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Loxapine - Generic Drug Details

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What are the generic sources for loxapine and what is the scope of loxapine patent protection?

Loxapine is the generic ingredient in five branded drugs marketed by Galen Uk , Actavis Labs Ut Inc, Elite Labs Inc, Lannett Holdings Inc, Mylan, and Watson Labs, and is included in eleven NDAs. There are eighteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Loxapine has two hundred and twenty-five patent family members in twenty countries.

There are eight drug master file entries for loxapine. Two suppliers are listed for this compound.

Summary for loxapine

International Patents:	225
US Patents:	18
Tradenames:	5
Applicants:	6
NDAs:	11
Drug Master File Entries:	8
Suppliers / Packagers:	2
Bulk Api Vendors:	22
Clinical Trials:	23
Patent Applications:	5,265
Formulation / Manufacturing:	see details
Drug Prices:	see low prices
DailyMed Link:	loxapine at DailyMed

Medical Subject Heading (MeSH) Categories for loxapine

Antipsychotic Agents

Dopamine Antagonists

Synonyms for loxapine

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

13-CHLORO-10-(4-METHYLPIPERAZIN-1-YL)-2-OXA-9-AZATRICYCLO[9.4.0.0(3),?]PENTADECA-1(15),3,5,7,9,11,13-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

Adasuve (TN)

AKOS030526111

API0006785

AZ-004

BDBM22871

BPBio1_000226

BRD-K39915878-036-04-6

BRD-K39915878-036-05-3

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

D0U5OE

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

Loxapac (TN)

Loxapin

Loxapina

Loxapina [INN-Spanish]

Loxapine (USAN/INN)

Loxapine [USAN:BAN:INN]

Loxapine [USAN:INN:BAN]

Loxapinsuccinate

Loxapinum

Loxapinum [INN-Latin]

Loxepine

Loxipine Maleate

Loxitane

Loxitane (TN)

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

PL039237

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 loxapine

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Elite Labs Inc	LOXAPINE SUCCINATE	loxapine succinate	CAPSULE;ORAL	076868-002	Aug 4, 2005	AB	RX	No	No
Galen Uk	ADASUVE	loxapine	POWDER;INHALATION	022549-001	Dec 21, 2012		RX	Yes	Yes			Y
Galen Uk	ADASUVE	loxapine	POWDER;INHALATION	022549-001	Dec 21, 2012		RX	Yes	Yes			Y
Actavis Labs Ut Inc	LOXITANE	loxapine succinate	CAPSULE;ORAL	017525-002	Approved Prior to Jan 1, 1982		DISCN	Yes	No

Non-Orange Book US Patents for loxapine

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No.	Title	Estimated Patent Expiration
7,449,174	Delivery of analgesics through an inhalation route
7,063,832	Delivery of muscle relaxants through an inhalation route
9,308,208	Aerosol generating method and device
7,078,016	Delivery of caffeine through an inhalation route

International Patents for loxapine

Country	Document Number	Estimated Expiration
Canada	2447099
New Zealand	529416
World Intellectual Property Organization (WIPO)	02098389
Poland	364002

Supplementary Protection Certificates for loxapine

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0609	Netherlands		PRODUCT NAME: LOXAPINE; REGISTRATION NO/DATE: EU/1/13/823/001-002 20130220
90040-2	Sweden		PRODUCT NAME: LOXAPIN; REG. NO/DATE: EU/1/13/823/001 20130220
3	Finland
2013 00046	Denmark		PRODUCT NAME: LOXAPIN; REG. NO/DATE: EU/1/13/823/001-002 20130220