fluoxetine hydrochloride - Profile

What are the generic drug 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, Aurobindo Pharma, Cadila Pharms Ltd, Carlsbad, Chartwell Rx, Cr Double Crane, Heritage, Ivax Sub Teva Pharms, Landela Pharm, Marksans Pharma, Micro Labs, Natco Pharma Usa, Pharmobedient, Regcon Holdings, Sandoz, Sciegen Pharms, Senores Pharms, Specgx Llc, Strides Pharma Intl, Sun Pharm Inds Ltd, Teva, Teva Pharms Usa, Eli Lilly And Co, Actavis Mid Atlantic, Bajaj, Chartwell Molecular, Lannett Co Inc, Novitium Pharma, Pharm Assoc, Pharmobedient Cnsltg, Solis Pharms, Upsher Smith Labs, Alembic, Aurobindo Pharma Ltd, Dr Reddys, Fosun Pharma, G And W Labs Inc, Inventia Hlthcare, Lupin, Ph Health, Rising, Somerset Theraps Llc, Strides Pharma, 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 is one tentative approval for this compound.

Summary for fluoxetine hydrochloride

US Patents:	0
Tradenames:	8
Applicants:	55
NDAs:	80

Generic filers with tentative approvals for FLUOXETINE HYDROCHLORIDE

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

US Patents and Regulatory Information for fluoxetine hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Barr	FLUOXETINE HYDROCHLORIDE	fluoxetine hydrochloride	CAPSULE, DELAYED REL PELLETS;ORAL	076237-001	Mar 24, 2010		DISCN	No	No
Dr Reddys Labs Ltd	FLUOXETINE HYDROCHLORIDE	fluoxetine hydrochloride	CAPSULE, DELAYED REL PELLETS;ORAL	078572-001	Mar 22, 2010		RX	No	Yes
Lilly	PROZAC WEEKLY	fluoxetine hydrochloride	CAPSULE, DELAYED REL PELLETS;ORAL	021235-001	Feb 26, 2001		DISCN	Yes	No
Sun Pharm Industries	FLUOXETINE	fluoxetine hydrochloride	CAPSULE;ORAL	075787-001	Jan 29, 2002		DISCN	No	No
Sun Pharm Industries	FLUOXETINE	fluoxetine hydrochloride	CAPSULE;ORAL	075787-002	Jan 29, 2002		DISCN	No	No
Watson Labs	FLUOXETINE	fluoxetine hydrochloride	CAPSULE;ORAL	075662-001	Jan 29, 2002		DISCN	No	No

Expired US Patents for fluoxetine hydrochloride

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	4,035,511
Eli Lilly And Co	PROZAC	fluoxetine hydrochloride	CAPSULE;ORAL	018936-001	Dec 29, 1987	4,329,356
Eli Lilly And Co	PROZAC	fluoxetine hydrochloride	CAPSULE;ORAL	018936-001	Dec 29, 1987	4,194,009
Lilly	PROZAC WEEKLY	fluoxetine hydrochloride	CAPSULE, DELAYED REL PELLETS;ORAL	021235-001	Feb 26, 2001	RE39030
Eli Lilly And Co	PROZAC	fluoxetine hydrochloride	CAPSULE;ORAL	018936-001	Dec 29, 1987	4,590,213
Eli Lilly And Co	PROZAC	fluoxetine hydrochloride	CAPSULE;ORAL	018936-001	Dec 29, 1987	4,083,982