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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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