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Last Updated: April 19, 2024

FLUOXETINE HYDROCHLORIDE - Generic Drug Details

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What are the generic drug sources for fluoxetine hydrochloride and what is the scope of patent protection?

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 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, Eli Lilly And Co, 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, Upsher Smith Labs, Apil, Epic Pharma Llc, Par Pharm, and Teva Pharms, and is included in seventy-eight NDAs. Additional information is available in the individual branded drug profile pages.

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

Summary for FLUOXETINE HYDROCHLORIDE

US Patents:	0
Tradenames:	8
Applicants:	59
NDAs:	78
Drug Master File Entries:	20
Finished Product Suppliers / Packagers:	69
Raw Ingredient (Bulk) Api Vendors:	174
Clinical Trials:	294
Patent Applications:	6,921
Formulation / Manufacturing:	see details
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
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

Generic filers with tentative approvals for FLUOXETINE HYDROCHLORIDE

Applicant	Application No.	Strength	Dosage Form
⤷ Try a Trial	⤷ Try a Trial	EQ 40MG BASE	CAPSULE;ORAL
⤷ Try a Trial	⤷ Try a Trial	EQ 20MG BASE	CAPSULE;ORAL
⤷ Try a Trial	⤷ Try a Trial	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

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
Sciegen Pharms Inc	FLUOXETINE HYDROCHLORIDE	fluoxetine hydrochloride	TABLET;ORAL	211282-001	Jan 10, 2019	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Alembic Pharms Ltd	FLUOXETINE HYDROCHLORIDE	fluoxetine hydrochloride	CAPSULE;ORAL	090223-001	Mar 19, 2009	AB1	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Apil	SARAFEM	fluoxetine hydrochloride	TABLET;ORAL	021860-003	May 19, 2006		DISCN	Yes	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Sandoz	FLUOXETINE HYDROCHLORIDE	fluoxetine hydrochloride	CAPSULE;ORAL	077469-001	Nov 17, 2008		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Lupin Ltd	FLUOXETINE HYDROCHLORIDE	fluoxetine hydrochloride	TABLET;ORAL	211653-002	Apr 15, 2019	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Epic Pharma Llc	OLANZAPINE AND FLUOXETINE HYDROCHLORIDE	fluoxetine hydrochloride; olanzapine	CAPSULE;ORAL	078901-001	Nov 16, 2012	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Teva Pharms	OLANZAPINE AND FLUOXETINE HYDROCHLORIDE	fluoxetine hydrochloride; olanzapine	CAPSULE;ORAL	077528-004	Jun 19, 2012	AB	RX	No	No	⤷ 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

Expired US Patents for FLUOXETINE HYDROCHLORIDE

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Lilly	PROZAC WEEKLY	fluoxetine hydrochloride	CAPSULE, DELAYED REL PELLETS;ORAL	021235-001	Feb 26, 2001	⤷ Try a Trial	⤷ Try a Trial
Eli Lilly And Co	PROZAC	fluoxetine hydrochloride	CAPSULE;ORAL	018936-006	Dec 23, 1992	⤷ Try a Trial	⤷ Try a Trial
Eli Lilly And Co	PROZAC	fluoxetine hydrochloride	CAPSULE;ORAL	018936-001	Dec 29, 1987	⤷ Try a Trial	⤷ Try a Trial
Eli Lilly And Co	PROZAC	fluoxetine hydrochloride	CAPSULE;ORAL	018936-006	Dec 23, 1992	⤷ Try a Trial	⤷ Try a Trial
Eli Lilly And Co	PROZAC	fluoxetine hydrochloride	CAPSULE;ORAL	018936-001	Dec 29, 1987	⤷ Try a Trial	⤷ Try a Trial
Lilly	PROZAC	fluoxetine hydrochloride	TABLET;ORAL	020974-002	Mar 9, 1999	⤷ Try a Trial	⤷ Try a Trial
Eli Lilly And Co	SARAFEM	fluoxetine hydrochloride	CAPSULE;ORAL	018936-008	Jul 6, 2000	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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