Loxapine - Generic Drug Details

What are the generic drug sources for loxapine and what is the scope of freedom to operate?

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 seven 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.

Summary for loxapine

International Patents:	227
US Patents:	7
Tradenames:	5
Applicants:	7
NDAs:	11
Drug Master File Entries:	8
Raw Ingredient (Bulk) Api Vendors:	40
Clinical Trials:	25
Patent Applications:	6,705
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
Lariboisière-Saint Louis clinical research unit	Phase 3
Assistance Publique - Hôpitaux de Paris	Phase 3
Lee's Pharmaceutical Limited	Phase 3

See all loxapine clinical trials

Medical Subject Heading (MeSH) Categories for loxapine

Antipsychotic Agents

Dopamine Antagonists

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
Alexza Pharms	ADASUVE	loxapine	POWDER;INHALATION	022549-001	Dec 21, 2012		RX	Yes	Yes			Y
Lannett Co Inc	LOXAPINE SUCCINATE	loxapine succinate	CAPSULE;ORAL	090695-001	Sep 26, 2011	AB	RX	No	No
Rising	LOXAPINE SUCCINATE	loxapine succinate	CAPSULE;ORAL	076762-004	Nov 1, 2004		DISCN	No	No
Alexza Pharms	ADASUVE	loxapine	POWDER;INHALATION	022549-001	Dec 21, 2012		RX	Yes	Yes			Y
Elite Labs Inc	LOXAPINE SUCCINATE	loxapine succinate	CAPSULE;ORAL	076868-001	Aug 4, 2005	AB	RX	No	No
Rising	LOXAPINE SUCCINATE	loxapine succinate	CAPSULE;ORAL	076762-002	Nov 1, 2004		DISCN	No	No

Expired US Patents for loxapine

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

International Patents for loxapine

Country	Patent Number	Title	Estimated Expiration
Austria	415155
World Intellectual Property Organization (WIPO)	2004104492
Mexico	PA03011268	DISPOSITIVO FORMADOR DE AEROSOL PARA UTILIZARSE EN TERAPIA DE INHALACION. (AN AEROSOL FORMING DEVICE FOR USE IN INHALATION THERAPY.)
Poland	363997	Sposób podawania leków przeciw zaburzeniom erekcji drogą inhalacji (DELIVERY OF ERECTILE DYSFUNCTION DRUGS THROUGH AN INHALATION ROUTE)
European Patent Office	1389097	APPORT DE COMPOSES POUR LE TRAITEMENT DE LA MALADIE DE PARKINSON PAR VOIE PULMONAIRE (DELIVERY OF COMPOUNDS FOR THE TREATMENT OF PARKINSONS THROUGH AN INHALATION ROUTE)
World Intellectual Property Organization (WIPO)	02094236

Supplementary Protection Certificates for loxapine

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1389098	2013C/054	Belgium		PRODUCT NAME: LOXAPINE; AUTHORISATION NUMBER AND DATE: EU/1/13/823/001 20130225
1389098	473	Finland
1389098	132013902184784	Italy		PRODUCT NAME: LOXAPINA(ADASUVE); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/13/823/001-002, 20130220
1389098	1390040-2	Sweden		PRODUCT NAME: LOXAPIN; REG. NO/DATE: EU/1/13/823/001 20130220
1389098	CA 2013 00046	Denmark		PRODUCT NAME: LOXAPIN; REG. NO/DATE: EU/1/13/823/001-002 20130220
1389098	300609	Netherlands		PRODUCT NAME: LOXAPINE; REGISTRATION NO/DATE: EU/1/13/823/001-002 20130220