LOXAPINE - Generic Drug Details

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

Loxapine is the generic ingredient in five branded drugs marketed by Alexza Pharms, Teva Branded Pharm, Actavis Labs Ut Inc, Elite Labs Inc, Lannett Co Inc, Rising, and Watson Labs, and is included in eleven NDAs. There are five patents protecting this compound. Additional information is available in the individual branded drug profile pages.

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

There are eight drug master file entries for loxapine. One supplier is listed for this compound.

Summary for LOXAPINE

International Patents:	227
US Patents:	5
Tradenames:	5
Applicants:	7
NDAs:	11
Drug Master File Entries:	8
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	52
Clinical Trials:	25
Patent Applications:	6,704
Formulation / Manufacturing:	see details
Drug Prices:	Drug price trends for LOXAPINE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for LOXAPINE
What excipients (inactive ingredients) are in LOXAPINE?	LOXAPINE excipients list
DailyMed Link:	LOXAPINE at DailyMed

See drug prices for LOXAPINE

Recent Clinical Trials for LOXAPINE

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

Sponsor	Phase
Assistance Publique - Hôpitaux de Paris	Phase 3
Lariboisière-Saint Louis clinical research unit	Phase 3
Lee's Pharmaceutical Limited	Phase 3

See all LOXAPINE clinical trials

Medical Subject Heading (MeSH) Categories for LOXAPINE

Antipsychotic Agents
Dopamine Antagonists

Anatomical Therapeutic Chemical (ATC) Classes for LOXAPINE

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

US Patents and Regulatory Information for LOXAPINE

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Glossary

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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
Alexza Pharms	ADASUVE	loxapine	POWDER;INHALATION	022549-001	Dec 21, 2012		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Elite Labs Inc	LOXAPINE SUCCINATE	loxapine succinate	CAPSULE;ORAL	076868-004	Aug 4, 2005	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Rising	LOXAPINE SUCCINATE	loxapine succinate	CAPSULE;ORAL	076762-003	Nov 1, 2004		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Actavis Labs Ut Inc	LOXITANE IM	loxapine hydrochloride	INJECTABLE;INJECTION	018039-001	Approved Prior to Jan 1, 1982		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Alexza Pharms	ADASUVE	loxapine	POWDER;INHALATION	022549-001	Dec 21, 2012		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Rising	LOXAPINE SUCCINATE	loxapine succinate	CAPSULE;ORAL	076762-004	Nov 1, 2004		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for LOXAPINE

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

EU/EMA Drug Approvals for LOXAPINE

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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
>Company	>Drugname	>Inn	>Product Number / Indication	>Status	>Generic	>Biosimilar	>Orphan	>Marketing Authorisation	>Marketing Refusal

International Patents for LOXAPINE

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Country	Patent Number	Title	Estimated Expiration
European Patent Office	1392259	ADMINISTRATION PAR VOIE PULMONAIRE DE MEDICAMENTS CONTRE LES TROUBLES DE L'ERECTION (DELIVERY OF ERECTILE DYSFUNCTION DRUGS THROUGH AN INHALATION ROUTE)	⤷ Sign Up
Canada	2447354	PROCEDE DE FORMATION D'UN AEROSOL POUR ADMINISTRATION PAR VOIE INHALEE (METHOD OF FORMING AN AEROSOL FOR INHALATION DELIVERY)	⤷ Sign Up
Austria	401063		⤷ Sign Up
Spain	2341594		⤷ Sign Up
Japan	4357842		⤷ Sign Up
World Intellectual Property Organization (WIPO)	03057188		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for LOXAPINE

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1389098	CA 2013 00046	Denmark	⤷ Sign Up	PRODUCT NAME: LOXAPIN; REG. NO/DATE: EU/1/13/823/001-002 20130220
1389098	2013C/054	Belgium	⤷ Sign Up	PRODUCT NAME: LOXAPINE; AUTHORISATION NUMBER AND DATE: EU/1/13/823/001 20130225
1389098	300609	Netherlands	⤷ Sign Up	PRODUCT NAME: LOXAPINE; REGISTRATION NO/DATE: EU/1/13/823/001-002 20130220
1389098	473	Finland	⤷ Sign Up
1389098	C300609	Netherlands	⤷ Sign Up	PRODUCT NAME: LOXAPINE; REGISTRATION NO/DATE: EU/1/13/823/001-002 20130220
1389098	132013902184784	Italy	⤷ Sign Up	PRODUCT NAME: LOXAPINA(ADASUVE); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/13/823/001-002, 20130220
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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