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Last Updated: June 19, 2021

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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 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, 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. Sixty-two 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
Avy L. & Roberta L. Miller FoundationPhase 2
Stanford UniversityPhase 2
Malawi Ministry of HealthPhase 4

See all fluoxetine hydrochloride clinical trials

Generic filers with tentative approvals for FLUOXETINE HYDROCHLORIDE
Applicant Application No. Strength Dosage Form
  Get Started Free  Get Started FreeEQ 40MG BASECAPSULE;ORAL
  Get Started Free  Get Started FreeEQ 20MG BASECAPSULE;ORAL
  Get Started Free  Get Started 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
SARAFEM CAPSULE;ORAL fluoxetine hydrochloride 018936
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

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
Sandoz OLANZAPINE AND FLUOXETINE HYDROCHLORIDE fluoxetine hydrochloride; olanzapine CAPSULE;ORAL 078901-004 Nov 16, 2012 AB RX No No   Get Started Free   Get Started Free   Get Started Free
Eli Lilly And Co SARAFEM fluoxetine hydrochloride CAPSULE;ORAL 018936-007 Jul 6, 2000 DISCN Yes No   Get Started Free   Get Started Free   Get Started Free
Eli Lilly And Co SARAFEM fluoxetine hydrochloride CAPSULE;ORAL 018936-008 Jul 6, 2000 DISCN Yes No   Get Started Free   Get Started Free   Get Started Free
Apil SARAFEM fluoxetine hydrochloride TABLET;ORAL 021860-001 May 19, 2006 DISCN Yes No   Get Started Free   Get Started Free   Get Started Free
Ani Pharms Inc FLUOXETINE HYDROCHLORIDE fluoxetine hydrochloride CAPSULE;ORAL 076287-002 May 20, 2008 DISCN No No   Get Started Free   Get Started Free   Get Started Free
Eli Lilly And Co PROZAC fluoxetine hydrochloride CAPSULE;ORAL 018936-006 Dec 23, 1992 AB1 RX Yes No   Get Started Free   Get Started Free   Get Started 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

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