Generic Methylin Availability

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

METHYLIN (methylphenidate hydrochloride - solution;oral)

  • Manufacturer: MALLINCKRODT
    Approval date: December 19, 2002
    Strength(s): 5MG/5ML [RLD] [AA], 10MG/5ML [RLD] [AA]

METHYLIN (methylphenidate hydrochloride - tablet, chewable;oral)

  • Manufacturer: MALLINCKRODT
    Approval date: April 15, 2003
    Strength(s): 2.5MG, 5MG, 10MG [RLD]

Has a generic version of Methylin been approved?

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

methylphenidate hydrochloride solution;oral

  • Manufacturer: SUN PHARM INDS INC
    Approval date: November 12, 2013
    Strength(s): 5MG/5ML [AA], 10MG/5ML [AA]
  • Manufacturer: TRIS PHARMA INC
    Approval date: July 23, 2010
    Strength(s): 5MG/5ML [AA], 10MG/5ML [AA]

Note: No generic formulation of the following product is available.

  • methylphenidate hydrochloride - tablet, chewable;oral

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Methylin. 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 solution and associated methods of administration and production
    Patent 7,691,880
    Issued: April 6, 2010
    Inventor(s): Herman; Clifford J.
    Assignee(s): Mallinckrodt Inc.
    A methylphenidate solution and associated methods of administration and production, which includes methylphenidate and at least one organic acid dissolved in a solvent system, where the solvent system includes at least one non-aqueous solvent. The solvent system may include water. The non-aqueous solvent can include, but is not limited to polyols and glycols and associated mixtures thereof. Pharmaceutical additives such as flavorings, colorants, buffers, preservatives and mixtures thereof may be optionally added to the methylphenidate solution.
    Patent expiration dates:
    • October 7, 2024
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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.
AAProducts in conventional dosage forms not presenting bioequivalence problems. Products coded as AA contain active ingredients and dosage forms that are not regarded as presenting either actual or potential bioequivalence problems or drug quality or standards issues. However, all oral dosage forms must, nonetheless, meet an appropriate in vitro bioequivalence standard that is acceptable to the Agency in order to be approved.
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