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Generic Rexulti Availability

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

REXULTI (brexpiprazole - tablet;oral)

  • Manufacturer: OTSUKA PHARM CO LTD
    Approval date: July 10, 2015
    Strength(s): 0.25MG, 0.5MG, 1MG, 2MG, 3MG, 4MG [RLD]

Has a generic version of Rexulti been approved?

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

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

  • Piperazine-substituted benzothiophenes for treatment of mental disorders
    Patent 7,888,362
    Issued: February 15, 2011
    Inventor(s): Yamashita; Hiroshi & Ito; Nobuaki & Miyamura; Shin & Oshima; Kunio & Matsubara; Jun & Kuroda; Hideaki & Takahashi; Haruka & Shimizu; Satoshi & Tanaka; Tatsuyoshi
    Assignee(s): Otsuka Pharmaceutical Co., Ltd.
    The present invention provides a heterocyclic compound represented by the general formula (1): The compound of the present invention has a wide treatment spectrum for mental disorders including central nervous system disorders, no side effects and high safety.
    Patent expiration dates:
    • February 23, 2027
      ✓ 
      Drug substance
  • Piperazine-substituted benzothiophenes for treatment of mental disorders
    Patent 8,349,840
    Issued: January 8, 2013
    Inventor(s): Yamashita; Hiroshi & Ito; Nobuaki & Miyamura; Shin & Oshima; Kunio & Matsubara; Jun & Kuroda; Hideaki & Takahashi; Haruka & Shimizu; Satoshi & Tanaka; Tatsuyoshi
    Assignee(s): Otsuka Pharmaceutical Co., Ltd.
    The present invention provides a heterocyclic compound represented by the general formula (1): The compound of the present invention has a wide treatment spectrum for mental disorders including central nervous system disorders, no side effects and high safety.
    Patent expiration dates:
    • April 12, 2026
      ✓ 
      Patent use: ADJUNCTIVE TREATMENT OF MAJOR DEPRESSIVE DISORDER (MDD)
      ✓ 
      Drug product
  • Piperazine-substituted benzothiophenes for treatment of mental disorders
    Patent 8,618,109
    Issued: December 31, 2013
    Assignee(s): Otsuka Parmaceutical Co., Ltd.
    The present invention provides a heterocyclic compound represented by the general formula (1): The compound of the present invention has a wide treatment spectrum for mental disorders including central nervous system disorders, no side effects and high safety.
    Patent expiration dates:
    • April 12, 2026
      ✓ 
      Patent use: TREATMENT OF SCHIZOPHRENIA

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:
    • September 23, 2019 -
    • July 10, 2020 - NEW CHEMICAL ENTITY

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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