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Generic Aptensio XR Availability

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

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

  • Manufacturer: RHODES PHARMS
    Approval date: April 17, 2015
    Strength(s): 10MG, 15MG, 20MG, 30MG, 40MG, 50MG, 60MG [RLD]

Has a generic version of Aptensio XR been approved?

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

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

  • Controlled release formulations having rapid onset and rapid decline of effective plasma drug concentrations
    Patent 6,419,960
    Issued: July 16, 2002
    Inventor(s): Thinnayam N.; Krishnamurthy & Andrew; Darke
    Assignee(s): Euro-Celtique S.A.
    The invention is directed to oral modified/controlled release drug formulations which provide a rapid initial onset of effect and a prolonged duration of effect. Preferably, the peak concentration is lower than that provided by the reference standard for immediate release formulations of the drug, and the duration of effect falls rapidly at the end of the dosing interval.
    Patent expiration dates:
    • December 16, 2019
      ✓ 
      Drug product
  • Controlled/modified release oral methylphenidate formulations
    Patent 7,083,808
    Issued: August 1, 2006
    Inventor(s): Goldenheim; Paul D. & Sackler; Richard S. & Krishnamurthy; Thinnayam N. & Darke; Andrew & Oshlaci; Benjamin
    Assignee(s): Euro-Celtique S.A.
    The invention is directed to oral modified/controlled release methylphenidate formulations which provide a rapid initial onset of effect and a prolonged duration of effect. Preferably, the peak concentration is lower than that provided by the reference standard for immediate release methylphenidate formulations, and the duration of effect falls rapidly at the end of the dosing interval so as not to affect the appetite of the patient at dinner nor the patient's sleep thereafter.
    Patent expiration dates:
    • December 16, 2019
      ✓ 
      Drug product
  • Controlled release formulations having rapid onset and rapid decline of effective plasma drug concentrations
    Patent 7,247,318
    Issued: July 24, 2007
    Inventor(s): Krishnamurthy; Thinnayam N. & Darke; Andrew
    Assignee(s): Purdue Pharma
    The invention is directed to oral modified/controlled release drug formulations which provide a rapid initial onset of effect and a prolonged duration of effect. Preferably, the peak concentration is lower than that provided by the reference standard for immediate release formulations of the drug, and the duration of effect falls rapidly at the end of the dosing interval.
    Patent expiration dates:
    • December 16, 2019
      ✓ 
      Drug product
  • Controlled release formulations having rapid onset and rapid decline of effective plasma drug concentrations
    Patent 7,438,930
    Issued: October 21, 2008
    Inventor(s): Krishnamurthy; Thinnayam N. & Darke; Andrew
    Assignee(s): Purdue Pharma
    The invention is directed to oral modified/controlled release drug formulations which provide a rapid initial onset of effect and a prolonged duration of effect. Preferably, the peak concentration is lower than that provided by the reference standard for immediate release formulations of the drug, and the duration of effect falls rapidly at the end of the dosing interval.
    Patent expiration dates:
    • December 16, 2019
      ✓ 
      Drug product
      ✓ 
      Sponsor has requested patent be delisted
  • Controlled release formulations having rapid onset and rapid decline of effective plasma drug concentrations
    Patent 8,580,310
    Issued: November 12, 2013
    Assignee(s): Purdue Pharma
    The invention is directed to oral modified/controlled release drug formulations which provide a rapid initial onset of effect and a prolonged duration of effect. Preferably, the peak concentration is lower than that provided by the reference standard for immediate release formulations of the drug, and the duration of effect falls rapidly at the end of the dosing interval.
    Patent expiration dates:
    • December 16, 2019
      ✓ 
      Drug product
  • Controlled release formulations having rapid onset and rapid decline of effective plasma drug concentrations
    Patent 9,066,869
    Issued: June 30, 2015
    Assignee(s): Purdue Pharma
    The invention is directed to oral modified/controlled release drug formulations which provide a rapid initial onset of effect and a prolonged duration of effect. Preferably, the peak concentration is lower than that provided by the reference standard for immediate release formulations of the drug, and the duration of effect falls rapidly at the end of the dosing interval.
    Patent expiration dates:
    • December 16, 2019
      ✓ 
      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:
    • April 17, 2018 - NEW 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.
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