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Last Updated: March 28, 2024

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 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

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for loxapine
Generic Entry Date for loxapine*:
Constraining patent/regulatory exclusivity:
Dosage:
POWDER;INHALATION

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

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
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 017525-003 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 017525-006 Approved Prior to Jan 1, 1982 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Watson Labs LOXAPINE SUCCINATE loxapine succinate CAPSULE;ORAL 072204-001 Jun 15, 1988 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Watson Labs LOXAPINE SUCCINATE loxapine succinate CAPSULE;ORAL 072062-001 Jun 15, 1988 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Teva Branded Pharm LOXITANE C loxapine hydrochloride CONCENTRATE;ORAL 017658-001 Approved Prior to Jan 1, 1982 DISCN No 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

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 ⤷  Try a Trial ⤷  Try a Trial
Alexza Pharms ADASUVE loxapine POWDER;INHALATION 022549-001 Dec 21, 2012 ⤷  Try a Trial ⤷  Try a Trial
Alexza Pharms ADASUVE loxapine POWDER;INHALATION 022549-001 Dec 21, 2012 ⤷  Try a Trial ⤷  Try a Trial
Alexza Pharms ADASUVE loxapine POWDER;INHALATION 022549-001 Dec 21, 2012 ⤷  Try a Trial ⤷  Try a Trial
Alexza Pharms ADASUVE loxapine POWDER;INHALATION 022549-001 Dec 21, 2012 ⤷  Try a Trial ⤷  Try a Trial
Alexza Pharms ADASUVE loxapine POWDER;INHALATION 022549-001 Dec 21, 2012 ⤷  Try a Trial ⤷  Try a Trial
>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
Germany 60236430 ⤷  Try a Trial
Australia 2003295823 TREATMENT OF HEADACHE WITH ANTIPSYCHOTICS DELIVERED BY INHALATION ⤷  Try a Trial
New Zealand 529421 Delivery of opioids through an inhalation route ⤷  Try a Trial
Germany 60220909 ⤷  Try a Trial
World Intellectual Property Organization (WIPO) 02094233 ⤷  Try a Trial
Japan 5629151 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for loxapine

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1389098 473 Finland ⤷  Try a Trial
1389098 CR 2013 00046 Denmark ⤷  Try a Trial PRODUCT NAME: LOXAPIN; REG. NO/DATE: EU/1/13/823/001-002 20130220
1389098 CA 2013 00046 Denmark ⤷  Try a Trial PRODUCT NAME: LOXAPIN; REG. NO/DATE: EU/1/13/823/001-002 20130220
1389098 300609 Netherlands ⤷  Try a Trial PRODUCT NAME: LOXAPINE; REGISTRATION NO/DATE: EU/1/13/823/001-002 20130220
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
1389098 2013C/054 Belgium ⤷  Try a Trial PRODUCT NAME: LOXAPINE; AUTHORISATION NUMBER AND DATE: EU/1/13/823/001 20130225
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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