Generic Namzaric Availability
Last updated on Jan 8, 2025.
Namzaric is a brand name of donepezil/memantine, approved by the FDA in the following formulation(s):
NAMZARIC (donepezil hydrochloride; memantine hydrochloride - capsule, extended release;oral)
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Manufacturer: ABBVIE
Approval date: December 23, 2014
Strength(s): 10MG;14MG [RLD] [AB], 10MG;28MG [RLD] [AB] -
Manufacturer: ABBVIE
Approval date: July 18, 2016
Strength(s): 10MG;7MG [RLD], 10MG;21MG [RLD] [AB]
Has a generic version of Namzaric been approved?
A generic version of Namzaric has been approved by the FDA. However, this does not mean that the product will necessarily be commercially available - possibly because of drug patents and/or drug exclusivity. The following products are equivalent to Namzaric and have been approved by the FDA:
MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE (donepezil hydrochloride; memantine hydrochloride capsule, extended release;oral)
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Manufacturer: AMNEAL PHARMS
Approval date: January 27, 2017
Strength(s): 10MG;14MG [AB], 10MG;28MG [AB] -
Manufacturer: ANI PHARMS
Approval date: December 15, 2023
Strength(s): 10MG;21MG [AB]
Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Namzaric. 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: Generic Drug FAQ.
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.
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Patent 8,039,009
Patent expiration dates:
- March 24, 2029✓
- March 24, 2029
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Patent 8039009*PED
Patent expiration dates:
- September 24, 2029✓
- September 24, 2029
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Patent 8,058,291
Patent expiration dates:
- December 5, 2029✓
- December 5, 2029
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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✓✓
- November 22, 2025
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Method and composition for administering an NMDA receptor antagonist to a subject
Patent 8168209*PED
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:
- May 22, 2026✓
- May 22, 2026
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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✓✓
- November 22, 2025
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Method and composition for administering an NMDA receptor antagonist to a subject
Patent 8173708*PED
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:
- May 22, 2026✓
- May 22, 2026
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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✓✓
- November 22, 2025
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Methods and compositions for the treatment of CNS-related conditions
Patent 8283379*PED
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:
- May 22, 2026✓
- May 22, 2026
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Methods and compositions for the treatment of CNS-related conditions
Patent 8,293,794
Issued: October 23, 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✓
- November 22, 2025
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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✓✓
- November 22, 2025
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Composition for administering an NMDA receptor antagonist to a subject
Patent 8329752*PED
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:
- May 22, 2026✓
- May 22, 2026
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Compositions for the treatment of CNS-related conditions
Patent 8,338,485
Issued: December 25, 2012
Inventor(s): Went Gregory T. & Fultz Timothy J. & Meyerson Laurence R.
Assignee(s): Adamas Pharmaceuticals, Inc.The invention provides compositions comprising extended release memantine in combination with immediate release donepezil to a subject. Memantine in an extended release form containing 22.5 to 30 mg memantine or a pharmaceutically acceptable salt thereof in combination with donepezil 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✓
- November 22, 2025
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Methods for the treatment of CNS-related conditions
Patent 8,338,486
Issued: December 25, 2012
Inventor(s): Went Gregory T. & Fultz Timothy J. & Meyerson Laurence R.
Assignee(s): Adamas Pharmaceuticals, Inc.The invention provides methods for administering extended release memantine in combination with immediate release donepezil to a subject. Memantine in an extended release form containing 22.5 to 30 mg memantine or a pharmaceutically acceptable salt thereof in combination with donepezil is administered to a patient suffering from a neurological condition, such as Alzheimer's disease, Parkinson's disease or dementia. The extended release form of memantine 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✓
- November 22, 2025
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Method for administering an NMDA receptor antagonist to a subject
Patent 8,362,085
Issued: January 29, 2013
Inventor(s): Went Gregory T. & Fultz Timothy J. & Meyerson Laurence R.
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✓✓
- November 22, 2025
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Method for administering an NMDA receptor antagonist to a subject
Patent 8362085*PED
Issued: January 29, 2013
Inventor(s): Went Gregory T. & Fultz Timothy J. & Meyerson Laurence R.
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:
- May 22, 2026✓
- May 22, 2026
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Compositions for the treatment of CNS-related conditions
Patent 8,580,858
Issued: November 12, 2013
Inventor(s): Went Gregory T. & Fultz Timothy J. & Meyerson Laurence R.
Assignee(s): Adamas Pharmaceuticals, Inc.The invention provides compositions comprising extended release memantine in combination with immediate release donepezil to a subject. Memantine in an extended release form containing 22.5 to 30 mg memantine or a pharmaceutically acceptable salt thereof in combination with donepezil 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✓
- November 22, 2025
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Method for administering an NMDA receptor antagonist to a subject
Patent 8,598,233
Issued: December 3, 2013
Inventor(s): Went Gregory T. & Fultz Timothy J. & Meyerson Laurence R.
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✓✓
- November 22, 2025
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Method for administering an NMDA receptor antagonist to a subject
Patent 8598233*PED
Issued: December 3, 2013
Inventor(s): Went Gregory T. & Fultz Timothy J. & Meyerson Laurence R.
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:
- May 22, 2026✓
- May 22, 2026
More about Namzaric (donepezil / memantine)
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- Drug class: cholinesterase inhibitors
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Glossary
Term | Definition |
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Drug Patent | A 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 Exclusivity | Exclusivity 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. |
RLD | A 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. |
AB | Products meeting necessary bioequivalence requirements. Multisource drug products listed under the same heading (e.g. identical active ingredients, dosage form, and routes of administration) and having the same strength (see Therapeutic Equivalence-Related Terms, Pharmaceutical Equivalents) generally will be coded AB if a study is submitted demonstrating bioequivalence. In certain instances, a number is added to the end of the AB code to make a three character code (e.g. AB1, AB2, AB7). Three-character codes are assigned only in situations when more than one reference listed drug of the same strength has been designated under the same heading. Two or more reference listed drugs are generally selected only when there are at least two potential reference drug products which are not bioequivalent to each other. If a study is submitted that demonstrates bioequivalence to a specific listed drug product, the generic product will be given the same three-character code as the reference listed drug it was compared against. |
Further information
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