 14121
Estimated Expiration: See Plans and Pricing

Patent: 98871
Estimated Expiration: See Plans and Pricing

Patent: 07534769
Estimated Expiration: See Plans and Pricing

Patent: 12162559
Estimated Expiration: See Plans and Pricing

Lithuania

Patent: 70128
Estimated Expiration: See Plans and Pricing

Luxembourg

Patent: 565
Estimated Expiration: See Plans and Pricing

Malaysia

Patent: 4753
Estimated Expiration: See Plans and Pricing

Mexico

Patent: 06012405
Estimated Expiration: See Plans and Pricing

Morocco

Patent: 631
Estimated Expiration: See Plans and Pricing

Netherlands

Patent: 0694
Estimated Expiration: See Plans and Pricing

New Zealand

Patent: 9997
Estimated Expiration: See Plans and Pricing

Norway

Patent: 8959
Estimated Expiration: See Plans and Pricing

Patent: 17017
Estimated Expiration: See Plans and Pricing

Patent: 17018
Estimated Expiration: See Plans and Pricing

Patent: 065417
Estimated Expiration: See Plans and Pricing

Peru

Patent: 060259
Estimated Expiration: See Plans and Pricing

Poland

Patent: 40177
Estimated Expiration: See Plans and Pricing

Patent: 70128
Estimated Expiration: See Plans and Pricing

Portugal

Patent: 40177
Estimated Expiration: See Plans and Pricing

Patent: 70128
Estimated Expiration: See Plans and Pricing

Singapore

Patent: 6597
Estimated Expiration: See Plans and Pricing

Slovenia

Patent: 40177
Estimated Expiration: See Plans and Pricing

Patent: 70128
Estimated Expiration: See Plans and Pricing

South Africa

Patent: 0608565
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 1037026
Estimated Expiration: See Plans and Pricing

Patent: 1152032
Estimated Expiration: See Plans and Pricing

Patent: 070015412
Estimated Expiration: See Plans and Pricing

Patent: 110010841
Estimated Expiration: See Plans and Pricing

Spain

Patent: 92848
Estimated Expiration: See Plans and Pricing

Patent: 00405
Estimated Expiration: See Plans and Pricing

Taiwan

Patent: 63759
Estimated Expiration: See Plans and Pricing

Patent: 0605887
Estimated Expiration: See Plans and Pricing

Ukraine

Patent: 768
Estimated Expiration: See Plans and Pricing

Uruguay

Patent: 871
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 INCRUSE ELLIPTA around the world.

Country Patent Number Title Estimated Expiration
European Patent Office 3111936 ANTAGONISTES DES RÉCEPTEURS MUSCARINIQUES DE L'ACÉTYLCHOLINE (MUSCARINIC ACETYLCHOLINE RECEPTOR ANTAGONISTS) See Plans and Pricing
Japan H04220266 INHALER See Plans and Pricing
Poland 167736 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for INCRUSE ELLIPTA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1740177 C 2014 041 Romania See Plans and Pricing PRODUCT NAME: BROMURADE UMECLIDINIUM4-[HIDROXI(DIFENIL)METIL]-1-{2-[(FENILMETIL)OXI]ETIL}-1-AZONIABI DATE OF NATIONAL AUTHORISATION: 20140428; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (CICLO[2.2.2]OCTAN; NATIONAL AUTHORISATION NUMBER: EU/1/14/922/001, EU/1/14/922/002, EU/1/14/922/003;EEA): EU/1/14/922/001, EU/1/14/922/002, EU/1/14/922/003; DATE OF FIRST AUTHORISATION IN EEA: 20140428
1740177 570 Finland See Plans and Pricing
1740177 C01740177/02 Switzerland See Plans and Pricing PRODUCT NAME: UMECLIDINIUM BROMID + VILANTEROL; REGISTRATION NO/DATE: SWISSMEDIC 63152 14.07.2014
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

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Merck

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.