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Last Updated: April 20, 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.

Summary for fluvoxamine maleate

US Patents:	0
Tradenames:	3
Applicants:	15
NDAs:	21
Drug Master File Entries:	10
Finished Product Suppliers / Packagers:	12
Raw Ingredient (Bulk) Api Vendors:	142
Clinical Trials:	6
Patent Applications:	2,974
Formulation / Manufacturing:	see details
Drug Prices:	Drug price trends for fluvoxamine maleate
What excipients (inactive ingredients) are in fluvoxamine maleate?	fluvoxamine maleate excipients list
DailyMed Link:	fluvoxamine maleate at DailyMed

See drug prices for fluvoxamine maleate

Recent Clinical Trials for fluvoxamine maleate

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
The Medical Research Network	Phase 4
AbbVie	Phase 4
Alphacait, LLC	Phase 2

See all fluvoxamine maleate clinical trials

Pharmacology for fluvoxamine maleate

Drug Class	Serotonin Reuptake Inhibitor
Mechanism of Action	Serotonin Uptake Inhibitors

Medical Subject Heading (MeSH) Categories for fluvoxamine maleate

Anti-Anxiety Agents
Antidepressive Agents, Second-Generation
Cytochrome P-450 CYP1A2 Inhibitors
Cytochrome P-450 CYP2C19 Inhibitors
Serotonin Uptake Inhibitors

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

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Mylan	FLUVOXAMINE MALEATE	fluvoxamine maleate	TABLET;ORAL	075889-002	Nov 29, 2000		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Bionpharma	FLUVOXAMINE MALEATE	fluvoxamine maleate	TABLET;ORAL	217917-003	Jan 22, 2024	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Sun Pharm Industries	FLUVOXAMINE MALEATE	fluvoxamine maleate	TABLET;ORAL	076125-003	Apr 29, 2002		DISCN	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

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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
Solvay	LUVOX	fluvoxamine maleate	TABLET;ORAL	020243-002	Dec 5, 1994	⤷ 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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