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Last Updated: May 19, 2024

Fluvoxamine maleate - Generic Drug Details


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What are the generic 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, Anchen Pharms, Bionpharma, Torrent, Jazz Pharms, Ani Pharms, Apotex, Chartwell Rx, Heritage Pharma, Mylan, 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.

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
Torrent FLUVOXAMINE MALEATE fluvoxamine maleate CAPSULE, EXTENDED RELEASE;ORAL 203240-001 Oct 31, 2014 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Mylan FLUVOXAMINE MALEATE fluvoxamine maleate TABLET;ORAL 075889-002 Nov 29, 2000 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Teva FLUVOXAMINE MALEATE fluvoxamine maleate TABLET;ORAL 075893-002 Sep 10, 2002 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Mylan FLUVOXAMINE MALEATE fluvoxamine maleate TABLET;ORAL 075889-003 Nov 29, 2000 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Ani Pharms FLUVOXAMINE MALEATE fluvoxamine maleate TABLET;ORAL 075897-001 Jan 25, 2001 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Apotex FLUVOXAMINE MALEATE fluvoxamine maleate TABLET;ORAL 075902-002 May 7, 2001 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Bionpharma FLUVOXAMINE MALEATE fluvoxamine maleate CAPSULE, EXTENDED RELEASE;ORAL 212182-001 May 11, 2020 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>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 020243-001 Dec 5, 1994 ⤷  Try a Trial ⤷  Try a Trial
Jazz Pharms LUVOX CR fluvoxamine maleate CAPSULE, EXTENDED RELEASE;ORAL 022033-001 Feb 28, 2008 ⤷  Try a Trial ⤷  Try a Trial
Solvay LUVOX fluvoxamine maleate TABLET;ORAL 020243-004 Dec 5, 1994 ⤷  Try a Trial ⤷  Try a Trial
Solvay LUVOX fluvoxamine maleate TABLET;ORAL 020243-002 Dec 5, 1994 ⤷  Try a Trial ⤷  Try a Trial
Jazz Pharms LUVOX CR fluvoxamine maleate CAPSULE, EXTENDED RELEASE;ORAL 022033-002 Feb 28, 2008 ⤷  Try a Trial ⤷  Try a Trial
Solvay LUVOX fluvoxamine maleate TABLET;ORAL 020243-003 Dec 5, 1994 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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