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Last Updated: March 19, 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 freedom to operate?

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
AbbViePhase 4
The Medical Research NetworkPhase 4
Alphacait, LLCPhase 2

See all fluvoxamine maleate clinical trials

Pharmacology 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
Synthon Pharms FLUVOXAMINE MALEATE fluvoxamine maleate TABLET;ORAL 075899-001 Jan 17, 2001 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Chartwell Rx FLUVOXAMINE MALEATE fluvoxamine maleate TABLET;ORAL 075900-003 Feb 23, 2006 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Upsher Smith Labs FLUVOXAMINE MALEATE fluvoxamine maleate TABLET;ORAL 075887-002 Jan 5, 2001 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Jazz Pharms LUVOX CR fluvoxamine maleate CAPSULE, EXTENDED RELEASE;ORAL 022033-002 Feb 28, 2008 DISCN Yes 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
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 020243-003 Dec 5, 1994 ⤷  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
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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