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Last Updated: November 21, 2024

FLUOXETINE Drug Patent Profile


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When do Fluoxetine patents expire, and when can generic versions of Fluoxetine launch?

Fluoxetine is a drug marketed by Sun Pharm Industries, Watson Labs, Barr, Dr Reddys Labs Ltd, Accord Hlthcare, Alembic Pharms Ltd, Ani Pharms, Apnar Pharma Lp, Aurobindo Pharma, Beximco Pharms Usa, Cadila Pharms Ltd, Carlsbad, Cr Double Crane, Granules, Heritage, Ivax Sub Teva Pharms, Landela Pharm, Marksans Pharma, Micro Labs, Natco Pharma Usa, Norvium Bioscience, Sandoz, Sciegen Pharms Inc, Specgx Llc, Strides Pharma, Sun Pharm Inds Ltd, Teva, Teva Pharms Usa, Actavis Mid Atlantic, Bajaj, Chartwell Molecular, Lannett Co Inc, Nostrum Labs Inc, Novitium Pharma, Pharm Assoc, Pharmobedient Cnsltg, Upsher Smith Labs, Alembic, Aurobindo Pharma Ltd, Dr Reddys, Endo Operations, Fosun Pharma, G And W Labs Inc, Inventia Hlthcare, Lupin Ltd, Rising, Slate Run Pharma, Taro, Torrent, and Twi Pharms. and is included in sixty-nine NDAs.

The generic ingredient in FLUOXETINE is fluoxetine hydrochloride. There are twenty-seven drug master file entries for this compound. Seventy-one suppliers are listed for this compound. Additional details are available on the fluoxetine hydrochloride profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Fluoxetine

A generic version of FLUOXETINE was approved as fluoxetine hydrochloride by APNAR PHARMA LP on August 2nd, 2001.

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Drug patent expirations by year for FLUOXETINE
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Drug Sales Revenue Trends for FLUOXETINE

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Recent Clinical Trials for FLUOXETINE

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SponsorPhase
Berry ConsultantsPhase 2
U.S. Army Medical Research and Development CommandPhase 2
CitelinePhase 2

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US Patents and Regulatory Information for FLUOXETINE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Teva Pharms Usa FLUOXETINE HYDROCHLORIDE fluoxetine hydrochloride CAPSULE;ORAL 076001-002 Jan 29, 2002 AB1 RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Ivax Sub Teva Pharms FLUOXETINE HYDROCHLORIDE fluoxetine hydrochloride TABLET;ORAL 075865-003 Aug 30, 2004 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Ivax Sub Teva Pharms FLUOXETINE HYDROCHLORIDE fluoxetine hydrochloride CAPSULE;ORAL 075245-003 Sep 28, 2004 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Cr Double Crane FLUOXETINE HYDROCHLORIDE fluoxetine hydrochloride CAPSULE;ORAL 076165-002 Feb 1, 2002 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Alembic FLUOXETINE HYDROCHLORIDE fluoxetine hydrochloride TABLET;ORAL 208698-002 Apr 5, 2017 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Strides Pharma FLUOXETINE HYDROCHLORIDE fluoxetine hydrochloride TABLET;ORAL 212683-001 Sep 13, 2024 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Micro Labs FLUOXETINE HYDROCHLORIDE fluoxetine hydrochloride CAPSULE;ORAL 216232-003 Mar 29, 2022 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>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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