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Last Updated: May 20, 2022

Loxapine - Generic Drug Details


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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.

Drug Prices for loxapine

See drug prices for loxapine

Recent Clinical Trials for loxapine

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

SponsorPhase
Lariboisière-Saint Louis clinical research unitPhase 3
Assistance Publique - Hôpitaux de ParisPhase 3
Lee's Pharmaceutical LimitedPhase 3

See all loxapine clinical trials

Medical Subject Heading (MeSH) Categories for loxapine

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

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

International Patents for loxapine

Country Patent Number Title Estimated Expiration
Austria 415155 See Plans and Pricing
World Intellectual Property Organization (WIPO) 2004104492 See Plans and Pricing
Mexico PA03011268 DISPOSITIVO FORMADOR DE AEROSOL PARA UTILIZARSE EN TERAPIA DE INHALACION. (AN AEROSOL FORMING DEVICE FOR USE IN INHALATION THERAPY.) See Plans and Pricing
Poland 363997 Sposób podawania leków przeciw zaburzeniom erekcji drogą inhalacji (DELIVERY OF ERECTILE DYSFUNCTION DRUGS THROUGH AN INHALATION ROUTE) See Plans and Pricing
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) See Plans and Pricing
World Intellectual Property Organization (WIPO) 02094236 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for loxapine

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

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