Generic Invega Sustenna Availability

See also: Generic Invega

Invega Sustenna is a brand name of paliperidone, approved by the FDA in the following formulation(s):

INVEGA SUSTENNA (paliperidone palmitate - suspension, extended release;intramuscular)

  • Manufacturer: JANSSEN PHARMS
    Approval date: July 31, 2009
    Strength(s): 39MG/0.25ML (39MG/0.25ML), 78MG/0.5ML (78MG/0.5ML), 117MG/0.75ML (117MG/0.75ML) [RLD], 156MG/ML (156MG/ML), 234MG/1.5ML (156MG/ML)

Has a generic version of Invega Sustenna been approved?

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

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

  • 3-piperidinyl-1,2-benzisoxazoles
    Patent 5,254,556
    Issued: October 19, 1993
    Inventor(s): Janssen; Cornelus G. M. & Knaeps; Alfonsus G. & Kennis; Ludo E. J. & Vandenberk; Jan
    Assignee(s): Janssen Pharmaceutica N.V.
    The invention relates to C.sub.2-20 alkanoic acid esters of 3-[2-[4-(6-fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl]ethyl]-6, 7,8,9-tetrahydro-9-hydroxy-2 -methyl-4H-pyrido[1,2-a]pyrimidin-4-one, pharmaceutically acceptable acid addition salts thereof, and enantiomeric forms thereof, which are useful in the treatment of warm-blooded animals suffering from psychotic diseases.
    Patent expiration dates:
    • October 15, 2013
      ✓ 
      Patent use: TREATMENT OF SCHIZOPHRENIA
      ✓ 
      Drug substance
      ✓ 
      Drug product
    • April 15, 2014
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      Pediatric exclusivity
  • Aqueous suspensions of 9-hydroxyrisperidone fatty acid esters
    Patent 6,077,843
    Issued: June 20, 2000
    Inventor(s): Fran.cedilla.ois; Marc Karel Jozef & Embrechts; Roger Carolus Augusta & Borghijs; Herman Karel & Monbaliu; Johan
    Assignee(s): Janssen Pharmaceutica, N.V.
    The present invention is concerned with a pharmaceutical composition suitable as a depot formulation for administration via intramuscular or subcutaneous injection, comprising: (1) as an active ingredient a therapeutically effective amount of a 9-hydroxyrisperidone fatty acid ester or a salt, or a stereoisomer or a stereoisomeric mixture thereof and (2) a pharmaceutically acceptable carrier; wherein the pharmaceutically acceptable carrier is water and the active ingredient is suspended therein; and with a process of preparing such a composition. The invention further concerns such a pharmaceutical composition for use as a medicament in the treatment of schizophrenia, non-schizophrenic psychoses, behavioural disturbances associated with neurodegenerative disorders, e.g. in dementia, behavioural disturbances in mental retardation and autism, bipolar mania, depression, anxiety.
    Patent expiration dates:
    • May 12, 2017
      ✓ 
      Patent use: TREATMENT OF SCHIZOPHRENIA
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      Drug product
    • November 12, 2017
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      Pediatric exclusivity
  • Aqueous suspensions of submicron 9-hydroxyrisperidone fatty acid esters
    Patent 6,555,544
    Issued: April 29, 2003
    Inventor(s): Marc Karel Jozef; François & Willy Maria Albert Carlo; Dries & Esther Dina Guido; Basstanie
    Assignee(s): Janssen Pharmaceutica, N.V.
    The present invention is concerned with a pharmaceutical composition suitable as a depot formulation for administration via intramuscular or subcutaneous injection, comprising: (1) as an active ingredient a therapeutically effective amount of a 9-hydroxy-risperidone fatty acid ester or a salt, or a stereoisomer or a stereoisomeric mixture thereof in submicron form and (2) a pharmaceutically acceptable carrier; wherein the pharmaceutically acceptable carrier is water and the active ingredient is suspended therein: and with a process of preparing such a composition. The invention further concerns such a pharmaceutical composition for use as a medicament in the treatment of psychosis, schizophrenia, schizoaffective disorders, non-schizophrenic psychoses, behavioural disturbances associated with neurodegenerative disorders, e.g. in dementia, behavioural disturbances in mental retardation and autism, Tourette's syndrome, bipolar mania, depression, anxiety.
    Patent expiration dates:
    • November 10, 2018
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      Patent use: TREATMENT OF SCHIZOPHRENIA
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      Drug product
    • May 10, 2019
      ✓ 
      Pediatric exclusivity

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:
    • August 29, 2015 - LABELING CHANGES REGARDING MISSED DOSES

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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