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 eight 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 eighty patent family members in thirty-six countries.

There are three drug master file entries for lenvatinib mesylate. One supplier is listed for this compound. There is one tentative approval for this compound.

Summary for LENVATINIB MESYLATE

International Patents:	180
US Patents:	8
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^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up 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

Generic filers with tentative approvals for LENVATINIB MESYLATE

Applicant	Application No.	Strength	Dosage Form
⤷ Sign Up	⤷ Sign Up	10MG	CAPSULE; ORAL
⤷ Sign Up	⤷ Sign Up	4MG	CAPSULE; ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

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

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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				⤷ 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				⤷ 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				⤷ 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

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Country	Patent Number	Title	Estimated Expiration
Poland	1698623		⤷ Sign Up
South Africa	200605226	A crystalline form of the salt of 4-(3-chloro-4-(cyclo-propylaminocarbonyl)aminophenoxy)-7-methoxy-6-quinolinecarboxamide or the solvate of the salt and a process for preparing the same	⤷ Sign Up
Norway	20074657		⤷ Sign Up
China	101337931	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
Portugal	1698623		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for LENVATINIB MESYLATE

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	SPC/GB15/063	United Kingdom	⤷ Sign Up	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	⤷ Sign Up	PRODUCT NAME: LENVATINIIB;REG NO/DATE: EU/1/15/1002 01.06.2015
1415987	92858	Luxembourg	⤷ Sign Up	PRODUCT NAME: LENVATINIB, OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES OU UN HYDRATE DE CELUI-CI
1415987	132016000024218	Italy	⤷ Sign Up	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
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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