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Last Updated: May 10, 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, Aptapharma Inc, Bajaj, Chartwell Molecular, Lannett Co Inc, Nostrum Labs Inc, Novitium Pharma, Pharm Assoc, Pharmobedient Cnsltg, Saptalis Pharms, 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-nine 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:	60
NDAs:	79
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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Glossary

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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
Par Form	FLUOXETINE HYDROCHLORIDE	fluoxetine hydrochloride	TABLET;ORAL	203836-002	Aug 19, 2016	AB	RX	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
Carlsbad	FLUOXETINE HYDROCHLORIDE	fluoxetine hydrochloride	CAPSULE;ORAL	076022-002	Jan 30, 2002		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Sciegen Pharms Inc	FLUOXETINE HYDROCHLORIDE	fluoxetine hydrochloride	TABLET;ORAL	210935-001	Mar 20, 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	078901-004	Nov 16, 2012	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Fosun Pharma	FLUOXETINE HYDROCHLORIDE	fluoxetine hydrochloride	TABLET;ORAL	076024-001	Jan 29, 2002		DISCN	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
Eli Lilly And Co	PROZAC	fluoxetine hydrochloride	CAPSULE;ORAL	018936-004	Jun 15, 1999	⤷ Try a Trial	⤷ Try a Trial
Lilly	PROZAC	fluoxetine hydrochloride	TABLET;ORAL	020974-001	Mar 9, 1999	⤷ 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
Lilly	PROZAC	fluoxetine hydrochloride	TABLET;ORAL	020974-002	Mar 9, 1999	⤷ Try a Trial	⤷ Try a Trial
Lilly	PROZAC	fluoxetine hydrochloride	SOLUTION;ORAL	020101-001	Apr 24, 1991	⤷ Try a Trial	⤷ Try a Trial
Lilly	PROZAC WEEKLY	fluoxetine hydrochloride	CAPSULE, DELAYED REL PELLETS;ORAL	021235-001	Feb 26, 2001	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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