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.
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 |
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 | 206947-002 | Feb 13, 2015 | RX | Yes | Yes | ⤷ 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 | ||||
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 | 206947-001 | Feb 13, 2015 | RX | Yes | No | ⤷ 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 |
---|---|---|---|
Hong Kong | 1094200 | -氯- 環丙基氨基羰基 氨基苯氧基 -甲氧基- -喹啉碳酰胺的鹽的晶體或其溶劑化物的晶體及這些物質的製備方法 (CRYSTAL OF SALT OF 4-(3-CHLORO-4-(CYCLOPROPYLAMINOCARBONYL) AMINO-PHENOXY)- 7-METHOXY-6-QUINOLINECARBOXAMIDE OR OF SOLVATE THEREOF AND PROCESSES FOR PRODUCING THESE 4-(3--4())-7--6-) | ⤷ Sign Up |
Austria | 355275 | ⤷ Sign Up | |
Israel | 250454 | תולדות קווינולין בדרגת נקיון גבוהה ושיטה להכנתן (High-purity quinoline derivative and method for manufacturing same) | ⤷ Sign Up |
European Patent Office | 1698623 | CRYSTAUX DE SEL DE 4-(3-CHLORO-4-(CYCLOPROPYLAMINOCARBONYL)AMINO-PHENOXY)-7-METHOXY-6-QUINOLINECARBOXAMIDE OU DE SES SOLVATE, ET LEUR PROCEDE DE PRODUCTION (CRYSTAL OF SALT OF 4-(3-CHLORO-4-(CYCLOPROPYLAMINOCARBONYL)AMINO-PHENOXY)-7-METHOXY-6-QUINOLINECARBOXAMIDE OR OF SOLVATE THEREOF AND PROCESSES FOR PRODUCING THESE) | ⤷ 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 | 2015/050 | Ireland | ⤷ Sign Up | PRODUCT NAME: LENVATINIB OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF OR A HYDRATE THEREOF; 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 | 15C0070 | France | ⤷ Sign Up | PRODUCT NAME: LENVATINIB OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI OU UN HYDRATE DE CELUI-CI; REGISTRATION NO/DATE: EU/1/15/1002 20150601 |
1698623 | PA2015039 | Lithuania | ⤷ Sign Up | PRODUCT NAME: LENVATINIBUM; REGISTRATION NO/DATE: EU/1/15/1002/001 - 002 20150528 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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