Generic Concerta Availability

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

CONCERTA (methylphenidate hydrochloride - tablet, extended release; oral)

  • Manufacturer: JANSSEN PHARMS
    Approval date: August 1, 2000
    Strength(s): 18MG, 36MG [AB]
  • Manufacturer: JANSSEN PHARMS
    Approval date: December 8, 2000
    Strength(s): 54MG [RLD] [AB]
  • Manufacturer: JANSSEN PHARMS
    Approval date: April 1, 2002
    Strength(s): 27MG [AB]

Has a generic version of Concerta been approved?

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

methylphenidate hydrochloride tablet, extended release; oral

  • Manufacturer: MALLINCKRODT INC
    Approval date: December 28, 2012
    Strength(s): 27MG [AB], 36MG [AB], 54MG [AB]

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

  • Methods and devices for providing prolonged drug therapy
    Patent 6,919,373
    Issued: July 19, 2005
    Inventor(s): Lam; Andrew C. & Shivanand; Padmaja & Ayer; Atul D. & Weyers; Richard G. & Gupta; Suneel K. & Guinta; Diane R. & Christopher; Carol A. & Saks; Samuel R. & Hamel; Lawrence G. & Wright; Jeri D. & Hatamkhany; Zahedeh
    Assignee(s): Alza Corporation
    Methods and devices for maintaining a desired therapeutic drug effect over a prolonged therapy period are provided. In particular, oral dosage forms that release drug within the gastrointestinal tract at an ascending release rate over an extended time period are provided. The dosage forms may additionally comprise an immediate-release dose of drug.
    Patent expiration dates:
    • July 31, 2017
      ✓ 
      Patent use: METHOD OF TREATING ADHD
    • January 31, 2018
      ✓ 
      Pediatric exclusivity
  • Methods and devices for providing prolonged drug therapy
    Patent 6,930,129
    Issued: August 16, 2005
    Inventor(s): Lam; Andrew C. & Shivanand; Padmaja & Ayer; Atul D. & Hatamkhany; Zahedeh & Gupta; Suneel K. & Guinta; Diane R. & Christopher; Carol A. & Saks; Samuel R. & Hamel; Lawrence G. & Wright; Jeri D. & Weyers; Richard G.
    Assignee(s): Alza Corporation
    Methods and devices for maintaining a desired therapeutic drug effect over a prolonged therapy period are provided. In particular, oral dosage forms that release drug within the gastrointestinal tract at an ascending release rate over an extended time period are provided. The dosage forms may additionally comprise an immediate-release dose of drug.
    Patent expiration dates:
    • July 31, 2017
      ✓ 
      Patent use: METHOD OF TREATING ADHD
    • January 31, 2018
      ✓ 
      Pediatric exclusivity
  • Methods and devices for providing prolonged drug therapy
    Patent 8,163,798
    Issued: April 24, 2012
    Inventor(s): Gupta; Suneel K. & Guinta; Diane R. & Christopher; Carol A. & Saks; Samuel R. & Hamel; Lawrence G.
    Assignee(s): Alza Corporation
    Methods and devices for maintaining a desired therapeutic drug effect over a prolonged therapy period are provided. In particular, oral dosage forms that release drug within the gastrointestinal tract at an ascending release rate over an extended time period are provided. The dosage forms may additionally comprise an immediate-release dose of drug.
    Patent expiration dates:
    • July 31, 2017
      ✓ 
      Drug product
    • January 31, 2018
      ✓ 
      Pediatric exclusivity

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:
    • November 4, 2012 - ADDITION OF INFORMATION REGARDING ABUSE POTENTIAL OF CONCERTA VERSUS IMMEDIATE-RELEASE METHYLPHENIDATE

See also...

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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