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Generic Rexulti Availability

Last updated on Jan 11, 2023.

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

REXULTI (brexpiprazole - tablet;oral)

Has a generic version of Rexulti been approved?

A generic version of Rexulti has been approved by the FDA. However, this does not mean that the product will necessarily be commercially available - possibly because of drug patents and/or drug exclusivity. The following products are equivalent to Rexulti and have been approved by the FDA:

brexpiprazole tablet;oral

  • Manufacturer: TEVA PHARMS USA INC
    Approval date: August 11, 2022
    Strength(s): 0.25MG [AB], 0.5MG [AB], 1MG [AB], 2MG [AB], 3MG [AB], 4MG [AB]
  • Manufacturer: ZYDUS PHARMS
    Approval date: January 10, 2023
    Strength(s): 0.25MG [AB], 0.5MG [AB], 1MG [AB], 2MG [AB], 3MG [AB], 4MG [AB]

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: 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.

  • Tablet comprising 7-[4-(4-benzo[b]thiopen-4-yl-piperazin-1-yl)butoxy]-1H-quinolin-2-one or a salt thereof
    Patent 10,307,419
    Issued: June 4, 2019
    Assignee(s): OTSUKA PHARMACEUTICAL CO., LTD.

    This invention relates to a tablet containing, as an active ingredient, 7-[4-(4-benzo[b]thiophen-4-yl -piperazin-1-yl)butoxy]-1H-quinolin-2-one or a salt thereof, that has excellent disintegration ability, storage stability and photostability. The tablet of the present invention comprising an uncoated tablet containing 7-[4-(4-benzo[b]thiophen-4 -yl-piperazin-1-yl)butoxy]-1H-quinolin-2-one or a salt thereof as an active ingredient, excipients such as lactose, corn starch, and microcrystalline cellulose; disintegrants such as low-substituted hydroxypropylcellulose, croscarmellose sodium, and sodium carboxymethyl starch; binders such as hydroxypropylcellulose; lubricants such as stearate; and further comprising a coating layer, containing hypromellose; talc; titanium oxide; colorant; and the like, the coating layer being applied to the surface of the uncoated tablet.

    Patent expiration dates:

    • October 12, 2032
      ✓ 
      Drug product
  • 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:

    • April 12, 2026
      ✓ 
      Drug substance
      ✓ 
      Sponsor has requested patent be delisted
  • 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
    • April 12, 2026
      ✓ 
      Patent use: TREATMENT OF SCHIZOPHRENIA IN ADULTS AND PEDIATRIC PATIENTS AGES 13 YEARS AND OLDER
  • Piperazine-substituted benzothiophenes for treatment of mental disorders
    Patent 9,839,637
    Issued: December 12, 2017
    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
    • April 12, 2026
      ✓ 
      Patent use: TREATMENT OF SCHIZOPHRENIA IN ADULTS AND PEDIATRIC PATIENTS AGES 13 YEARS AND OLDER
      ✓ 
      Drug product
    • April 12, 2026
      ✓ 
      Patent use: TREATMENT OF SCHIZOPHRENIA
      ✓ 
      Drug product
  • Patent RE48059

    Patent expiration dates:

    • December 23, 2028
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      Drug substance

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 27, 2024 - NEW PATIENT POPULATION

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.
AB Products meeting necessary bioequivalence requirements. Multisource drug products listed under the same heading (e.g. identical active ingredients, dosage form, and routes of administration) and having the same strength (see Therapeutic Equivalence-Related Terms, Pharmaceutical Equivalents) generally will be coded AB if a study is submitted demonstrating bioequivalence. In certain instances, a number is added to the end of the AB code to make a three character code (e.g. AB1, AB2, AB7). Three-character codes are assigned only in situations when more than one reference listed drug of the same strength has been designated under the same heading. Two or more reference listed drugs are generally selected only when there are at least two potential reference drug products which are not bioequivalent to each other. If a study is submitted that demonstrates bioequivalence to a specific listed drug product, the generic product will be given the same three-character code as the reference listed drug it was compared against.

Further information

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