LENVATINIB MESYLATE - Generic Drug Details
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What are the generic drug 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. There is one tentative approval 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 |
Generic filers with tentative approvals for LENVATINIB MESYLATE
Applicant | Application No. | Strength | Dosage Form |
⤷ Sign Up | ⤷ Sign Up | 10MG | CAPSULE; ORAL |
⤷ Sign Up | ⤷ Sign Up | 4MG | CAPSULE; ORAL |
The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.
Pharmacology for LENVATINIB MESYLATE
Drug Class | Kinase Inhibitor |
Mechanism of Action | Receptor Tyrosine Kinase Inhibitors |
Anatomical Therapeutic Chemical (ATC) Classes for LENVATINIB MESYLATE
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 | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Eisai Inc | LENVIMA | lenvatinib mesylate | CAPSULE;ORAL | 206947-002 | Feb 13, 2015 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Eisai Inc | LENVIMA | lenvatinib mesylate | CAPSULE;ORAL | 206947-002 | Feb 13, 2015 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Eisai Inc | LENVIMA | lenvatinib mesylate | CAPSULE;ORAL | 206947-001 | Feb 13, 2015 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Eisai Inc | LENVIMA | lenvatinib mesylate | CAPSULE;ORAL | 206947-002 | Feb 13, 2015 | RX | Yes | Yes | ⤷ 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 |
International Patents for LENVATINIB MESYLATE
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
China | 101024627 | ⤷ Sign Up | |
Germany | 60137273 | ⤷ Sign Up | |
Hungary | 0302603 | ⤷ Sign Up | |
Australia | 2006203099 | ⤷ Sign Up | |
South Korea | 100589032 | ⤷ Sign Up | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for LENVATINIB MESYLATE
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1415987 | 553 | Finland | ⤷ Sign Up | |
1415987 | 132016000024218 | Italy | ⤷ Sign Up | PRODUCT NAME: LENVATINIB O UN SUO SALE ACCETTABILE FARMACEUTICAMENTE O SUO IDRATO(LENVIMA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/15/1002/001-002, 20150601 |
1698623 | PA2015039,C1698623 | Lithuania | ⤷ Sign Up | PRODUCT NAME: LENVATINIBAS; REGISTRATION NO/DATE: EU/1/15/1002/001 - 002 20150528 |
1698623 | 261 5023-2015 | Slovakia | ⤷ Sign Up | PRODUCT NAME: LENVATINIB MESYLAT; REGISTRATION NO/DATE: EU/1/15/1002/001 - EU/1/15/1002/002 20150601 |
1415987 | C01415987/01 | Switzerland | ⤷ Sign Up | 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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