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Last Updated: June 16, 2021

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INCRUSE ELLIPTA Drug 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: 49
Patent Applications: 322
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 ActionCholinergic Antagonists

US Patents and Regulatory Information for INCRUSE ELLIPTA

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

Supplementary Protection Certificates for INCRUSE ELLIPTA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2506844 2018C/022 Belgium   Get Started Free PRODUCT NAME: EEN FARMACEUTISCH COMBINATIEPRODUCT DAT EEN FARMACEUTISCH AANVAARDBAAR ZOUT VAN UMECLIDINIUM (BV. UMECLIDINIUMBROMIDE), VILANTEROL OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN (BV. VILANTEROLTRIFENATAAT) EN FLUTICASONEFUROAAT OMVAT; AUTHORISATION NUMBER AND DATE: EU/1/17/1236 20171117
1740177 570 Finland   Get Started Free
1740177 92565 Luxembourg   Get Started Free PRODUCT NAME: BROMURE D'UMECLIDINUM; FIRST REGISTRATION DATE: 20140428
2506844 LUC00077 Luxembourg   Get Started Free PRODUCT NAME: PRODUIT DE COMBINAISON PHARMACEUTIQUE COMPRENANT UN SEL PHARMACEUTIQUEMENT ACCEPTABLE D'UMECLIDINIUM (PAR EXEMPLE LE BROMURE D'UMECLIDINIUM), LE VILANTEROL OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLE (PAR EXEMPLE LE TRIFENATATE DE VILANTEROL) ET LE FUROATE DE FLUTICASONE; AUTHORISATION NUMBER AND DATE: EU/1/17/1236 20171117
1740177 208 50012-2014 Slovakia   Get Started Free PRODUCT NAME: UMEKLIDINIUMBROMID; REGISTRATION NO/DATE: EU/1/14/922/001 - EU/1/14/922/003 20140430
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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