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Last Updated: March 28, 2024

Fluoxetine hydrochloride - Generic Drug Details


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What are the generic sources for fluoxetine hydrochloride and what is the scope of freedom to operate?

Fluoxetine hydrochloride is the generic ingredient in eight branded drugs marketed by Barr, Dr Reddys Labs Ltd, Lilly, Sun Pharm Industries, Watson Labs, Accord Hlthcare, Alembic Pharms Ltd, Ani Pharms, Apnar Pharma Lp, Aurobindo Pharma, Beximco Pharms Usa, Cadila Pharms Ltd, Carlsbad, Cr Double Crane, Granules, Heritage Pharms, Ivax Sub Teva Pharms, Landela Pharm, Marksans Pharma, Micro Labs, Mylan, Mylan Pharms Inc, Natco Pharma Usa, Sandoz, Sciegen Pharms Inc, Specgx Llc, Strides Pharma, Sun Pharm Inds Ltd, Teva, Teva Pharms Usa, Eli Lilly And Co, Actavis Mid Atlantic, Akorn, Aptapharma Inc, Chartwell Molecular, Lannett Co Inc, Nostrum Labs Inc, Novitium Pharma, Pharm Assoc, Pharmobedient Cnsltg, Alembic, Aurobindo Pharma Ltd, Dr Reddys, Fosun Pharma, G And W Labs Inc, Inventia Hlthcare, Lupin Ltd, Par Form, Par Pharm Inc, Rising, Slate Run Pharma, Taro, Torrent, Twi Pharms, Upsher Smith Labs, Apil, Epic Pharma Llc, Par Pharm, and Teva Pharms, and is included in seventy-eight NDAs. Additional information is available in the individual branded drug profile pages.

There are twenty drug master file entries for fluoxetine hydrochloride. Sixty-eight suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for fluoxetine hydrochloride
Recent Clinical Trials for fluoxetine hydrochloride

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

SponsorPhase
First Affiliated Hospital Xi'an Jiaotong UniversityN/A
Chen QianEarly Phase 1
First Affiliated Hospital of Chongqing Medical UniversityPhase 1/Phase 2

See all fluoxetine hydrochloride clinical trials

Generic filers with tentative approvals for FLUOXETINE HYDROCHLORIDE
Applicant Application No. Strength Dosage Form
⤷  Try a Trial⤷  Try a TrialEQ 40MG BASECAPSULE;ORAL
⤷  Try a Trial⤷  Try a TrialEQ 20MG BASECAPSULE;ORAL
⤷  Try a Trial⤷  Try a TrialEQ 10MG BASECAPSULE;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for fluoxetine hydrochloride
Medical Subject Heading (MeSH) Categories for fluoxetine hydrochloride

US Patents and Regulatory Information for fluoxetine hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Aurobindo Pharma Ltd FLUOXETINE HYDROCHLORIDE fluoxetine hydrochloride TABLET;ORAL 213286-001 Apr 8, 2020 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Carlsbad FLUOXETINE HYDROCHLORIDE fluoxetine hydrochloride CAPSULE;ORAL 076022-001 Jan 30, 2002 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Aptapharma Inc FLUOXETINE HYDROCHLORIDE fluoxetine hydrochloride SOLUTION;ORAL 216953-001 Nov 15, 2022 AA RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Beximco Pharms Usa FLUOXETINE HYDROCHLORIDE fluoxetine hydrochloride CAPSULE;ORAL 075807-002 Jan 29, 2002 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Alembic FLUOXETINE HYDROCHLORIDE fluoxetine hydrochloride TABLET;ORAL 208698-002 Apr 5, 2017 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Eli Lilly And Co SARAFEM fluoxetine hydrochloride CAPSULE;ORAL 018936-007 Jul 6, 2000 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Mylan FLUOXETINE HYDROCHLORIDE fluoxetine hydrochloride CAPSULE;ORAL 075207-002 Jan 30, 2002 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a 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 fluoxetine hydrochloride

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