Generic Vivitrol Availability

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

VIVITROL (naltrexone - for suspension, extended release;intramuscular)

  • Manufacturer: ALKERMES
    Approval date: April 13, 2006
    Strength(s): 380MG/VIAL [RLD]

Has a generic version of Vivitrol been approved?

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

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Vivitrol. 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
  • 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
  • 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
  • Method for preparing microparticles having a selected polymer molecular weight
    Patent 6,264,987
    Issued: July 24, 2001
    Inventor(s): Wright; Steven G. & Rickey; Michael E. & Ramstack; J. Michael & Lyons; Shawn L. & Hotz; Joyce M.
    Assignee(s): Alkermes Controlled Therapeutics Inc. II
    A method for preparing microparticles having a selected polymer molecular weight. The hold time and temperature of a solution containing a nucleophilic compound and a polymer having a starting molecular weight are controlled in order to control the molecular weight of the polymer in the finished microparticle product. In this manner, a selected polymer molecular weight in the finished microparticle product can be achieved from a variety of starting material molecular weights.
    Patent expiration dates:
    • May 19, 2020
      ✓ 
      Drug product
  • Apparatus and method for preparing microparticles
    Patent 6,331,317
    Issued: December 18, 2001
    Inventor(s): Lyons; Shawn L. & Wright; Steven G.
    Assignee(s): Alkermes Controlled Therapeutics II Inc.
    Apparatus and method for preparing microparticles. An emulsion is formed by combining two phases in a static mixing assembly. The static mixing assembly preferably includes a preblending static mixer and a manifold. The emulsion flows out of the static mixing assembly into a quench liquid whereby droplets of the emulsion form microparticles. The residence time of the emulsion in the static mixing assembly is controlled to obtain a predetermined particle size distribution of the resulting microparticles.
    Patent expiration dates:
    • November 12, 2019
      ✓ 
      Drug product
  • 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
  • Method for preparing microparticles having a selected polymer molecular weight
    Patent 6,379,704
    Issued: April 30, 2002
    Inventor(s): Steven G.; Wright & Michael E.; Rickey & J. Michael; Ramstack & Shawn L.; Lyons & Joyce M.; Hotz
    Assignee(s): Alkermes Controlled Therapeutics Inc. II
    A method for preparing microparticles having a selected polymer molecular weight. The hold time and temperature of a solution containing a nucleophilic compound and a polymer having a starting molecular weight are controlled in order to control the molecular weight of the polymer in the finished microparticle product. In this manner, a selected polymer molecular weight in the finished microparticle product can be achieved from a variety of starting material molecular weights.
    Patent expiration dates:
    • May 19, 2020
      ✓ 
      Drug product
  • Apparatus and method for preparing microparticles
    Patent 6,395,304
    Issued: May 28, 2002
    Inventor(s): Shawn L.; Lyons & Steven G.; Wright
    Assignee(s): Alkermes Controlled Therapeutics Inc. II
    Apparatus and method for preparing microparticles. An emulsion is formed by combining two phases in a static mixing assembly. The static mixing assembly preferably includes a preblending static mixer and a manifold. The emulsion flows out of the static mixing assembly into a quench liquid whereby droplets of the emulsion form microparticles. The residence time of the emulsion in the static mixing assembly is controlled to obtain a predetermined particle size distribution of the resulting microparticles.
    Patent expiration dates:
    • November 12, 2019
      ✓ 
      Drug product
  • 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
  • Preparation of injectable suspensions having improved injectability
    Patent 6,495,164
    Issued: December 17, 2002
    Inventor(s): J. Michael; Ramstack & M. Gary I.; Riley & Stephen E.; Zale & Joyce M.; Hotz & Olufunmi L.; Johnson
    Assignee(s): Alkermes Controlled Therapeutics, Inc. I
    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
  • Apparatus and method for preparing microparticles using in-line solvent extraction
    Patent 6,495,166
    Issued: December 17, 2002
    Inventor(s): Shawn L.; Lyons & Steven G.; Wright
    Assignee(s): Alkermes Controlled Therapeutics Inc.
    Apparatus and method for preparing microparticles using in-line solvent extraction. An emulsion is formed by combining two phases in a static mixer. The emulsion is combined with an extraction liquid in a blending static mixer. The outflow of the blending static mixer is combined with additional extraction liquid. The additional extraction liquid and the outflow of the blending static mixer can be combined in a vessel, or through the use of a static mixer manifold that includes a plurality of static mixers.
    Patent expiration dates:
    • November 12, 2019
      ✓ 
      Drug product
  • Method for preparing microparticles having a selected polymer molecular weight
    Patent 6,534,092
    Issued: March 18, 2003
    Inventor(s): Steven G.; Wright & Michael E.; Rickey & J. Michael; Ramstack & Shawn L.; Lyons & Joyce M.; Hotz
    Assignee(s): Alkermes Controlled Therapeutics, Inc. II
    A method for preparing microparticles having a selected polymer molecular weight. The hold time and temperature of a solution containing a nucleophilic compound and a polymer having a starting molecular weight are controlled in order to control the molecular weight of the polymer in the finished microparticle product. In this manner a selected polymer molecular weight in the finished microparticle product can be achieved from a variety of starting material molecular weights.
    Patent expiration dates:
    • May 19, 2020
      ✓ 
      Drug product
  • Apparatus and method for preparing microparticles
    Patent 6,537,586
    Issued: March 25, 2003
    Inventor(s): Shawn L.; Lyons & Steven G.; Wright
    Assignee(s): Alkermes Controlled Therapeutics Inc. II
    Apparatus and method for preparing microparticles. An emulsion is formed by combining two phases in a static mixing assembly. The static mixing assembly preferably includes a preblending static mixer and a manifold. The emulsion flows out of the static mixing assembly into a quench liquid whereby droplets of the emulsion form microparticles. The residence time of the emulsion in the static mixing assembly is controlled to obtain a predetermined particle size distribution of the resulting microparticles.
    Patent expiration dates:
    • November 12, 2019
      ✓ 
      Drug product
  • 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
  • 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
  • Apparatus and method for preparing microparticles
    Patent 6,713,090
    Issued: March 30, 2004
    Inventor(s): Shawn L.; Lyons & Steven G.; Wright
    Assignee(s): Alkermas Controlled Therapeutics Inc. II
    Apparatus and method for preparing microparticles. An emulsion is formed by combining two phases in a static mixing assembly. The static mixing assembly preferably includes a preblending static mixer and a manifold. The emulsion flows out of the static mixing assembly into a quench liquid whereby droplets of the emulsion form microparticles. The residence time of the emulsion in the static mixing assembly is controlled to obtain a predetermined particle size distribution of the resulting microparticles.
    Patent expiration dates:
    • November 12, 2019
      ✓ 
      Drug product
  • Method and apparatus for preparing microparticles using in-line solvent extraction
    Patent 6,939,033
    Issued: September 6, 2005
    Inventor(s): Lyons; Shawn L. & Wright; Steven G.
    Assignee(s): Alkermes Controlled Therapeutics, Inc. II
    Apparatus and method for preparing microparticles using in-line solvent extraction. An emulsion is formed by combining two phases in a static mixer. The emulsion is combined with an extraction liquid in a blending static mixer. The outflow of the blending static mixer is combined with additional extraction liquid. The additional extraction liquid and the outflow of the blending static mixer can be combined in a vessel, or through the use of a static mixer manifold that includes a plurality of static mixers.
    Patent expiration dates:
    • November 12, 2019
      ✓ 
      Drug product
  • Preparation of injectable suspensions having improved injectability
    Patent 7,799,345
    Issued: September 21, 2010
    Inventor(s): Zale; Stephen E. & Ramstack; J. Michael & Hotz; Joyce M. & Riley; M. Gary I. & Johnson; Olufunmi L.
    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
  • Naltrexone long acting formulations and methods of use
    Patent 7,919,499
    Issued: April 5, 2011
    Inventor(s): Ehrich; Elliot
    Assignee(s): Alkermes, Inc.
    The inventions described herein arose from unexpected discoveries made during clinical trials with a long acting formulation of naltrexone. As such, the invention includes a method for treating an individual in need of naltrexone comprising the step of parenterally administering a long acting formulation comprising naltrexone and to the use of naltrexone in the manufacture of medicaments for use in such methods.
    Patent expiration dates:
    • October 15, 2029
      ✓ 
      Patent use: PREVENTION OF RELAPSE TO OPIOID DEPENDENCE, FOLLOWING OPIOID DETOXIFICATION
    • October 15, 2029
      ✓ 
      Patent use: TREATMENT OF ALCOHOL DEPENDENCE

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 12, 2013 - PREVENTION OF RELAPSE TO OPIOID DEPENDENCE FOLLOWING OPIOID DETOXIFICATION

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.
Hide
(web5)