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Last Updated: November 8, 2024

FLUOXETINE Drug Patent Profile

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When do Fluoxetine patents expire, and when can generic versions of Fluoxetine launch?

Fluoxetine is a drug marketed by Sun Pharm Industries, Watson Labs, 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, Ivax Sub Teva Pharms, Landela Pharm, Marksans Pharma, Micro Labs, Natco Pharma Usa, Norvium Bioscience, Sandoz, Sciegen Pharms Inc, Specgx Llc, Strides Pharma, Sun Pharm Inds Ltd, Teva, Teva Pharms Usa, Actavis Mid Atlantic, Bajaj, Chartwell Molecular, Lannett Co Inc, Nostrum Labs Inc, Novitium Pharma, Pharm Assoc, Pharmobedient Cnsltg, Upsher Smith Labs, Alembic, Aurobindo Pharma Ltd, Dr Reddys, Endo Operations, Fosun Pharma, G And W Labs Inc, Inventia Hlthcare, Lupin Ltd, Rising, Slate Run Pharma, Taro, Torrent, and Twi Pharms. and is included in sixty-nine NDAs.

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

DrugPatentWatch^® Litigation and Generic Entry Outlook for Fluoxetine

A generic version of FLUOXETINE was approved as fluoxetine hydrochloride by APNAR PHARMA LP on August 2^nd, 2001.

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Summary for FLUOXETINE

US Patents:	0
Applicants:	50
NDAs:	69
Raw Ingredient (Bulk) Api Vendors:	86
Clinical Trials:	298
Patent Applications:	4,374
Drug Prices:	Drug price information for FLUOXETINE
Drug Sales Revenues:	Drug sales revenues for FLUOXETINE
DailyMed Link:	FLUOXETINE at DailyMed

Drug patent expirations by year for FLUOXETINE

Drug Prices for FLUOXETINE

Recent Clinical Trials for FLUOXETINE

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

Sponsor	Phase
Idorsia Pharmaceuticals Ltd.	Phase 2
Berry Consultants	Phase 2
U.S. Army Medical Research and Development Command	Phase 2

See all FLUOXETINE clinical trials

US Patents and Regulatory Information for FLUOXETINE

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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
Teva Pharms Usa	FLUOXETINE HYDROCHLORIDE	fluoxetine hydrochloride	CAPSULE;ORAL	076001-002	Jan 29, 2002	AB1	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Ivax Sub Teva Pharms	FLUOXETINE HYDROCHLORIDE	fluoxetine hydrochloride	TABLET;ORAL	075865-003	Aug 30, 2004		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Ivax Sub Teva Pharms	FLUOXETINE HYDROCHLORIDE	fluoxetine hydrochloride	CAPSULE;ORAL	075245-003	Sep 28, 2004	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Cr Double Crane	FLUOXETINE HYDROCHLORIDE	fluoxetine hydrochloride	CAPSULE;ORAL	076165-002	Feb 1, 2002		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Alembic	FLUOXETINE HYDROCHLORIDE	fluoxetine hydrochloride	TABLET;ORAL	208698-002	Apr 5, 2017	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Strides Pharma	FLUOXETINE HYDROCHLORIDE	fluoxetine hydrochloride	TABLET;ORAL	212683-001	Sep 13, 2024	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Micro Labs	FLUOXETINE HYDROCHLORIDE	fluoxetine hydrochloride	CAPSULE;ORAL	216232-003	Mar 29, 2022	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>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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