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, Endo Operations, Fosun Pharma, G And W Labs Inc, Inventia Hlthcare, Lupin Ltd, Rising, Slate Run Pharma, Taro, Torrent, Twi Pharms, Upsher Smith Labs, Apil, Epic Pharma Llc, 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:	58
NDAs:	79
Drug Master File Entries:	20
Finished Product Suppliers / Packagers:	69
Raw Ingredient (Bulk) Api Vendors:	174
Clinical Trials:	295
Patent Applications:	7,337
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
⤷ 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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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
Strides Pharma	FLUOXETINE HYDROCHLORIDE	fluoxetine hydrochloride	TABLET;ORAL	212684-001	Apr 5, 2024	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Mylan	FLUOXETINE HYDROCHLORIDE	fluoxetine hydrochloride	CAPSULE;ORAL	075207-002	Jan 30, 2002		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Dr Reddys Labs Ltd	FLUOXETINE HYDROCHLORIDE	fluoxetine hydrochloride	CAPSULE, DELAYED REL PELLETS;ORAL	078572-001	Mar 22, 2010		RX	No	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Teva Pharms	OLANZAPINE AND FLUOXETINE HYDROCHLORIDE	fluoxetine hydrochloride; olanzapine	CAPSULE;ORAL	077528-001	Jun 19, 2012	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
Torrent	FLUOXETINE HYDROCHLORIDE	fluoxetine hydrochloride	TABLET;ORAL	206937-001	Oct 21, 2016		RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Eli Lilly And Co	PROZAC	fluoxetine hydrochloride	CAPSULE;ORAL	018936-001	Dec 29, 1987	AB1	RX	Yes	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
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
Eli Lilly And Co	SARAFEM	fluoxetine hydrochloride	CAPSULE;ORAL	018936-008	Jul 6, 2000	⤷ Sign Up	⤷ Sign Up
Lilly	PROZAC	fluoxetine hydrochloride	TABLET;ORAL	020974-002	Mar 9, 1999	⤷ Sign Up	⤷ Sign Up
Eli Lilly And Co	PROZAC	fluoxetine hydrochloride	CAPSULE;ORAL	018936-006	Dec 23, 1992	⤷ Sign Up	⤷ Sign Up
Eli Lilly And Co	PROZAC	fluoxetine hydrochloride	CAPSULE;ORAL	018936-003	Jun 15, 1999	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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