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Last Updated: August 13, 2020

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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, Anchen Pharms, Bionpharma Inc, Torrent, Jazz Pharms, Ani Pharms Inc, Apotex, Eci Pharms Llc, Heritage Pharma, Mylan, Sun Pharm Industries, Synthon Pharms, Teva, Upsher Smith Labs, Ani Pharms, and Solvay, and is included in twenty NDAs. There is one patent protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Fluvoxamine maleate has twenty-four patent family members in eighteen countries.

There are eleven drug master file entries for fluvoxamine maleate. Nine 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
Haining Health-Coming Biotech Co., Ltd.Phase 2
Guangdong General HospitalPhase 4
Meiji Seika Pharma Co., Ltd.Phase 3

See all FLUVOXAMINE MALEATE clinical trials

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
Solvay LUVOX fluvoxamine maleate TABLET;ORAL 020243-004 Dec 5, 1994 DISCN Yes No   Start Trial   Start Trial   Start Trial
Synthon Pharms FLUVOXAMINE MALEATE fluvoxamine maleate TABLET;ORAL 075899-003 Jan 17, 2001 DISCN No No   Start Trial   Start Trial   Start Trial
Ani Pharms LUVOX fluvoxamine maleate TABLET;ORAL 021519-002 Dec 20, 2007 AB RX 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

Expired US Patents for FLUVOXAMINE MALEATE

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

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Serving leading biopharmaceutical companies globally:

Medtronic
Dow
McKinsey
Colorcon
Harvard Business School
AstraZeneca

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