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, Bionpharma, Endo Operations, Torrent, Jazz Pharms, Ani Pharms, Apotex, Chartwell Rx, Heritage Pharma, Mylan, Norvium Bioscience, 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: | 16 |
NDAs: | 21 |
Drug Master File Entries: | 10 |
Finished Product Suppliers / Packagers: | 12 |
Raw Ingredient (Bulk) Api Vendors: | 142 |
Clinical Trials: | 6 |
Patent Applications: | 2,762 |
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 |
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 |
Pharmacology for FLUVOXAMINE MALEATE
Drug Class | Serotonin Reuptake Inhibitor |
Mechanism of Action | Serotonin Uptake Inhibitors |
Medical Subject Heading (MeSH) Categories for FLUVOXAMINE MALEATE
Anatomical Therapeutic Chemical (ATC) Classes 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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Actavis Elizabeth | FLUVOXAMINE MALEATE | fluvoxamine maleate | TABLET;ORAL | 075901-001 | Dec 28, 2000 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Upsher Smith Labs | FLUVOXAMINE MALEATE | fluvoxamine maleate | TABLET;ORAL | 075888-003 | Nov 29, 2000 | AB | RX | No | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Ani Pharms | LUVOX | fluvoxamine maleate | TABLET;ORAL | 021519-002 | Dec 20, 2007 | AB | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Ani Pharms | FLUVOXAMINE MALEATE | fluvoxamine maleate | TABLET;ORAL | 075897-003 | Jan 25, 2001 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Synthon Pharms | FLUVOXAMINE MALEATE | fluvoxamine maleate | TABLET;ORAL | 075899-003 | Jan 17, 2001 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
>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 | 020243-002 | Dec 5, 1994 | ⤷ Sign Up | ⤷ Sign Up |
Jazz Pharms | LUVOX CR | fluvoxamine maleate | CAPSULE, EXTENDED RELEASE;ORAL | 022033-001 | Feb 28, 2008 | ⤷ Sign Up | ⤷ Sign Up |
Solvay | LUVOX | fluvoxamine maleate | TABLET;ORAL | 020243-001 | Dec 5, 1994 | ⤷ Sign Up | ⤷ Sign Up |
Solvay | LUVOX | fluvoxamine maleate | TABLET;ORAL | 020243-004 | Dec 5, 1994 | ⤷ Sign Up | ⤷ Sign Up |
Jazz Pharms | LUVOX CR | fluvoxamine maleate | CAPSULE, EXTENDED RELEASE;ORAL | 022033-002 | Feb 28, 2008 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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