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Generic Adzenys XR-ODT Availability

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

ADZENYS XR-ODT (amphetamine - tablet, orally disintegrating, extended release;oral)

  • Manufacturer: NEOS THERAPS
    Approval date: January 27, 2016
    Strength(s): EQ 3.1MG BASE, EQ 6.3MG BASE, EQ 9.4MG BASE, EQ 12.5MG BASE, EQ 15.7MG BASE, EQ 18.8MG BASE [RLD]

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

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

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

  • Composition comprising a mixture of dextro- and levo-amphetamines complexed with ion-exchange resin particles to form drug resin particles
    Patent 8,709,491
    Issued: April 29, 2014
    Assignee(s): NEOS Terapeutics, LP
    The invention relates to dosage forms that provide prolonged therapy. In particular, the invention relates to dosage forms including various pluralities of drug-containing resin particles. In a particular embodiment, the drug dosage form comprises a mixture of dextro- and levo-amphetamines complexed with ion-exchange resin particles to form drug resin particles. The invention also relates to methods of making these dosage forms and methods of treating using these dosage forms.
    Patent expiration dates:
    • June 28, 2032
      ✓ 
      Drug product
  • 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:
    • April 9, 2026
      ✓ 
      Drug product
  • Composition comprising a mixture of dextro- and levo-amphetamines complexed with ion-exchange resin particles to form drug resin particles
    Patent 9,017,731
    Issued: April 28, 2015
    Assignee(s): Neos Therapeutics, LP
    The invention relates to dosage forms that provide prolonged therapy. In particular, the invention relates to dosage forms including various pluralities of drug-containing resin particles. In a particular embodiment, the drug dosage form comprises a mixture of dextro- and levo-amphetamines complexed with ion-exchange resin particles to form drug resin particles. The invention also relates to methods of making these dosage forms and methods of treating using these dosage forms.
    Patent expiration dates:
    • June 28, 2032
      ✓ 
      Drug product
  • Pharmaceutical composition comprising amphetamines complexed with ion-exchange resin particles
    Patent 9,265,737
    Issued: February 23, 2016
    Assignee(s): NEOS THERAPEUTICS, LP
    The invention relates to a pharmaceutical composition comprising amphetamines complexed with ion-exchanged resin particles to form drug-resin particles. The composition provides for prolonged therapy.
    Patent expiration dates:
    • June 28, 2032
      ✓ 
      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.
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