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INCRUSE ELLIPTA Drug Patent Profile

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 seven patents protecting this drug.

This drug has one hundred and seven patent family members in thirty-seven 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 have been two patent litigation cases 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

Summary for INCRUSE ELLIPTA

International Patents:	107
US Patents:	7
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	57
Patent Applications:	335
Drug Prices:	Drug price information for INCRUSE ELLIPTA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for INCRUSE ELLIPTA
What excipients (inactive ingredients) are in INCRUSE ELLIPTA?	INCRUSE ELLIPTA excipients list
DailyMed Link:	INCRUSE ELLIPTA at DailyMed

See drug prices for INCRUSE ELLIPTA

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for INCRUSE ELLIPTA

NDA:

205382

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 Class	Anticholinergic
Mechanism of Action	Cholinergic Antagonists

Anatomical Therapeutic Chemical (ATC) Classes for INCRUSE ELLIPTA

R03BB	Anticholinergics
R03B	OTHER DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES, INHALANTS
R03	DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
R	Respiratory system

US Patents and Regulatory Information for INCRUSE ELLIPTA

INCRUSE ELLIPTA is protected by seven US patents.

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

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
Glaxo Grp England	INCRUSE ELLIPTA	umeclidinium bromide	POWDER;INHALATION	205382-001	Apr 30, 2014		RX	Yes	Yes			Y
Glaxo Grp England	INCRUSE ELLIPTA	umeclidinium bromide	POWDER;INHALATION	205382-001	Apr 30, 2014		RX	Yes	Yes			Y
Glaxo Grp England	INCRUSE ELLIPTA	umeclidinium bromide	POWDER;INHALATION	205382-001	Apr 30, 2014		RX	Yes	Yes
Glaxo Grp England	INCRUSE ELLIPTA	umeclidinium bromide	POWDER;INHALATION	205382-001	Apr 30, 2014		RX	Yes	Yes			Y	Y
Glaxo Grp England	INCRUSE ELLIPTA	umeclidinium bromide	POWDER;INHALATION	205382-001	Apr 30, 2014		RX	Yes	Yes			Y	Y
Glaxo Grp England	INCRUSE ELLIPTA	umeclidinium bromide	POWDER;INHALATION	205382-001	Apr 30, 2014		RX	Yes	Yes			Y

Expired US Patents for INCRUSE ELLIPTA

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

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

International Patents for INCRUSE ELLIPTA

See the table below for patents covering INCRUSE ELLIPTA around the world.

Country	Patent Number	Title	Estimated Expiration
Austria	401007
Hungary	E028513
Japan	5608197
Australia	5926794
South Africa	200805029	MANIFOLD FOR USE IN MEDICAMENT DISPENSER
China	1030491
Australia	2005215216	Counter for use with a medicament dispenser

Supplementary Protection Certificates for INCRUSE ELLIPTA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1740177	PA2014038	Lithuania		PRODUCT NAME: UMECLIDINIUM BROMIDIUM; REGISTRATION NO/DATE: EU/1/14/922 20140428
1740177	1490060-9	Sweden		MARKETING AUTHORIZATION NUMBER AND DATE OF GRANT/NOTIFICATION: EU/1/14/922, 2014-04-30; PERIOD OF VALIDITY (FROM - UNTIL): 20250428 - 20240429
1740177	CR 2014 00052	Denmark		PRODUCT NAME: UMECLIDINIUMBROMID; REG. NO/DATE: EU/1/14/922/001-003 20140430
2506844	2018C/022	Belgium		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
1740177	CA 2014 00052	Denmark		PRODUCT NAME: UMECLIDINIUMBROMID; REG. NO/DATE: EU/1/14/922/001-003 20140428
1740177	122014000096	Germany		PRODUCT NAME: UMECLIDINIUMBROMID; REGISTRATION NO/DATE: EU/1/14/922/001-003 20140428