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Serving leading biopharmaceutical companies globally:

Cantor Fitzgerald
Cerilliant
Baxter
Mallinckrodt
Teva
Moodys
McKinsey
US Department of Justice
Boehringer Ingelheim
AstraZeneca

Generated: December 11, 2017

DrugPatentWatch Database Preview

FLUOXETINE HYDROCHLORIDE - Generic Drug Details

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What are the generic drug 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 Barr, Dr Reddys Labs Ltd, Lilly, Sun Pharm Industries, Watson Labs, Alembic Pharms Ltd, Ani Pharms Inc, Aurobindo Pharma, Carlsbad, Cr Double Crane, Heritage Pharms Inc, Ivax Sub Teva Pharms, Landela Pharm, Mallinckrodt, Mylan, Mylan Pharms Inc, Par Pharm, Sandoz, Sciegen Pharms Inc, Sun Pharm Inds Ltd, Teva, Teva Pharms Usa, Wockhardt Ltd, Eli Lilly And Co, Actavis Mid Atlantic, Apotex Inc, Aurobindo Pharma Ltd, Hi Tech Pharma, Lannett, Pharm Assoc, Silarx, Wockhardt, Alvogen, Dr Reddys Labs Inc, Par Form, Par Pharm Inc, Torrent Pharms Ltd, Apil, and Teva Pharms, and is included in sixty 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.

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 Patent Submitted Product Substance Delist Req. Exclusivity Expiration
BarrFLUOXETINE HYDROCHLORIDEfluoxetine hydrochlorideCAPSULE;ORAL074803-001Aug 2, 2001AB1RXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Teva Pharms UsaSELFEMRAfluoxetine hydrochlorideTABLET;ORAL200151-001Feb 3, 2014AB1RXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
LillySYMBYAXfluoxetine hydrochloride; olanzapineCAPSULE;ORAL021520-003Dec 24, 2003ABRXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
SandozOLANZAPINE AND FLUOXETINE HYDROCHLORIDEfluoxetine hydrochloride; olanzapineCAPSULE;ORAL078901-004Nov 16, 2012ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
LillySYMBYAXfluoxetine hydrochloride; olanzapineCAPSULE;ORAL021520-005Dec 24, 2003ABRXYesNo► Subscribe► Subscribe► SubscribeYYY► Subscribe
WockhardtFLUOXETINE HYDROCHLORIDEfluoxetine hydrochlorideSOLUTION;ORAL075514-001Aug 29, 2002AARXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Par PharmOLANZAPINE AND FLUOXETINE HYDROCHLORIDEfluoxetine hydrochloride; olanzapineCAPSULE;ORAL077742-001Nov 2, 2012ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
LillySYMBYAXfluoxetine hydrochloride; olanzapineCAPSULE;ORAL021520-001Apr 9, 2007ABRXYesNo► Subscribe► Subscribe► Subscribe► Subscribe
Landela PharmFLUOXETINE HYDROCHLORIDEfluoxetine hydrochlorideCAPSULE;ORAL075464-001Jan 30, 2002AB1RXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
LillySYMBYAXfluoxetine hydrochloride; olanzapineCAPSULE;ORAL021520-004Dec 24, 2003ABRXYesNo► Subscribe► 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 CoPROZACfluoxetine hydrochlorideCAPSULE;ORAL018936-006Dec 23, 1992► Subscribe► Subscribe
LillyPROZACfluoxetine hydrochlorideSOLUTION;ORAL020101-001Apr 24, 1991► Subscribe► Subscribe
Eli Lilly And CoPROZACfluoxetine hydrochlorideCAPSULE;ORAL018936-003Jun 15, 1999► Subscribe► Subscribe
Eli Lilly And CoPROZACfluoxetine hydrochlorideCAPSULE;ORAL018936-006Dec 23, 1992► Subscribe► Subscribe
Eli Lilly And CoPROZACfluoxetine hydrochlorideCAPSULE;ORAL018936-001Dec 29, 1987► Subscribe► Subscribe
Eli Lilly And CoSARAFEMfluoxetine hydrochlorideCAPSULE;ORAL018936-008Jul 6, 2000► Subscribe► Subscribe
Eli Lilly And CoPROZACfluoxetine hydrochlorideCAPSULE;ORAL018936-001Dec 29, 1987► Subscribe► Subscribe
LillyPROZACfluoxetine hydrochlorideTABLET;ORAL020974-002Mar 9, 1999► Subscribe► Subscribe
LillyPROZAC WEEKLYfluoxetine hydrochlorideCAPSULE, DELAYED REL PELLETS;ORAL021235-001Feb 26, 2001► Subscribe► Subscribe
Eli Lilly And CoPROZACfluoxetine hydrochlorideCAPSULE;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
World Intellectual Property Organization (WIPO)9961027► Subscribe
Indonesia20343► Subscribe
Poland344331► Subscribe
Brazil9911049► Subscribe
TaiwanI239838► Subscribe
Greece980100188► Subscribe
CroatiaP20000797► Subscribe
Norway982197► 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:

Merck
US Department of Justice
Mallinckrodt
Julphar
McKesson
Cipla
UBS
Deloitte
Baxter
Fuji

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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