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Generic Adderall XR Availability

See also: Generic Adderall

Adderall XR is a brand name of amphetamine/dextroamphetamine, approved by the FDA in the following formulation(s):

ADDERALL XR 10 (amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate - capsule, extended release;oral)

  • Manufacturer: SHIRE
    Approval date: October 11, 2001
    Strength(s): 2.5MG;2.5MG;2.5MG;2.5MG [RLD] [AB]
  • Manufacturer: SHIRE
    Approval date: May 22, 2002
    Strength(s): 3.75MG;3.75MG;3.75MG;3.75MG [RLD] [AB]
  • Manufacturer: SHIRE
    Approval date: October 11, 2001
    Strength(s): 5MG;5MG;5MG;5MG [RLD] [AB]
  • Manufacturer: SHIRE
    Approval date: May 22, 2002
    Strength(s): 6.25MG;6.25MG;6.25MG;6.25MG [RLD] [AB]
  • Manufacturer: SHIRE
    Approval date: October 11, 2001
    Strength(s): 7.5MG;7.5MG;7.5MG;7.5MG [RLD] [AB]
  • Manufacturer: SHIRE
    Approval date: May 22, 2002
    Strength(s): 1.25MG;1.25MG;1.25MG;1.25MG [RLD] [AB]

Has a generic version of Adderall XR been approved?

A generic version of Adderall XR has been approved by the FDA. However, this does not mean that the product will necessarily be commercially available - possibly because of drug patents and/or drug exclusivity. The following products are equivalent to Adderall XR and have been approved by the FDA:

DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE (amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate capsule, extended release;oral)

  • Manufacturer: ACTAVIS ELIZABETH
    Approval date: June 22, 2012
    Strength(s): 1.25MG;1.25MG;1.25MG;1.25MG [AB], 2.5MG;2.5MG;2.5MG;2.5MG [AB], 3.75MG;3.75MG;3.75MG;3.75MG [AB], 5MG;5MG;5MG;5MG [AB], 6.25MG;6.25MG;6.25MG;6.25MG [AB], 7.5MG;7.5MG;7.5MG;7.5MG [AB]
  • Manufacturer: IMPAX LABS
    Approval date: February 16, 2016
    Strength(s): 1.25MG;1.25MG;1.25MG;1.25MG [AB], 2.5MG;2.5MG;2.5MG;2.5MG [AB], 3.75MG;3.75MG;3.75MG;3.75MG [AB], 5MG;5MG;5MG;5MG [AB], 6.25MG;6.25MG;6.25MG;6.25MG [AB], 7.5MG;7.5MG;7.5MG;7.5MG [AB]
  • Manufacturer: TEVA
    Approval date: April 29, 2013
    Strength(s): 1.25MG;1.25MG;1.25MG;1.25MG [AB], 2.5MG;2.5MG;2.5MG;2.5MG [AB], 3.75MG;3.75MG;3.75MG;3.75MG [AB], 5MG;5MG;5MG;5MG [AB], 6.25MG;6.25MG;6.25MG;6.25MG [AB], 7.5MG;7.5MG;7.5MG;7.5MG [AB]

DEXTROAMP SACCHARATE,AMP ASPARTATE,DEXTROAMP SULFATE AND AMP SULFATE (amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate capsule, extended release;oral)

  • Manufacturer: BARR LABS INC
    Approval date: February 12, 2013
    Strength(s): 1.25MG;1.25MG;1.25MG;1.25MG [AB], 2.5MG;2.5MG;2.5MG;2.5MG [AB], 3.75MG;3.75MG;3.75MG;3.75MG [AB], 5MG;5MG;5MG;5MG [AB], 6.25MG;6.25MG;6.25MG;6.25MG [AB], 7.5MG;7.5MG;7.5MG;7.5MG [AB]

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

  • Oral pulsed dose drug delivery system
    Patent 6,322,819
    Issued: November 27, 2001
    Inventor(s): Burnside; Beth A. & Guo; Xiaodi & Fiske; Kimberly & Couch; Richard A. & Treacy; Donald J. & Chang; Rong-Kun & McGuinness; Charlotte & Rudnic; Edward M.
    Assignee(s): Shire Laboratories, Inc.

    A multiple pulsed dose drug delivery system for pharmaceutically active amphetamine salts, comprising an immediate-release component and an enteric delayed-release component wherein (1) the enteric release coating has a defined minimum thickness and/or (2) there is a protective layer between the pharmaceutically active amphetamine salt and the enteric release coating and/or (3) there is a protective layer over the enteric release coating. The product can be composed of either one or a number of beads in a dosage form, including either capsule, tablet, or sachet method for administering the beads.

    Patent expiration dates:

    • October 21, 2018
    • April 21, 2019
      ✓ 
      Pediatric exclusivity
  • Oral pulsed dose drug delivery system
    Patent 6,605,300
    Issued: August 12, 2003
    Inventor(s): Beth A.; Burnside & Xiaodi; Guo & Kimberly; Fiske & Richard A.; Couch & Donald J.; Treacy & Rong-Kun; Chang & Charlotte M.; McGuinness & Edward M.; Rudnic
    Assignee(s): Shire Laboratories, Inc.

    A multiple pulsed dose drug delivery system for pharmaceutically active amphetamine salts, comprising an immediate-release component and an enteric delayed-release component wherein (1) the enteric release coating has a defined minimum thickness and/or (2) there is a protective layer between the pharmaceutically active amphetamine salt and the enteric release coating and/or (3) there is a protective layer over the enteric release coating. The product can be composed of either one or a number of beads in a dosage form, including either capsule, tablet, or sachet method for administering the beads.

    Patent expiration dates:

    • October 21, 2018
    • April 21, 2019
      ✓ 
      Pediatric exclusivity
  • Oral pulsed dose drug delivery system
    Patent RE41148
    Issued: February 23, 2010
    Inventor(s): Burnside; Beth A. & Guo; Xiaodi & Fiske; Kimberly & Couch; Richard A. & Treacy; Donald J. & Chang; Rong-Kun & Rudnic; Edward M. & McGuinness; Charlotte M.
    Assignee(s): Shire Laboratories, Inc.

    A multiple pulsed dose drug delivery system for pharmaceutically active amphetamine salts, comprising an immediate-release component and an enteric delayed-release component wherein (1) the enteric release coating has a defined minimum thickness and/or (2) there is a protective layer between the pharmaceutically active amphetamine salt and the enteric release coating and/or (3) there is a protective layer over the enteric release coating. The product can be composed of either one or a number of beads in a dosage form, including either capsule, tablet, or sachet method for administering the beads.

    Patent expiration dates:

    • October 21, 2018
      ✓ 
      Drug product
    • April 21, 2019
      ✓ 
      Pediatric exclusivity
  • Oral pulsed dose drug delivery system
    Patent RE42096
    Issued: February 1, 2011
    Inventor(s): Burnside; Beth A. & Guo; Xiaodi & Fiske; Kimberly & Couch; Richard A. & Chang; Rong-Kun & Treacy; Donald J. & McGuiness; Charlotte M. & Rudnic; Edward M.
    Assignee(s): Shire LLC, USA

    A multiple pulsed dose drug delivery system for pharmaceutically active amphetamine salts, comprising an immediate-release component and an enteric delayed-release component wherein (1) the enteric release coating has a defined minimum thickness and/or (2) there is a protective layer between the pharmaceutically active amphetamine salt and the enteric release coating and/or (3) there is a protective layer over the enteric release coating. The product can be composed of either one of a number of beads in a dosage form, including either capsule, tablet, or sachet method for administering the beads.

    Patent expiration dates:

    • October 21, 2018
      ✓ 
      Drug product
    • April 21, 2019
      ✓ 
      Pediatric exclusivity

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.
ABProducts meeting necessary bioequivalence requirements. Multisource drug products listed under the same heading (i.e., identical active ingredients(s), dosage form, and route(s) of administration) and having the same strength (see Therapeutic Equivalence-Related Terms, Pharmaceutical Equivalents) generally will be coded AB if a study is submitted demonstrating bioequivalence. In certain instances, a number is added to the end of the AB code to make a three character code (i.e., AB1, AB2, AB3, etc.). Three-character codes are assigned only in situations when more than one reference listed drug of the same strength has been designated under the same heading. Two or more reference listed drugs are generally selected only when there are at least two potential reference drug products which are not bioequivalent to each other. If a study is submitted that demonstrates bioequivalence to a specific listed drug product, the generic product will be given the same three-character code as the reference listed drug it was compared against.
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