➤ Get the DrugPatentWatch Daily Briefing

Get Daily Updates on Generic Entry, Litigation, Biosimilars, and more …

Serving leading biopharmaceutical companies globally:

AstraZeneca
McKesson
Harvard Business School
Medtronic
Colorcon
Express Scripts

Last Updated: August 12, 2020

DrugPatentWatch Database Preview

FLUOXETINE HYDROCHLORIDE - Generic Drug Details

➤ Get the DrugPatentWatch Daily Briefing
» See Plans and Pricing

« Back to Dashboard

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, 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, 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, Upsher Smith Labs, Apil, and Teva Pharms, and is included in seventy-three NDAs. Additional information is available in the individual branded drug profile pages.

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

Recent Clinical Trials for FLUOXETINE HYDROCHLORIDE

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

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

See all FLUOXETINE HYDROCHLORIDE clinical trials

Generic filers with tentative approvals for FLUOXETINE HYDROCHLORIDE
Applicant Application No. Strength Dosage Form
  Start Trial  Start TrialEQ 40MG BASECAPSULE;ORAL
  Start Trial  Start TrialEQ 20MG BASECAPSULE;ORAL
  Start Trial  Start 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
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
Beximco Pharms Usa FLUOXETINE HYDROCHLORIDE fluoxetine hydrochloride CAPSULE;ORAL 075807-001 Jan 29, 2002 DISCN No No   Start Trial   Start Trial   Start Trial
Mylan FLUOXETINE HYDROCHLORIDE fluoxetine hydrochloride CAPSULE;ORAL 075207-001 Jan 30, 2002 DISCN No No   Start Trial   Start Trial   Start Trial
Aurobindo Pharma FLUOXETINE HYDROCHLORIDE fluoxetine hydrochloride CAPSULE;ORAL 078619-002 Jan 31, 2008 AB1 RX No No   Start Trial   Start Trial   Start Trial
Inventia Hlthcare FLUOXETINE HYDROCHLORIDE fluoxetine hydrochloride TABLET;ORAL 209695-001 Nov 20, 2017 AB RX No No   Start Trial   Start Trial   Start Trial
Sciegen Pharms Inc FLUOXETINE HYDROCHLORIDE fluoxetine hydrochloride TABLET;ORAL 211282-001 Jan 10, 2019 AB RX 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
>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 SARAFEM fluoxetine hydrochloride CAPSULE;ORAL 018936-007 Jul 6, 2000   Start Trial   Start Trial
Eli Lilly And Co PROZAC fluoxetine hydrochloride CAPSULE;ORAL 018936-006 Dec 23, 1992   Start Trial   Start Trial
Lilly PROZAC fluoxetine hydrochloride SOLUTION;ORAL 020101-001 Apr 24, 1991   Start Trial   Start Trial
Lilly PROZAC fluoxetine hydrochloride SOLUTION;ORAL 020101-001 Apr 24, 1991   Start Trial   Start Trial
Eli Lilly And Co PROZAC fluoxetine hydrochloride CAPSULE;ORAL 018936-003 Jun 15, 1999   Start Trial   Start Trial
Eli Lilly And Co PROZAC fluoxetine hydrochloride CAPSULE;ORAL 018936-001 Dec 29, 1987   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
McKinsey
Mallinckrodt
McKesson
Express Scripts
Harvard Business School

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.