Last Updated: August 2, 2026

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, Aurobindo Pharma, Cadila Pharms Ltd, Carlsbad, Chartwell Rx, Cr Double Crane, Heritage, Ivax Sub Teva Pharms, Landela Pharm, Marksans Pharma, Micro Labs, Natco Pharma Usa, Pharmobedient, Regcon Holdings, Sandoz, Sciegen Pharms, Senores Pharms, Specgx Llc, Strides Pharma Intl, Sun Pharm Inds Ltd, Teva, Teva Pharms Usa, Actavis Mid Atlantic, Bajaj, Chartwell Molecular, Lannett Co Inc, Novitium Pharma, Pharm Assoc, Pharmobedient Cnsltg, Solis Pharms, Upsher Smith Labs, Alembic, Aurobindo Pharma Ltd, Dr Reddys, Fosun Pharma, G And W Labs Inc, Inventia Hlthcare, Lupin, Ph Health, Rising, Somerset Theraps Llc, Strides Pharma, Torrent, and Twi Pharms. and is included in sixty-seven NDAs.

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

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Summary for FLUOXETINE HYDROCHLORIDE

US Patents:	0
Applicants:	48
NDAs:	67

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
Chartwell Molecular	FLUOXETINE HYDROCHLORIDE	fluoxetine hydrochloride	SOLUTION;ORAL	076458-001	May 14, 2004		DISCN	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Ph Health	FLUOXETINE HYDROCHLORIDE	fluoxetine hydrochloride	TABLET;ORAL	203836-002	Aug 19, 2016	AB	RX	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Natco Pharma Usa	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	075245-003	Sep 28, 2004	AB	RX	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Barr	FLUOXETINE HYDROCHLORIDE	fluoxetine hydrochloride	TABLET;ORAL	075810-001	Feb 1, 2002		DISCN	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Teva	FLUOXETINE HYDROCHLORIDE	fluoxetine hydrochloride	TABLET;ORAL	075872-001	Jan 29, 2002		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

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