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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 Inc, Torrent, Jazz Pharms, Ani Pharms Inc, Apotex, Heritage Pharma, Mylan, Pharma Life, 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.
Summary for fluvoxamine maleate
International Patents: | 24 |
US Patents: | 1 |
Tradenames: | 3 |
Applicants: | 16 |
NDAs: | 20 |
Drug Master File Entries: | 11 |
Suppliers / Packagers: | 9 |
Bulk Api Vendors: | 121 |
Clinical Trials: | 5 |
Patent Applications: | 1,394 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price trends for fluvoxamine maleate |
DailyMed Link: | fluvoxamine maleate at DailyMed |
Recent Clinical Trials for fluvoxamine maleate
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Haining Health-Coming Biotech Co., Ltd. | Phase 2 |
Guangdong General Hospital | Phase 4 |
AbbVie | Phase 3 |
Pharmacology for fluvoxamine maleate
Drug Class | Serotonin Reuptake Inhibitor |
Mechanism of Action | Serotonin Uptake Inhibitors |
Medical Subject Heading (MeSH) Categories 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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Heritage Pharma | FLUVOXAMINE MALEATE | fluvoxamine maleate | TABLET;ORAL | 075894-002 | Apr 18, 2001 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
Anchen Pharms | FLUVOXAMINE MALEATE | fluvoxamine maleate | CAPSULE, EXTENDED RELEASE;ORAL | 091476-002 | Mar 13, 2013 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
Ani Pharms | LUVOX | fluvoxamine maleate | TABLET;ORAL | 021519-001 | Dec 20, 2007 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
Bionpharma Inc | FLUVOXAMINE MALEATE | fluvoxamine maleate | CAPSULE, EXTENDED RELEASE;ORAL | 212182-002 | Sep 16, 2020 | 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 |
---|---|---|---|---|---|---|---|
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 | 020243-002 | Dec 5, 1994 | Start Trial | Start Trial |
Jazz Pharms | LUVOX CR | fluvoxamine maleate | CAPSULE, EXTENDED RELEASE;ORAL | 022033-002 | Feb 28, 2008 | Start Trial | Start Trial |
Solvay | LUVOX | fluvoxamine maleate | TABLET;ORAL | 020243-003 | Dec 5, 1994 | Start Trial | Start Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for fluvoxamine maleate
Country | Patent Number | Estimated Expiration |
---|---|---|
Russian Federation | 2275191 | Start Trial |
Canada | 2374039 | Start Trial |
Denmark | 1178780 | Start Trial |
European Patent Office | 1852111 | Start Trial |
>Country | >Patent Number | >Estimated Expiration |
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