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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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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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