Generic Focalin XR Availability

See also: Generic Focalin

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

FOCALIN XR (dexmethylphenidate hydrochloride - capsule, extended release;oral)

  • Manufacturer: NOVARTIS
    Approval date: May 26, 2005
    Strength(s): 5MG [AB], 10MG [AB], 20MG [AB]
  • Manufacturer: NOVARTIS
    Approval date: August 1, 2006
    Strength(s): 15MG [AB]
  • Manufacturer: NOVARTIS
    Approval date: October 23, 2009
    Strength(s): 30MG [AB]
  • Manufacturer: NOVARTIS
    Approval date: August 11, 2010
    Strength(s): 40MG [RLD] [AB]
  • Manufacturer: NOVARTIS
    Approval date: April 21, 2011
    Strength(s): 25MG, 35MG

Has a generic version of Focalin XR been approved?

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

dexmethylphenidate hydrochloride capsule, extended release;oral

  • Manufacturer: INTELLIPHARMACEUTICS
    Approval date: November 18, 2013
    Strength(s): 15MG [AB], 30MG [AB]
  • Manufacturer: MYLAN PHARMS INC
    Approval date: August 28, 2013
    Strength(s): 30MG [AB]
  • Manufacturer: TEVA PHARMS USA
    Approval date: November 19, 2013
    Strength(s): 5MG [AB], 10MG [AB], 20MG [AB], 40MG [AB]
  • Manufacturer: WATSON LABS INC
    Approval date: November 21, 2013
    Strength(s): 30MG [AB]

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

  • Delivery of multiple doses of medications
    Patent 5,837,284
    Issued: November 17, 1998
    Inventor(s): Mehta; Atul M. & Zeitlin; Andrew L. & Dariani; Maghsoud M.
    Dosage forms for oral administration of a methylphenidate drug are provided. The dosage forms provide a substantially immediate dose of methylphenidate upon ingestion, followed by one or more additional doses at predetermined times. By providing such a drug release profile, the dosage forms eliminate the need for a patient to carry an additional dose for ingestion during the day. The dosage forms and methods provided are useful in administering methylphenidate and pharmaceutically acceptable salts thereof, which generally require one or more doses throughout the day.
    Patent expiration dates:
    • December 4, 2015
      ✓ 
      Drug product
    • December 4, 2015
      ✓ 
      Patent use: A METHOD OF TREATING DISEASE AMENABLE TO TREATMENT WITH A PHENIDATE DRUG BY ONCE DAILY ORAL ADMINISTRATION OF AN EXTENDED RELEASE DOSAGE FORM
      ✓ 
      Drug product
  • 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
      ✓ 
      Patent use: METHOD OF TREATING ATTENTION DEFICIT DISORDER AND/OR ATTENTION DEFICIT HYPERACTIVITY DISORDER
      ✓ 
      Drug product
    • December 4, 2015
      ✓ 
      Patent use: METHOD OF TREATING ATTENTION DEFICIT DISORDER AND/OR ATTENTION DEFICIT HYPERACTIVITY DISORDER
  • Multiparticulate modified release composition
    Patent 6,228,398
    Issued: May 8, 2001
    Inventor(s): Devane; John G. & Stark; Paul & Fanning; Niall M. M.
    Assignee(s): Elan Corporation, PLC
    The invention relates to a multiparticulate modified release composition that in operation delivers an active ingredient in a pulsed or bimodal manner. The multiparticulate modified release composition comprises an immediate release component and a modified release component; the immediate release component comprising a first population of active ingredient containing particles and the modified release component compnsimg a second population of active ingredient containing particles coated with a controlled release coating; wherein the combination of the immediate release and modified release components in operation deliver the active ingredient in a pulsed or a bimodal manner. The invention also relates to a solid oral dosage form containing such a multiparticulate modified release composition. The plasma profile achieved by the multiparticulate modified release composition is advantageous in reducing patient tolerance to the active ingredient and in increasing patient compliance by reducing dosage frequency.
    Patent expiration dates:
    • November 1, 2019
      ✓ 
      Patent use: METHOD OF TREATING ATTENTION DEFICIT DISORDER USING ORAL ADMINISTRATION OF A BI-MODAL OR PULSATILE RELEASE COMPOSITION
      ✓ 
      Drug product
  • 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
      ✓ 
      Drug product
  • 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
      ✓ 
      Drug product
  • Delivery of multiple doses of medications
    Patent 6,635,284
    Issued: October 21, 2003
    Inventor(s): Atul M.; Mehta & Andrew L.; Zeitlin & Maghsoud M.; Dariani
    Assignee(s): Celegene Corporation
    Dosage forms for oral administration of a methylphenidate drug are provided. The dosage forms provide a substantially immediate dose of methylphenidate upon ingestion, followed by one or more additional doses at predetermined times. By providing such a drug release profile, the dosage forms eliminate the need for a patient to carry an additional dose for ingestion during the day. The dosage forms and methods provided are useful in administering methylphenidate and pharmaceutically acceptable salts thereof, which generally require one or more doses throughout the day.
    Patent expiration dates:
    • December 4, 2015
      ✓ 
      Patent use: A METHOD OF TREATING DISEASE AMENABLE TO TREATMENT WITH A PHENIDATE DRUG BY ONCE DAILY ORAL ADMINISTRATION OF AN EXTENDED RELEASE DOSAGE FORM
      ✓ 
      Drug product
  • Multiparticulate modified release composition
    Patent 6,730,325
    Issued: May 4, 2004
    Inventor(s): John G.; Devane & Paul; Stark & Niall M. M.; Fanning
    Assignee(s): Elan Corporation, plc
    The invention relates to a multiparticulate modified release composition that in operation delivers an active ingredient in a pulsed or bimodal manner. The multiparticulate modified release composition comprises an immediate release component and a modified release component; the immediate release component comprising a first population of active ingredient containing particles and the modified release component comprising a second population of active ingredient containing particles coated with a controlled release coating; wherein the combination of the immediate release and modified release components in operation deliver the active ingredient in a pulsed or a bimodal manner. The invention also relates to a solid oral dosage form containing such a multiparticulate modified release composition. The plasma profile achieved by the multiparticulate modified release composition is advantageous in reducing patient tolerance to the active ingredient and in increasing patient compliance by reducing dosage frequency.
    Patent expiration dates:
    • November 1, 2019
      ✓ 
      Patent use: METHOD OF TREATING ATTENTION DEFICIT DISORDER USING ORAL ADMINISTRATION OF A BI-MODAL OR PULSATILE RELEASE COMPOSITION
      ✓ 
      Drug product
  • Delivery of multiple doses of medications
    Patent 7,431,944
    Issued: October 7, 2008
    Inventor(s): Mehta; Atul M. & Zeitlin; Andrew L. & Dariani; Maghsoud M.
    Assignee(s): Celgene Corporation
    Dosage forms for oral administration of a methylphenidate drug are provided. The dosage forms provide a substantially immediate dose of methylphenidate upon ingestion, followed by one or more additional doses at predetermined times. By providing such a drug release profile, the dosage forms eliminate the need for a patient to carry an additional dose for ingestion during the day. The dosage forms and methods provided are useful in administering methylphenidate and pharmaceutically acceptable salts thereof, which generally require one or more doses throughout the day.
    Patent expiration dates:
    • December 4, 2015
      ✓ 
      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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