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Last Updated: November 21, 2024

Fluoxetine hydrochloride - Generic Drug Details

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What are the generic sources for fluoxetine hydrochloride and what is the scope of freedom to operate?

Fluoxetine hydrochloride is the generic ingredient in eight branded drugs marketed by Barr, Dr Reddys Labs Ltd, Lilly, Sun Pharm Industries, Watson Labs, 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, Eli Lilly And Co, 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, Twi Pharms, Apil, Epic Pharma Llc, and Teva Pharms, and is included in eighty NDAs. Additional information is available in the individual branded drug profile pages.

There are twenty drug master file entries for fluoxetine hydrochloride. Seventy-one suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for fluoxetine hydrochloride

US Patents:	0
Tradenames:	8
Applicants:	55
NDAs:	80
Drug Master File Entries:	20
Finished Product Suppliers / Packagers:	71
Raw Ingredient (Bulk) Api Vendors:	174
Clinical Trials:	298
Patent Applications:	7,337
What excipients (inactive ingredients) are in fluoxetine hydrochloride?	fluoxetine hydrochloride excipients list
DailyMed Link:	fluoxetine hydrochloride at DailyMed

Recent Clinical Trials for fluoxetine hydrochloride

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 hydrochloride clinical trials

Generic filers with tentative approvals for FLUOXETINE HYDROCHLORIDE

Applicant	Application No.	Strength	Dosage Form
⤷ Sign Up	⤷ Sign Up	EQ 40MG BASE	CAPSULE;ORAL
⤷ Sign Up	⤷ Sign Up	EQ 20MG BASE	CAPSULE;ORAL
⤷ Sign Up	⤷ Sign Up	EQ 10MG BASE	CAPSULE;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

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
Torrent	FLUOXETINE HYDROCHLORIDE	fluoxetine hydrochloride	TABLET;ORAL	206937-002	Oct 21, 2016		RX	No	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Teva Pharms	OLANZAPINE AND FLUOXETINE HYDROCHLORIDE	fluoxetine hydrochloride; olanzapine	CAPSULE;ORAL	077528-004	Jun 19, 2012	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Accord Hlthcare	FLUOXETINE HYDROCHLORIDE	fluoxetine hydrochloride	CAPSULE;ORAL	202729-003	Aug 27, 2020		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Eli Lilly And Co	PROZAC	fluoxetine hydrochloride	CAPSULE;ORAL	018936-003	Jun 15, 1999	AB	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Teva Pharms	OLANZAPINE AND FLUOXETINE HYDROCHLORIDE	fluoxetine hydrochloride; olanzapine	CAPSULE;ORAL	077528-002	Jun 19, 2012	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Lilly	PROZAC	fluoxetine hydrochloride	TABLET;ORAL	020974-001	Mar 9, 1999		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Landela Pharm	FLUOXETINE HYDROCHLORIDE	fluoxetine hydrochloride	CAPSULE;ORAL	075464-001	Jan 30, 2002	AB1	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

Expired US Patents for fluoxetine hydrochloride

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Lilly	PROZAC	fluoxetine hydrochloride	TABLET;ORAL	020974-002	Mar 9, 1999	⤷ Sign Up	⤷ Sign Up
Eli Lilly And Co	PROZAC	fluoxetine hydrochloride	CAPSULE;ORAL	018936-001	Dec 29, 1987	⤷ Sign Up	⤷ Sign Up
Eli Lilly And Co	PROZAC	fluoxetine hydrochloride	CAPSULE;ORAL	018936-001	Dec 29, 1987	⤷ Sign Up	⤷ Sign Up
Lilly	PROZAC	fluoxetine hydrochloride	TABLET;ORAL	020974-001	Mar 9, 1999	⤷ Sign Up	⤷ Sign Up
Eli Lilly And Co	PROZAC	fluoxetine hydrochloride	CAPSULE;ORAL	018936-001	Dec 29, 1987	⤷ Sign Up	⤷ Sign Up
Lilly	PROZAC WEEKLY	fluoxetine hydrochloride	CAPSULE, DELAYED REL PELLETS;ORAL	021235-001	Feb 26, 2001	⤷ Sign Up	⤷ Sign Up
Eli Lilly And Co	PROZAC	fluoxetine hydrochloride	CAPSULE;ORAL	018936-004	Jun 15, 1999	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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