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Last Updated: October 31, 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
The Medical Research NetworkPhase 4
AbbViePhase 4
Alphacait, LLCPhase 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 075888-003 Nov 29, 2000 AB RX No Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Ani Pharms LUVOX fluvoxamine maleate TABLET;ORAL 021519-002 Dec 20, 2007 AB RX Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Ani Pharms FLUVOXAMINE MALEATE fluvoxamine maleate TABLET;ORAL 075897-003 Jan 25, 2001 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Synthon Pharms FLUVOXAMINE MALEATE fluvoxamine maleate TABLET;ORAL 075899-003 Jan 17, 2001 DISCN 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
Solvay LUVOX fluvoxamine maleate TABLET;ORAL 020243-002 Dec 5, 1994 ⤷  Sign Up ⤷  Sign Up
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 020243-001 Dec 5, 1994 ⤷  Sign Up ⤷  Sign Up
Solvay LUVOX fluvoxamine maleate TABLET;ORAL 020243-004 Dec 5, 1994 ⤷  Sign Up ⤷  Sign Up
Jazz Pharms LUVOX CR fluvoxamine maleate CAPSULE, EXTENDED RELEASE;ORAL 022033-002 Feb 28, 2008 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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