Generic Focalin Availability

See also: Generic Focalin XR

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

FOCALIN (dexmethylphenidate hydrochloride - tablet;oral)

  • Manufacturer: NOVARTIS
    Approval date: November 13, 2001
    Strength(s): 2.5MG [AB], 5MG [AB], 10MG [RLD] [AB]

Has a generic version of Focalin been approved?

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

dexmethylphenidate hydrochloride tablet;oral

  • Manufacturer: TEVA PHARMS
    Approval date: January 29, 2007
    Strength(s): 2.5MG [AB], 5MG [AB], 10MG [AB]

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Focalin. 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 of treating attention deficit disorders with d-threo methylphenidate
    Patent 5,908,850
    Issued: June 1, 1999
    Inventor(s): Zeitlin; Andrew L. & Dariani; Maghsoud M. & Stirling; David I.
    Assignee(s): Celgene Corporation
    Methods for treating Attention Deficit Disorder, Attention Deficit Hyperactivity Disorder, AIDS Dementia Complex and cognitive decline in HIV-AIDS while minimizing drug hypersensitivity, toxicity, side effects, euphoric effect, and drug abuse potential by administration of d-threo-methylphenidate or pharmaceutically acceptable salts thereof.
    Patent expiration dates:
    • December 4, 2015
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      Patent use: METHOD OF TREATING AT LEAST ONE OF ATTENTION DEFICIT DISORDER AND ATTENTION DEFICIT HYPERACTIVITY DISORDER
  • Phenidate drug formulations having diminished abuse potential
    Patent 6,355,656
    Issued: March 12, 2002
    Inventor(s): Andrew L.; Zeitlin & Maghsoud M.; Dariani
    Assignee(s): Celgene Corporation
    Phenidate drug formulations are provided having reduced potential for drug abuse. Dosage forms for treating Attention Deficit Disorder, Attention Deficit Hyperactivity Disorder, AIDS Dementia Complex and cognitive decline in HIV-AIDS are provided which minimize drug hypersensitivity, toxicity, side effects, euphoric effect, and drug abuse potential. Such dosage forms comprise D-threo stereoisomer of a phenidate in the substantial absence of all other stereoisomers.
    Patent expiration dates:
    • December 4, 2015
  • Phenidate drug formulations having diminished abuse potential
    Patent 6,528,530
    Issued: March 4, 2003
    Inventor(s): Andrew L.; Zeitlin & Maghsoud M.; Dariani
    Assignee(s): Celgene Corporation
    Phenidate drug formulations are provided having reduced potential for drug abuse. Dosage forms for treating Attention Deficit Disorder, Attention Deficit Hyperactivity Disorder, AIDS Dementia Complex and cognitive decline in HIV-AIDS are provided which minimize drug hypersensitivity, toxicity, side effects, euphoric effect, and drug abuse potential. Such dosage forms comprise D-threo stereoisomer of a phenidate in the substantial absence of all other stereoisomers.
    Patent expiration dates:
    • December 4, 2015
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      Drug substance
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      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.
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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