LOXITANE Drug Patent Profile

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Loxitane is a drug marketed by Teva Branded Pharm and Actavis Labs Ut Inc and is included in three NDAs.

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

US Patents:	0
Applicants:	2
NDAs:	3
Raw Ingredient (Bulk) Api Vendors:	51
Clinical Trials:	1
Patent Applications:	4,071
Formulation / Manufacturing:	see details
DailyMed Link:	LOXITANE at DailyMed

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

Sponsor	Phase
Mylan Pharmaceuticals	Phase 1

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

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Teva Branded Pharm	LOXITANE	loxapine succinate	CAPSULE;ORAL	017525-001	Approved Prior to Jan 1, 1982		DISCN	Yes	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Teva Branded Pharm	LOXITANE	loxapine succinate	TABLET;ORAL	017525-008	Approved Prior to Jan 1, 1982		DISCN	Yes	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Teva Branded Pharm	LOXITANE	loxapine succinate	CAPSULE;ORAL	017525-004	Approved Prior to Jan 1, 1982		DISCN	Yes	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Teva Branded Pharm	LOXITANE	loxapine succinate	CAPSULE;ORAL	017525-003	Approved Prior to Jan 1, 1982	⤷ Try a Trial	⤷ Try a Trial
Teva Branded Pharm	LOXITANE	loxapine succinate	CAPSULE;ORAL	017525-004	Approved Prior to Jan 1, 1982	⤷ Try a Trial	⤷ Try a Trial
Teva Branded Pharm	LOXITANE	loxapine succinate	CAPSULE;ORAL	017525-001	Approved Prior to Jan 1, 1982	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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

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Country	Patent Number	Title	Estimated Expiration
Switzerland	485749	Verfahren zur Herstellung basisch substituierter Heterocyclen	⤷ Try a Trial
Switzerland	481133	Verfahren zur Herstellung basisch substituierter Heterocyclen	⤷ Try a Trial
Austria	292721		⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1389098	C300609	Netherlands	⤷ Try a Trial	PRODUCT NAME: LOXAPINE; REGISTRATION NO/DATE: EU/1/13/823/001-002 20130220
1389098	2013C/054	Belgium	⤷ Try a Trial	PRODUCT NAME: LOXAPINE; AUTHORISATION NUMBER AND DATE: EU/1/13/823/001 20130225
1389098	SPC/GB13/055	United Kingdom	⤷ Try a Trial	PRODUCT NAME: LOXAPINE; REGISTERED: UK EU/1/13/823/001 20130220; UK EU/1/13/823/002 20130220
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description