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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-five 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

Adasuve was eligible for patent challenges on December 31, 1968.

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.

Indicators of Generic Entry

Summary for ADASUVE

International Patents:	225
US Patents:	18
Applicants:	1
NDAs:	1
Suppliers / Packagers:	1
Bulk Api Vendors:	28
Clinical Trials:	5
Patent Applications:	3,390
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information 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

Synonyms for ADASUVE

13-chloro-10-(4-methylpiperazin-1-yl)-2-oxa-9-azatricyclo[9.4.0.0^{3,8}]pentadeca-1(11),3,5,7,9,12,14-heptaene

13-chloro-10-(4-methylpiperazin-1-yl)-2-oxa-9-azatricyclo[9.4.0.0;{3,8}]pentadeca-1(11),3(8),4,6,9,12,14-heptaene

1977-10-2

2-Chloro-11-(4-methyl-1-piperazinyl)-dibenz(b,f)(1,4)oxazepine

2-Chloro-11-(4-methyl-1-piperazinyl)dibenz(b,f)(1,4)oxazepine

2-Chloro-11-(4-methyl-1-piperazinyl)dibenz[b,f][1,4]oxazepine

2-chloro-11-(4-methylpiperazin-1-yl)dibenzo[b,f][1,4]oxazepine

2-Chloro-11-(4-methylpiperazino)dibenz[b,f][1,4]oxazepine

2-Chloro-11-(4-methylpiperazino)dibenzo(b,f)(1,4)oxazepine

27833-64-3 (succinate)

3785AH

54810-23-0 (mono-hydrochloride)

8-chloro-6-(4-methylpiperazin-1-yl)benzo[b][1,4]benzoxazepine

8-chloro-6-(4-methylpiperazin-1-yl)benzo[b][1,5]benzoxazepine

8-chloro-6-(4-methylpiperazino)benzo[b][1,4]benzoxazepine;succinic acid

977L102

AB00053735_15

AB00053735_16

AC1L1H3Z

AC1Q3ZWR

Adasuve (TN)

AKOS030526111

API0006785

AZ-004

BDBM22871

BPBio1_000226

BRD-K39915878-036-04-6

BRD-K39915878-036-05-3

BRD-K39915878-036-15-2

BRN 0626753

BSPBio_000204

BSPBio_003479

C07104

C18H18ClN3O

CCG-204805

CHEBI:50841

CHEMBL831

CL 62,362

CL 62362

CL-62362

CL-71,563

CL-71563

CL71,563

Cloxazepine

CS-1105

D02340

DB00408

Dibenz(b,f)(1,4)oxazepine, 2-chloro-11-(4-methyl-1-piperazinyl)-

Dibenz[b,f][1,4]oxazepine, 2-chloro-11-(4-methyl-1-piperazinyl)-

Dibenzacepin

Dibenzoazepine

DivK1c_006919

DTXSID7023229

EINECS 217-835-3

GTPL205

HF 3170

HF3170

HSDB 3111

HY-17390

Hydrofluoride 3170

KBio1_001863

KBio2_000835

KBio2_003403

KBio2_005971

KBio3_002983

KBioSS_000835

L001085

LER583670J

Lopac0_000720

Lossapina

Lossapina [DCIT]

Loxapac

Loxapin

Loxapina

Loxapina [INN-Spanish]

loxapine

Loxapine (DMSO)

Loxapine (USAN/INN)

Loxapine (water)

Loxapine [USAN:BAN:INN]

Loxapine [USAN:INN:BAN]

Loxapinsuccinate

Loxapinum

Loxapinum [INN-Latin]

Loxepine

Loxitane

LOXITANE C

Loxitane IM

Loxitane Intramuscular

Loxitane-C Oral Suspension

LS-61562

LW 3170

NCGC00021145-01

NCGC00021145-02

NCGC00021145-03

NCGC00021145-04

NCGC00021145-05

NCGC00021145-06

NCGC00021145-07

NCGC00021145-08

NCGC00022279-03

NCGC00022279-04

NCGC00022279-05

Oxilapine

PDSP1_001058

PDSP2_001042

Prestwick0_000132

Prestwick1_000132

Prestwick2_000132

Prestwick3_000132

QTL1_000050

S 805

S-805

SCHEMBL94146

SPBio_001814

SPBio_002143

SpecPlus_000823

Spectrum_000355

Spectrum2_001737

Spectrum3_001830

Spectrum5_001857

Staccato loxapine

SUM 3170

SUM-3170

UNII-LER583670J

W-5098

XJGVXQDUIWGIRW-UHFFFAOYSA-N

ZINC19796158

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
Alexza Pharms	ADASUVE	loxapine	POWDER;INHALATION	022549-001	Dec 21, 2012		RX	Yes	Yes			Y

International Patents for ADASUVE

Country	Patent Number	Estimated Expiration
Japan	2010270138
Portugal	1389098
World Intellectual Property Organization (WIPO)	02094230
European Patent Office	1565184
China	101623528
World Intellectual Property Organization (WIPO)	03045484
Germany	60227660

Supplementary Protection Certificates for ADASUVE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1389098	300609	Netherlands		PRODUCT NAME: LOXAPINE; REGISTRATION NO/DATE: EU/1/13/823/001-002 20130220
1389098	C300609	Netherlands		PRODUCT NAME: LOXAPINE; REGISTRATION 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	CA 2013 00046	Denmark		PRODUCT NAME: LOXAPIN; REG. NO/DATE: EU/1/13/823/001-002 20130220
1389098	473	Finland
1389098	1390040-2	Sweden		PRODUCT NAME: LOXAPIN; REG. NO/DATE: EU/1/13/823/001 20130220
1389098	CR 2013 00046	Denmark		PRODUCT NAME: LOXAPIN; REG. NO/DATE: EU/1/13/823/001-002 20130220