Generic Razadyne Availability

See also: Generic Razadyne ER

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

RAZADYNE (galantamine hydrobromide - solution;oral)

RAZADYNE (galantamine hydrobromide - tablet;oral)

  • Manufacturer: JANSSEN PHARMS
    Approval date: February 28, 2001
    Strength(s): EQ 4MG BASE [RLD] [AB], EQ 8MG BASE [AB], EQ 12MG BASE [AB]

Has a generic version of Razadyne been approved?

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

galantamine hydrobromide solution;oral

  • Manufacturer: ROXANE
    Approval date: January 30, 2009
    Strength(s): 4MG/ML [AA]

galantamine hydrobromide tablet;oral

  • Manufacturer: APOTEX INC
    Approval date: September 27, 2011
    Strength(s): EQ 4MG BASE [AB], EQ 8MG BASE [AB], EQ 12MG BASE [AB]
  • Manufacturer: AUROBINDO PHARMA LTD
    Approval date: March 29, 2011
    Strength(s): EQ 4MG BASE [AB], EQ 8MG BASE [AB], EQ 12MG BASE [AB]
  • Manufacturer: BARR
    Approval date: August 28, 2008
    Strength(s): EQ 4MG BASE [AB], EQ 8MG BASE [AB], EQ 12MG BASE [AB]
  • Manufacturer: DR REDDYS LABS LTD
    Approval date: September 11, 2008
    Strength(s): EQ 4MG BASE [AB], EQ 8MG BASE [AB], EQ 12MG BASE [AB]
  • Manufacturer: MYLAN
    Approval date: August 28, 2008
    Strength(s): EQ 4MG BASE [AB], EQ 8MG BASE [AB], EQ 12MG BASE [AB]
  • Manufacturer: MYLAN
    Approval date: May 29, 2009
    Strength(s): EQ 4MG BASE [AB], EQ 8MG BASE [AB], EQ 12MG BASE [AB]
  • Manufacturer: ROXANE
    Approval date: February 11, 2009
    Strength(s): EQ 4MG BASE [AB], EQ 8MG BASE [AB], EQ 12MG BASE [AB]
  • Manufacturer: SANDOZ
    Approval date: June 22, 2009
    Strength(s): EQ 4MG BASE [AB], EQ 8MG BASE [AB], EQ 12MG BASE [AB]
  • Manufacturer: TEVA PHARMS
    Approval date: July 9, 2009
    Strength(s): EQ 4MG BASE [AB], EQ 8MG BASE [AB], EQ 12MG BASE [AB]
  • Manufacturer: ZYDUS PHARMS USA INC
    Approval date: February 17, 2011
    Strength(s): EQ 4MG BASE [AB], EQ 8MG BASE [AB], EQ 12MG BASE [AB]

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

  • Fast-dissolving galanthamine hydrobromide tablet
    Patent 6,099,863
    Issued: August 8, 2000
    Inventor(s): Gilis; Paul Marie Victor & De Conde; Valentin Florent Victor
    Assignee(s): Janssen Pharmaceutica N.V.
    The present invention is concerned with a fast-dissolving tablet for oral administration comprising as an active ingredient a therapeutically effective amount of galanthamine hydrobromide (1:1) and a pharmaceutically acceptable carrier, characterized in that said carrier comprises a spray-dried mixture of lactose monohydrate and microcrystalline cellulose (75:25) as a diluent, and a disintegrant; and with a direct compression process of preparing such fast-dissolving tablets.
    Patent expiration dates:
    • June 6, 2017
  • Fast-dissolving galanthamine hydrobromide tablet
    Patent 6,358,527
    Issued: March 19, 2002
    Inventor(s): Paul Marie Victor; Gilis & Valentin Florent Victor; De Condé
    Assignee(s): Janssen Pharmaceutica N.V.
    The present invention is concerned with a fast-dissolving tablet for oral administration comprising as an active ingredient a therapeutically effective amount of galanthamine hydrobromide (1:1) and a pharmaceutically acceptable carrier, characterized in that said carrier comprises a spray dried mixture of lactose monohydrate and microcrystalline cellulose (75:25) as a diluent, and a disintegrant; and with a direct compression process of preparing such fast-dissolving tablets.
    Patent expiration dates:
    • June 6, 2017
      ✓ 
      Patent use: TREATMENT OF ALZHEIMER'S DEMENTIA
      ✓ 
      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.
AAProducts in conventional dosage forms not presenting bioequivalence problems. Products coded as AA contain active ingredients and dosage forms that are not regarded as presenting either actual or potential bioequivalence problems or drug quality or standards issues. However, all oral dosage forms must, nonetheless, meet an appropriate in vitro bioequivalence standard that is acceptable to the Agency in order to be approved.
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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