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Generated: September 23, 2017

DrugPatentWatch Database Preview

Fluoxetine hydrochloride - Generic Drug Details

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What are the generic sources for fluoxetine hydrochloride and what is the scope of fluoxetine hydrochloride freedom to operate?

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 Pharma Ltd, Wockhardt, Pharm Assoc, Aurobindo Pharma, Mallinckrodt, Carlsbad, Par Pharm, Alembic Pharms Ltd, Hi Tech Pharma, Alvogen, 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-nine NDAs. There are five patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Fluoxetine hydrochloride has eighty-four patent family members in fifty-one countries.

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

Summary for Generic Name: fluoxetine hydrochloride

Tradenames:8
Patents:5
Applicants:38
NDAs:59
Drug Master File Entries: see list27
Suppliers / Packagers: see list72
Bulk Api Vendors: see list83
Clinical Trials: see list2,473
Patent Applications: see list5,111
Therapeutic Class:Antidepressants
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:fluoxetine hydrochloride at DailyMed

Pharmacology for Ingredient: fluoxetine hydrochloride

Tentative approvals for FLUOXETINE HYDROCHLORIDE

Applicant Application No. Strength Dosage Form
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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
Carlsbad
FLUOXETINE HYDROCHLORIDE
fluoxetine hydrochloride
CAPSULE;ORAL076022-001Jan 30, 2002DISCNNoNo► Subscribe► Subscribe► Subscribe
Teva Pharms
OLANZAPINE AND FLUOXETINE HYDROCHLORIDE
fluoxetine hydrochloride; olanzapine
CAPSULE;ORAL202074-001Mar 25, 2013ABRXNoNo► Subscribe► Subscribe► Subscribe
Dr Reddys Labs Ltd
FLUOXETINE HYDROCHLORIDE
fluoxetine hydrochloride
CAPSULE;ORAL075465-001Jan 29, 2002AB1RXNoNo► Subscribe► Subscribe► Subscribe
Sandoz
FLUOXETINE HYDROCHLORIDE
fluoxetine hydrochloride
CAPSULE;ORAL075049-003Jan 29, 2002ABRXNoNo► Subscribe► Subscribe► Subscribe
Apotex Inc
FLUOXETINE HYDROCHLORIDE
fluoxetine hydrochloride
SOLUTION;ORAL075292-001Feb 7, 2002DISCNNoNo► Subscribe► Subscribe► Subscribe
Sciegen Pharms Inc
FLUOXETINE HYDROCHLORIDE
fluoxetine hydrochloride
CAPSULE;ORAL204597-003Mar 16, 2015ABRXNoNo► Subscribe► Subscribe► Subscribe
Sun Pharm Inds
FLUOXETINE
fluoxetine hydrochloride
CAPSULE;ORAL075787-001Jan 29, 2002DISCNNoNo► Subscribe► Subscribe► Subscribe
Mallinckrodt
FLUOXETINE HYDROCHLORIDE
fluoxetine hydrochloride
SOLUTION;ORAL075920-001Jan 29, 2002AARXNoNo► Subscribe► Subscribe► Subscribe
Alembic Pharms Ltd
FLUOXETINE HYDROCHLORIDE
fluoxetine hydrochloride
TABLET;ORAL208698-001Apr 5, 2017ABRXNoNo► Subscribe► Subscribe► Subscribe
Teva Pharms Usa
FLUOXETINE HYDROCHLORIDE
fluoxetine hydrochloride
CAPSULE;ORAL076001-002Jan 29, 2002AB1RXNoNo► Subscribe► Subscribe► Subscribe
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Expired Orange Book Patents for Generic Ingredient: fluoxetine hydrochloride

International Patent Family for Ingredient: fluoxetine hydrochloride

Country Document Number Estimated Expiration
Netherlands1009259► Subscribe
Eurasian Patent Organization004539► Subscribe
Malaysia127938► Subscribe
Australia726690► Subscribe
Ukraine78181► Subscribe
Canada2332814► Subscribe
Slovenia9800128► Subscribe
ItalyMI980908► Subscribe
United Kingdom2325623► Subscribe
Luxembourg90245► 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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Serving 500+ biopharmaceutical companies globally:

Colorcon
Queensland Health
McKinsey
UBS
US Department of Justice
Healthtrust
Chinese Patent Office
Cerilliant
Farmers Insurance
Chubb

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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