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 six 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 forty-three 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:	143
US Patents:	6
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	3
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	54
Clinical Trials:	12
Patent Applications:	850
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for lenvatinib mesylate
DailyMed Link:	lenvatinib mesylate at DailyMed

Recent Clinical Trials for lenvatinib mesylate

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Shanghai Junshi Bioscience Co., Ltd.	Phase 3
RenJi Hospital	N/A
Shanghai Zhongshan Hospital	Phase 2

See all lenvatinib mesylate clinical trials

Pharmacology for lenvatinib mesylate

Drug Class	Kinase Inhibitor
Mechanism of Action	Receptor Tyrosine Kinase Inhibitors

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				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	Y

International Patents for lenvatinib mesylate

Country	Patent Number	Title	Estimated Expiration
European Patent Office	1777218	Procédé pour la préparation des dérivés de 4-phenoxy quinolines (Process for the preparation of 4-phenoxy quinoline derivatives)
Israel	250454
Malaysia	139232	A CRYSTALLINE FROM OF THE SALT OF 4-(3-CHLORO-4-(CYCLOPROPYLAMINOCARBONYL) AMINOPHENOXY)-7-METHOXY-6-QUINOLINECARBOXAMIDE OR THE SOLVATE OF THE SALT AND A PROCESS FOR PREPARING THE SAME.

Supplementary Protection Certificates for lenvatinib mesylate

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	553	Finland
1415987	57/2015	Austria		PRODUCT NAME: LENVATINIB ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON ODER EIN HYDRAT DAVON; REGISTRATION NO/DATE: EU/1/15/1002/001-002 (MITTEILUNG) 20150601