Generic Hetlioz LQ Availability

Last updated on May 7, 2025.

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]

Is there a generic version of Hetlioz LQ available?

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.

• Highly purifid pharmaceutical grade tasimelteon
  Patent 10,071,977
  Issued: September 11, 2018
  Inventor(s): Phadke Deepak & Platt Natalie M & Pandrapragada Ravi K
  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
    
    ✓ 
    Drug substance
    ✓ 
    Drug product
• Treatment of circadian rhythm disorders
  Patent 10,149,829
  Issued: December 11, 2018
  Inventor(s): Dressman Marlene Michelle & Feeney John Joseph & Licamele Louis William & Polymeropoulos Mihael H.
  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
    
    ✓ 
    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
  Inventor(s): Lavedan Christian & Polymeropoulos Mihael H.
  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
    
    ✓ 
    Patent use: TREATMENT OF NIGHTTIME SLEEP DISTURBANCES IN SMITH-MAGENIS SYNDROME BY ADMINISTERING TASIMELTEON
• Method of treatment
  Patent 10,376,487
  Issued: August 13, 2019
  Inventor(s): Dressman Marlene Michelle & Polymeropoulos Mihael H. & Baroldi Paolo
  Assignee(s): Vanda Pharmaceuticals Inc.
  

  One embodiment of the invention provides a method for administering tasimelteon to a human patient that comprises orally administering an effective dose of tasimelteon under fasted conditions. Fasted conditions may comprise administering the tasimelteon without food, no food at least ½ hour prior to administration, no food at least 1 hour prior to administration, no food at least 1½ hours prior to administration, no food at least 2 hours prior to administration, no food at least 2½ hours prior to administration, or no food at least 3 hours prior to administration. According to such embodiments, tasimelteon may be administered, for example, at a dose of 20 mg/d. Tasimelteon may be administered where, for example, the patient is being treated for a circadian rhythm disorder or for a sleep disorder, including, for example, Non-24 Disorder.

  Patent expiration dates:

  • July 27, 2035
    
    ✓ 
    Patent use: TREATMENT OF NIGHTTIME SLEEP DISTURBANCES IN SMITH-MAGENIS SYNDROME BY AVOIDING THE ADMINISTRATION OF TASIMELTEON WITH FOOD
• Treatment of circadian rhythm disorders
  Patent 10,610,510
  Issued: April 7, 2020
  Inventor(s): Dressman Marlene Michelle & Feeney John Joseph & Licamele Louis William & Polymeropoulos Mihael H.
  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
    
    ✓ 
    Patent use: TREATMENT OF NIGHTTIME SLEEP DISTURBANCES IN SMITH-MAGENIS SYNDROME BY ADMINISTERING TASIMELTEON TO PATIENTS WITH A SMOKING HISTORY
• Method of treatment
  Patent 10,610,511
  Issued: April 7, 2020
  Inventor(s): Dressman Marlene Michelle & Polymeropoulos Mihael H. & Baroldi Paolo
  Assignee(s): Vanda Pharmaceuticals Inc.
  

  One embodiment of the invention provides a method for administering tasimelteon to a human patient that comprises orally administering an effective dose of tasimelteon under fasted conditions. Fasted conditions may comprise administering the tasimelteon without food, no food at least ½ hour prior to administration, no food at least 1 hour prior to administration, no food at least 1½ hours prior to administration, no food at least 2 hours prior to administration, no food at least 2½ hours prior to administration, or no food at least 3 hours prior to administration. According to such embodiments, tasimelteon may be administered, for example, at a dose of 20 mg/d. Tasimelteon may be administered where, for example, the patient is being treated for a circadian rhythm disorder or for a sleep disorder, including, for example, Non-24 Disorder.

  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
• Highly purified pharmaceutical grade tasimelteon
  Patent 10,829,465
  Issued: November 10, 2020
  Inventor(s): Phadke Deepak & Platt Natalie M. & Pandrapragada Ravi K.
  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
    
    ✓ 
    Drug substance
    ✓ 
    Drug product
• Treatment of circadian rhythm disorders
  Patent 10,980,770
  Issued: April 20, 2021
  Inventor(s): Dressman; Marlene Michelle et al.
  Assignee(s): Vanda Pharmaceuticals Inc. (Washington, DC)
  

  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
    
    ✓ 
    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
• Method of treatment
  Patent 11,141,400
  Issued: October 12, 2021
  Inventor(s): Dressman Marlene Michelle & Polymeropoulos Mihael H. & Baroldi Paolo
  Assignee(s): Vanda Pharmaceuticals Inc.
  

  One embodiment of the invention provides a method for administering tasimelteon to a human patient that comprises orally administering an effective dose of tasimelteon under fasted conditions. Fasted conditions may comprise administering the tasimelteon without food, no food at least ½ hour prior to administration, no food at least 1 hour prior to administration, no food at least 1½ hours prior to administration, no food at least 2 hours prior to administration, no food at least 2½ hours prior to administration, or no food at least 3 hours prior to administration. According to such embodiments, tasimelteon may be administered, for example, at a dose of 20 mg/d. Tasimelteon may be administered where, for example, the patient is being treated for a circadian rhythm disorder or for a sleep disorder, including, for example, Non-24 Disorder.

  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
• Liquid tasimelteon formulations and methods of use thereof
  Patent 11,202,770
  Issued: December 21, 2021
  Inventor(s): Phadke Deepak & Polymeropoulos Mihael
  Assignee(s): VANDA PHARMACEUTICALS INC.
  

  Liquid suspensions of tasimelteon and methods for their use.

  Patent expiration dates:

  • December 11, 2040
    
    ✓ 
    Drug product
• Method of treatment
  Patent 11,266,622
  Issued: March 8, 2022
  Inventor(s): Lavedan Christian & Polymeropoulos Mihael H.
  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
    
    ✓ 
    Patent use: TREATMENT OF NIGHTTIME SLEEP DISTURBANCES IN SMITH-MAGENIS SYNDROME BY ADMINISTERING TASIMELTEON
• Treatment of circadian rhythm disorders
  Patent 11,285,129
  Issued: March 29, 2022
  Inventor(s): Dressman Marlene Michelle & Feeney John Joseph & Licamele Louis William & Polymeropoulos Mihael H.
  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
    
    ✓ 
    Patent use: TREATMENT OF NIGHTTIME SLEEP DISTURBANCES IN SMITH-MAGENIS SYNDROME BY AVOIDING THE ADMINISTRATION OF TASIMELTEON WITH BETA-ADRENERGIC RECEPTOR ANTAGONISTS
• Highly purified pharmaceutical grade tasimelteon
  Patent 11,566,011
  Issued: January 31, 2023
  Inventor(s): Phadke; Deepak et al.
  Assignee(s): VANDA PHARMACEUTICALS INC. (Washington, DC)
  

  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
    
    ✓ 
    Drug substance
    ✓ 
    Drug product
• Treatment of circadian rhythm disorders
  Patent 11,633,377
  Issued: April 25, 2023
  Inventor(s): Dressman; Marlene Michelle et al.
  Assignee(s): Vanda Pharmaceuticals Inc. (Washington, DC)
  

  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
    
    ✓ 
    Patent use: TREATMENT OF NIGHTTIME SLEEP DISTURBANCES IN SMITH-MAGENIS SYNDROME BY ADMINISTERING TASIMELTEON
• Liquid tasimelteon formulations and methods of use thereof
  Patent 11,759,446
  Issued: September 19, 2023
  Inventor(s): Phadke; Deepak et al.
  Assignee(s): VANDA PHARMACEUTICALS INC. (Washington, DC)
  

  Liquid suspensions of tasimelteon and methods for their use.

  Patent expiration dates:

  • February 21, 2041
    
    ✓ 
    Patent use: TREATMENT OF NIGHTTIME SLEEP DISTURBANCES IN SMITH-MAGENIS SYNDROME BY ADMINISTERING TASIMELTEON
• Highly purified pharmaceutical grade tasimelteon
  Patent 11,760,740
  Issued: September 19, 2023
  Inventor(s): Phadke; Deepak et al.
  Assignee(s): VANDA PHARMACEUTICALS INC. (Washington, DC)
  

  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
    
    ✓ 
    Drug substance
    ✓ 
    Drug product
• Method of treatment
  Patent 11,786,502
  Issued: October 17, 2023
  Inventor(s): Dressman; Marlene Michelle et al.
  Assignee(s): VANDA PHARMACEUTICALS INC. (Washington, DC)
  

  One embodiment of the invention provides a method for administering tasimelteon to a human patient that comprises orally administering an effective dose of tasimelteon under fasted conditions. Fasted conditions may comprise administering the tasimelteon without food, no food at least ½ hour prior to administration, no food at least 1 hour prior to administration, no food at least 1½ hours prior to administration, no food at least 2 hours prior to administration, no food at least 2½ hours prior to administration, or no food at least 3 hours prior to administration. According to such embodiments, tasimelteon may be administered, for example, at a dose of 20 mg/d. Tasimelteon may be administered where, for example, the patient is being treated for a circadian rhythm disorder or for a sleep disorder, including, for example, Non-24 Disorder.

  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
• Treatment of circadian rhythm disorders
  Patent 11,826,339
  Issued: November 28, 2023
  Inventor(s): Dressman; Marlene Michelle et al.
  Assignee(s): VANDA PHARMACEUTICALS INC. (Washington, DC)
  

  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
    
    ✓ 
    Patent use: TREATMENT OF NIGHTTIME SLEEP DISTURBANCES IN SMITH-MAGENIS SYNDROME BY AVOIDING THE ADMINISTRATION OF TASIMELTEON WITH BETA-ADRENERGIC RECEPTOR ANTAGONISTS
• Treatment of circadian rhythm disorders
  Patent 11,833,130
  Issued: December 5, 2023
  Inventor(s): Dressman; Marlene Michelle et al.
  Assignee(s): VANDA PHARMACEUTICALS INC. (Washington, DC)
  

  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
    
    ✓ 
    Patent use: TREATMENT OF NIGHTTIME SLEEP DISTURBANCES IN SMITH-MAGENIS SYNDROME BY ADMINISTERING TASIMELTEON
• Treatment of circadian rhythm disorders
  Patent 11,850,229
  Issued: December 26, 2023
  Inventor(s): Dressman; Marlene Michelle et al.
  Assignee(s): Vanda Pharmaceuticals Inc. (Washington, DC)
  

  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
    
    ✓ 
    Patent use: TREATMENT OF NIGHTTIME SLEEP DISTURBANCES IN SMITH-MAGENIS SYNDROME BY AVOIDING THE ADMINISTRATION OF TASIMELTEON WITH BETA-ADRENERGIC RECEPTOR ANTAGONISTS
• Treatment of circadian rhythm disorders
  Patent 11,918,556
  Issued: March 5, 2024
  Inventor(s): Dressman; Marlene Michelle et al.
  Assignee(s): Vanda Pharmaceuticals Inc. (Washington, DC)
  

  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:

  • April 7, 2033
    
    ✓ 
    Patent use: TREATMENT OF NIGHTTIME SLEEP DISTURBANCES IN SMITH-MAGENIS SYNDROME BY AVOIDING THE ADMINISTRATION OF TASIMELTEON WITH BETA-ADRENERGIC RECEPTOR ANTAGONISTS
• Treatment of circadian rhythm disorders
  Patent 11,918,557
  Issued: March 5, 2024
  Inventor(s): Dressman; Marlene Michelle et al.
  Assignee(s): VANDA PHARMACEUTICALS INC. (Washington, DC)
  

  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
    
    ✓ 
    Patent use: TREATMENT OF NIGHTTIME SLEEP DISTURBANCES IN SMITH-MAGENIS SYNDROME BY ADMINISTERING TASIMELTEON
• Highly purified pharmaceutical grade tasimelteon
  Patent 12,049,457
  Issued: July 30, 2024
  Inventor(s): Phadke; Deepak et al.
  Assignee(s): VANDA PHARMACEUTICALS INC. (Washington, DC)
  

  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
    
    ✓ 
    Drug substance
    ✓ 
    Drug product
• Treatment of circadian rhythm disorders
  Patent 12,201,604
  Issued: January 21, 2025
  Inventor(s): Dressman; Marlene Michelle et al.
  Assignee(s): Vanda Pharmaceuticals Inc. (Washington, DC)
  

  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
    
    ✓ 
    Patent use: TREATMENT OF NIGHTTIME SLEEP DISTURBANCES IN SMITH-MAGENIS SYNDROME BY ADMINISTERING TASIMELTEON
• Treatment of circadian rhythm disorders
  Patent 9,539,234
  Issued: January 10, 2017
  Inventor(s): Dressman Marlene Michelle & Feeney John Joseph & Licamele Louis William & Polymeropoulos Mihael H.
  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
    
    ✓ 
    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
  Inventor(s): Dressman Marlene Michelle & Feeney John Joseph & Licamele Louis William & Polymeropoulos Mihael H.
  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
    
    ✓ 
    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, 2027 - FOR THE TREATMENT OF NIGHTTIME SLEEP DISTURBANCES IN SMITH-MAGENIS SYNDROME (SMS) IN PEDIATRIC PATIENTS 3 TO 15 YEARS OF AGE

Further information

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

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