Lenvatinib mesylate - Generic Drug Details

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

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

See all lenvatinib mesylate clinical trials

Pharmacology for lenvatinib mesylate

Drug Class	Kinase Inhibitor
Mechanism of Action	Receptor Tyrosine Kinase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for lenvatinib mesylate

L01EX	Other protein kinase inhibitors
L01E	PROTEIN KINASE INHIBITORS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

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
Eisai Inc	LENVIMA	lenvatinib mesylate	CAPSULE;ORAL	206947-002	Feb 13, 2015		RX	Yes	Yes
Eisai Inc	LENVIMA	lenvatinib mesylate	CAPSULE;ORAL	206947-001	Feb 13, 2015		RX	Yes	No				Y
Eisai Inc	LENVIMA	lenvatinib mesylate	CAPSULE;ORAL	206947-002	Feb 13, 2015		RX	Yes	Yes				Y
Eisai Inc	LENVIMA	lenvatinib mesylate	CAPSULE;ORAL	206947-002	Feb 13, 2015		RX	Yes	Yes				Y
Eisai Inc	LENVIMA	lenvatinib mesylate	CAPSULE;ORAL	206947-002	Feb 13, 2015		RX	Yes	Yes
Eisai Inc	LENVIMA	lenvatinib mesylate	CAPSULE;ORAL	206947-002	Feb 13, 2015		RX	Yes	Yes

International Patents for lenvatinib mesylate

Country	Patent Number	Title	Estimated Expiration
Poland	1698623
Russian Federation	2264389	АЗОТСОДЕРЖАЩИЕ АРОМАТИЧЕСКИЕ ПРОИЗВОДНЫЕ, ИХ ПРИМЕНЕНИЕ, ЛЕКАРСТВЕННОЕ СРЕДСТВО НА ИХ ОСНОВЕ И СПОСОБ ЛЕЧЕНИЯ (NITROGEN-CONTAINING AROMATIC DERIVATIVES, THEIR USING, MEDICINAL AGENT BASED ON THEREOF AND METHOD FOR TREATMENT)
Taiwan	I331996
World Intellectual Property Organization (WIPO)	2016136745
Montenegro	02184	KRISTALNI OBLIK SOLI 4 -(3-HLORO-4- (CIKLOPROPILAMINOKARBONIL)AMINO-FENOKSI)-7-METOKSI-6-HINOLINKARBOKSAMIDA lLI NJEGOVIH SOLVATA l PROCES ZA NJIHOVU PROIZVODNJU (CRYSTAL OF SALT OF 4 - (3-CHLOR0-4- (CYCLOPROPYLAMINOCARBONYL)AMINO-PHENOXY)-7-METHOXY-6-QUINOUNECARBOXAMIDE OR OF SOLVATE THEREOF AND PROCESSES FOR PRODUCING THESE)
Mexico	2022009299	DERIVADO DE QUINOLINA MUY PURO Y METODO PARA SU PRODUCCION. (HIGH-PURITY QUINOLINE DERIVATIVE AND METHOD FOR MANUFACTURING SAME.)
Portugal	3524595

Supplementary Protection Certificates for lenvatinib mesylate

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1415987	122015000083	Germany		PRODUCT NAME: LENVATINIB ODER EINES SEINER PHARMAZEUTISCH AKZEPTABLEN SALZE ODER EINES SEINER HYDRATE; REGISTRATION NO/DATE: EU/1/15/1002/001-002 20150528
1415987	C01415987/01	Switzerland		PRODUCT NAME: LENVATINIB; REGISTRATION NO/DATE: SWISSMEDIC 65512 19.08.2015
1415987	1590053-3	Sweden		PRODUCT NAME: LENVATINIB OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF OR A HYDRATE THEREOF; REG. NO/DATE: EU/1/15/1002 20150601
1415987	132016000024218	Italy		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
1415987	SPC/GB15/063	United Kingdom		PRODUCT NAME: LENVATINIB, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT OR A HYDRATE THEREOF; REGISTERED: UK EU/1/15/1002/001-002 20150601
1698623	C20150042 00382	Estonia		PRODUCT NAME: LENVATINIIB;REG NO/DATE: EU/1/15/1002 01.06.2015
1415987	CA 2015 00053	Denmark		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