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Last Updated: October 26, 2021

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Loxapine hydrochloride - Generic Drug Details

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What are the generic sources for loxapine hydrochloride and what is the scope of patent protection?

Loxapine hydrochloride is the generic ingredient in two branded drugs marketed by Teva Branded Pharm and Actavis Labs Ut Inc, and is included in two NDAs. Additional information is available in the individual branded drug profile pages.

There are eight drug master file entries for loxapine hydrochloride.

Recent Clinical Trials for loxapine hydrochloride

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

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

See all loxapine hydrochloride clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for loxapine hydrochloride

US Patents and Regulatory Information for loxapine hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Actavis Labs Ut Inc LOXITANE IM loxapine hydrochloride INJECTABLE;INJECTION 018039-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Teva Branded Pharm LOXITANE C loxapine hydrochloride CONCENTRATE;ORAL 017658-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever 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 hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Teva Branded Pharm LOXITANE C loxapine hydrochloride CONCENTRATE;ORAL 017658-001 Approved Prior to Jan 1, 1982 ⤷  Free Forever Trial ⤷  Free Forever Trial
Actavis Labs Ut Inc LOXITANE IM loxapine hydrochloride INJECTABLE;INJECTION 018039-001 Approved Prior to Jan 1, 1982 ⤷  Free Forever Trial ⤷  Free Forever Trial
Teva Branded Pharm LOXITANE C loxapine hydrochloride CONCENTRATE;ORAL 017658-001 Approved Prior to Jan 1, 1982 ⤷  Free Forever Trial ⤷  Free Forever Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

Baxter
Dow
Boehringer Ingelheim
McKinsey
Merck
Moodys

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