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Last Updated: July 23, 2021

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FLUOXETINE HYDROCHLORIDE - Generic Drug Details

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What are the generic drug sources for fluoxetine hydrochloride and what is the scope of patent protection?

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, 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, Eli Lilly And Co, Actavis Mid Atlantic, Akorn, Aurobindo Pharma Ltd, 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, Upsher Smith Labs, Apil, and Teva Pharms, and is included in seventy-four NDAs. Additional information is available in the individual branded drug profile pages.

There are twenty-seven drug master file entries for fluoxetine hydrochloride. Twenty-three 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
Stanford UniversityPhase 2
Avy L. & Roberta L. Miller FoundationPhase 2
Brigham and Women's HospitalPhase 4

See all FLUOXETINE HYDROCHLORIDE clinical trials

Generic filers with tentative approvals for FLUOXETINE HYDROCHLORIDE
Applicant Application No. Strength Dosage Form
⤷  Try it Free⤷  Try it FreeEQ 40MG BASECAPSULE;ORAL
⤷  Try it Free⤷  Try it FreeEQ 20MG BASECAPSULE;ORAL
⤷  Try it Free⤷  Try it FreeEQ 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
Paragraph IV (Patent) Challenges for FLUOXETINE HYDROCHLORIDE
Tradename Dosage Ingredient NDA Submissiondate
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
PROZAC SOLUTION;ORAL fluoxetine hydrochloride 020101

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
Par Pharm OLANZAPINE AND FLUOXETINE HYDROCHLORIDE fluoxetine hydrochloride; olanzapine CAPSULE;ORAL 077742-001 Nov 2, 2012 AB RX No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Celltrion FLUOXETINE HYDROCHLORIDE fluoxetine hydrochloride CAPSULE;ORAL 078143-003 Jan 16, 2008 DISCN No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Teva Pharms Usa SELFEMRA fluoxetine hydrochloride TABLET;ORAL 200151-001 Feb 3, 2014 DISCN No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
>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 ⤷  Try it Free ⤷  Try it Free
Lilly PROZAC fluoxetine hydrochloride TABLET;ORAL 020974-001 Mar 9, 1999 ⤷  Try it Free ⤷  Try it Free
Eli Lilly And Co PROZAC fluoxetine hydrochloride CAPSULE;ORAL 018936-001 Dec 29, 1987 ⤷  Try it Free ⤷  Try it Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
McKinsey
Mallinckrodt
McKesson
Express Scripts
Harvard Business School

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