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Generic Hetlioz LQ Availability

Last updated on Sep 6, 2023.

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 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.

  • Patent 10,071,977

    Patent expiration dates:

    • February 12, 2035
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      Drug substance
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      Drug product
  • Patent 10,149,829

    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
  • Patent 10,179,119

    Patent expiration dates:

    • August 29, 2035
      ✓ 
      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
      ✓ 
      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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      Drug substance
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      Drug product
  • Patent 10,980,770

    Patent expiration dates:

    • January 25, 2033
      ✓ 
      Patent use: TREATMENT OF NIGHTTIME SLEEP DISTURBANCES IN SMITH-MAGENIS SYNDROME BY AVOIDING THE ADMINISTRATION OF TASIMELTEON TO SMOKERS OR TO PATIENTS BEING TREATED WITH A CYP1A2 INHIBITOR
  • Patent 11,141,400

    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 11,202,770

    Patent expiration dates:

    • December 11, 2040
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      Drug product
  • Patent 11,266,622

    Patent expiration dates:

    • August 29, 2035
      ✓ 
      Patent use: TREATMENT OF NIGHTTIME SLEEP DISTURBANCES IN SMITH-MAGENIS SYNDROME BY ADMINISTERING TASIMELTEON
  • Patent 11,285,129

    Patent expiration dates:

    • January 25, 2033
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      Patent use: TREATMENT OF NIGHTTIME SLEEP DISTURBANCES IN SMITH-MAGENIS SYNDROME BY AVOIDING THE ADMINISTRATION OF TASIMELTEON WITH BETA-ADRENERGIC RECEPTOR ANTAGONISTS
  • Patent 11,566,011

    Patent expiration dates:

    • February 12, 2035
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      Drug substance
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      Drug product
  • Patent 11,633,377

    Patent expiration dates:

    • January 25, 2033
      ✓ 
      Patent use: TREATMENT OF NIGHTTIME SLEEP DISTURBANCES IN SMITH-MAGENIS SYNDROME BY ADMINISTERING TASIMELTEON
  • Patent 9,539,234

    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
  • Patent 9,730,910

    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
    • December 1, 2027 - FOR THE TREATMENT OF NIGHTTIME SLEEP DISTURBANCES IN SMITH-MAGENIS SYNDROME (SMS) IN PEDIATRIC PATIENTS 3 TO 15 YEARS OF AGE

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.

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