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Fluoxetine hydrochloride - Generic Drug Details

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What are the generic drug sources, and freedom to operate, for fluoxetine hydrochloride?

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-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. Sixty-eight suppliers are listed for this compound.

Summary for Generic Name: fluoxetine hydrochloride

Tradenames:8
Patents:6
Applicants:38
NDAs:58
Drug Master File Entries: see list27
Suppliers / Packagers: see list68
Bulk Api Vendors: see list83
Clinical Trials: see list1,051
Patent Applications: see list3,088
Therapeutic Class:Antidepressants
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:fluoxetine hydrochloride at DailyMed

Pharmacology for Ingredient: fluoxetine hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Lilly
PROZAC
fluoxetine hydrochloride
TABLET;ORAL020974-001Mar 9, 1999DISCNYesNo► Subscribe► Subscribe
Eli Lilly And Co
PROZAC
fluoxetine hydrochloride
CAPSULE;ORAL018936-001Dec 29, 1987RXYesNo6,960,577► Subscribe ► Subscribe
Wockhardt Ltd
FLUOXETINE HYDROCHLORIDE
fluoxetine hydrochloride
CAPSULE;ORAL078143-003Jan 16, 2008DISCNNoNo► Subscribe► Subscribe
Ivax Sub Teva Pharms
FLUOXETINE HYDROCHLORIDE
fluoxetine hydrochloride
TABLET;ORAL075865-003Aug 30, 2004DISCNNoNo► Subscribe► Subscribe
Lilly
SYMBYAX
fluoxetine hydrochloride; olanzapine
CAPSULE;ORAL021520-002Dec 24, 2003RXYesNo► 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
Lilly
PROZAC
fluoxetine hydrochloride
SOLUTION;ORAL020101-001Apr 24, 19914,626,549*PED► Subscribe
Lilly
PROZAC
fluoxetine hydrochloride
TABLET;ORAL020974-002Mar 9, 19994,626,549*PED► Subscribe
Eli Lilly And Co
PROZAC
fluoxetine hydrochloride
CAPSULE;ORAL018936-003Jun 15, 19994,314,081*PED► Subscribe
Eli Lilly And Co
SARAFEM
fluoxetine hydrochloride
CAPSULE;ORAL018936-008Jul 6, 20005,744,501*PED► Subscribe
Eli Lilly And Co
SARAFEM
fluoxetine hydrochloride
CAPSULE;ORAL018936-008Jul 6, 20005,114,976*PED► Subscribe
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International Patent Family for Ingredient: fluoxetine hydrochloride

Country Document Number Estimated Expiration
China1311681► Subscribe
Lithuania4477► Subscribe
Portugal102152► Subscribe
Czech Republic20004279► Subscribe
TaiwanI239838► 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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