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Generic Aricept Availability

Last updated on Nov 7, 2023.

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

ARICEPT (donepezil hydrochloride - solution;oral)

  • Manufacturer: EISAI INC
    Approval date: October 18, 2004
    Strength(s): 5MG/5ML (discontinued) [RLD]

ARICEPT (donepezil hydrochloride - tablet;oral)

  • Manufacturer: EISAI INC
    Approval date: November 25, 1996
    Strength(s): 5MG [RLD] [AB], 10MG [RLD] [AB]
  • Manufacturer: EISAI INC
    Approval date: July 23, 2010
    Strength(s): 23MG [RLD] [AB]

Has a generic version of Aricept been approved?

A generic version of Aricept 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 Aricept and have been approved by the FDA:

donepezil hydrochloride tablet;oral

  • Manufacturer: ACI
    Approval date: May 31, 2011
    Strength(s): 5MG [AB], 10MG [AB]
  • Manufacturer: ALEMBIC PHARMS LTD
    Approval date: February 25, 2013
    Strength(s): 5MG [AB], 10MG [AB]
  • Manufacturer: AUROBINDO
    Approval date: May 31, 2011
    Strength(s): 5MG [AB], 10MG [AB]
  • Manufacturer: CADILA
    Approval date: October 24, 2012
    Strength(s): 5MG [AB], 10MG [AB]
  • Manufacturer: CADILA PHARMS LTD
    Approval date: September 19, 2017
    Strength(s): 5MG [AB], 10MG [AB]
  • Manufacturer: CHARTWELL RX
    Approval date: May 31, 2011
    Strength(s): 5MG [AB], 10MG [AB]
  • Manufacturer: CIPLA LTD
    Approval date: May 31, 2011
    Strength(s): 5MG [AB], 10MG [AB]
  • Manufacturer: DEXCEL
    Approval date: February 19, 2016
    Strength(s): 23MG [AB]
  • Manufacturer: DR REDDYS
    Approval date: July 24, 2013
    Strength(s): 23MG [AB]
  • Manufacturer: DR REDDYS LABS LTD
    Approval date: May 31, 2011
    Strength(s): 5MG [AB], 10MG [AB]
  • Manufacturer: HETERO LABS LTD V
    Approval date: January 30, 2015
    Strength(s): 5MG [AB], 10MG [AB]
  • Manufacturer: INDICUS PHARMA
    Approval date: June 13, 2012
    Strength(s): 5MG [AB], 10MG [AB]
  • Manufacturer: JUBILANT GENERICS
    Approval date: May 31, 2011
    Strength(s): 5MG [AB], 10MG [AB]
  • Manufacturer: LUPIN LTD
    Approval date: October 30, 2015
    Strength(s): 23MG [AB]
  • Manufacturer: MACLEODS PHARMS LTD
    Approval date: August 17, 2012
    Strength(s): 5MG [AB], 10MG [AB]
  • Manufacturer: MACLEODS PHARMS LTD
    Approval date: January 22, 2014
    Strength(s): 23MG [AB]
  • Manufacturer: PRINSTON INC
    Approval date: May 31, 2011
    Strength(s): 5MG [AB], 10MG [AB]
  • Manufacturer: RISING
    Approval date: July 5, 2013
    Strength(s): 5MG [AB], 10MG [AB]
  • Manufacturer: SCIEGEN PHARMS INC
    Approval date: October 29, 2014
    Strength(s): 5MG [AB], 10MG [AB]
  • Manufacturer: STRIDES PHARMA
    Approval date: May 31, 2011
    Strength(s): 5MG [AB], 10MG [AB]
  • Manufacturer: SUN PHARM INDS
    Approval date: May 31, 2011
    Strength(s): 5MG [AB], 10MG [AB]
  • Manufacturer: TORRENT PHARMS
    Approval date: May 31, 2011
    Strength(s): 5MG [AB], 10MG [AB]
  • Manufacturer: TWI PHARMS
    Approval date: October 29, 2014
    Strength(s): 23MG [AB]
  • Manufacturer: ZYDUS PHARMS
    Approval date: August 31, 2017
    Strength(s): 23MG [AB]

Note: No generic formulation of the following product is available.

  • donepezil hydrochloride - solution;oral

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

  • Method for stabilizing anti-dementia drug
    Patent 8,481,565
    Issued: July 9, 2013
    Inventor(s): Ueki Yosuke & Suzuki Yasuyuki & Fujioka Satoshi
    Assignee(s): Eisai R&D Management Co., Ltd.

    The present invention provides a method for stabilizing an anti-dementia drug in a pharmaceutical composition containing the anti-dementia drug and a high molecular weight basic substance by adding a high molecular weight acidic substance to said pharmaceutical composition. Further, the present invention provides a pharmaceutical composition containing an anti-dementia drug and a high molecular basic substance in which a high molecular weight acidic substance is contained for stabilizing the anti-dementia drug. Furthermore, the present invention provides a method for manufacturing a pharmaceutical composition which comprises steps wherein a solution or suspension containing a high molecular weight acidic substance is added to a mixture of an anti-dementia drug and a high molecular weight basic substance for the sake of stabilizing the anti-dementia drug.

    Patent expiration dates:

    • October 4, 2026
      ✓ 
      Drug product

Glossary

Term Definition
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

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.