Friday, February 26, 2010

Risperdal Consta


See also: Generic Risperdal


Risperdal Consta is a brand name of risperidone, approved by the FDA in the following formulation(s):


RISPERDAL CONSTA (risperidone - injectable; intramuscular)



  • Manufacturer: JANSSEN PHARMS

    Approval date: October 29, 2003

    Strength(s): 25MG/VIAL [RLD], 37.5MG/VIAL, 50MG/VIAL


  • Manufacturer: JANSSEN PHARMS

    Approval date: April 12, 2007

    Strength(s): 12.5MG/VIAL

Has a generic version of Risperdal Consta been approved?


No. There is currently no therapeutically equivalent version of Risperdal Consta available.


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




  • Method of inhibiting neurotransmitter activity using microencapsulated 3-piperidiny2-substituted 1,2-benzisoxazoles and 1,2-benzisothiazoles
    Patent 5,688,801
    Issued: November 18, 1997
    Inventor(s): Mesens; Jean & Rickey; Michael E. & Atkins; Thomas J.
    Assignee(s): Janssen Pharmaceutica
    Alkermes Controlled Therapeutics Inc. II
    A pharmaceutical composition comprising a biodegradable and biocompatible composition comprising a 1,2 benzazole within a polymeric matrix. The 1,2 benzazole composition, pharmaceutically acceptable acid addition salts thereof, are potent antagonists of a series of neurotransmitters, particularly serotonin and dopamine. A method of inhibiting both serotonergic overactivity and dopaminergic overstimulation in animals is provided by administration of a biodegradable and biocompatible microparticle composition comprising a 1,2 benzazole or a pharmaceutically acceptable acid addition salt thereof. A method of treating warm blooded animals suffering from psychotic disorders, and a method of preparing the biodegradable and biocompatible composition are also described.
    Patent expiration dates:

    • November 18, 2014
      ✓ 
      Patent use: TREATMENT OF SCHIZOPHRENIA


    • November 18, 2014
      ✓ 
      Patent use: MONOTHERAPY OR AS ADJUNCTIVE THERAPY TO LITHIUM OR VALPROATE FOR THE MAINTENANCE TREATMENT OF BIPOLAR I DISORDER


    • May 18, 2015
      ✓ 
      Pediatric exclusivity




  • Preparation of extended shelf-life biodegradable, biocompatible microparticles containing a biologically active agent
    Patent 5,792,477
    Issued: August 11, 1998
    Inventor(s): Rickey; Michael E. & Ramstack; J. Michael & Lewis; Danny H. & Mesens; Jean
    Assignee(s): Alkermes Controlled Therapeutics, Inc. II
    Janssen Pharmaceutica
    A method for preparing biodegradable, biocompatible microparticles. A first phase is prepared that includes a biodegradable, biocompatible polymeric encapsulating binder, and an active agent having limited water solubility dissolved or dispersed in a solvent. An aqueous second phase is prepared. The first and second phases are combined to form an emulsion in which the first phase is discontinuous and the second phase is continuous. The two phases are separated. The discontinuous first phase is washed with water, or an aqueous solution of water and a solvent for residual solvent in the first phase, to reduce the level of residual solvent in the microparticles to less than about 2% by weight of the microparticles. Also disclosed are a microencapsulated drug prepared by the method for preparing biodegradable, biocompatible microparticles, and a pharmaceutical composition that includes biodegradable and biocompatible microparticles in a pharmaceutically acceptable carrier.
    Patent expiration dates:

    • May 2, 2017
      ✓ 
      Drug product


    • November 2, 2017
      ✓ 
      Pediatric exclusivity




  • Preparation of biodegradable, biocompatible microparticles containing a biologically active agent
    Patent 5,916,598
    Issued: June 29, 1999
    Inventor(s): Rickey; Michael E. & Ramstack; J. Michael & Lewis; Danny H.
    Assignee(s): Alkermes Controlled Therapeutics Inc. II
    A method for preparing biodegradable, biocompatible microparticles. A first phase is prepared that includes a biodegradable, biocompatible polymer, an active agent, and a solvent. An immiscible second phase is prepared. The first and second phases are combined to form an emulsion in which the first phase is discontinuous and the second phase is continuous. The two phases are immersed in a quench liquid that includes a quench medium and a quantity of the solvent. The quantity of the solvent is selected to control a rate of extraction of the solvent from the first phase. The first phase is isolated in the form of microparticles. Also disclosed is a microencapsulated active agent prepared by the method for preparing biodegradable, biocompatible microparticles.
    Patent expiration dates:

    • May 2, 2017
      ✓ 
      Drug product


    • November 2, 2017
      ✓ 
      Pediatric exclusivity




  • Microencapsulated 3-piperidinyl-substituted 1,2-benzisoxazoles and 1,2-benzisothiazoles
    Patent 5,965,168
    Issued: October 12, 1999
    Inventor(s): Mesens; Jean & Rickey; Michael E. & Atkins; Thomas J.
    Assignee(s): Alkermes Controlled Therapeutics, Inc. II
    Janssen Pharmaceutica
    The invention relates to a pharmaceutical composition comprising a biodegradable and biocompatible microparticle composition comprising a 1,2-benzazole of the formula ##STR1## and the pharmaceutically acceptable acid addition salts thereof, within a polymeric matrix.
    Patent expiration dates:

    • November 19, 2013
      ✓ 
      Drug product


    • May 19, 2014
      ✓ 
      Pediatric exclusivity




  • Preparation of biodegradable, biocompatible microparticles containing a biologically active agent
    Patent 6,110,503
    Issued: August 29, 2000
    Inventor(s): Rickey; Michael E. & Ramstack; J. Michael & Lewis; Danny H.
    Assignee(s): Alkermes Controlled Therapeutics Inc.
    A method for preparing biodegradable, biocompatible microparticles. A first phase is prepared that includes a biodegradable, biocompatible polymer, an active agent, and a solvent. An immiscible second phase is prepared. The first and second phases are combined to form an emulsion in which the first phase is discontinuous and the second phase is continuous. The two phases are immersed in a quench liquid that includes a quench medium and a quantity of the solvent. The quantity of the solvent is selected to control a rate of extraction of the solvent from the first phase. The first phase is isolated in the form of microparticles. Also disclosed is a microencapsulated active agent prepared by the method for preparing biodegradable, biocompatible microparticles.
    Patent expiration dates:

    • May 2, 2017
      ✓ 
      Drug product


    • November 2, 2017
      ✓ 
      Pediatric exclusivity




  • Microencapsulated 3-piperidinyl-substituted 1,2-benzisoxazoles and 1,2-benzisothiazoles
    Patent 6,110,921
    Issued: August 29, 2000
    Inventor(s): Mesens; Jean & Rickey; Michael E. & Atkins; Thomas J.
    Assignee(s): Alkermes Controlled Therapeutics Inc. II
    Janssen Pharmaceutica
    The invention relates to a method of treating psychotic disorders comprising a biodegradable and biocompatible microparticle composition comprising a 1,2-benzazole of the formula ##STR1## and the pharmaceutically acceptable acid addition salts thereof.
    Patent expiration dates:

    • November 19, 2013
      ✓ 
      Patent use: TREATMENT OF SCHIZOPHRENIA


    • May 19, 2014
      ✓ 
      Pediatric exclusivity




  • Preparation of microparticles having a selected release profile
    Patent 6,194,006
    Issued: February 27, 2001
    Inventor(s): Lyons; Shawn L. & Ramstack; J. Michael & Wright; Steven G.
    Assignee(s): Alkermes Controlled Therapeutics Inc. II
    An improved method for preparing microparticles that exhibit controlled release of an effective amount of an active agent over an extended period of time. More particularly, a method is provided for preparing microparticles having a selected release profile for release of active agent contained in the microparticles. By adjusting the degree of drying that is performed during the preparation of the microparticles, the release profile can be controlled. By performing no intermediate drying, an initial burst and a substantially linear release profile is achieved. By performing substantially complete intermediate drying, an initial lag phase and a substantially sigmoidal release profile is achieved.
    Patent expiration dates:

    • December 30, 2018
      ✓ 
      Drug product


    • June 30, 2019
      ✓ 
      Pediatric exclusivity




  • Microencapsulated 3-piperidinyl-substituted 1,2-benzisoxazoles and 1,2-benzisothiazoles
    Patent 6,368,632
    Issued: April 9, 2002
    Inventor(s): Jean; Mesens & Michael E.; Rickey & Thomas J.; Atkins
    Assignee(s): Janssen Pharmaceutica
    Alkermes Controlled Therapeutics Inc. II
    Method of treating warm blooded animals suffering from psychotic disorders. The method includes administering a pharmaceutically effective amount of sustained-release microparticles that include risperidone, or a pharmaceutically acceptable acid addition salt thereof, and a biodegradable and biocompatible polymeric matrix.
    Patent expiration dates:

    • November 19, 2013
      ✓ 
      Patent use: TREATMENT OF SCHIZOPHRENIA


    • May 19, 2014
      ✓ 
      Pediatric exclusivity




  • Preparation of microparticles having a selected release profile
    Patent 6,379,703
    Issued: April 30, 2002
    Inventor(s): Shawn L.; Lyons & J. Michael; Ramstack & Steven G.; Wright
    Assignee(s): Alkermes Controlled Therapeutics Inc., II
    An improved method for preparing microparticles that exhibit controlled release of an effective amount of an active agent over an extended period of time. More particularly, a method is provided for preparing microparticles having a selected release profile for release of active agent contained in the microparticles. By adjusting the degree of drying that is performed during the preparation of the microparticles, the release profile can be controlled. By performing no intermediate drying, an initial burst and a substantially linear release profile is achieved. By performing substantially complete intermediate drying, an initial lag phase and a substantially sigmoidal release profile is achieved.
    Patent expiration dates:

    • December 30, 2018
      ✓ 
      Drug product


    • June 30, 2019
      ✓ 
      Pediatric exclusivity




  • Preparation of biodegradable, biocompatible microparticles containing a biologically active agent
    Patent 6,403,114
    Issued: June 11, 2002
    Inventor(s): Michael E.; Rickey & J. Michael; Ramstack & Danny H.; Lewis
    Assignee(s): Alkermes Controlled Therapeutics Inc. II
    A method for preparing biodegradable, biocompatible microparticles. A first phase is prepared that includes a biodegradable, biocompatible polymer, an active agent, and a solvent. A second phase is prepared. The first and second phases are combined to form an emulsion in which the first phase is discontinuous and the second phase is continuous. The discontinuous first phase is separated from the continuous second phase. The residual level of solvent in the discontinuous first phase is reduced to less than about 2% by weight.
    Patent expiration dates:

    • May 2, 2017
      ✓ 
      Drug product


    • November 2, 2017
      ✓ 
      Pediatric exclusivity




  • Preparation of microparticles having a selected release profile
    Patent 6,596,316
    Issued: July 22, 2003
    Inventor(s): Shawn L.; Lyons & J. Michael; Ramstack & Steven G.; Wright
    Assignee(s): Alkermes Controlled Therapeutics, Inc. II
    An improved method for preparing microparticles that exhibit controlled release of an effective amount of an active agent over an extended period of time. More particularly, a method is provided for preparing microparticles having a selected release profile for release of active agent contained in the microparticles. By adjusting the degree of drying that is performed during the preparation of the microparticles, the release profile can be controlled. By performing no intermediate drying, an initial burst and a substantially linear release profile is achieved. By performing substantially complete intermediate drying, an initial lag phase and a substantially sigmoidal release profile is achieved.
    Patent expiration dates:

    • December 30, 2018
      ✓ 
      Drug product


    • June 30, 2019
      ✓ 
      Pediatric exclusivity




  • Preparation of injectable suspensions having improved injectability
    Patent 6,667,061
    Issued: December 23, 2003
    Inventor(s): J. Michael; Ramstack & M. Gary I.; Riley & Stephen E.; Zale & Joyce M.; Hotz & Olufunmi L.; Johnson
    Assignee(s): Alkermes Controlled Therapeutics, Inc.
    Injectable compositions having improved injectability. The injectable compositions include microparticles suspended in an aqueous injection vehicle having a viscosity of at least 20 cp at 20° C. The increased viscosity of the injection vehicle that constitutes the fluid phase of the suspension significantly reduces in vivo injectability failures. The injectable compositions can be made by mixing dry microparticles with an aqueous injection vehicle to form a suspension, and then mixing the suspension with a viscosity enhancing agent to increase the viscosity of the fluid phase of the suspension to the desired level for improved injectability.
    Patent expiration dates:

    • May 25, 2020
      ✓ 
      Drug product


    • November 25, 2020
      ✓ 
      Pediatric exclusivity




  • Microencapsulated 3-piperidinyl-substituted 1,2-benzisoxazoles and 1,2-benzisothiazoles
    Patent 7,547,452
    Issued: June 16, 2009
    Inventor(s): Atkins; Thomas J. & Rickey; Michael E. & Mesens; Jean
    Assignee(s): Alkermes, Inc.
    Janssen Pharmaceutica, N.V
    Sustained-release microparticle composition. The microparticle composition can be formulated to provide extended release over a period of from about 7 days to about 200 days. The microparticles may be formulated with a biodegradable and biocompatible polymer, and an active agent, such as risperidone, 9-hydroxy-risperidone, and pharmaceutically acceptable acid addition salts of the foregoing.
    Patent expiration dates:

    • November 19, 2013
      ✓ 
      Drug product


    • May 19, 2014
      ✓ 
      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:
    • May 15, 2012 - USE AS ADJUNCTIVE THERAPY WITH LITHIUM OR VALPROATE FOR THE MAINTENANCE TREATMENT OF BIPOLAR I DISORDER

    • May 15, 2012 - MONOTHERAPY FOR THE MAINTENANCE TREATMENT OF BIPOLAR I DISORDER

See also...

  • Risperdal Consta Consumer Information (Drugs.com)
  • Risperdal Consta Consumer Information (Wolters Kluwer)
  • Risperdal Consta Advanced Consumer Information (Micromedex)
  • Risperidone Consumer Information (Drugs.com)
  • Risperidone Consumer Information (Wolters Kluwer)
  • Risperidone Orally Disintegrating Tablets Consumer Information (Wolters Kluwer)
  • Risperidone Solution Consumer Information (Wolters Kluwer)
  • Risperidone Tablets Consumer Information (Wolters Kluwer)
  • Risperidone Consumer Information (Cerner Multum)
  • Risperidone Advanced Consumer Information (Micromedex)
  • Risperidone Intramuscular Advanced Consumer Information (Micromedex)
  • Risperidone AHFS DI Monographs (ASHP)

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