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Serving leading biopharmaceutical companies globally:

Mallinckrodt
QuintilesIMS
Express Scripts
US Department of Justice
Colorcon
Healthtrust
Baxter
Chubb
UBS
Chinese Patent Office

Generated: November 21, 2017

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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-three suppliers are listed for this compound. There is one tentative approval for this compound.

Pharmacology for fluoxetine hydrochloride

Medical Subject Heading (MeSH) Categories for fluoxetine hydrochloride

Tentative approvals for FLUOXETINE HYDROCHLORIDE

Applicant Application No. Strength Dosage Form
u► SubscribeEQ 10MG BASECAPSULE;ORAL
u► SubscribeEQ 40MG BASECAPSULE;ORAL
u► SubscribeEQ 20MG BASECAPSULE;ORAL
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Mallinckrodt
FLUOXETINE HYDROCHLORIDE
fluoxetine hydrochloride
SOLUTION;ORAL075920-001Jan 29, 2002AARXNoNo► Subscribe► Subscribe► Subscribe
Alembic Pharms Ltd
FLUOXETINE HYDROCHLORIDE
fluoxetine hydrochloride
TABLET;ORAL208698-002Apr 5, 2017ABRXNoNo► Subscribe► Subscribe► Subscribe
Dr Reddys Labs Ltd
FLUOXETINE HYDROCHLORIDE
fluoxetine hydrochloride
CAPSULE;ORAL075465-002Jan 29, 2002AB1RXNoNo► Subscribe► Subscribe► Subscribe
Sun Pharm Inds
FLUOXETINE
fluoxetine hydrochloride
CAPSULE;ORAL075787-001Jan 29, 2002DISCNNoNo► Subscribe► Subscribe► Subscribe
Eli Lilly And Co
PROZAC
fluoxetine hydrochloride
CAPSULE;ORAL018936-004Jun 15, 1999DISCNNoNo► Subscribe► Subscribe► Subscribe
Hi Tech Pharma
FLUOXETINE HYDROCHLORIDE
fluoxetine hydrochloride
SOLUTION;ORAL075525-001Jun 27, 2002DISCNNoNo► Subscribe► Subscribe► Subscribe
Silarx
FLUOXETINE HYDROCHLORIDE
fluoxetine hydrochloride
SOLUTION;ORAL077849-001Feb 9, 2007AARXNoNo► Subscribe► Subscribe► Subscribe
Teva Pharms Usa
SELFEMRA
fluoxetine hydrochloride
TABLET;ORAL200151-002Feb 3, 2014AB1RXNoNo► Subscribe► Subscribe► Subscribe
Ivax Sub Teva Pharms
FLUOXETINE HYDROCHLORIDE
fluoxetine hydrochloride
CAPSULE;ORAL075245-003Sep 28, 2004ABRXNoNo► Subscribe► Subscribe► Subscribe
Alembic Pharms Ltd
FLUOXETINE HYDROCHLORIDE
fluoxetine hydrochloride
TABLET;ORAL208698-001Apr 5, 2017ABRXNoNo► Subscribe► Subscribe► Subscribe
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Expired Orange Book Patents for Generic Ingredient: fluoxetine hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Eli Lilly And Co
SARAFEM
fluoxetine hydrochloride
CAPSULE;ORAL018936-007Jul 6, 2000► Subscribe► Subscribe
Eli Lilly And Co
SARAFEM
fluoxetine hydrochloride
CAPSULE;ORAL018936-007Jul 6, 2000► Subscribe► Subscribe
Eli Lilly And Co
PROZAC
fluoxetine hydrochloride
CAPSULE;ORAL018936-006Dec 23, 1992► Subscribe► Subscribe
Eli Lilly And Co
PROZAC
fluoxetine hydrochloride
CAPSULE;ORAL018936-004Jun 15, 1999► Subscribe► Subscribe
Eli Lilly And Co
PROZAC
fluoxetine hydrochloride
CAPSULE;ORAL018936-003Jun 15, 1999► Subscribe► Subscribe
Eli Lilly And Co
PROZAC
fluoxetine hydrochloride
CAPSULE;ORAL018936-006Dec 23, 1992► Subscribe► Subscribe
Lilly
PROZAC
fluoxetine hydrochloride
SOLUTION;ORAL020101-001Apr 24, 1991► Subscribe► Subscribe
Lilly
PROZAC
fluoxetine hydrochloride
TABLET;ORAL020974-002Mar 9, 1999► Subscribe► Subscribe
Eli Lilly And Co
PROZAC
fluoxetine hydrochloride
CAPSULE;ORAL018936-001Dec 29, 1987► Subscribe► Subscribe
Eli Lilly And Co
PROZAC
fluoxetine hydrochloride
CAPSULE;ORAL018936-001Dec 29, 1987► Subscribe► Subscribe
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International Patent Family for Ingredient: fluoxetine hydrochloride

Country Document Number Estimated Expiration
Denmark176776► Subscribe
Japan2002516282► Subscribe
European Patent Office0958824► Subscribe
Greece980100188► Subscribe
Slovenia9800128► Subscribe
CroatiaP20000797► Subscribe
Turkey9800937► Subscribe
Serbia49827► Subscribe
World Intellectual Property Organization (WIPO)9961027► Subscribe
Portugal102152► 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 leading biopharmaceutical companies globally:

Daiichi Sankyo
Merck
Johnson and Johnson
Medtronic
US Army
Cipla
Dow
Novartis
Deloitte
Federal Trade Commission

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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