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Generic Risperdal Consta Availability

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 in the United States.

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.

  • 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
  • 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
  • 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

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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