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Fluvoxamine maleate - Generic Drug Details

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What are the generic drug sources, and freedom to operate, for fluvoxamine maleate?

Fluvoxamine maleate is the generic ingredient in three branded drugs marketed by Nostrum Labs Inc, Actavis Elizabeth, Apotex, Ani Pharms, Sun Pharm Inds, Jazz Pharms, Torrent Pharms Ltd, Solvay, Mylan, Anchen Pharms, Upsher-smith Labs, Teva, Watson Labs, Ani Pharms Inc, and Synthon Pharms, and is included in nineteen NDAs. There is one patent protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

This ingredient has twenty-one patent family members in seventeen countries.

There are eleven drug master file entries for fluvoxamine maleate. Sixteen suppliers are listed for this compound.

Summary for Generic Name: fluvoxamine maleate

Tradenames:3
Patents:2
Applicants:15
NDAs:19
Drug Master File Entries: see list11
Suppliers / Packagers: see list16
Bulk Api Vendors: see list71
Clinical Trials: see list86
Patent Applications: see list5,221
Therapeutic Class:Antidepressants
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:fluvoxamine maleate at DailyMed

Pharmacology for Ingredient: fluvoxamine maleate

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Apotex
FLUVOXAMINE MALEATE
fluvoxamine maleate
TABLET;ORAL075902-001May 7, 2001RXNoNo► Subscribe► Subscribe
Ani Pharms Inc
FLUVOXAMINE MALEATE
fluvoxamine maleate
TABLET;ORAL075897-003Jan 25, 2001RXNoNo► Subscribe► Subscribe
Torrent Pharms Ltd
FLUVOXAMINE MALEATE
fluvoxamine maleate
CAPSULE, EXTENDED RELEASE;ORAL203240-001Oct 31, 2014RXNoNo► Subscribe► Subscribe
Sun Pharm Inds
FLUVOXAMINE MALEATE
fluvoxamine maleate
TABLET;ORAL076125-003Apr 29, 2002DISCNNoNo► Subscribe► Subscribe
Upsher-smith Labs
FLUVOXAMINE MALEATE
fluvoxamine maleate
TABLET;ORAL075887-003Jan 5, 2001DISCNNoNo► Subscribe► Subscribe
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Expired Orange Book Patents for Generic Ingredient: fluvoxamine maleate

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Solvay
LUVOX
fluvoxamine maleate
TABLET;ORAL020243-001Dec 5, 19944,085,225► Subscribe
Solvay
LUVOX
fluvoxamine maleate
TABLET;ORAL020243-002Dec 5, 19944,085,225► Subscribe
Solvay
LUVOX
fluvoxamine maleate
TABLET;ORAL020243-004Dec 5, 19944,085,225► Subscribe
Solvay
LUVOX
fluvoxamine maleate
TABLET;ORAL020243-003Dec 5, 19944,085,225► Subscribe
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International Patent Family for Ingredient: fluvoxamine maleate

Country Document Number Estimated Expiration
Ireland990406► Subscribe
Czech Republic302388► Subscribe
Denmark1178780► Subscribe
Czech Republic20014618► Subscribe
European Patent Office1178780► 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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