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Generic Aristada Availability

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

ARISTADA (aripiprazole lauroxil - suspension, extended release;intramuscular)

  • Manufacturer: ALKERMES INC
    Approval date: October 5, 2015
    Strength(s): 441MG/1.6ML (275.63MG/ML), 662MG/2.4ML (275.83MG/ML), 882MG/3.2ML (275.63MG/ML) [RLD]

Has a generic version of Aristada been approved?

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

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

  • Heterocyclic compounds for the treatment of neurological and psychological disorders
    Patent 8,431,576
    Issued: April 30, 2013
    Assignee(s): Alkermes Pharma Ireland Limited
    Lactam compounds of Formula I and their use for the treatment of neurological and psychiatric disorders including schizophrenia, bipolar disorder, anxiety disorder and insomnia is disclosed.
    Patent expiration dates:
    • October 26, 2030
      ✓ 
      Drug substance
  • Heterocyclic compounds for the treatment of neurological and psychological disorders
    Patent 8,796,276
    Issued: August 5, 2014
    Assignee(s): Alkermes Pharma Ireland Limited
    Lactam compounds of Formula I and their use for the treatment of neurological and psychiatric disorders including schizophrenia, bipolar disorder, anxiety disorder and insomnia is disclosed.
    Patent expiration dates:
    • June 24, 2030
      ✓ 
      Patent use: TREATMENT OF SCHIZOPHRENIA
  • Pharmaceutical compositions comprising sorbitan esters
    Patent 9,034,867
    Issued: May 19, 2015
    Assignee(s): ALKERMES PHARMA IRELAND LIMITED
    The present invention relates to a pharmaceutical composition comprising sorbitan esters of carboxylic acids that are useful for the delivery of anti-psychotic drugs.
    Patent expiration dates:
    • November 7, 2032
      ✓ 
      Patent use: TREATMENT OF SCHIZOPHRENIA
      ✓ 
      Drug product
  • Pharmaceutical compositions having improved storage stability
    Patent 9,193,685
    Issued: November 24, 2015
    Assignee(s): ALKERMES PHARMA IRELAND LIMITED
    The present invention relates to a pharmaceutical composition that provides long-term stability of a hydrolytically labile antipsychotic agent
    Patent expiration dates:
    • October 24, 2033
      ✓ 
      Patent use: TREATMENT OF SCHIZOPHRENIA
      ✓ 
      Drug product
  • Aripiprazole formulations having increased injection speeds
    Patent 9,452,131
    Issued: September 27, 2016
    Assignee(s): ALKERMES PHARMA IRELAND LIMITED
    The present invention relates to pharmaceutical compositions comprising a compound of Formula (I) that are useful for the intramuscular delivery of antipsychotic drugs using rapid injection rates.
    Patent expiration dates:
    • March 19, 2035
      ✓ 
      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:
    • October 5, 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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