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Last Updated: November 22, 2024

FLUVOXAMINE MALEATE - Generic Drug Details


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What are the generic drug sources for fluvoxamine maleate and what is the scope of patent protection?

Fluvoxamine maleate is the generic ingredient in three branded drugs marketed by Actavis Elizabeth, Bionpharma, Endo Operations, Torrent, Jazz Pharms, Ani Pharms, Apotex, Chartwell Rx, Heritage Pharma, Mylan, Norvium Bioscience, Sun Pharm Industries, Synthon Pharms, Teva, Upsher Smith Labs, and Solvay, and is included in twenty-one NDAs. Additional information is available in the individual branded drug profile pages.

There are ten drug master file entries for fluvoxamine maleate. Twelve suppliers are listed for this compound.

Summary for FLUVOXAMINE MALEATE
Drug Prices for FLUVOXAMINE MALEATE

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Recent Clinical Trials for FLUVOXAMINE MALEATE

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
AbbViePhase 4
The Medical Research NetworkPhase 4
Haining Health-Coming Biotech Co., Ltd.Phase 2

See all FLUVOXAMINE MALEATE clinical trials

Pharmacology for FLUVOXAMINE MALEATE
Anatomical Therapeutic Chemical (ATC) Classes for FLUVOXAMINE MALEATE
Paragraph IV (Patent) Challenges for FLUVOXAMINE MALEATE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
LUVOX CR Extended-release Capsules fluvoxamine maleate 100 mg 022033 1 2009-04-20
LUVOX CR Extended-release Capsules fluvoxamine maleate 150 mg 022033 1 2009-04-13

US Patents and Regulatory Information for FLUVOXAMINE MALEATE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Actavis Elizabeth FLUVOXAMINE MALEATE fluvoxamine maleate TABLET;ORAL 075901-001 Dec 28, 2000 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Upsher Smith Labs FLUVOXAMINE MALEATE fluvoxamine maleate TABLET;ORAL 075887-001 Jan 5, 2001 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Sun Pharm Industries FLUVOXAMINE MALEATE fluvoxamine maleate TABLET;ORAL 076125-002 Apr 29, 2002 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Upsher Smith Labs FLUVOXAMINE MALEATE fluvoxamine maleate TABLET;ORAL 075888-001 Nov 29, 2000 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for FLUVOXAMINE MALEATE

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Jazz Pharms LUVOX CR fluvoxamine maleate CAPSULE, EXTENDED RELEASE;ORAL 022033-001 Feb 28, 2008 ⤷  Sign Up ⤷  Sign Up
Solvay LUVOX fluvoxamine maleate TABLET;ORAL 020243-002 Dec 5, 1994 ⤷  Sign Up ⤷  Sign Up
Solvay LUVOX fluvoxamine maleate TABLET;ORAL 020243-003 Dec 5, 1994 ⤷  Sign Up ⤷  Sign Up
Solvay LUVOX fluvoxamine maleate TABLET;ORAL 020243-004 Dec 5, 1994 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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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 verification 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.