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Last Updated: October 31, 2024

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.

Drug Prices for LOXAPINE

See drug prices for LOXAPINE

Recent Clinical Trials for LOXAPINE

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

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

See all LOXAPINE clinical trials

Medical Subject Heading (MeSH) Categories for LOXAPINE
Anatomical Therapeutic Chemical (ATC) Classes 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
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
Lannett Co Inc LOXAPINE SUCCINATE loxapine succinate CAPSULE;ORAL 090695-001 Sep 26, 2011 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Teva Branded Pharm LOXITANE loxapine succinate TABLET;ORAL 017525-008 Approved Prior to Jan 1, 1982 DISCN Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Rising LOXAPINE SUCCINATE loxapine succinate CAPSULE;ORAL 076762-001 Nov 1, 2004 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
Alexza Pharms ADASUVE loxapine POWDER;INHALATION 022549-001 Dec 21, 2012 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  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

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
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

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

Country Patent Number Title Estimated Expiration
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) ⤷  Sign Up
Austria 425784 ⤷  Sign Up
European Patent Office 1389099 ADMINISTRATION DE BETABLOQUANTS PAR VOIE D'INHALATION (DELIVERY OF BETA-BLOCKERS THROUGH AN INHALATION ROUTE) ⤷  Sign Up
World Intellectual Property Organization (WIPO) 03051367 ⤷  Sign Up
Portugal 1389098 ⤷  Sign Up
New Zealand 529296 An aerosol forming device for use in inhalation therapy ⤷  Sign Up
Japan 2004532860 ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for LOXAPINE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1389098 C300609 Netherlands ⤷  Sign Up PRODUCT NAME: LOXAPINE; REGISTRATION NO/DATE: EU/1/13/823/001-002 20130220
1389098 300609 Netherlands ⤷  Sign Up PRODUCT NAME: LOXAPINE; REGISTRATION NO/DATE: EU/1/13/823/001-002 20130220
1389098 1390040-2 Sweden ⤷  Sign Up PRODUCT NAME: LOXAPIN; REG. NO/DATE: EU/1/13/823/001 20130220
1389098 CR 2013 00046 Denmark ⤷  Sign Up PRODUCT NAME: LOXAPIN; REG. 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
1389098 SPC/GB13/055 United Kingdom ⤷  Sign Up PRODUCT NAME: LOXAPINE; REGISTERED: UK EU/1/13/823/001 20130220; UK EU/1/13/823/002 20130220
1389098 C01389098/01 Switzerland ⤷  Sign Up PRODUCT NAME: LOXAPINUM; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 65461 13.12.2016
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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