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): 10MG, 20MG, 5MG
Manufacturer: NOVARTIS
Approval date: August 1, 2006
Strength(s): 15MG
Manufacturer: NOVARTIS
Approval date: October 23, 2009
Strength(s): 30MG
Manufacturer: NOVARTIS
Approval date: August 11, 2010
Strength(s): 40MG [RLD]
Manufacturer: NOVARTIS
Approval date: April 21, 2011
Strength(s): 25MG, 35MG
Has a generic version of Focalin XR been approved?
No. There is currently no therapeutically equivalent version of Focalin XR available.
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✓
- December 4, 2015✓✓
- December 4, 2015
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✓
- December 4, 2015✓✓
- December 4, 2015
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✓✓
- November 1, 2019
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✓
- 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✓
- December 4, 2015
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✓✓
- December 4, 2015
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✓✓
- November 1, 2019
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✓
- December 4, 2015
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:
- October 17, 2011 - ADDITIONAL TIME POINT OF 30 MINUTES (0.5 HOUR) IN CHILDREN AGED 6-12 YEARS WITH A DIAGNOSIS OF ATTENTION-DEFICIT HYPERACTIVITY DISORDER (ADHD)
- October 23, 2012 - CHANGE TO REMOVE 20 MG MAXIMUM DOSAGE RESTRICTION
See also...
- Focalin XR Extended-Release Capsules Consumer Information (Wolters Kluwer)
- Focalin XR Consumer Information (Cerner Multum)
- Focalin XR Advanced Consumer Information (Micromedex)
- Dexmethylphenidate Consumer Information (Wolters Kluwer)
- Dexmethylphenidate Extended-Release Capsules Consumer Information (Wolters Kluwer)
- Dexmethylphenidate Consumer Information (Cerner Multum)
- Dexmethylphenidate Advanced Consumer Information (Micromedex)
- Dexmethylphenidate Hydrochloride AHFS DI Monographs (ASHP)
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