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Last Updated: July 16, 2020

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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-five 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
Watson Labs LOXAPINE SUCCINATE loxapine succinate CAPSULE;ORAL 072204-001 Jun 15, 1988 AB RX No No   Start Trial   Start Trial   Start Trial
Mylan LOXAPINE SUCCINATE loxapine succinate CAPSULE;ORAL 076762-004 Nov 1, 2004 AB RX No No   Start Trial   Start Trial   Start Trial
Alexza Pharms ADASUVE loxapine POWDER;INHALATION 022549-001 Dec 21, 2012 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Alexza Pharms ADASUVE loxapine POWDER;INHALATION 022549-001 Dec 21, 2012 RX Yes Yes   Start Trial   Start Trial Y   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 CA 2013 00046 Denmark   Start Trial PRODUCT NAME: LOXAPIN; REG. 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 300609 Netherlands   Start Trial PRODUCT NAME: LOXAPINE; REGISTRATION NO/DATE: EU/1/13/823/001-002 20130220
1389098 473 Finland   Start Trial
1389098 C300609 Netherlands   Start Trial PRODUCT NAME: LOXAPINE; REGISTRATION NO/DATE: EU/1/13/823/001-002 20130220
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Express Scripts
McKesson
Merck
Johnson and Johnson
Mallinckrodt
Medtronic

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