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Generic Hetlioz Availability

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

HETLIOZ (tasimelteon - capsule;oral)

  • Manufacturer: VANDA PHARMS INC
    Approval date: January 31, 2014
    Strength(s): 20MG [RLD]

Has a generic version of Hetlioz been approved?

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

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

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.

  • 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, 2017
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      Patent use: TREATMENT OF NON-24-HOUR SLEEP-WAKE DISORDER
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      Drug substance
      ✓ 
      Drug product
  • Treatment of circadian rhythm disorders
    Patent 8,785,492
    Issued: July 22, 2014
    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 NON-24-HOUR SLEEP-WAKE DISORDER
  • Treatment of circadian rhythm disorders
    Patent 9,060,995
    Issued: June 23, 2015
    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 NON-24-HOUR SLEEP-WAKE DISORDER BY AVOIDING THE USE OF TASIMELTEON IN COMBINATION WITH FLUVOXAMINE

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:
    • January 31, 2019 - NEW CHEMICAL ENTITY
    • January 31, 2021 - ORPHAN DRUG EXCLUSIVITY

Glossary

TermDefinition
Drug PatentA 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 ExclusivityExclusivity 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.
RLDA 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.
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