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Generic Razadyne ER Availability

See also: Generic Razadyne

Razadyne ER is a brand name of galantamine, approved by the FDA in the following formulation(s):

RAZADYNE ER (galantamine hydrobromide - capsule, extended release;oral)

  • Manufacturer: JANSSEN PHARMS
    Approval date: April 1, 2005
    Strength(s): EQ 8MG BASE [RLD] [AB], EQ 16MG BASE [RLD] [AB], EQ 24MG BASE [RLD] [AB]

Has a generic version of Razadyne ER been approved?

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

galantamine hydrobromide capsule, extended release;oral

  • Manufacturer: AUROBINDO PHARMA LTD
    Approval date: August 5, 2016
    Strength(s): EQ 8MG BASE [AB], EQ 16MG BASE [AB], EQ 24MG BASE [AB]
  • Manufacturer: BARR
    Approval date: September 15, 2008
    Strength(s): EQ 8MG BASE [AB], EQ 16MG BASE [AB], EQ 24MG BASE [AB]
  • Manufacturer: SUN PHARMA GLOBAL
    Approval date: February 2, 2011
    Strength(s): EQ 8MG BASE [AB], EQ 16MG BASE [AB], EQ 24MG BASE [AB]
  • Manufacturer: WATSON LABS
    Approval date: December 15, 2008
    Strength(s): EQ 8MG BASE [AB], EQ 16MG BASE [AB], EQ 24MG BASE [AB]

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Razadyne ER. 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 FAQs.

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.

  • Controlled release galantamine composition
    Patent 7,160,559
    Issued: January 9, 2007
    Inventor(s): McGee; John Paul & Gilis; Paul Marie Victor & De Weer; Marc Maurice Germain & de Condé; Valentin Florent Victor & de Bruijn; Herman Johannes Catherina & Van Dycke; Frederic Anne Rodolf
    Assignee(s): Janssen Pharmaceutica N.V.

    The present invention is concerned with controlled release compositions for oral administration comprising galantamine; and with processes of preparing such controlled release compositions.

    Patent expiration dates:

    • December 20, 2019
      Drug product

Further information

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

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.