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Generic Barhemsys Availability

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

BARHEMSYS (amisulpride - solution;intravenous)

  • Manufacturer: ACACIA PHARMA LTD
    Approval date: February 26, 2020
    Strength(s): 5MG/2ML (2.5MG/ML) [RLD]

Has a generic version of Barhemsys been approved?

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

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

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 10,525,033

    Patent expiration dates:

    • March 10, 2031
      ✓ 
      Drug product
  • Use of amisulpride as an anti-emetic
    Patent 9,084,765
    Issued: July 21, 2015
    Assignee(s): Acacia Pharma Limited

    Amisulpride is used in the therapy of nausea, vomiting or retches. The therapy may utilize a novel injectable formulation, in unit dosage form, comprising less than 50 mg amisulpride.

    Patent expiration dates:

    • March 10, 2031
      ✓ 
      Patent use: PREVENTION OF POST-OPERATIVE NAUSEA AND VOMITING
    • March 10, 2031
      ✓ 
      Patent use: TREATMENT OF POST-OPERATIVE NAUSEA AND VOMITING
  • Use of amisulpride as an anti-emetic
    Patent 9,545,426
    Issued: January 17, 2017
    Assignee(s): Acacia Pharma Limited

    Amisulpride is used in the therapy of nausea, vomiting or retches. The therapy may utilize a novel injectable formulation, in unit dosage form, comprising less than 50 mg amisulpride.

    Patent expiration dates:

    • March 10, 2031
      ✓ 
      Patent use: PREVENTION OF POST-OPERATIVE NAUSEA AND VOMITING
    • March 10, 2031
      ✓ 
      Patent use: TREATMENT OF POST-OPERATIVE NAUSEA AND VOMITING
  • Use of amisulpride as an anti-emetic
    Patent 9,889,118
    Issued: February 13, 2018
    Assignee(s): Acacia Pharma Limited

    Amisulpride is used in the therapy of nausea, vomiting or retches. The therapy may utilize a novel injectable formulation, in unit dosage form, comprising less than 50 mg amisulpride.

    Patent expiration dates:

    • March 10, 2031
      ✓ 
      Patent use: TREATMENT OF POST-OPERATIVE NAUSEA AND VOMITING
    • March 10, 2031
      ✓ 
      Patent use: PREVENTION OF POST-OPERATIVE NAUSEA AND VOMITING

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:

    • February 26, 2025 - NEW CHEMICAL ENTITY

Further information

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

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.