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Last Updated: April 19, 2021

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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, Mylan, and Watson Labs, and is included in eleven NDAs. There are eighteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.

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

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

Drug Prices for loxapine

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Recent Clinical Trials for loxapine

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

SponsorPhase
Lee's Pharmaceutical LimitedPhase 3
Mount Sinai Hospital, ChicagoPhase 4
University of ArkansasPhase 4

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   Start Trial   Start Trial Y   Start Trial
Teva Branded Pharm LOXITANE loxapine succinate CAPSULE;ORAL 017525-003 Approved Prior to Jan 1, 1982 DISCN Yes No   Start Trial   Start Trial   Start Trial
Teva Branded Pharm LOXITANE loxapine succinate TABLET;ORAL 017525-006 Approved Prior to Jan 1, 1982 DISCN Yes No   Start Trial   Start Trial   Start Trial
Lannett Co Inc LOXAPINE SUCCINATE loxapine succinate CAPSULE;ORAL 090695-001 Sep 26, 2011 AB RX No No   Start Trial   Start Trial   Start Trial
Watson Labs LOXAPINE SUCCINATE loxapine succinate CAPSULE;ORAL 072205-001 Jun 15, 1988 AB RX No No   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for loxapine

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1389098 SPC/GB13/055 United Kingdom   Start Trial PRODUCT NAME: LOXAPINE; REGISTERED: UK EU/1/13/823/001 20130220; UK EU/1/13/823/002 20130220
1389098 C300609 Netherlands   Start Trial PRODUCT NAME: LOXAPINE; REGISTRATION NO/DATE: EU/1/13/823/001-002 20130220
1389098 2013C/054 Belgium   Start Trial PRODUCT NAME: ADASUVE-LOXAPINE; AUTHORISATION NUMBER AND DATE: EU/1/13/823/001 20130225
1389098 C01389098/01 Switzerland   Start Trial PRODUCT NAME: LOXAPINUM; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 65461 13.12.2016
1389098 132013902184784 Italy   Start Trial 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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Serving leading biopharmaceutical companies globally:

Express Scripts
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Johnson and Johnson
Mallinckrodt
Medtronic

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