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Last Updated: July 10, 2020

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FLUVOXAMINE MALEATE Drug Profile


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When do Fluvoxamine Maleate patents expire, and when can generic versions of Fluvoxamine Maleate launch?

Fluvoxamine Maleate is a drug marketed by Actavis Elizabeth, Anchen Pharms, Bionpharma Inc, Torrent, Ani Pharms Inc, Apotex, Eci Pharms Llc, Heritage Pharma, Mylan, Sun Pharm Industries, Synthon Pharms, Teva, and Upsher Smith Labs. and is included in seventeen NDAs.

The generic ingredient in FLUVOXAMINE MALEATE is fluvoxamine maleate. There are eleven drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the fluvoxamine maleate profile page.

US ANDA Litigation and Generic Entry Outlook for Fluvoxamine Maleate

A generic version of FLUVOXAMINE MALEATE was approved as fluvoxamine maleate by UPSHER SMITH LABS on November 29th, 2000.

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Drug patent expirations by year for FLUVOXAMINE MALEATE
Drug Prices for FLUVOXAMINE MALEATE

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Recent Clinical Trials for FLUVOXAMINE MALEATE

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SponsorPhase
Haining Health-Coming Biotech Co., Ltd.Phase 2
Guangdong General HospitalPhase 4
AbbViePhase 3

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Pharmacology for FLUVOXAMINE MALEATE
Paragraph IV (Patent) Challenges for FLUVOXAMINE MALEATE
Tradename Dosage Ingredient NDA Submissiondate
LUVOX CR CAPSULE, EXTENDED RELEASE;ORAL fluvoxamine maleate 022033 2009-04-20
LUVOX CR CAPSULE, EXTENDED RELEASE;ORAL fluvoxamine maleate 022033 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
Upsher Smith Labs FLUVOXAMINE MALEATE fluvoxamine maleate TABLET;ORAL 075888-001 Nov 29, 2000 AB RX No No   Start Trial   Start Trial   Start Trial
Sun Pharm Industries FLUVOXAMINE MALEATE fluvoxamine maleate TABLET;ORAL 076125-002 Apr 29, 2002 DISCN No No   Start Trial   Start Trial   Start Trial
Upsher Smith Labs FLUVOXAMINE MALEATE fluvoxamine maleate TABLET;ORAL 075888-003 Nov 29, 2000 AB RX No Yes   Start Trial   Start Trial   Start Trial
Mylan FLUVOXAMINE MALEATE fluvoxamine maleate TABLET;ORAL 075950-001 Oct 15, 2001 DISCN No No   Start Trial   Start Trial   Start Trial
Sun Pharm Industries FLUVOXAMINE MALEATE fluvoxamine maleate TABLET;ORAL 076125-003 Apr 29, 2002 DISCN No No   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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Serving leading biopharmaceutical companies globally:

Dow
Johnson and Johnson
Harvard Business School
Medtronic
Moodys
Mallinckrodt

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