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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 2^nd, 2001.

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Summary for FLUOXETINE HYDROCHLORIDE

US Patents:	0
Applicants:	41
NDAs:	59
Suppliers / Packagers:	58
Bulk Api Vendors:	122
Clinical Trials:	240
Patent Applications:	3,683
Formulation / Manufacturing:	see details
DailyMed Link:	FLUOXETINE HYDROCHLORIDE at DailyMed

Drug patent expirations by year for FLUOXETINE HYDROCHLORIDE

Recent Clinical Trials for FLUOXETINE HYDROCHLORIDE

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Sponsor	Phase
University of Toledo Health Science Campus	Phase 4
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine	N/A
Huadong Hospital	N/A

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Pharmacology for FLUOXETINE HYDROCHLORIDE

Drug Class	Serotonin Reuptake Inhibitor
Mechanism of Action	Serotonin Uptake Inhibitors

Medical Subject Heading (MeSH) Categories for FLUOXETINE HYDROCHLORIDE

Antidepressive Agents, Second-Generation
Cytochrome P-450 CYP2D6 Inhibitors
Serotonin Uptake Inhibitors

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

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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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