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Generic Wakix Availability

Last updated on Sep 8, 2021.

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

WAKIX (pitolisant hydrochloride - tablet;oral)

  • Manufacturer: HARMONY
    Approval date: August 14, 2019
    Strength(s): EQ 4.45MG BASE [RLD], EQ 17.8MG BASE [RLD]

Has a generic version of Wakix been approved?

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

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Wakix. 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.

  • Monohydrochloride salt of 1-[3-[3-(4-chlorophenyl) propoxy] propyl] -piperidine
    Patent 8,207,197
    Issued: June 26, 2012
    Inventor(s): Raga; Manuel & Sallares; Juan & Guerrero; Marta & Guglietta; Antonio & Arrang; Jean-Michel & Schwartz; Jean-Charles & Stark; Holger & Schunack; Walter & Ligneau; Xavier & Lecomte; Jeanne-Marie & Ganellin; Charon
    Assignee(s): Bioprojet

    The invention relates to new crystalline 1-[3-[3-(4-chlorophenyl)propoxy]propyl]-piperidine monohydrochloride, the respective manufacture and methods of use, and compositions containing such a compound.

    Patent expiration dates:

    • February 25, 2029
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      Drug substance
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      Drug product
  • Monohydrochloride salt of 1-[3-[3-(4-chlorophenyl) propoxy]propyl]-piperidine
    Patent 8,354,430
    Issued: January 15, 2013
    Assignee(s): Bioprojet

    A method is provided for the treatment of sleep apnea and other conditions wherein an effective amount of crystalline 1-[3-[3-(4-chlorophenyl)propoxy]propyl]-piperidine monohydrochloride of formula (I): optionally comprising water up to 6%, and having an X-ray diffractogram that comprises characteristic peaks (2θ) at 11.2°, 19.9°, 20.7° and 34.1°±0.2° is administered to a patient in need thereof.

    Patent expiration dates:

    • February 6, 2026
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      Patent use: METHOD OF TREATING EXCESSIVE DAYTIME SLEEPINESS IN PATIENTS WITH NARCOLEPSY
    • February 6, 2026
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      Patent use: METHOD OF TREATING CATAPLEXY IN PATIENTS WITH NARCOLEPSY
  • Treatment of Parkinson's disease, obstructive sleep apnea, dementia with Lewy bodies, vascular dementia with non-imidazole alkylamines histamine H3-receptor ligands
    Patent 8,486,947
    Issued: July 16, 2013
    Assignee(s): Bioprojet

    The present invention provides new method of treatment of Parkinson's disease, obstructive sleep apnea, narcolepsy, dementia with Lewy bodies, vascular dementia with non-imidazole alkylamine derivatives that constitute antagonists of the H3-receptors of histamine.

    Patent expiration dates:

    • September 26, 2029
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      Patent use: METHOD OF TREATING EXCESSIVE DAYTIME SLEEPINESS IN PATIENTS WITH NARCOLEPSY
    • September 26, 2029
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      Patent use: METHOD OF TREATING CATAPLEXY IN PATIENTS WITH NARCOLEPSY

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:

    • October 13, 2023 - TREATMENT OF CATAPLEXY IN ADULT PATIENTS WITH NACROLEPSY
    • August 14, 2024 - NEW CHEMICAL ENTITY
    • August 14, 2026 -
    • October 13, 2027 -

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.