Generic Hetlioz LQ Availability

Last updated on Dec 12, 2024.

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.

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
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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
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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
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
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  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
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  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
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  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
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  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
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  Drug substance
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Patent 10,980,770
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 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
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  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
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  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
Patent 11,566,011
Patent expiration dates:
- February 12, 2035
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  Drug substance
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Patent 11,633,377
Patent expiration dates:
- January 25, 2033
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  Patent use: TREATMENT OF NIGHTTIME SLEEP DISTURBANCES IN SMITH-MAGENIS SYNDROME BY ADMINISTERING TASIMELTEON
Patent 11,759,446
Patent expiration dates:
- February 21, 2041
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  Patent use: TREATMENT OF NIGHTTIME SLEEP DISTURBANCES IN SMITH-MAGENIS SYNDROME BY ADMINISTERING TASIMELTEON
Patent 11,760,740
Patent expiration dates:
- February 12, 2035
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  Drug substance
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Patent 11,786,502
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 11,826,339
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
Patent 11,833,130
Patent expiration dates:
- January 25, 2033
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  Patent use: TREATMENT OF NIGHTTIME SLEEP DISTURBANCES IN SMITH-MAGENIS SYNDROME BY ADMINISTERING TASIMELTEON
Patent 11,850,229
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 11,918,556
Patent expiration dates:
- April 7, 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 11,918,557
Patent expiration dates:
- January 25, 2033
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  Patent use: TREATMENT OF NIGHTTIME SLEEP DISTURBANCES IN SMITH-MAGENIS SYNDROME BY ADMINISTERING TASIMELTEON
Patent 12,049,457
Patent expiration dates:
- February 12, 2035
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  Drug substance
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  Drug product
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
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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, 2027 - FOR THE TREATMENT OF NIGHTTIME SLEEP DISTURBANCES IN SMITH-MAGENIS SYNDROME (SMS) IN PEDIATRIC PATIENTS 3 TO 15 YEARS OF AGE

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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

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Drug Status

Availability Prescription only Rx

Pregnancy & Lactation Risk data available

CSA Schedule* Not a controlled drug N/A

Approval History Drug history at FDA

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