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Generic Dayvigo Availability

Last updated on July 7, 2021.

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

DAYVIGO (lemborexant - tablet;oral)

  • Manufacturer: EISAI INC
    Approval date: April 7, 2020
    Strength(s): 5MG [RLD], 10MG [RLD]

Has a generic version of Dayvigo been approved?

No. There is currently no therapeutically equivalent version of Dayvigo available in the United States.

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Dayvigo. 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.

  • Compositions and methods for treating insomnia
    Patent 10,188,652
    Issued: January 29, 2019
    Assignee(s): Eisai R&D Management Co., Ltd.

    In the present invention, compound such as (1R,2S)-2-(((2,4-dimethylpyrimidin-5-yl)oxy)methyl)-2-(3-fluorophenyl)-N-(5-fluoropyridin-2-yl) cyclopropanecarboxamide have been found to be potent orexin receptor antagonists, and may be useful in the treatment of sleep disorders such as insomnia, as well as for other therapeutic uses.

    Patent expiration dates:

    • October 21, 2035
      ✓ 
      Patent use: TREATMENT OF ADULT PATIENTS WITH INSOMNIA, CHARACTERIZED BY DIFFICULTIES WITH SLEEP ONSET AND/OR SLEEP MAINTENANCE
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      Drug product
  • Cyclopropane compound
    Patent 8,268,848
    Issued: September 18, 2012
    Inventor(s): Terauchi; Taro & Takemura; Ayumi & Doko; Takashi & Yoshida; Yu & Tanaka; Toshiaki & Sorimachi; Keiichi & Naoe; Yoshimitsu & Beuckmann; Carsten & Kazuta; Yuji
    Assignee(s): Eisai R&D Management Co., Ltd.

    A cyclopropane compound represented by the following formula (A) or a pharmaceutically acceptable salt thereof has orexin receptor antagonism, and therefore has a potencial of usefulness for the treatment of sleep disorder for which orexin receptor antagonism is effective, for example, insomnia: wherein Q represents —CH— or a nitrogen atom, R1a and R1b each independently represent a C1-6 alkyl group and the like, R1c represents a hydrogen atom and the like, R2a, R2b, R2c and R2d each independently represent a hydrogen atom, a halogen atom, a C1-6 alkyl group and the like, R3a, R3b and R3c each independently represent a hydrogen atom, a halogen atom and the like, and R3d represents a hydrogen atom and the like.

    Patent expiration dates:

    • September 20, 2031
      ✓ 
      Patent use: TREATMENT OF ADULT PATIENTS WITH INSOMNIA, CHARACTERIZED BY DIFFICULTIES WITH SLEEP ONSET AND/OR SLEEP MAINTENANCE
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      Drug substance
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      Drug product

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:

    • April 7, 2025 - NEW CHEMICAL ENTITY

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

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.