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Last Updated: March 19, 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
Sciegen Pharms Inc FLUOXETINE HYDROCHLORIDE fluoxetine hydrochloride CAPSULE;ORAL 204597-003 Mar 16, 2015 AB RX 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
Rising FLUOXETINE HYDROCHLORIDE fluoxetine hydrochloride TABLET;ORAL 075755-002 Aug 2, 2001 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

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Lilly PROZAC fluoxetine hydrochloride SOLUTION;ORAL 020101-001 Apr 24, 1991 ⤷  Try a Trial ⤷  Try a Trial
Eli Lilly And Co PROZAC fluoxetine hydrochloride CAPSULE;ORAL 018936-006 Dec 23, 1992 ⤷  Try a Trial ⤷  Try a Trial
Eli Lilly And Co PROZAC fluoxetine hydrochloride CAPSULE;ORAL 018936-004 Jun 15, 1999 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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