Thursday, October 13, 2016

Invega Sustenna


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): 117MG/0.75ML (117MG/0.75ML) [RLD], 156MG/ML (156MG/ML), 234MG/1.5ML (156MG/ML), 39MG/0.25ML (39MG/0.25ML), 78MG/0.5ML (78MG/0.5ML)

Has a generic version of Invega Sustenna been approved?


No. There is currently no therapeutically equivalent version of Invega Sustenna available.


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 27, 2012
      ✓ 
      Patent use: TREATMENT OF SCHIZOPHRENIA
      ✓ 
      Drug substance
      ✓ 
      Drug product


    • April 27, 2013
      ✓ 
      Pediatric exclusivity




  • Use of purified surface modifiers to prevent particle aggregation during sterilization
    Patent 5,352,459
    Issued: October 4, 1994
    Inventor(s): Hollister; Kenneth R. & Ladd; David & McIntire; Gregory L. & Na; George C. & Rajagopalan; Natarajan & Yuan; Barbara O.
    Assignee(s): Sterling Winthrop Inc.
    This invention discloses a composition comprised of nanoparticles having a purified polymeric surfactant as a surface modifier adsorbed on the surface thereof and a cloud point modifier associated therewith, which cloud point modifier is present in an amount sufficient to increase the cloud point of the surface modifier. Preferred purified polymeric surfactants are purified polyalkyleneoxide substituted ethylenediamine surfactants. A preferred cloud point modifier is polyethylene glycol. This invention further discloses a method of making nanoparticles having a purified polymeric surfactant as a surface modifier adsorbed on the surface and a cloud point modifier associated therewith, comprised of contacting said nanoparticles with the cloud point modifier for a time and under conditions sufficient to increase the cloud point of the surface modifier.
    Patent expiration dates:

    • December 16, 2012
      ✓ 
      Drug product


    • June 16, 2013
      ✓ 
      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
      ✓ 
      Drug product


    • November 12, 2017
      ✓ 
      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
      ✓ 
      Patent use: TREATMENT OF SCHIZOPHRENIA
      ✓ 
      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:
    • December 19, 2011 - NEW CHEMICAL ENTITY

    • June 19, 2012 - PEDIATRIC EXCLUSIVITY

    • July 31, 2012 - NEW DOSAGE FORM

    • January 31, 2013 - PEDIATRIC EXCLUSIVITY

See also...

  • Invega Sustenna Consumer Information (Wolters Kluwer)
  • Invega Sustenna Advanced Consumer Information (Micromedex)
  • Paliperidone Consumer Information (Wolters Kluwer)
  • Paliperidone Extended-Release Tablets Consumer Information (Wolters Kluwer)
  • Paliperidone Consumer Information (Cerner Multum)
  • Paliperidone Advanced Consumer Information (Micromedex)
  • Paliperidone Intramuscular Advanced Consumer Information (Micromedex)
  • Paliperidone AHFS DI Monographs (ASHP)

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