Generic Metadate CD Availability

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

METADATE CD (methylphenidate hydrochloride - capsule, extended release;oral)

  • Manufacturer: UCB INC
    Approval date: April 3, 2001
    Strength(s): 20MG [AB2]
  • Manufacturer: UCB INC
    Approval date: May 27, 2003
    Strength(s): 10MG [AB2]
  • Manufacturer: UCB INC
    Approval date: June 19, 2003
    Strength(s): 30MG [AB2]
  • Manufacturer: UCB INC
    Approval date: February 19, 2006
    Strength(s): 40MG [AB2], 50MG [AB2], 60MG [RLD] [AB2]

Has a generic version of Metadate CD been approved?

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

methylphenidate hydrochloride capsule, extended release;oral

  • Manufacturer: TEVA PHARMS
    Approval date: July 19, 2012
    Strength(s): 10MG [AB2], 20MG [AB2], 30MG [AB2], 40MG [AB2], 50MG [AB2], 60MG [AB2]

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

  • Methylphenidate modified release formulations
    Patent 6,344,215
    Issued: February 5, 2002
    Inventor(s): Marie J.; Bettman & Phillip J.; Percel & Dan L.; Hensley & Krishna S.; Vishnupad & Gopi M.; Venkatesh
    Assignee(s): Eurand America, Inc.
    A pharmaceutical MR (modified release) multiparticulate dosage form such as a capsule (once-a-day MR Capsule) of Methylphenidate indicated for the treatment of children with attention deficit hyperactivity disorder (ADHD), capable of delivering a portion of the dose for rapid onset of action and the remainder of the dose in a controlled manner for about 12 hours, is composed of a multitude of multicoated particles made of two populations of drug layered beads, IR (immediate release) and ER (extended release) Beads. The IR beads preferably are made by layering an aqueous solution comprising a drug and a binder on to non-pareil sugar spheres and then applying a seal coat to the drug coated cores. The ER Beads are made by applying an extended release coating of a water insoluble dissolution rate controlling polymer such as ethylcellulose to IR Beads. The MR Capsules are manufactured by filling IR and ER Beads in a proper ratio; the dose and the ratio required for an efficacious, cost effective and patient compliant treatment of children with ADHD were determined from extensive clinical investigations and in vitro- in vivo correlations performed as per FDA Guidelines, Guidance for Industry: Extended Release Oral Dosage Forms.
    Patent expiration dates:
    • October 27, 2020
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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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