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Generic Lenvima Availability

Lenvima is a brand name of lenvatinib, approved by the FDA in the following formulation(s):

LENVIMA (lenvatinib mesylate - capsule;oral)

  • Manufacturer: EISAI INC
    Approval date: February 13, 2015
    Strength(s): EQ 4MG BASE, EQ 10MG BASE [RLD]

Has a generic version of Lenvima been approved?

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: About generic drugs.

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.

  • Nitrogen-containing aromatic derivatives
    Patent 7,253,286
    Issued: August 7, 2007
    Inventor(s): Funahashi; Yasuhiro & Tsuruoka; Akihiko & Matsukura; Masayuki & Haneda; Toru & Fukuda; Yoshio & Kamata; Junichi & Takahashi; Keiko & Matsushima; Tomohiro & Miyazaki; Kazuki & Nomoto; Ken-ichi & Watanabe; Tatsuo & Obaishi; Hiroshi & Yamaguchi; Atsumi & Suzuki; Sachi & Nakamura; Katsu
    Assignee(s): Eisai Co., Ltd
    Compounds represented by the following general formula: [wherein Ag is an optionally substituted 5- to 14-membered heterocyclic group, etc.; Xg is —O—, —S—, etc.; Yg is an optionally substituted C6-14 aryl group, an optionally substituted 5- to 14-membered heterocyclic group, etc.; and Tg1 is a group represented by the following general formula: (wherein Eg is a single bond or —N(Rg2)—, Rg1 and Rg2 each independently represent a hydrogen atom, an optionally substituted C1-6 alkyl group, etc. and Zg represents a C1-8 alkyl group, a C3-8 alicyclic hydrocarbon group, a C6-14 aryl group, etc.)], salts thereof or hydrates of the foregoing.
    Patent expiration dates:
    • October 19, 2021
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      Drug product
  • Crystalline form 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
    Patent 7,612,208
    Issued: November 3, 2009
    Inventor(s): Matsushima; Tomohiro & Nakamura; Taiju & Yoshizawa; Kazuhiro & Kamada; Atsushi & Ayata; Yusuke & Suzuki; Naoko & Arimoto; Itaru & Sakaguchi; Takahisa & Gotoda; Masaharu
    Assignee(s): Eisai R&D Management Co., Ltd.
    A crystal of a 4-(3-chloro-4-(cyclopropylaminocarbonyl)aminophenoxy)-7-methoxy-6-quinolinecarboxamide hydrochloride, hydrobromide, p-toluenesulfonate, sulfate, methanesulfonate or ethanesulfonate, or a solvate thereof.
    Patent expiration dates:
    • September 19, 2026
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  • Antitumor agent for thyroid cancer
    Patent 9,006,256
    Issued: April 14, 2015
    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
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      Patent use: METHOD FOR TREATING THYROID CARCINOMA INCLUDING DIFFERENTIATED THYROID CANCER

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:
    • May 13, 2019 - EXPANDED INDICATION FOR THE USE OF LENVIMA IN COMBINATION WITH EVEROLIMUS FOR THE TREATMENT OF PATIENTS WITH ADVANCED RCC FOLLOWING ONE PRIOR ANTI-ANGIOGENIC THERAPY.
    • February 13, 2020 - NEW CHEMICAL ENTITY
    • February 13, 2022 - ORPHAN DRUG EXCLUSIVITY

Glossary

TermDefinition
Drug PatentA 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 ExclusivityExclusivity 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.
RLDA 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.
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