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Last Updated: April 18, 2024

FLUOXETINE HYDROCHLORIDE Drug Patent 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, Accord Hlthcare, Alembic Pharms Ltd, Ani Pharms, Apnar Pharma Lp, Aurobindo Pharma, Beximco Pharms Usa, Cadila Pharms Ltd, Carlsbad, Cr Double Crane, Granules, Heritage Pharms, Ivax Sub Teva Pharms, Landela Pharm, Marksans Pharma, Micro Labs, Mylan, Mylan Pharms Inc, Natco Pharma Usa, Sandoz, Sciegen Pharms Inc, Specgx Llc, Strides Pharma, Sun Pharm Inds Ltd, Teva, Teva Pharms Usa, Actavis Mid Atlantic, Akorn, Aptapharma Inc, Chartwell Molecular, Lannett Co Inc, Nostrum Labs Inc, Novitium Pharma, Pharm Assoc, Pharmobedient Cnsltg, Alembic, Aurobindo Pharma Ltd, Dr Reddys, Fosun Pharma, G And W Labs Inc, Inventia Hlthcare, Lupin Ltd, Par Form, Par Pharm Inc, Rising, Slate Run Pharma, Taro, Torrent, Twi Pharms, and Upsher Smith Labs. and is included in sixty-five NDAs.

The generic ingredient in FLUOXETINE HYDROCHLORIDE is fluoxetine hydrochloride. There are twenty-seven drug master file entries for this compound. Sixty-nine 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 2^nd, 2001.

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Summary for FLUOXETINE HYDROCHLORIDE

US Patents:	0
Applicants:	51
NDAs:	65
Finished Product Suppliers / Packagers:	68
Raw Ingredient (Bulk) Api Vendors:	174
Clinical Trials:	294
Patent Applications:	4,684
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

Sponsor	Phase
First Affiliated Hospital Xi'an Jiaotong University	N/A
Chen Qian	Early Phase 1
First Affiliated Hospital of Chongqing Medical University	Phase 1/Phase 2

See all FLUOXETINE HYDROCHLORIDE clinical trials

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

Anatomical Therapeutic Chemical (ATC) Classes for FLUOXETINE HYDROCHLORIDE

N06AB	Selective serotonin reuptake inhibitors
N06A	ANTIDEPRESSANTS
N06	PSYCHOANALEPTICS
N	Nervous system

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
Aurobindo Pharma	FLUOXETINE HYDROCHLORIDE	fluoxetine hydrochloride	SOLUTION;ORAL	079209-001	Mar 20, 2009	AA	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Rising	FLUOXETINE HYDROCHLORIDE	fluoxetine hydrochloride	TABLET;ORAL	075755-001	Aug 2, 2001		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Marksans Pharma	FLUOXETINE HYDROCHLORIDE	fluoxetine hydrochloride	CAPSULE;ORAL	075465-002	Jan 29, 2002	AB1	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Heritage Pharms	FLUOXETINE HYDROCHLORIDE	fluoxetine hydrochloride	CAPSULE;ORAL	201336-001	Oct 1, 2012	AB1	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Barr	FLUOXETINE HYDROCHLORIDE	fluoxetine hydrochloride	TABLET;ORAL	075810-001	Feb 1, 2002		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Twi Pharms	FLUOXETINE HYDROCHLORIDE	fluoxetine hydrochloride	TABLET;ORAL	202133-001	Oct 6, 2011	AB	RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a 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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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.