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Generic Jornay PM Availability

Last updated on Aug 11, 2021.

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

JORNAY PM (methylphenidate hydrochloride - capsule, extended release;oral)

  • Manufacturer: IRONSHORE PHARMS
    Approval date: August 8, 2018
    Strength(s): 20MG [RLD], 40MG [RLD], 60MG [RLD], 80MG [RLD], 100MG [RLD]

Has a generic version of Jornay PM been approved?

No. There is currently no therapeutically equivalent version of Jornay PM available in the United States.

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Jornay PM. 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 FAQ.

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 for treatment of attention deficit hyperactivity disorder
    Patent 10,182,995
    Issued: January 22, 2019
    Assignee(s): IRONSHORE PHARMACEUTICALS & DEVELOPMENT, INC.

    Therapeutic compositions deliver a therapeutic amount of methylphenidate in a delayed and extended release formulation. The dosage form exhibits a lag time prior to release of from 6 to 8 hours or longer, followed by a sustained release period.

    Patent expiration dates:

    • March 23, 2032
      ✓ 
      Drug product
  • Methods of treatment of attention deficit hyperactivity disorder
    Patent 10,292,937
    Issued: May 21, 2019
    Assignee(s): IRONSHORE PHARMACEUTICALS & DEVELOPMENT, INC.

    Therapeutic compositions and methods for treatment of attention deficit disorder (ADD) or attention deficit hyperactivity disorder (ADHD) include dosage forms that deliver a therapeutic amount of active drug in a delayed and controlled release formulation. The dosage form can be administered at night and drug release is delayed for from 5 to 7 hours or longer, followed by an ascending release rate. When administered at night the composition provides early morning improvement in symptoms of ADHD and sustained improvement over a period of at least 12 hours.

    Patent expiration dates:

    • March 23, 2032
      ✓ 
      Patent use: METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
  • Patent 10,617,651

    Patent expiration dates:

    • March 23, 2032
      ✓ 
      Patent use: METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
  • Patent 10,881,618

    Patent expiration dates:

    • March 23, 2032
      ✓ 
      Patent use: METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
  • Patent 10,905,652

    Patent expiration dates:

    • March 23, 2032
      ✓ 
      Drug product
  • Methods for treatment of attention deficit hyperactivity disorder
    Patent 8,916,588
    Issued: December 23, 2014
    Assignee(s): Ironshore Pharmaceuticals & Development, Inc.

    Therapeutic compositions and methods for treatment of attention deficit disorder (ADD) or attention deficit hyperactivity disorder (ADHD) include dosage forms that deliver a therapeutic amount of active drug in a delayed and controlled release formulation. The dosage form can be administered at night and drug release is delayed for from 4 to 6 hours or longer, followed by an ascending release rate.

    Patent expiration dates:

    • March 23, 2032
      ✓ 
      Patent use: METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
  • Compositions for treatment of attention deficit hyperactivity disorder
    Patent 8,927,010
    Issued: January 6, 2015
    Assignee(s): Ironshore Pharmaceuticals & Development, Inc.

    Therapeutic compositions and methods for treatment of attention deficit disorder (ADD) or attention deficit hyperactivity disorder (ADHD) include dosage forms that deliver a therapeutic amount of active drug in a delayed and controlled release formulation. The dosage form can be administered at night and drug release is delayed for from 4 to 6 hours or longer, followed by an ascending release rate.

    Patent expiration dates:

    • March 23, 2032
      ✓ 
      Drug product
  • Compositions for treatment of attention deficit hyperactivity disorder
    Patent 9,023,389
    Issued: May 5, 2015
    Assignee(s): Ironshore Pharmaceuticals & Development, Inc.

    Therapeutic compositions and methods for treatment of attention deficit disorder (ADD) or attention deficit hyperactivity disorder (ADHD) include dosage forms that deliver a therapeutic amount of active drug in a delayed and controlled release formulation. The dosage form can be administered at night and drug release is delayed for from 4 to 6 hours or longer, followed by an ascending release rate.

    Patent expiration dates:

    • March 23, 2032
      ✓ 
      Drug product
  • Methods and compositions for treatment of attention deficit disorder
    Patent 9,028,868
    Issued: May 12, 2015
    Assignee(s): Ironshore Pharmaceuticals & Development, Inc.

    Therapeutic compositions and methods for treatment of attention deficit disorder (ADD) or attention deficit hyperactivity disorder (ADHD) include dosage forms that deliver a therapeutic amount of active drug in a delayed and controlled release formulation. The dosage form can be administered at night and drug release is delayed for from 3 to 8 hours, followed by an ascending release rate.

    Patent expiration dates:

    • March 23, 2032
      ✓ 
      Patent use: METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
  • Methods for treatment of attention deficit hyperactivity disorder
    Patent 9,034,902
    Issued: May 19, 2015
    Assignee(s): Ironshore Pharmaceuticals & Development, Inc.

    Therapeutic compositions and methods for treatment of attention deficit disorder (ADD) or attention deficit hyperactivity disorder (ADHD) include dosage forms that deliver a therapeutic amount of active drug in a delayed and controlled release formulation. The dosage form can be administered at night and drug release is delayed for from 4 to 6 hours or longer, followed by an ascending release rate.

    Patent expiration dates:

    • March 23, 2032
      ✓ 
      Patent use: METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
  • Compositions for treatment of attention deficit hyperactivity disorder
    Patent 9,283,214
    Issued: March 15, 2016
    Assignee(s): Ironshore Pharmaceuticals & Development, Inc.

    Therapeutic compositions and methods for treatment of attention deficit disorder (ADD) or attention deficit hyperactivity disorder (ADHD) include dosage forms that deliver a therapeutic amount of active drug in a delayed and controlled release formulation. The dosage form can be administered at night and drug release is delayed for from 4 to 6 hours or longer, followed by an ascending release rate.

    Patent expiration dates:

    • March 23, 2032
      ✓ 
      Drug product
  • Compositions for treatment of attention deficit hyperactivity disorder
    Patent 9,498,447
    Issued: November 22, 2016
    Assignee(s): Ironshore Pharmaceuticals & Development, Inc.

    Therapeutic compositions deliver a therapeutic amount of methylphenidate in a delayed and extended release formulation. The dosage form exhibits a lag time prior to release of from 6 to 8 hours or longer, followed by a sustained release period.

    Patent expiration dates:

    • March 23, 2032
      ✓ 
      Drug product
  • Methods of treatment of attention deficit hyperactivity disorder
    Patent 9,603,809
    Issued: March 28, 2017
    Assignee(s): Ironshore Pharmaceuticals & Development, Inc.

    Therapeutic compositions and methods for treatment of attention deficit disorder (ADD) or attention deficit hyperactivity disorder (ADHD) include dosage forms that deliver a therapeutic amount of active drug in a delayed and controlled release formulation. The dosage form can be administered at night and drug release is delayed for from 5 to 7 hours or longer, followed by an ascending release rate. When administered at night the composition provides early morning improvement in symptoms of ADHD and sustained improvement over a period of at least 12 hours.

    Patent expiration dates:

    • March 23, 2032
      ✓ 
      Patent use: METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)

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:

    • August 8, 2021 - NEW PRODUCT

Glossary

Term Definition
Drug Patent A 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 Exclusivity Exclusivity 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.
RLD A 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.

Further information

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