Generic Aricept Availability

See also: Generic Aricept ODT

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

ARICEPT (donepezil hydrochloride - tablet;oral)

  • Manufacturer: EISAI INC
    Approval date: November 25, 1996
    Strength(s): 5MG [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: ALEMBIC PHARMS LTD
    Approval date: February 25, 2013
    Strength(s): 5MG [AB], 10MG [AB]
  • Manufacturer: APOTEX
    Approval date: June 2, 2011
    Strength(s): 5MG [AB], 10MG [AB]
  • Manufacturer: AUROBINDO
    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: CSPC OUYI PHARM CO
    Approval date: July 5, 2013
    Strength(s): 5MG [AB], 10MG [AB]
  • Manufacturer: DR REDDYS LABS LTD
    Approval date: May 31, 2011
    Strength(s): 5MG [AB], 10MG [AB]
  • Manufacturer: DR REDDYS LABS LTD
    Approval date: July 24, 2013
    Strength(s): 23MG [AB]
  • Manufacturer: HIKMA PHARMS
    Approval date: May 31, 2011
    Strength(s): 5MG [AB], 10MG [AB]
  • Manufacturer: INDICUS PHARMA
    Approval date: June 13, 2012
    Strength(s): 5MG [AB], 10MG [AB]
  • Manufacturer: JUBILANT LIFE
    Approval date: May 31, 2011
    Strength(s): 5MG [AB], 10MG [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: MYLAN PHARMS INC
    Approval date: May 31, 2011
    Strength(s): 5MG [AB], 10MG [AB]
  • Manufacturer: PAR PHARM
    Approval date: July 24, 2013
    Strength(s): 23MG [AB]
  • Manufacturer: PLIVA HRVATSKA DOO
    Approval date: May 31, 2011
    Strength(s): 5MG [AB], 10MG [AB]
  • Manufacturer: PRINSTON INC
    Approval date: May 31, 2011
    Strength(s): 5MG [AB], 10MG [AB]
  • Manufacturer: RANBAXY
    Approval date: November 26, 2010
    Strength(s): 5MG [AB], 10MG [AB]
  • Manufacturer: ROXANE
    Approval date: May 31, 2011
    Strength(s): 5MG [AB], 10MG [AB]
  • Manufacturer: SANDOZ
    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: TEVA
    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: VIVIMED LABS
    Approval date: May 31, 2011
    Strength(s): 5MG [AB], 10MG [AB]
  • Manufacturer: WOCKHARDT
    Approval date: May 31, 2011
    Strength(s): 5MG [AB], 10MG [AB]
  • Manufacturer: ZYDUS PHARMS USA INC
    Approval date: October 24, 2012
    Strength(s): 5MG [AB], 10MG [AB]

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: 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.

  • Method for stabilizing anti-dementia drug
    Patent 8,481,565
    Issued: July 9, 2013
    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

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:
    • July 23, 2013 - NEW 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.
ABProducts meeting necessary bioequivalence requirements. Multisource drug products listed under the same heading (i.e., identical active ingredients(s), dosage form, and route(s) 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 (i.e., AB1, AB2, AB3, etc.). 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.
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