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Lenvatinib mesylate - Generic Drug Details
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What are the generic sources for lenvatinib mesylate and what is the scope of patent protection?
Lenvatinib mesylate
is the generic ingredient in one branded drug marketed by Eisai Inc and is included in one NDA. There are five patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.Lenvatinib mesylate has one hundred and twenty-five patent family members in thirty-four countries.
There are four drug master file entries for lenvatinib mesylate. One supplier is listed for this compound.
Summary for lenvatinib mesylate
| International Patents: | 125 |
| US Patents: | 5 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Drug Master File Entries: | 4 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 38 |
| Clinical Trials: | 5 |
| Patent Applications: | 23 |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for lenvatinib mesylate |
| DailyMed Link: | lenvatinib mesylate at DailyMed |
Recent Clinical Trials for lenvatinib mesylate
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Shanghai Jiahui International Hospital | Phase 2 |
| Shanghai Zhongshan Hospital | Phase 2 |
| Merck Sharp & Dohme Corp. | Phase 2 |
Pharmacology for lenvatinib mesylate
| Drug Class | Kinase Inhibitor |
| Mechanism of Action | Receptor Tyrosine Kinase Inhibitors |
Paragraph IV (Patent) Challenges for LENVATINIB MESYLATE
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| LENVIMA | CAPSULE;ORAL | lenvatinib mesylate | 206947 | 2019-02-13 |
US Patents and Regulatory Information for lenvatinib mesylate
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Eisai Inc | LENVIMA | lenvatinib mesylate | CAPSULE;ORAL | 206947-002 | Feb 13, 2015 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Eisai Inc | LENVIMA | lenvatinib mesylate | CAPSULE;ORAL | 206947-002 | Feb 13, 2015 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Eisai Inc | LENVIMA | lenvatinib mesylate | CAPSULE;ORAL | 206947-001 | Feb 13, 2015 | RX | Yes | No | Start Trial | Start Trial | Start Trial | ||||
| Eisai Inc | LENVIMA | lenvatinib mesylate | CAPSULE;ORAL | 206947-001 | Feb 13, 2015 | RX | Yes | No | Start Trial | Start Trial | Y | Y | Start Trial | ||
| Eisai Inc | LENVIMA | lenvatinib mesylate | CAPSULE;ORAL | 206947-001 | Feb 13, 2015 | RX | Yes | 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 |
International Patents for lenvatinib mesylate
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Norway | 339110 | Start Trial |
| China | 101337933 | Start Trial |
| Hong Kong | 1102027 | Start Trial |
| South Africa | 200303567 | Start Trial |
| Serbia | 54033 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for lenvatinib mesylate
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1415987 | 553 | Finland | Start Trial | |
| 1415987 | CA 2015 00053 | Denmark | Start Trial | PRODUCT NAME: LENVATINIB, ELLER ET FARMAKOLOGISK ACCEPTABELT SALT DERAF ELLER ET HYDRAT, HERUNDER LEVATINIB MESILAT; REG. NO/DATE: EU/1/15/1002/001-002 20150601 |
| 1415987 | 92858 | Luxembourg | Start Trial | PRODUCT NAME: LENVATINIB, OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES OU UN HYDRATE DE CELUI-CI |
| 1698623 | PA2015039,C1698623 | Lithuania | Start Trial | PRODUCT NAME: LENVATINIBAS; REGISTRATION NO/DATE: EU/1/15/1002/001 - 002 20150528 |
| 1415987 | C01415987/01 | Switzerland | Start Trial | PRODUCT NAME: LENVATINIB; REGISTRATION NO/DATE: SWISSMEDIC 65512 19.08.2015 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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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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