➤ Get the DrugPatentWatch Daily Briefing

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

Serving leading biopharmaceutical companies globally:

AstraZeneca
Dow
Colorcon
Medtronic
Mallinckrodt
McKinsey

Last Updated: April 12, 2021

DrugPatentWatch Database Preview

FLUOXETINE HYDROCHLORIDE Drug Profile

➤ Get the DrugPatentWatch Daily Briefing
» See Plans and Pricing

« Back to Dashboard

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

Fluoxetine Hydrochloride is a drug marketed by Barr, Dr Reddys Labs Ltd, 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, 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, and Upsher Smith Labs. and is included in sixty-one NDAs.

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

DrugPatentWatch® 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.

  Start Trial

Summary for FLUOXETINE HYDROCHLORIDE
US Patents:0
Applicants:42
NDAs:61
Suppliers / Packagers: 60
Bulk Api Vendors: 141
Clinical Trials: 244
Patent Applications: 3,937
Formulation / Manufacturing:see details
What excipients (inactive ingredients) are in FLUOXETINE HYDROCHLORIDE?FLUOXETINE HYDROCHLORIDE excipients list
DailyMed Link:FLUOXETINE HYDROCHLORIDE at DailyMed
Drug patent expirations by year for FLUOXETINE HYDROCHLORIDE
Recent Clinical Trials for FLUOXETINE HYDROCHLORIDE

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

SponsorPhase
Harvard UniversityN/A
Washington State UniversityN/A
Ann & Robert H Lurie Children's Hospital of ChicagoPhase 3

See all FLUOXETINE HYDROCHLORIDE clinical trials

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
Pharm Assoc FLUOXETINE HYDROCHLORIDE fluoxetine hydrochloride SOLUTION;ORAL 076015-001 Jan 30, 2002 AA RX No Yes   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
Marksans Pharma FLUOXETINE HYDROCHLORIDE fluoxetine hydrochloride CAPSULE;ORAL 075465-002 Jan 29, 2002 AB1 RX No No   Start Trial   Start Trial   Start Trial
Heritage Pharms Inc FLUOXETINE HYDROCHLORIDE fluoxetine hydrochloride CAPSULE;ORAL 201336-001 Oct 1, 2012 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

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

Serving leading biopharmaceutical companies globally:

Moodys
McKinsey
Express Scripts
Baxter
Merck
Dow

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.