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Last Updated: July 12, 2020

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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-six 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.

US ANDA Litigation and 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
Drug patent expirations by year for INCRUSE ELLIPTA
Drug Prices for INCRUSE ELLIPTA

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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   Start Trial   Start Trial   Start Trial
Glaxo Grp England INCRUSE ELLIPTA umeclidinium bromide POWDER;INHALATION 205382-001 Apr 30, 2014 RX Yes Yes   Start Trial   Start Trial Y Y   Start Trial
Glaxo Grp England INCRUSE ELLIPTA umeclidinium bromide POWDER;INHALATION 205382-001 Apr 30, 2014 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Glaxo Grp England INCRUSE ELLIPTA umeclidinium bromide POWDER;INHALATION 205382-001 Apr 30, 2014 RX Yes Yes   Start Trial   Start Trial Y Y   Start Trial
Glaxo Grp England INCRUSE ELLIPTA umeclidinium bromide POWDER;INHALATION 205382-001 Apr 30, 2014 RX Yes Yes   Start Trial   Start Trial   Start Trial
Glaxo Grp England INCRUSE ELLIPTA umeclidinium bromide POWDER;INHALATION 205382-001 Apr 30, 2014 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Glaxo Grp England INCRUSE ELLIPTA umeclidinium bromide POWDER;INHALATION 205382-001 Apr 30, 2014 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
>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
1740177 CA 2014 00052 Denmark   Start Trial PRODUCT NAME: UMECLIDINIUMBROMID; REG. NO/DATE: EU/1/14/922/001-003 20140428
1740177 1490060-9 Sweden   Start Trial MARKETING AUTHORIZATION NUMBER AND DATE OF GRANT/NOTIFICATION: EU/1/14/922, 2014-04-30; PERIOD OF VALIDITY (FROM - UNTIL): 20250428 - 20240429
2506844 23/2018 Austria   Start Trial PRODUCT NAME: EIN PHARMAZEUTISCHES KOMBINATIONSPRODUKT, UMFASSEND EIN PHARMAZEUTISCH ANNEHMBARES SALZ VON UMECLIDINIUM, VILANTEROL ODER EINEM PHARMAZEUTISCH ANNEHMBAREN SALZ DAVON UND FLUTICASONFUROAT; REGISTRATION NO/DATE: EU/1/17/1236 (MITTEILUNG) 20171117
2506844 122018000060 Germany   Start Trial PRODUCT NAME: PHARMAZEUTISCHES KOMBINATIONSPRODUKT UMFASSEND EIN PHARMAZEUTISCH ANNEHMBARES SALZ VON UMCELIDINIUM (Z.B. UMECLIDINIUMBROMID), VILANTEROL ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON (Z.B. VILANTEROLTRIFENATAT) UND FLUTICASONFUROAT.; REGISTRATION NO/DATE: EU/1/17/1236 20171115
2506844 300942 Netherlands   Start 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
1740177 CR 2014 00052 Denmark   Start Trial PRODUCT NAME: UMECLIDINIUMBROMID; REG. NO/DATE: EU/1/14/922/001-003 20140430
2506844 CA 2018 00023 Denmark   Start Trial 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Baxter
Colorcon
Dow
Moodys
Medtronic
Merck

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