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Generic Hetlioz LQ Availability

See also: Generic Hetlioz

Hetlioz LQ is a brand name of tasimelteon, approved by the FDA in the following formulation(s):

HETLIOZ LQ (tasimelteon - suspension;oral)

  • Manufacturer: VANDA PHARMS INC
    Approval date: December 1, 2020
    Strength(s): 4MG/ML [RLD]

Has a generic version of Hetlioz LQ been approved?

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

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Hetlioz LQ. 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 FAQs.

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.

  • Highly purifid pharmaceutical grade tasimelteon
    Patent 10,071,977
    Issued: September 11, 2018
    Assignee(s): VANDA PHARMACEUTICALS INC.

    A process for preparing a batch of highly purified, pharmaceutical grade tasimelteon comprises analyzing a batch of tasimelteon synthesized under GMP conditions for the presence of one or more identified impurities.

    Patent expiration dates:

    • February 12, 2035
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  • Treatment of circadian rhythm disorders
    Patent 10,149,829
    Issued: December 11, 2018
    Assignee(s): Vanda Pharmaceuticals Inc.

    Embodiments of the invention relate to the use of a melatonin agonist in the treatment of free running circadian rhythms in patients, including light perception impaired patients, e.g., blind patients, and to methods of measuring circadian rhythm.

    Patent expiration dates:

    • January 25, 2033
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      Patent use: TREATMENT OF NIGHTTIME SLEEP DISTURBANCES IN SMITH-MAGENIS SYNDROME NON-24 HOUR SLEEP-WAKE DISORDER BY AVOIDING THE USE OF TASIMELTEON IN COMBINATION WITH CYP1A2 STRONG INHIBITORS
  • Method of treatment
    Patent 10,179,119
    Issued: January 15, 2019
    Assignee(s): VANDA PHARMACEUTICALS INC.

    Embodiments of the invention relate to the treatment of sleep disturbances in individuals with Smith-Magenis Syndrome (SMS).

    Patent expiration dates:

    • August 29, 2035
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      Patent use: TREATMENT OF NIGHTTIME SLEEP DISTURBANCES IN SMITH-MAGENIS SYNDROME BY ADMINISTERING TASIMELTEON
  • Patent 10,376,487

    Patent expiration dates:

    • July 27, 2035
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      Patent use: TREATMENT OF NIGHTTIME SLEEP DISTURBANCES IN SMITH-MAGENIS SYNDROME BY AVOIDING THE ADMINISTRATION OF TASIMELTEON WITH FOOD
  • Patent 10,610,510

    Patent expiration dates:

    • January 25, 2033
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      Patent use: TREATMENT OF NIGHTTIME SLEEP DISTURBANCES IN SMITH-MAGENIS SYNDROME BY ADMINISTERING TASIMELTEON TO PATIENTS WITH A SMOKING HISTORY
  • Patent 10,610,511

    Patent expiration dates:

    • October 10, 2034
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      Patent use: TREATMENT OF NIGHTTIME SLEEP DISTURBANCES IN SMITH-MAGENIS SYNDROME BY AVOIDING THE ADMINISTRATION OF TASIMELTEON WITH FOOD
  • Patent 10,829,465

    Patent expiration dates:

    • February 12, 2035
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  • Benzofuran and dihydrobenzofuran melatonergic agents
    Patent 5,856,529
    Issued: January 5, 1999
    Inventor(s): Catt; John D. & Johnson; Graham & Keavy; Daniel J. & Mattson; Ronald J. & Parker; Michael F. & Takaki; Katherine S. & Yevich; Joseph P.
    Assignee(s): Bristol-Myers Squibb Company

    Novel derivatives of benzofuran and dihydrobenzofuran are provided which are useful as melatonergic agents.

    Patent expiration dates:

    • December 9, 2022
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      Patent use: TREATMENT OF NIGHTTIME SLEEP DISTURBANCES IN SMITH-MAGENIS SYNDROME BY ADMINISTERING TASIMELTEON
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  • Treatment of circadian rhythm disorders
    Patent 9,539,234
    Issued: January 10, 2017
    Assignee(s): Vanda Pharmaceuticals, Inc.

    Embodiments of the invention relate to the use of a melatonin agonist in the treatment of free running circadian rhythms in patients, including light perception impaired patients, e.g., blind patients, and to methods of measuring circadian rhythm.

    Patent expiration dates:

    • January 25, 2033
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      Patent use: TREATMENT OF NIGHTTIME SLEEP DISTURBANCES IN SMITH-MAGENIS SYNDROME BY AVOIDING THE AVOIDING THE USE OF TASIMELTEON IN COMBINATION WITH A STRONG CYP1A2 INHIBITOR
  • Treatment of circadian rhythm disorders
    Patent 9,730,910
    Issued: August 15, 2017
    Assignee(s): Vanda Pharmaceuticals, Inc.

    Embodiments of the invention relate to the use of a melatonin agonist in the treatment of free running circadian rhythms in patients, including light perception impaired patients, e.g., blind patients, and to methods of measuring circadian rhythm.

    Patent expiration dates:

    • May 17, 2034
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      Patent use: TREATMENT OF NIGHTTIME SLEEP DISTURBANCES IN SMITH-MAGENIS SYNDROME BY AVOIDING THE USE OF TASIMELTEON WITH RIFAMPIN

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:

    • December 1, 2023 - NEW PRODUCT

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.