DrugPatentWatch Database Preview
LENVIMA Drug Profile
Join the DrugPatentWatch Referral Program Get access to a free drug patent landscape report or a free one-month subscription
When do Lenvima patents expire, and when can generic versions of Lenvima launch?
Lenvima is a drug marketed by Eisai Inc and is included in one NDA. There are five patents protecting this drug and one Paragraph IV challenge.
This drug has one hundred and twenty-two patent family members in thirty-three countries.
The generic ingredient in LENVIMA is lenvatinib mesylate. There are four drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the lenvatinib mesylate profile page.
US ANDA Litigation and Generic Entry Outlook for Lenvima
Lenvima was eligible for patent challenges on February 13th, 2019.
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be August 26th, 2035. This may change due to patent challenges or generic licensing.
There have been two patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.
Summary for LENVIMA
| International Patents: | 122 |
| US Patents: | 5 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 110 |
| Clinical Trials: | 11 |
| Patent Applications: | 99 |
| Drug Prices: | Drug price information for LENVIMA |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for LENVIMA |
| DailyMed Link: | LENVIMA at DailyMed |
Generic Entry Opportunity Date for LENVIMA
Generic Entry Date for LENVIMA*:
Constraining patent/regulatory exclusivity:
NDA:
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 LENVIMA
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Taipei Veterans General Hospital, Taiwan | Phase 1/Phase 2 |
| National Taiwan University Hospital | Phase 1/Phase 2 |
| M.D. Anderson Cancer Center | Phase 1 |
Recent Litigation for LENVIMA
Identify potential future generic entrants
District Court Litigation
| Case Name | Date |
|---|---|
| EISAI R&D MANAGEMENT CO., LTD. v. SUN PHARMACEUTICAL INDUSTRIES LTD. | 2019-12-23 |
| EISAI R&D MANAGEMENT CO., LTD. v. SHILPA MEDICARE LIMITED | 2019-11-08 |
Pharmacology for LENVIMA
| Drug Class | Kinase Inhibitor |
| Mechanism of Action | Receptor Tyrosine Kinase Inhibitors |
Synonyms for LENVIMA
| 3J78384F61 |
| 4-(3-chloro-4-(3-cyclopropylureido)phenoxy)-7-methoxyquinoline-6-carboxamide |
| 4-(3-Chloro-4-(cyclopropylaminocarbonyl)aminophenoxy)-7-methoxy-6-quinolinecarboxamide |
| 4-(3-chloro-4-(N'-cyclopropylureido)phenoxy)-7-methoxyquinoline-6-carboxamide |
| 4-[3-chloranyl-4-(cyclopropylcarbamoylamino)phenoxy]-7-methoxy-quinoline-6-carboxamide |
| 4-[3-Chloro-4-(cyclopropylaminocarbonyl)aminophenoxy]-7-methoxy-6-quinolinecarboxamide |
| 4-[3-chloro-4-(cyclopropylcarbamoylamino)phenoxy]-7-methoxy-quinoline-6-carboxamide |
| 4-[3-chloro-4-(cyclopropylcarbamoylamino)phenoxy]-7-methoxyquinoline-6-carboxamide |
| 4-[3-chloro-4-[[(cyclopropylamino)-oxomethyl]amino]phenoxy]-7-methoxy-6-quinolinecarboxamide |
| 4-[3-Chloro-4-[[(cyclopropylamino)carbonyl]amino]phenoxy]-7-methoxy-6-quinolinecarboxamide monomethanesulfonate |
| 4-{3-Chloro-4-[(Cyclopropylcarbamoyl)amino]phenoxy}-7-Methoxyquinoline-6-Carboxamide |
| 417716-92-8 |
| 4CA-0485 |
| 6-carbamoyl-4-{3-chloro-4-[(cyclopropylcarbamoyl)amino]phenoxy}-7-methoxyquinolin-1-ium methanesulfonate |
| 6-Quinolinecarboxamide, 4-(3-chloro-4- (((cyclopropylamino)carbonyl)amino)phenoxy)-7-methoxy- |
| 6-Quinolinecarboxamide, 4-(3-chloro-4-(((cyclopropylamino)carbonyl)amino)phenoxy)- 7-methoxy-, methanesulfonate (1:1) |
| 716C928 |
| 857890-39-2 |
| 942407-57-0 |
| A1-04306 |
| A825653 |
| ABP000863 |
| AC-25047 |
| AC-30100 |
| AK175809 |
| AK543419 |
| AKOS025401742 |
| AKOS030632716 |
| AN-6642 |
| AOB87766 |
| AS-16203 |
| BC252209 |
| BCP01799 |
| BCP11858 |
| BCP9000633 |
| BCPP000247 |
| BDBM50331094 |
| BRD-K39974922-001-02-7 |
| CHEBI:85994 |
| CHEBI:85995 |
| CHEMBL1289601 |
| CHEMBL2105704 |
| CS-0109 |
| CTK1D4875 |
| D09919 |
| D09920 |
| DB-070219 |
| DB09078 |
| DS-19245 |
| DTXSID50194605 |
| DTXSID90235081 |
| E 7080 |
| E-7080 |
| E7080 |
| E7080 (Lenvatinib) |
| E7080, E 7080 |
| E7080/E-7080 |
| E7080Mesylate |
| EE083865G2 |
| ER-203492-00 |
| EX-A249 |
| FT-0700727 |
| GTPL7426 |
| HMS3244A07 |
| HMS3244A08 |
| HMS3244B07 |
| HMS3654A14 |
| HY-10981 |
| J-513372 |
| KB-145996 |
| KB-78118 |
| Kisplyx |
| KS-00000638 |
| KS-00000TO1 |
| Lenvatinib |
| Lenvatinib (E7080) |
| Lenvatinib (USAN/INN) |
| Lenvatinib [USAN:INN] |
| Lenvatinib mesilate |
| Lenvatinib mesilate (JAN) |
| LENVATINIB MESYLATE |
| Lenvatinib mesylate (USAN) |
| Lenvatinib mesylate [USAN] |
| Lenvatinib; E7080 |
| LenvatinibE7080) |
| Lenvima (TN) |
| LEV |
| methanesulfonic acid--4-{3-chloro-4-[(cyclopropylcarbamoyl)amino]phenoxy}-7-methoxyquinoline-6-carboxamide (1/1) |
| MLS006011239 |
| MolPort-009-679-469 |
| N-(4-((6-Carbamoyl-7-methoxyquinolin-4-yl)oxy)-2-chlorophenyl)-N'-cyclopropylurea monomethanesulfonate |
| NCGC00263198-01 |
| NCGC00263198-07 |
| QCR-115 |
| RS0099 |
| s1164 |
| SB16580 |
| SB16581 |
| SC-87813 |
| SCHEMBL864638 |
| SCHEMBL865174 |
| SMR004702999 |
| SW219259-1 |
| SYN1038 |
| UNII-3J78384F61 |
| UNII-EE083865G2 |
| WOSKHXYHFSIKNG-UHFFFAOYSA-N |
| ZINC3816292 |
Paragraph IV (Patent) Challenges for LENVIMA
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| LENVIMA | CAPSULE;ORAL | lenvatinib mesylate | 206947 | 2019-02-13 |
US Patents and Regulatory Information for LENVIMA
| 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 | Start Trial | Start Trial | 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 | 206947-002 | Feb 13, 2015 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Eisai Inc | LENVIMA | lenvatinib mesylate | CAPSULE;ORAL | 206947-002 | Feb 13, 2015 | RX | Yes | Yes | 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 LENVIMA
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Japan | 2009215313 | Start Trial |
| Portugal | 1698623 | Start Trial |
| Canada | 2543650 | Start Trial |
| Austria | 399766 | Start Trial |
| Taiwan | I331996 | Start Trial |
| Denmark | 1698623 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for LENVIMA
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1415987 | C01415987/01 | Switzerland | Start Trial | PRODUCT NAME: LENVATINIB; REGISTRATION NO/DATE: SWISSMEDIC 65512 19.08.2015 |
| 1415987 | 553 | Finland | Start Trial | |
| 1415987 | 15C0070 | France | Start Trial | 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 |
| 1415987 | 92858 | Luxembourg | Start Trial | PRODUCT NAME: LENVATINIB, OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES OU UN HYDRATE DE CELUI-CI |
| 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 |
| 1698623 | C 2015 041 | Romania | Start 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 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
