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Last Updated: November 4, 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, 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, Eli Lilly And Co, 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, Twi Pharms, Apil, Epic Pharma Llc, and Teva Pharms, and is included in eighty NDAs. Additional information is available in the individual branded drug profile pages.

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

Summary for fluoxetine hydrochloride
US Patents:0
Tradenames:8
Applicants:55
NDAs:80
Drug Master File Entries: 20
Finished Product Suppliers / Packagers: 70
Raw Ingredient (Bulk) Api Vendors: 174
Clinical Trials: 298
Patent Applications: 7,337
What excipients (inactive ingredients) are in fluoxetine hydrochloride?fluoxetine hydrochloride excipients list
DailyMed Link:fluoxetine hydrochloride at DailyMed
Recent Clinical Trials for fluoxetine hydrochloride

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

SponsorPhase
Idorsia Pharmaceuticals Ltd.Phase 2
Berry ConsultantsPhase 2
U.S. Army Medical Research and Development CommandPhase 2

See all fluoxetine hydrochloride clinical trials

Generic filers with tentative approvals for FLUOXETINE HYDROCHLORIDE
Applicant Application No. Strength Dosage Form
⤷  Sign Up⤷  Sign UpEQ 40MG BASECAPSULE;ORAL
⤷  Sign Up⤷  Sign UpEQ 20MG BASECAPSULE;ORAL
⤷  Sign Up⤷  Sign UpEQ 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
Anatomical Therapeutic Chemical (ATC) Classes 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
Lupin Ltd FLUOXETINE HYDROCHLORIDE fluoxetine hydrochloride TABLET;ORAL 211653-002 Apr 15, 2019 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Epic Pharma Llc OLANZAPINE AND FLUOXETINE HYDROCHLORIDE fluoxetine hydrochloride; olanzapine CAPSULE;ORAL 078901-003 Nov 16, 2012 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Heritage FLUOXETINE HYDROCHLORIDE fluoxetine hydrochloride CAPSULE;ORAL 201336-001 Oct 1, 2012 AB1 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

Expired US Patents for fluoxetine hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Eli Lilly And Co PROZAC fluoxetine hydrochloride CAPSULE;ORAL 018936-001 Dec 29, 1987 ⤷  Sign Up ⤷  Sign Up
Eli Lilly And Co SARAFEM fluoxetine hydrochloride CAPSULE;ORAL 018936-007 Jul 6, 2000 ⤷  Sign Up ⤷  Sign Up
Eli Lilly And Co PROZAC fluoxetine hydrochloride CAPSULE;ORAL 018936-003 Jun 15, 1999 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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