Generic Lenvima Availability
Last updated on Apr 10, 2025.
Lenvima is a brand name of lenvatinib, approved by the FDA in the following formulation(s):
LENVIMA (lenvatinib mesylate - capsule;oral)
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Manufacturer: EISAI INC
Approval date: February 13, 2015
Strength(s): EQ 4MG BASE [RLD], EQ 10MG BASE [RLD]
Is there a generic version of Lenvima available?
No. There is currently no therapeutically equivalent version of Lenvima available in the United States.
Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Lenvima. These medications may be counterfeit and potentially unsafe. If you purchase medications online, be sure you are buying from a reputable and valid online pharmacy. Ask your health care provider for advice if you are unsure about the online purchase of any medication.
See also: Generic Drug FAQ.
Related patents
Patents are granted by the U.S. Patent and Trademark Office at any time during a drug's development and may include a wide range of claims.
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High-purity quinoline derivative and method for manufacturing same
Patent 10,259,791
Issued: April 16, 2019
Inventor(s): Nakamura Taiju & Abe Taichi & Miyashita Yusuke & Kuroda Hirofumi & Ayata Yusuke & Akao Atsushi
Assignee(s): Eisai R&D Management Co., Ltd.Provided is a compound represented by formula (IV) or a salt thereof, wherein the content of the compound represented by formula (I) is 350 ppm by mass or less.
Patent expiration dates:
- August 26, 2035✓
- August 26, 2035
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High-purity quinoline derivative and method for manufacturing same
Patent 10259791*PE
Issued: April 16, 2019
Inventor(s): Nakamura Taiju & Abe Taichi & Miyashita Yusuke & Kuroda Hirofumi & Ayata Yusuke & Akao Atsushi
Assignee(s): Eisai R&D Management Co., Ltd.Provided is a compound represented by formula (IV) or a salt thereof, wherein the content of the compound represented by formula (I) is 350 ppm by mass or less.
Patent expiration dates:
- February 26, 2036
- February 26, 2036
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High-purity quinoline derivative and method for manufacturing same
Patent 10,407,393
Issued: September 10, 2019
Inventor(s): Nakamura Taiju & Abe Taichi & Miyashita Yusuke & Kuroda Hirofumi & Ayata Yusuke & Akao Atsushi
Assignee(s): Eisai R&D Management Co., Ltd.Provided is a compound represented by formula (IV) or a salt thereof, wherein the content of the compound represented by formula (I) is 350 ppm by mass or less.
Patent expiration dates:
- August 26, 2035✓
- August 26, 2035
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High-purity quinoline derivative and method for manufacturing same
Patent 10407393*PE
Issued: September 10, 2019
Inventor(s): Nakamura Taiju & Abe Taichi & Miyashita Yusuke & Kuroda Hirofumi & Ayata Yusuke & Akao Atsushi
Assignee(s): Eisai R&D Management Co., Ltd.Provided is a compound represented by formula (IV) or a salt thereof, wherein the content of the compound represented by formula (I) is 350 ppm by mass or less.
Patent expiration dates:
- February 26, 2036
- February 26, 2036
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Method for suppressing bitterness of quinoline derivative
Patent 11,090,386
Issued: August 17, 2021
Inventor(s): Nagane; Kentaro et al.
Assignee(s): Eisai R&D Management Co., Ltd. (Tokyo, JP)The present invention provides a method for suppressing bitterness of a quinoline derivative.
Patent expiration dates:
- February 23, 2036✓
- February 23, 2036
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Method for suppressing bitterness of quinoline derivative
Patent 11090386*PE
Issued: August 17, 2021
Inventor(s): Nagane; Kentaro et al.
Assignee(s): Eisai R&D Management Co., Ltd. (Tokyo, JP)The present invention provides a method for suppressing bitterness of a quinoline derivative.
Patent expiration dates:
- August 23, 2036
- August 23, 2036
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High-purity quinoline derivative and method for manufacturing same
Patent 11,186,547
Issued: November 30, 2021
Inventor(s): Nakamura Taiju & Abe Taichi & Miyashita Yusuke & Kuroda Hirofumi & Ayata Yusuke & Akao Atsushi
Assignee(s): Eisai R&D Management Co., Ltd.Provided is a compound represented by formula (IV) or a salt thereof, wherein the content of the compound represented by formula (I) is 350 ppm by mass or less.
Patent expiration dates:
- August 26, 2035✓
- August 26, 2035
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High-purity quinoline derivative and method for manufacturing same
Patent 11186547*PE
Issued: November 30, 2021
Inventor(s): Nakamura Taiju & Abe Taichi & Miyashita Yusuke & Kuroda Hirofumi & Ayata Yusuke & Akao Atsushi
Assignee(s): Eisai R&D Management Co., Ltd.Provided is a compound represented by formula (IV) or a salt thereof, wherein the content of the compound represented by formula (I) is 350 ppm by mass or less.
Patent expiration dates:
- February 26, 2036
- February 26, 2036
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Combination of a PD-1 antagonist and a VEGFR/FGFR/RET tyrosine kinase inhibitor for treating cancer
Patent 12,083,112
Issued: September 10, 2024
Inventor(s): Denker; Andrew Evan et al.
Assignee(s): EISAI R&D MANAGEMENT CO., LTD. (Tokyo, JP); Merck Sharp & Dohme LLC (Rahway, NJ)The present disclosure describes combination therapies comprising an antagonist of Programmed Death 1 receptor (PD-1) and a multi-RTK inhibitor, and the use of the combination therapies for the treatment of cancer. The multi-RTK inhibitor may be represented by Formula (I): ##STR00001##
wherein R.sup.1 is C.sub.1-6 alkyl or C.sub.3-8 cycloalkyl, R.sup.2 is a hydrogen atom or C.sub.1-6 alkoxy, and R.sup.3 is a hydrogen atom or a halogen atom. A tumor therapeutic agent is disclosed that combines a compound or pharmaceutically acceptable salt thereof represented by Formula I and an anti-PD-1 antibody.Patent expiration dates:
- March 3, 2036✓
- March 3, 2036✓
- March 3, 2036
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Treatment of hepatocellular carcinoma
Patent 12,226,409
Issued: February 18, 2025
Inventor(s): Tamai; Toshiyuki
Assignee(s): Eisai R&D Management Co., Ltd. (Tokyo, JP)This disclosure provides methods for treating a hepatocellular carcinoma (e.g., unresectable HCC) with lenvatinib or a pharmaceutically acceptable salt thereof. Also encompassed by the disclosure are dosage regimens described herein of lenvatinib or a pharmaceutically acceptable salt thereof for use in treating hepatocellular carcinoma (e.g., unresectable hepatocellular carcinoma) according to any of the methods described herein. Particularly useful dosages and dose modifications upon the occurrence of an adverse event or events are also disclosed.
Patent expiration dates:
- May 15, 2038✓
- May 15, 2038
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Nitrogen-containing aromatic derivatives
Patent 7,253,286
Issued: August 7, 2007
Inventor(s): Funahashi; Yasuhiro et al.
Assignee(s): Eisai Co., Ltd (Bunkyo-ku, Tokyo, JP)Compounds represented by the following general formula: ##STR00001## [wherein A.sup.g is an optionally substituted 5- to 14-membered heterocyclic group, etc.; X.sup.g is --O--, --S--, etc.; Y.sup.g is an optionally substituted C.sub.6-14 aryl group, an optionally substituted 5- to 14-membered heterocyclic group, etc.; and T.sup.g1 is a group represented by the following general formula: ##STR00002## (wherein E.sup.g is a single bond or --N(R.sup.g2)--, R.sup.g1 and R.sup.g2 each independently represent a hydrogen atom, an optionally substituted C.sub.1-6 alkyl group, etc. and Z.sup.g represents a C.sub.1-8 alkyl group, a C.sub.3-8 alicyclic hydrocarbon group, a C.sub.6-14 aryl group, etc.)], salts thereof or hydrates of the foregoing.
Patent expiration dates:
- October 24, 2025✓✓
- October 24, 2025
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Nitrogen-containing aromatic derivatives
Patent 7253286*PED
Issued: August 7, 2007
Inventor(s): Funahashi; Yasuhiro et al.
Assignee(s): Eisai Co., Ltd (Bunkyo-ku, Tokyo, JP)Compounds represented by the following general formula: ##STR00001## [wherein A.sup.g is an optionally substituted 5- to 14-membered heterocyclic group, etc.; X.sup.g is --O--, --S--, etc.; Y.sup.g is an optionally substituted C.sub.6-14 aryl group, an optionally substituted 5- to 14-membered heterocyclic group, etc.; and T.sup.g1 is a group represented by the following general formula: ##STR00002## (wherein E.sup.g is a single bond or --N(R.sup.g2)--, R.sup.g1 and R.sup.g2 each independently represent a hydrogen atom, an optionally substituted C.sub.1-6 alkyl group, etc. and Z.sup.g represents a C.sub.1-8 alkyl group, a C.sub.3-8 alicyclic hydrocarbon group, a C.sub.6-14 aryl group, etc.)], salts thereof or hydrates of the foregoing.
Patent expiration dates:
- April 24, 2026✓
- April 24, 2026
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Crystalline form of the salt of 4-(3-chloro-4-(cyclopropylaminocarbonyl)aminophenoxy)-7-methoxy-6-quinoli- necarboxamide or the solvate of the salt and a process for preparing the same
Patent 7,612,208
Issued: November 3, 2009
Inventor(s): Matsushima; Tomohiro et al.
Assignee(s): Eisai R&D Management Co., Ltd. (Tokyo, JP)A crystal of a 4-(3-chloro-4-(cyclopropylaminocarbonyl)aminophenoxy)-7-methoxy-6-quinoli- necarboxamide hydrochloride, hydrobromide, p-toluenesulfonate, sulfate, methanesulfonate or ethanesulfonate, or a solvate thereof.
Patent expiration dates:
- September 19, 2026✓✓
- September 19, 2026
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Crystalline form of the salt of 4-(3-chloro-4-(cyclopropylaminocarbonyl)aminophenoxy)-7-methoxy-6-quinoli- necarboxamide or the solvate of the salt and a process for preparing the same
Patent 7612208*PED
Issued: November 3, 2009
Inventor(s): Matsushima; Tomohiro et al.
Assignee(s): Eisai R&D Management Co., Ltd. (Tokyo, JP)A crystal of a 4-(3-chloro-4-(cyclopropylaminocarbonyl)aminophenoxy)-7-methoxy-6-quinoli- necarboxamide hydrochloride, hydrobromide, p-toluenesulfonate, sulfate, methanesulfonate or ethanesulfonate, or a solvate thereof.
Patent expiration dates:
- March 19, 2027✓
- March 19, 2027
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Antitumor agent for thyroid cancer
Patent 9,006,256
Issued: April 14, 2015
Inventor(s): Matsui Junji
Assignee(s): Eisai R&D Management Co., Ltd.The present invention provides pharmaceutical compositions and therapeutic methods for treating diseases such as multiple endocrine neoplasia type IIA, multiple endocrine neoplasia type IIB, familial medullary thyroid carcinoma, thyroid carcinoma, papillary thyroid carcinoma, sporadic medullary thyroid carcinoma, Hirschsprung disease, pheochromocytoma, parathyroid hyperplasia and mucosal neuromas of the gastrointestinal tract. The therapeutic methods and pharmaceutical compositions use a RET kinase inhibiting substance, such as 4-(3-chloro-4-(cyclopropylaminocarbonyl)aminophenoxy)-7-methoxy-6-quinolinecarboxamide and pharmacologically acceptable salts thereof, and involve a step of administering the RET kinase inhibiting substance to a patient.
Patent expiration dates:
- July 27, 2027✓
- July 27, 2027
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Antitumor agent for thyroid cancer
Patent 9006256*PED
Issued: April 14, 2015
Inventor(s): Matsui Junji
Assignee(s): Eisai R&D Management Co., Ltd.The present invention provides pharmaceutical compositions and therapeutic methods for treating diseases such as multiple endocrine neoplasia type IIA, multiple endocrine neoplasia type IIB, familial medullary thyroid carcinoma, thyroid carcinoma, papillary thyroid carcinoma, sporadic medullary thyroid carcinoma, Hirschsprung disease, pheochromocytoma, parathyroid hyperplasia and mucosal neuromas of the gastrointestinal tract. The therapeutic methods and pharmaceutical compositions use a RET kinase inhibiting substance, such as 4-(3-chloro-4-(cyclopropylaminocarbonyl)aminophenoxy)-7-methoxy-6-quinolinecarboxamide and pharmacologically acceptable salts thereof, and involve a step of administering the RET kinase inhibiting substance to a patient.
Patent expiration dates:
- January 27, 2028✓
- January 27, 2028
Related exclusivities
Exclusivity is exclusive marketing rights granted by the FDA upon approval of a drug and can run concurrently with a patent or not. Exclusivity is a statutory provision and is granted to an NDA applicant if statutory requirements are met.
Exclusivity expiration dates:
- August 15, 2025 - INDICATED FOR THE FIRST-LINE TREATMENT OF PATIENTS WITH UNRESECTABLE HEPATOCELLULAR CARCINOMA (HCC)
- February 15, 2026 - PEDIATRIC EXCLUSIVITY
- April 3, 2027 - ADDITIONAL CLINICAL TRIAL INFORMATION ADDED TO PEDIATRIC USE SUBSECTION
- October 3, 2027 - PEDIATRIC EXCLUSIVITY
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Patient resources
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- Lenvima (14 MG Daily Dose)
- Lenvima (20 MG Daily Dose)
- Lenvima (8 MG Daily Dose)
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Glossary
| Term | Definition |
|---|---|
| Drug Patent | A drug patent is assigned by the U.S. Patent and Trademark Office and assigns exclusive legal right to the patent holder to protect the proprietary chemical formulation. The patent assigns exclusive legal right to the inventor or patent holder, and may include entities such as the drug brand name, trademark, product dosage form, ingredient formulation, or manufacturing process A patent usually expires 20 years from the date of filing, but can be variable based on many factors, including development of new formulations of the original chemical, and patent infringement litigation. |
| Drug Exclusivity | Exclusivity is the sole marketing rights granted by the FDA to a manufacturer upon the approval of a drug and may run simultaneously with a patent. Exclusivity periods can run from 180 days to seven years depending upon the circumstance of the exclusivity grant. |
| RLD | A Reference Listed Drug (RLD) is an approved drug product to which new generic versions are compared to show that they are bioequivalent. A drug company seeking approval to market a generic equivalent must refer to the Reference Listed Drug in its Abbreviated New Drug Application (ANDA). By designating a single reference listed drug as the standard to which all generic versions must be shown to be bioequivalent, FDA hopes to avoid possible significant variations among generic drugs and their brand name counterpart. |
Further information
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