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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 lenvatinib mesylate freedom to operate?
Lenvatinib mesylate is the generic ingredient in one branded drug marketed by Eisai Inc and is included in one NDA. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Lenvatinib mesylate has one hundred and seven patent family members in thirty countries.

There is one drug master file entry for lenvatinib mesylate. One supplier is listed for this compound.

Summary for lenvatinib mesylate

International Patents:	107
US Patents:	3
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	1
Suppliers / Packagers:	1
Bulk Api Vendors:	20
Clinical Trials:	2
Patent Applications:	15
DailyMed Link:	lenvatinib mesylate at DailyMed

Pharmacology for lenvatinib mesylate

Drug Class	Kinase Inhibitor
Mechanism of Action	Receptor Tyrosine Kinase Inhibitors

Synonyms for lenvatinib mesylate

3J78384F61
4-[3-Chloro-4-[[(cyclopropylamino)carbonyl]amino]phenoxy]-7-methoxy-6-quinolinecarboxamide monomethanesulfonate
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-, methanesulfonate (1:1)
857890-39-2
AKOS030632716
CHEBI:85995
CHEMBL2105704
D09920
DTXSID90235081
HE071028
KB-145996
KS-00000TO1
Lenvatinib mesilate
Lenvatinib mesilate (JAN)
Lenvatinib mesylate (USAN)
Lenvatinib mesylate [USAN]
LENVATINIB; METHANESULFONIC ACID
Lenvima (TN)
methanesulfonic acid--4-{3-chloro-4-[(cyclopropylcarbamoyl)amino]phenoxy}-7-methoxyquinoline-6-carboxamide (1/1)
MFCD18633219
N-(4-((6-Carbamoyl-7-methoxyquinolin-4-yl)oxy)-2-chlorophenyl)-N'-cyclopropylurea monomethanesulfonate
SCHEMBL865174
UNII-3J78384F61

US Patents and Regulatory Information for lenvatinib mesylate

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Glossary

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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	Y	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	206947-002	Feb 13, 2015		RX	Yes	Yes	➤ Sign Up	➤ Sign Up	Y	Y		➤ 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

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Non-Orange Book US Patents for lenvatinib mesylate

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

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Patent No.	Title	Estimated Patent Expiration
7,612,092	Nitrogen-containing aromatic derivatives	➤ Sign Up
7,973,160	Nitrogen-containing aromatic derivatives	➤ Sign Up
8,372,981	Nitrogen-containing aromatic derivatives	➤ Sign Up
Patent No.	Title	Estimated Patent Expiration

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International Patents for lenvatinib mesylate

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Country	Document Number	Estimated Expiration
Austria	399766	➤ Sign Up
South Korea	20070107185	➤ Sign Up
Germany	60126997	➤ Sign Up
Taiwan	I304061	➤ Sign Up
Country	Document Number	Estimated Expiration

Supplementary Protection Certificates for lenvatinib mesylate

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Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2015039	Lithuania	➤ Sign Up	PRODUCT NAME: LENVATINIBUM; REGISTRATION NO/DATE: EU/1/15/1002/001 - 002 20150528
/2015	Austria	➤ Sign Up	PRODUCT NAME: LENVATINIB ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON ODER EIN HYDRAT DAVON; REGISTRATION NO/DATE: EU/1/15/1002/001-002 (MITTEILUNG) 20150601
2015000083	Germany	➤ Sign Up	PRODUCT NAME: LENVATINIB ODER EINES SEINER PHARMAZEUTISCH AKZEPTABLEN SALZE ODER EINES SEINER HYDRATE; REGISTRATION NO/DATE: EU/1/15/1002/001-002 20150528
2015 00053	Denmark	➤ Sign Up	PRODUCT NAME: LENVATINIB, ELLER ET FARMAKOLOGISK ACCEPTABELT SALT DERAF ELLER ET HYDRAT DERAF, HERUNDER LENVATINIB MESILAT; REG. NO/DATE: EU/1/15/1002/001-002 20150601
Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description