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Generic Vraylar Availability

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

VRAYLAR (cariprazine hydrochloride - capsule;oral)

  • Manufacturer: ALLERGAN SALES LLC
    Approval date: September 17, 2015
    Strength(s): EQ 1.5MG BASE [RLD], EQ 3MG BASE [RLD], EQ 4.5MG BASE [RLD], EQ 6MG BASE [RLD]

Has a generic version of Vraylar been approved?

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

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

  • (Thio) carbamoyl-cyclohexane derivatives as D3/D2 receptor antagonists
    Patent 7,737,142
    Issued: June 15, 2010
    Inventor(s): Againe Csongor; Eva & Galambos; Janos & Nogradi; Katalin & Vago; Istvan & Gyertyan; Istvan & Kiss; Bela & Laszlovszky; Istvan & Laszy; Judit & Saghy; Katalin
    Assignee(s): Richter Gedeon Vegyeszeti Gyar Rt.

    The present invention relates to new D3 and D2 dopamine receptor subtype preferring ligands of formula (I): wherein R1 and R2 represent independently a substituent selected from hydrogen, alkyl, aryl, cycloalkyl, aroyl, or R1 and R2 may form a heterocyclic ring with the adjacent nitrogen atom; X represents an oxygen or sulphur atom; n is an integer of from 1 to 2, and/or geometric isomers and/or stereoisomers and/or diastereomers and/or salts and/or hydrates and/or solvates thereof, to the processes for producing the same, to pharmaceutical compositions containing the same and to their use in therapy and/or prevention of a condition which requires modulation of dopamine receptors.

    Patent expiration dates:

    • March 27, 2027
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      Patent use: TREATMENT OF SCHIZOPHRENIA AND/OR ACUTE MANIC OR MIXED EPISODES ASSOCIATED WITH BIPOLAR I DISORDER WITH CARIPRAZINE
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      Drug substance
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      Drug product
  • Salts of piperazine compounds as D3/D2 antagonists
    Patent 7,943,621
    Issued: May 17, 2011
    Inventor(s): Czibula; Laszlo & Sebok; Ferenc & Greiner; Istvan & Domany; Gyorgy & Csongor; Eva Againe
    Assignee(s): Richter Gedeon Nyrt.

    The present invention relates to novel monohydrochloride, dihydrochloride, monohydrobromide, maleate and methanesulphonate salts of trans 4-{2-[4-(2,3-dichlorophenyl)-piperazine-1-yl]-ethyl}-N,N-dimethylcarbamoyl-cyclohexylamine and/or their hydrates and/or solvates. Moreover, the invention relates to the process for preparing the salts and their hydrates and/or solvates, to their use in the treatment and/or prevention of conditions which require modulation of dopamine receptor and to pharmaceutical compositions containing them.

    Patent expiration dates:

    • December 16, 2028
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      Drug substance
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      Drug product

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 17, 2020 - NEW CHEMICAL ENTITY
    • November 9, 2020 - INFORMATION ADDED TO THE LABELING TO INCLUDE THE EFFICACY AND SAFETY OF CARIPRAZINE RELATIVE TO PLACEBO IN THE PREVENTION OF RELAPSE OF SYMPTOMS IN PATIENTS WITH SCHIZOPHRENIA

Further information

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

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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