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, 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, Aptapharma Inc, Bajaj, Chartwell Molecular, Lannett Co Inc, Nostrum Labs Inc, Novitium Pharma, Pharm Assoc, Pharmobedient Cnsltg, 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. Seventy suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for FLUOXETINE HYDROCHLORIDE

US Patents:	0
Tradenames:	8
Applicants:	56
NDAs:	79
Drug Master File Entries:	20
Finished Product Suppliers / Packagers:	70
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
U.S. Army Medical Research and Development Command	Phase 2
Citeline	Phase 2
PPD	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
Teva	FLUOXETINE HYDROCHLORIDE	fluoxetine hydrochloride	TABLET;ORAL	075872-001	Jan 29, 2002		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Eli Lilly And Co	SARAFEM	fluoxetine hydrochloride	CAPSULE;ORAL	018936-007	Jul 6, 2000		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Endo Operations	OLANZAPINE AND FLUOXETINE HYDROCHLORIDE	fluoxetine hydrochloride; olanzapine	CAPSULE;ORAL	077742-005	Nov 2, 2012	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Twi Pharms	FLUOXETINE HYDROCHLORIDE	fluoxetine hydrochloride	TABLET;ORAL	202133-001	Oct 6, 2011	AB	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Ani Pharms	FLUOXETINE HYDROCHLORIDE	fluoxetine hydrochloride	CAPSULE;ORAL	076287-001	May 20, 2008		DISCN	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	SOLUTION;ORAL	020101-001	Apr 24, 1991	⤷ 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	SARAFEM	fluoxetine hydrochloride	CAPSULE;ORAL	018936-008	Jul 6, 2000	⤷ 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
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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