Details for New Drug Application (NDA): 205382

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NDA 205382 describes INCRUSE ELLIPTA, which is a drug marketed by Glaxo Grp England and is included in one NDA. It is available from one supplier. There are ten patents protecting this drug. Additional details are available on the INCRUSE ELLIPTA profile page.

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.

Summary for 205382

Tradename:	INCRUSE ELLIPTA
Applicant:	Glaxo Grp England
Ingredient:	umeclidinium bromide
Patents:	10

DrugPatentWatch^® Estimated Generic Entry Opportunity Date for 205382

Generic Entry Date for 205382^: ⤷ Free Forever Trial* Constraining patent/regulatory exclusivity: ⤷ Free Forever Trial 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 NDA: 205382

Mechanism of Action	Cholinergic Antagonists

Suppliers and Packaging for NDA: 205382

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
INCRUSE ELLIPTA	umeclidinium bromide	POWDER;INHALATION	205382	NDA	GlaxoSmithKline LLC	0173-0873	0173-0873-06	1 TRAY in 1 CARTON (0173-0873-06) > 1 INHALER in 1 TRAY > 7 AEROSOL, POWDER in 1 INHALER
INCRUSE ELLIPTA	umeclidinium bromide	POWDER;INHALATION	205382	NDA	GlaxoSmithKline LLC	0173-0873	0173-0873-10	1 TRAY in 1 CARTON (0173-0873-10) > 1 INHALER in 1 TRAY > 30 AEROSOL, POWDER in 1 INHALER

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	POWDER;INHALATION			Strength	EQ 62.5MCG BASE/INH
Approval Date:	Apr 30, 2014	TE:		RLD:	Yes
Regulatory Exclusivity Expiration:	Jun 9, 2022
Regulatory Exclusivity Use:	ADDITIONAL INFORMATION ADDED TO THE LABELING BASED ON SAFETY AND EFFICACY DATA FROM THE IMPACT TRIAL
Patent:	⤷ Free Forever Trial	Patent Expiration:	Dec 18, 2027	Product Flag?	Y	Substance Flag?	Y	Delist Request?
Patent:	⤷ Free Forever Trial	Patent Expiration:	Apr 27, 2025	Product Flag?	Y	Substance Flag?	Y	Delist Request?

Expired US Patents for NDA 205382

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Glaxo Grp England	INCRUSE ELLIPTA	umeclidinium bromide	POWDER;INHALATION	205382-001	Apr 30, 2014	⤷ Free Forever Trial	⤷ Free Forever Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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