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 seven 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 sixty-seven patent family members in thirty-six countries.
There are three drug master file entries for lenvatinib mesylate. One supplier is listed for this compound.
Summary for lenvatinib mesylate
International Patents: | 167 |
US Patents: | 7 |
Tradenames: | 1 |
Applicants: | 1 |
NDAs: | 1 |
Drug Master File Entries: | 3 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 60 |
Clinical Trials: | 13 |
Patent Applications: | 645 |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for lenvatinib mesylate |
DailyMed Link: | lenvatinib mesylate at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for lenvatinib mesylate
Generic Entry Date for lenvatinib mesylate*:
Constraining patent/regulatory exclusivity:
Dosage:
CAPSULE;ORAL |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Recent Clinical Trials for lenvatinib mesylate
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Henan Cancer Hospital | Phase 2 |
Shanghai Junshi Bioscience Co., Ltd. | Phase 3 |
RenJi Hospital | N/A |
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 | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
LENVIMA | Capsules | lenvatinib mesylate | 4 mg and 10 mg | 206947 | 2 | 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 | 206947-001 | Feb 13, 2015 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Eisai Inc | LENVIMA | lenvatinib mesylate | CAPSULE;ORAL | 206947-002 | Feb 13, 2015 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Eisai Inc | LENVIMA | lenvatinib mesylate | CAPSULE;ORAL | 206947-002 | Feb 13, 2015 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Eisai Inc | LENVIMA | lenvatinib mesylate | CAPSULE;ORAL | 206947-002 | Feb 13, 2015 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Eisai Inc | LENVIMA | lenvatinib mesylate | CAPSULE;ORAL | 206947-002 | Feb 13, 2015 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a 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 | Title | Estimated Expiration |
---|---|---|---|
Norway | 2015021 | ⤷ Try a Trial | |
European Patent Office | 2036557 | AGENT ANTITUMORAL DESTINÉ AU CANCER DE LA THYROÏDE (ANTITUMOR AGENT FOR THYROID CANCER) | ⤷ Try a Trial |
China | 101024627 | ⤷ Try a Trial | |
South Korea | 102329681 | ⤷ Try a Trial | |
Russian Federation | 2328489 | КРИСТАЛЛИЧЕСКАЯ ФОРМА СОЛИ 4-(3-ХЛОР-4-(ЦИКЛОПРОПИЛАМИНОКАРБОНИЛ)АМИНОФЕНОКСИ)-7-МЕТОКСИ-6-ХИНОЛИНКАРБОКСАМИДА ИЛИ СОЛЬВАТА ЭТОЙ СОЛИ И СПОСОБЫ ЕЕ ПОЛУЧЕНИЯ (CRYSTAL FORM OF 4-(3-CHLORINE-4-(CYCLOPROPYLAMINOCARBONYL)AMINOPHENOXY)-7-METHOXY-6-QUINOLINECARBOXAMIDE SALT OR ITS SOLVATE AND METHODS FOR ITS PRODUCING) | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for lenvatinib mesylate
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1415987 | CA 2015 00053 | Denmark | ⤷ Try a 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 | 57/2015 | Austria | ⤷ Try a Trial | PRODUCT NAME: LENVATINIB ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON ODER EIN HYDRAT DAVON; REGISTRATION NO/DATE: EU/1/15/1002/001-002 (MITTEILUNG) 20150601 |
1415987 | 553 | Finland | ⤷ Try a Trial | |
1698623 | C 2015 041 | Romania | ⤷ Try a Trial | PRODUCT NAME: LENVATINIB; NATIONAL AUTHORISATION NUMBER: DATA NOTIFICARII 01.06.2015 EU/1/15/001, EU/1/15/002; DATE OF NATIONAL AUTHORISATION: 20150528; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): DATA NOTIFICARII 01.06.2015 EU/1/15/001, EU/1/15/002; DATE OF FIRST AUTHORISATION IN EEA: 20150528 |
1698623 | C20150042 00382 | Estonia | ⤷ Try a Trial | PRODUCT NAME: LENVATINIIB;REG NO/DATE: EU/1/15/1002 01.06.2015 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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