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Generic Adhansia XR Availability

Medically reviewed by Drugs.com. Last updated on May 11, 2021.

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

ADHANSIA XR (methylphenidate hydrochloride - capsule, extended release;oral)

Has a generic version of Adhansia XR been approved?

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

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

  • Methods and compositions particularly for treatment of attention deficit disorder
    Patent 10,111,839
    Issued: October 30, 2018
    Assignee(s): Purdue Pharma

    There is described, inter alia, a coated bead comprising: (a) a granule; (b) a first layer coated over the granule, the first layer comprising a first amount of an active pharmaceutical ingredient comprising a central nervous system stimulant; and (c) a second layer coated over the first layer, the second layer being present in an amount sufficient to substantially delay release of the active pharmaceutical ingredient in the first layer until after the coated bead reaches a distal intestine portion of a subject to whom the coated bead is administered; and (d) the third layer coated over the second layer, the third layer comprising a second amount of the active pharmaceutical ingredient, the third layer being configured to permit substantially immediate release of the active pharmaceutical ingredient comprised therein. Embodiments related to a solid oral pharmaceutical composition are also described.

    Patent expiration dates:

    • October 30, 2035
      ✓ 
      Patent use: METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
  • Methods and compositions particularly for treatment of attention deficit disorder
    Patent 10,292,938
    Issued: May 21, 2019
    Assignee(s): Purdue Pharma L.P.

    There is described, inter alia, a coated bead comprising: (a) a granule; (b) a first layer coated over the granule, the first layer comprising a first amount of an active pharmaceutical ingredient comprising a central nervous system stimulant; and (c) a second layer coated over the first layer, the second layer being present in an amount sufficient to substantially delay release of the active pharmaceutical ingredient in the first layer until after the coated bead reaches a distal intestine portion of a subject to whom the coated bead is administered; and (d) the third layer coated over the second layer, the third layer comprising a second amount of the active pharmaceutical ingredient, the third layer being configured to permit substantially immediate release of the active pharmaceutical ingredient comprised therein. Embodiments related to a solid oral pharmaceutical composition are also described.

    Patent expiration dates:

    • October 30, 2035
      ✓ 
      Drug product
  • Methods and compositions particularly for treatment of attention deficit disorder
    Patent 10,292,939
    Issued: May 21, 2019
    Assignee(s): Purdue Pharma L.P.

    There is described, inter alia, a coated bead comprising: (a) a granule; (b) a first layer coated over the granule, the first layer comprising a first amount of an active pharmaceutical ingredient comprising a central nervous system stimulant; and (c) a second layer coated over the first layer, the second layer being present in an amount sufficient to substantially delay release of the active pharmaceutical ingredient in the first layer until after the coated bead reaches a distal intestine portion of a subject to whom the coated bead is administered; and (d) the third layer coated over the second layer, the third layer comprising a second amount of the active pharmaceutical ingredient, the third layer being configured to permit substantially immediate release of the active pharmaceutical ingredient comprised therein. Embodiments related to a solid oral pharmaceutical composition are also described.

    Patent expiration dates:

    • October 30, 2035
      ✓ 
      Patent use: METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
      ✓ 
      Drug product
  • Patent 10,449,159

    Patent expiration dates:

    • October 30, 2035
      ✓ 
      Patent use: METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
  • Patent 10,500,162

    Patent expiration dates:

    • October 30, 2035
      ✓ 
      Patent use: METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
  • Patent 10,507,186

    Patent expiration dates:

    • October 30, 2035
      ✓ 
      Drug product
  • Methods and compositions particularly for treatment of attention deficit disorder
    Patent 10,512,612
    Issued: December 24, 2019
    Assignee(s): PURDUE PHARMA L.P.

    There is described, inter alia, a coated bead comprising: (a) a granule; (b) a first layer coated over the granule, the first layer comprising a first amount of an active pharmaceutical ingredient comprising a central nervous system stimulant; and (c) a second layer coated over the first layer, the second layer being present in an amount sufficient to substantially delay release of the active pharmaceutical ingredient in the first layer until after the coated bead reaches a distal intestine portion of a subject to whom the coated bead is administered; and (d) the third layer coated over the second layer, the third layer comprising a second amount of the active pharmaceutical ingredient, the third layer being configured to permit substantially immediate release of the active pharmaceutical ingredient comprised therein. Embodiments related to a solid oral pharmaceutical composition are also described.

    Patent expiration dates:

    • October 30, 2035
      ✓ 
      Drug product
  • Methods and compositions particularly for treatment of attention deficit disorder
    Patent 10,512,613
    Issued: December 24, 2019
    Assignee(s): PURDUE PHARMA L.P.

    There is described, inter alia, a coated bead comprising: (a) a granule; (b) a first layer coated over the granule, the first layer comprising a first amount of an active pharmaceutical ingredient comprising a central nervous system stimulant; and (c) a second layer coated over the first layer, the second layer being present in an amount sufficient to substantially delay release of the active pharmaceutical ingredient in the first layer until after the coated bead reaches a distal intestine portion of a subject to whom the coated bead is administered; and (d) the third layer coated over the second layer, the third layer comprising a second amount of the active pharmaceutical ingredient, the third layer being configured to permit substantially immediate release of the active pharmaceutical ingredient comprised therein. Embodiments related to a solid oral pharmaceutical composition are also described.

    Patent expiration dates:

    • October 30, 2035
      ✓ 
      Patent use: METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
  • Patent 10,568,841

    Patent expiration dates:

    • October 30, 2035
      ✓ 
      Patent use: METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
      ✓ 
      Drug product
  • Patent 10,688,060

    Patent expiration dates:

    • October 30, 2035
      ✓ 
      Drug product
  • Patent 10,722,473

    Patent expiration dates:

    • November 19, 2038
      ✓ 
      Patent use: METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
  • Methods and compositions particularly for treatment of attention deficit disorder
    Patent 9,974,752
    Issued: May 22, 2018
    Assignee(s): PURDUE PHARMA

    There is described, inter alia, a coated bead comprising: (a) a granule; (b) a first layer coated over the granule, the first layer comprising a first amount of an active pharmaceutical ingredient comprising a central nervous system stimulant; and (c) a second layer coated over the first layer, the second layer being present in an amount sufficient to substantially delay release of the active pharmaceutical ingredient in the first layer until after the coated bead reaches a distal intestine portion of a subject to whom the coated bead is administered; and (d) the third layer coated over the second layer, the third layer comprising a second amount of the active pharmaceutical ingredient, the third layer being configured to permit substantially immediate release of the active pharmaceutical ingredient comprised therein. Embodiments related to a solid oral pharmaceutical composition are also described.

    Patent expiration dates:

    • October 30, 2035
      ✓ 
      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:

    • February 27, 2022 - 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.