Last Updated: June 22, 2026

FLUPHENAZINE Drug Patent Profile


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When do Fluphenazine patents expire, and what generic alternatives are available?

Fluphenazine is a drug marketed by Eugia Pharma, Fresenius Kabi Usa, Gland, Hikma, Hospira, MSN, Mylan Labs Ltd, Ph Health, Teva Parenteral, Ani Pharms, Pharm Assoc, Ajanta Pharma Ltd, Alembic, Amneal, Apotex, Aurobindo Pharma Ltd, Breckenridge, Dr Reddys, Glenmark Pharms Ltd, Hetero Labs Ltd Iii, Lannett Co Inc, Novitium Pharma, Prasco, Rising, Sandoz, Taro, Torrent, Twi Pharms, Upsher Smith Labs, Watson Labs, Zameer Pharms, and Zydus Lifesciences. and is included in thirty-nine NDAs.

The generic ingredient in FLUPHENAZINE is fluphenazine hydrochloride. There are nineteen drug master file entries for this compound. Twenty-nine suppliers are listed for this compound. Additional details are available on the fluphenazine hydrochloride profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Fluphenazine

A generic version of FLUPHENAZINE was approved as fluphenazine hydrochloride by FRESENIUS KABI USA on April 16th, 1987.

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Summary for FLUPHENAZINE
US Patents:0
Applicants:32
NDAs:39
Drug Prices: Drug price information for FLUPHENAZINE
DailyMed Link:FLUPHENAZINE at DailyMed

US Patents and Regulatory Information for FLUPHENAZINE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sandoz FLUPHENAZINE HYDROCHLORIDE fluphenazine hydrochloride TABLET;ORAL 089586-003 Oct 16, 1987 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Zydus Lifesciences FLUPHENAZINE HYDROCHLORIDE fluphenazine hydrochloride TABLET;ORAL 214552-003 May 27, 2021 AB RX No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Dr Reddys FLUPHENAZINE HYDROCHLORIDE fluphenazine hydrochloride TABLET;ORAL 214534-003 Jan 7, 2021 AB RX No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Aurobindo Pharma Ltd FLUPHENAZINE HYDROCHLORIDE fluphenazine hydrochloride TABLET;ORAL 218055-002 Aug 18, 2023 AB RX No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Twi Pharms FLUPHENAZINE HYDROCHLORIDE fluphenazine hydrochloride TABLET;ORAL 215848-003 Apr 1, 2022 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Hetero Labs Ltd Iii FLUPHENAZINE HYDROCHLORIDE fluphenazine hydrochloride TABLET;ORAL 218769-003 Nov 18, 2025 AB RX No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Novitium Pharma FLUPHENAZINE HYDROCHLORIDE fluphenazine hydrochloride TABLET;ORAL 214674-002 Mar 1, 2021 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
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.