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Fluoxetine hydrochloride - Generic Drug Details

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Fluoxetine hydrochloride is the generic ingredient in eight branded drugs marketed by Teva Pharms Usa, Lilly, Barr, Teva, Dr Reddys Labs Inc, Mylan, Sandoz, Aurobindo Pharm, Wockhardt, Pharm Assoc, Aurobindo Pharma, Mallinckrodt, Carlsbad, Par Pharm, Alembic Pharms Ltd, Hi Tech Pharma, Edgemont Pharms Llc, Heritage Pharms Inc, Eli Lilly And Co, Par Form, Torrent Pharms Ltd, Wockhardt Ltd, Ivax Sub Teva Pharms, Silarx, Lannett, Apil, Watson Labs, Landela Pharm, Cr Double Crane, Dr Reddys Labs Ltd, Mylan Pharms Inc, Sun Pharm Inds, Ani Pharms Inc, Sun Pharm Inds Ltd, Actavis Mid Atlantic, Apotex Inc, Sciegen Pharms Inc, and Teva Pharms, and is included in fifty-eight NDAs. There are five patents protecting this compound. Additional information is available in the individual branded drug profile pages.

This ingredient has eighty-three patent family members in fifty-one countries.

There are twenty-seven drug master file entries for fluoxetine hydrochloride. Seventy-one suppliers are listed for this compound.

Summary for Generic Name: fluoxetine hydrochloride

Tradenames:8
Patents:5
Applicants:38
NDAs:58
Drug Master File Entries: see list27
Suppliers / Packaging: see list71
Therapeutic Class:Antidepressants
Formulation / Manufacturing:see details
Drug Prices:see low prices

Pharmacology for Ingredient: fluoxetine hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sciegen Pharms Inc
FLUOXETINE HYDROCHLORIDE
fluoxetine hydrochloride
CAPSULE;ORAL204597-001Mar 16, 2015RXNo► subscribe► subscribe
Wockhardt Ltd
FLUOXETINE HYDROCHLORIDE
fluoxetine hydrochloride
CAPSULE;ORAL078143-001Jan 16, 2008DISCNNo► subscribe► subscribe
Par Pharm
FLUOXETINE HYDROCHLORIDE
fluoxetine hydrochloride
CAPSULE;ORAL076922-003Dec 16, 2004RXNo► subscribe► subscribe
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Expired Orange Book Patents for Generic Ingredient: 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;ORAL018936-001Dec 29, 19874,314,081*PED► subscribe
Eli Lilly And Co
PROZAC
fluoxetine hydrochloride
CAPSULE;ORAL018936-001Dec 29, 19874,018,895► subscribe
Eli Lilly And Co
PROZAC
fluoxetine hydrochloride
CAPSULE;ORAL018936-006Dec 23, 19924,018,895► subscribe
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International Patent Family for Ingredient: fluoxetine hydrochloride

Country Document Number Estimated Expiration
Poland192293► subscribe
France2763846► subscribe
Australia4008699► subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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