Generic Namenda XR Availability

See also: Generic Namenda

Namenda XR is a brand name of memantine, approved by the FDA in the following formulation(s):

NAMENDA XR (memantine hydrochloride - capsule, extended release;oral)

  • Manufacturer: FOREST LABS
    Approval date: June 21, 2010
    Strength(s): 7MG, 14MG, 21MG, 28MG [RLD]

Has a generic version of Namenda XR been approved?

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

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Namenda XR. 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.

  • Adamantane derivatives in the prevention and treatment of cerebral ischemia
    Patent 5,061,703
    Issued: October 29, 1991
    Inventor(s): Bormann; Joachim & Gold; Markus R. & Schatton; Wolfgang
    Assignee(s): Merz + Co. GmbH & Co.
    A method for the prevention and treatment of cerebral ischemia using an adamantane derivative of the formula ##STR1## wherein R.sub.1 and R.sub.2 are identical or different, representing hydrogen or a straight or branched alkyl group of 1 to 6 C atoms or, in conjunction with N, a heterocyclic group with 5 or 6 ring C atoms; wherein R.sub.3 and R.sub.4 are identical or different, being selected from hydrogen, a straight or branched alkyl group of 1 to 6 C atoms, a cycloalkyl group with 5 or 6 C atoms, and phenyl; wherein R.sub.5 is hydrogen or a straight or branched C.sub.1 -C.sub.6 alkyl group, or a pharmaceutically-acceptable salt thereof, is disclosed.
    Patent expiration dates:
    • April 11, 2015
      ✓ 
      Patent use: TREATMENT OF MODERATE TO SEVERE DEMENTIA OF THE ALZHEIMER'S TYPE
  • Modified release formulations of memantine oral dosage forms
    Patent 8,039,009
    Issued: October 18, 2011
    Inventor(s): Rastogi; Suneel K. & Rao; Niranjan & Periclou; Antonia & Abramowitz; Wattanaporn & Dedhiya; Mahendra G. & Mahashabde; Shashank
    Assignee(s): Forest Laboratories Holdings Limited
    The present invention provides pharmaceutical compositions given once daily containing at least one therapeutically active ingredient selected from the group consisting of memantine and a pharmaceutically acceptable salt of memantine, and a pharmaceutically acceptable polymeric matrix carrier. The dosage forms of the invention sustain the release of the therapeutically active agent from about 4 to about 24 hours when said dosage form is exposed to aqueous solutions. following entry of said form into a use environment, wherein said dosage form has a dissolution rate of more than about 80% after passage of about 6 hours to about 12 hours following said entry into said use environment.
    Patent expiration dates:
    • March 24, 2029
      ✓ 
      Patent use: TREATMENT OF MODERATE TO SEVERE DEMENTIA OF THE ALZHEIMER'S TYPE
  • Method and composition for administering an NMDA receptor antagonist to a subject
    Patent 8,168,209
    Issued: May 1, 2012
    Inventor(s): Went; Gregory T. & Fultz; Timothy J. & Porter; Seth & Meyerson; Laurence R. & Burkoth; Timothy S.
    Assignee(s): Adamas Pharmaceuticals, Inc.
    The invention provides methods and compositions for administering an NMDA receptor antagonist (e.g., memantine) to a subject.
    Patent expiration dates:
    • November 22, 2025
      ✓ 
      Drug product
  • Method and composition for administering an NMDA receptor antagonist to a subject
    Patent 8,173,708
    Issued: May 8, 2012
    Inventor(s): Went; Gregory T. & Fultz; Timothy J. & Meyerson; Laurence R.
    Assignee(s): Adamas Pharmaceuticals, Inc.
    The invention provides methods and compositions for administering an NMDA receptor antagonist (e.g., memantine) to a subject.
    Patent expiration dates:
    • November 22, 2025
      ✓ 
      Patent use: TREATMENT OF MODERATE TO SEVERE DEMENTIA OF THE ALZHEIMER'S TYPE
  • Methods and compositions for the treatment of CNS-related conditions
    Patent 8,283,379
    Issued: October 9, 2012
    Inventor(s): Went; Gregory T. & Fultz; Timothy J. & Meyerson; Laurence R.
    Assignee(s): Adamas Pharmaceuticals, Inc.
    The present invention provides novel methods and compositions for the treatment and prevention of CNS-related conditions. One of the CNS-related conditions treated by the methods and compositions of the invention is Alzheimer's disease.
    Patent expiration dates:
    • November 22, 2025
      ✓ 
      Patent use: TREATMENT OF MODERATE TO SEVERE DEMENTIA OF THE ALZHEIMER'S TYPE
  • Composition for administering an NMDA receptor antagonist to a subject
    Patent 8,329,752
    Issued: December 11, 2012
    Inventor(s): Went; Gregory T. & Fultz; Timothy J. & Meyerson; Laurence R.
    Assignee(s): Adamas Pharmaceuticals, Inc.
    The invention provides compostions for administering memantine to a subject. Memantine in an extended release form containing 22.5 to 30 mg memantine or a pharmaceutically acceptable salt achieves particular pharmacokinetic criteria such as change in plasma concentration of memantine over time and ratio of maximum memantine plasma concentration to mean memantine plasma concentration.
    Patent expiration dates:
    • November 22, 2025
      ✓ 
      Drug product
  • Method for administering an NMDA receptor antagonist to a subject
    Patent 8,362,085
    Issued: January 29, 2013
    Assignee(s): Adamas Pharmaceuticals, Inc.
    The invention provides methods for administering memantine to a subject. Memantine in an extended release form containing 22.5 to 30 mg memantine or a pharmaceutically acceptable salt is administered to a patient suffering from a neurological condition, such as Alzheimer's disease, Parkinson's disease or dementia. The extended release form achieves particular pharmacokinetic criteria such as change in plasma concentration of memantine over time and ratio of maximum memantine plasma concentration to mean memantine plasma concentration.
    Patent expiration dates:
    • November 22, 2025
      ✓ 
      Patent use: TREATMENT OF MODERATE TO SEVERE DEMENTIA OF THE ALZHEIMER'S TYPE
  • Method for administering an NMDA receptor antagonist to a subject
    Patent 8,598,233
    Issued: December 3, 2013
    Assignee(s): Adamas Pharmacueticals, Inc.
    Compositions and methods for administering memantine to a subject are provided. In particular, a solid pharmaceutical composition in a unit dosage form for once daily oral administration is provided. The compositions comprises an extended release formulation of 22.5 mg to 33.75 mg memantine, or a pharmaceutically acceptable salt thereof, wherein administration of a dose of the composition to a human subject provides a mean plasma memantine concentration profile characterized by a change in memantine concentration as a function of time (dC/dT) that is less than 50% of the dC/dT provided by the same quantity of an immediate release form of memantine, determined in a time period between 0 hours to 6 hours after administration of memantine, and wherein dC/dT is measured in a single-dose human PK study. Methods of treating dementia, in particular Alzheimer's diseases, using the compositions are provided.
    Patent expiration dates:
    • November 22, 2025
      ✓ 
      Drug product

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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