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Last Updated: July 13, 2020

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FLUOXETINE HYDROCHLORIDE Drug Profile


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

Fluoxetine Hydrochloride is a drug marketed by Barr, Dr Reddys Labs Ltd, Alembic Pharms Ltd, Ani Pharms Inc, Apnar Pharma Lp, Aurobindo Pharma, Beximco Pharms Usa, Cadila Pharms Ltd, Carlsbad, Celltrion, Cr Double Crane, Heritage Pharms Inc, Ivax Sub Teva Pharms, Landela Pharm, Marksans Pharma, Mylan, Mylan Pharms Inc, Par Pharm, Sandoz, Sciegen Pharms Inc, Specgx Llc, Sun Pharm Inds Ltd, Teva, Teva Pharms Usa, Actavis Mid Atlantic, Aurobindo Pharma Ltd, Hi Tech Pharma, Lannett Co Inc, Nostrum Labs Inc, Pharm Assoc, Wockhardt Bio Ag, Alvogen, Fosun Pharma, G And W Labs Inc, Inventia Hlthcare, Lupin Ltd, Par Form, Par Pharm Inc, Taro, Torrent, and Upsher Smith Labs. and is included in fifty-nine NDAs.

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

US ANDA Litigation and Generic Entry Outlook for Fluoxetine Hydrochloride

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

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Drug patent expirations by year for FLUOXETINE HYDROCHLORIDE
Recent Clinical Trials for FLUOXETINE HYDROCHLORIDE

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SponsorPhase
University of Toledo Health Science CampusPhase 4
Shanghai General Hospital, Shanghai Jiao Tong University School of MedicineN/A
Huadong HospitalN/A

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Pharmacology for FLUOXETINE HYDROCHLORIDE
Medical Subject Heading (MeSH) Categories for FLUOXETINE HYDROCHLORIDE
Paragraph IV (Patent) Challenges for FLUOXETINE HYDROCHLORIDE
Tradename Dosage Ingredient NDA Submissiondate
PROZAC SOLUTION;ORAL fluoxetine hydrochloride 020101
PROZAC TABLET;ORAL fluoxetine hydrochloride 020974
PROZAC CAPSULE;ORAL fluoxetine hydrochloride 018936
PROZAC WEEKLY CAPSULE, DELAYED REL PELLETS;ORAL fluoxetine hydrochloride 021235
SARAFEM CAPSULE;ORAL fluoxetine hydrochloride 018936

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
Wockhardt Bio Ag FLUOXETINE HYDROCHLORIDE fluoxetine hydrochloride SOLUTION;ORAL 075514-001 Aug 29, 2002 AA RX No No   Start Trial   Start Trial   Start Trial
Teva Pharms Usa FLUOXETINE HYDROCHLORIDE fluoxetine hydrochloride TABLET;ORAL 211051-001 Dec 3, 2018 AB RX No No   Start Trial   Start Trial   Start Trial
Mylan FLUOXETINE HYDROCHLORIDE fluoxetine hydrochloride CAPSULE;ORAL 078045-001 Nov 17, 2008 DISCN No No   Start Trial   Start Trial   Start Trial
Ivax Sub Teva Pharms FLUOXETINE HYDROCHLORIDE fluoxetine hydrochloride CAPSULE;ORAL 075245-002 Jan 31, 2002 AB1 RX No No   Start Trial   Start Trial   Start Trial
Ivax Sub Teva Pharms FLUOXETINE HYDROCHLORIDE fluoxetine hydrochloride TABLET;ORAL 075865-003 Aug 30, 2004 DISCN No No   Start Trial   Start Trial   Start Trial
Par Pharm FLUOXETINE HYDROCHLORIDE fluoxetine hydrochloride CAPSULE;ORAL 076922-003 Dec 16, 2004 DISCN No No   Start Trial   Start Trial   Start Trial
Teva FLUOXETINE HYDROCHLORIDE fluoxetine hydrochloride CAPSULE;ORAL 075452-003 Jan 29, 2002 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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