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ADASUVE Drug Patent Profile

Which patents cover Adasuve, and when can generic versions of Adasuve launch?

Adasuve is a drug marketed by Alexza Pharms and is included in one NDA. There are five patents protecting this drug.

This drug has two hundred and twenty-seven patent family members in twenty-one countries.

The generic ingredient in ADASUVE is loxapine. There are eight drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the loxapine profile page.

DrugPatentWatch^® Generic Entry Outlook for Adasuve

There has been one patent litigation case 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 ADASUVE

International Patents:	227
US Patents:	5
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	51
Clinical Trials:	13
Patent Applications:	5,118
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for ADASUVE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ADASUVE
What excipients (inactive ingredients) are in ADASUVE?	ADASUVE excipients list
DailyMed Link:	ADASUVE at DailyMed

See drug prices for ADASUVE

Recent Clinical Trials for ADASUVE

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Lee's Pharmaceutical Limited	Phase 3
University of Arkansas	Phase 4
Mount Sinai Hospital, Chicago	Phase 4

See all ADASUVE clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for ADASUVE

N05AH	Diazepines, oxazepines, thiazepines and oxepines
N05A	ANTIPSYCHOTICS
N05	PSYCHOLEPTICS
N	Nervous system

US Patents and Regulatory Information for ADASUVE

ADASUVE is protected by five US patents.

Patents protecting ADASUVE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Alexza Pharms	ADASUVE	loxapine	POWDER;INHALATION	022549-001	Dec 21, 2012		RX	Yes	Yes			Y
Alexza Pharms	ADASUVE	loxapine	POWDER;INHALATION	022549-001	Dec 21, 2012		RX	Yes	Yes			Y
Alexza Pharms	ADASUVE	loxapine	POWDER;INHALATION	022549-001	Dec 21, 2012		RX	Yes	Yes			Y
Alexza Pharms	ADASUVE	loxapine	POWDER;INHALATION	022549-001	Dec 21, 2012		RX	Yes	Yes			Y

Expired US Patents for ADASUVE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Alexza Pharms	ADASUVE	loxapine	POWDER;INHALATION	022549-001	Dec 21, 2012
Alexza Pharms	ADASUVE	loxapine	POWDER;INHALATION	022549-001	Dec 21, 2012
Alexza Pharms	ADASUVE	loxapine	POWDER;INHALATION	022549-001	Dec 21, 2012
Alexza Pharms	ADASUVE	loxapine	POWDER;INHALATION	022549-001	Dec 21, 2012

EU/EMA Drug Approvals for ADASUVE

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Ferrer Internacional S.A.	Adasuve	loxapine	EMEA/H/C/002400 Adasuve is indicated for the rapid control of mild-to-moderate agitation in adult patients with schizophrenia or bipolar disorder. Patients should receive regular treatment immediately after control of acute agitation symptoms.	Authorised	no	no	no	2013-02-20

International Patents for ADASUVE

See the table below for patents covering ADASUVE around the world.

Country	Patent Number	Title	Estimated Expiration
Japan	2005525178
Japan	2005503425
Japan	4601619
European Patent Office	3207954	PROCÉDÉ ET APPAREIL DE VAPORISATION D'UN COMPOSÉ (METHOD AND APPARATUS FOR VAPORIZING A COMPOUND)

Supplementary Protection Certificates for ADASUVE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1389098	C01389098/01	Switzerland		PRODUCT NAME: LOXAPINUM; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 65461 13.12.2016
1389098	300609	Netherlands		PRODUCT NAME: LOXAPINE; REGISTRATION NO/DATE: EU/1/13/823/001-002 20130220
1389098	132013902184784	Italy		PRODUCT NAME: LOXAPINA(ADASUVE); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/13/823/001-002, 20130220
1389098	SPC/GB13/055	United Kingdom		PRODUCT NAME: LOXAPINE; REGISTERED: UK EU/1/13/823/001 20130220; UK EU/1/13/823/002 20130220