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ADASUVE Drug Profile

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Which patents cover Adasuve, and what generic alternatives are available?

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

This drug has two hundred and twenty-six patent family members in twenty 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.

US ANDA Litigation and Generic Entry Outlook for Adasuve

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be October 26, 2021. This may change due to patent challenges or generic licensing.

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:	226
US Patents:	18
Applicants:	1
NDAs:	1
Suppliers / Packagers:	1
Bulk Api Vendors:	30
Clinical Trials:	5
Patent Applications:	3,435
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for ADASUVE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ADASUVE
DailyMed Link:	ADASUVE at DailyMed

See drug prices for ADASUVE

Generic Entry Opportunity Date for ADASUVE

NDA:

022549

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.

Recent Clinical Trials for ADASUVE

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

Sponsor	Phase
Lee's Pharmaceutical Limited	Phase 3
Advocate Health Care	N/A
Teva Branded Pharmaceutical Products, R&D Inc.	Phase 1

See all ADASUVE clinical trials

US Patents and Regulatory Information for 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
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	Y

International Patents for ADASUVE

Country	Patent Number	Estimated Expiration
Austria	425746
European Patent Office	1625334
Spain	2623467
Hong Kong	1068268
Spain	2361908
European Patent Office	1455875

Supplementary Protection Certificates for ADASUVE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1389098	132013902184784	Italy		PRODUCT NAME: LOXAPINA(ADASUVE); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/13/823/001-002, 20130220
1389098	CA 2013 00046	Denmark		PRODUCT NAME: LOXAPIN; REG. NO/DATE: 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
1389098	CR 2013 00046	Denmark		PRODUCT NAME: LOXAPIN; REG. NO/DATE: EU/1/13/823/001-002 20130220
1389098	473	Finland
1389098	C300609	Netherlands		PRODUCT NAME: LOXAPINE; REGISTRATION NO/DATE: EU/1/13/823/001-002 20130220