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Generic Cotempla XR-ODT Availability

Cotempla XR-ODT is a brand name of methylphenidate, approved by the FDA in the following formulation(s):

COTEMPLA XR-ODT (methylphenidate - tablet, orally disintegrating, extended release;oral)

  • Manufacturer: NEOS THERAPS INC
    Approval date: June 19, 2017
    Strength(s): 8.6MG [RLD], 17.3MG [RLD], 25.9MG [RLD]

Has a generic version of Cotempla XR-ODT been approved?

No. There is currently no therapeutically equivalent version of Cotempla XR-ODT available in the United States.

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Cotempla XR-ODT. 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: Generic Drug FAQs.

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.

  • Compositions and methods of making rapidly dissolving ionically masked formulations
    Patent 8,840,924
    Issued: September 23, 2014
    Assignee(s): NEOS Therapeutics, LP

    The present invention includes compositions and methods for reduce the taste of the drug in the drug resin complex. The composition may include one or more drug-resin complexes and a highly compressible, free-flowing pharmaceutical excipient. The resin is present in an amount effective to reduce the taste of the drug in the drug resin complex relative to an otherwise identical pharmaceutical composition without the resin; and wherein the highly compressible, free-flowing pharmaceutical excipient causes release of the drug-resin complex in the mouth.

    Patent expiration dates:

    • June 5, 2026
      ✓ 
      Drug product
  • Compositions comprising methylphenidate complexed with ion-exchange resin particles
    Patent 9,072,680
    Issued: July 7, 2015
    Assignee(s): NEOS THERAPEUTICS, LLP

    Pharmaceutical compositions of methylphenidate complexed with ion-exchange resin particles to form drug-resin particles are provided. The compositions have a first plurality of drug-resin particles that are uncoated and a second plurality of drug-resin particles that are coated with a delayed release coating. Preferably, the second plurality of drug-resin particles are coated with a triggered-release coating triggered by a pH change and a diffusion barrier coating.

    Patent expiration dates:

    • June 28, 2032
      ✓ 
      Drug product
  • Compositions comprising methylphenidate complexed with ion-exchange resin particles
    Patent 9,089,496
    Issued: July 28, 2015
    Assignee(s): NEOS THERAPEUTICS, LP

    Pharmaceutical compositions of methylphenidate complexed with ion-exchange resin particles to form drug-resin particles are provided. The compositions have a first plurality of drug-resin particles that are uncoated and a second plurality of drug-resin particles that are coated with a delayed release coating.

    Patent expiration dates:

    • June 28, 2032
      ✓ 
      Drug product

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:

    • June 19, 2020 - NEW PRODUCT

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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.
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