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Generic Qudexy XR Availability

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

QUDEXY XR (topiramate - capsule, extended release;oral)

  • Manufacturer: UPSHER-SMITH LABS
    Approval date: March 11, 2014
    Strength(s): 25MG, 50MG, 100MG, 150MG, 200MG [RLD]

Has a generic version of Qudexy XR been approved?

An Authorized Generic version of Qudexy XR has been approved. An Authorized Generic is a prescription drug that is produced by a brand company under a New Drug Application (NDA) and marketed as a generic under a private label. It is identical to the branded product in appearance, and unlike a generic, the Authorized Generic has exactly the same inactive ingredients.

List of authorized generic versions:

  • Topiramate ORAL CAPSULE, EXTENDED RELEASE 25 mg
    Upsher-Smith Laboratories, Inc.
    NDC Code: 008321071
  • Topiramate ORAL CAPSULE, EXTENDED RELEASE 50 mg
    Upsher-Smith Laboratories, Inc.
    NDC Code: 008321072
  • Topiramate ORAL CAPSULE, EXTENDED RELEASE 200 mg
    Upsher-Smith Laboratories, Inc.
    NDC Code: 008321073
  • Topiramate ORAL CAPSULE, EXTENDED RELEASE 100 mg
    Upsher-Smith Laboratories, Inc.
    NDC Code: 008321074
  • Topiramate ORAL CAPSULE, EXTENDED RELEASE 150 mg
    Upsher-Smith Laboratories, Inc.
    NDC Code: 008321075
  • Topiramate ORAL CAPSULE, EXTENDED RELEASE 100 mg
    REMEDYREPACK INC.
    NDC Code: 617860863

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

  • Extended-release topiramate capsules
    Patent 8,652,527
    Issued: February 18, 2014
    Assignee(s): Upsher-Smith Laboratories, Inc
    An extended-release topiramate capsule that includes a capsule shell containing a single population of coated particles; wherein each coated particle includes a core and a coating thereon; wherein each particle core includes a homogeneous mixture comprising topiramate throughout its core; and wherein the coating includes one or more release controlling agent(s).
    Patent expiration dates:
    • March 19, 2033
      ✓ 
      Drug product
  • Extended-release topiramate capsules
    Patent 8,889,190
    Issued: November 18, 2014
    Assignee(s): Upsher-Smith Laboratories, Inc.
    An extended-release topiramate capsule that includes a capsule shell containing a single population of coated particles; wherein each coated particle includes a core and a coating thereon; wherein each particle core includes a homogeneous mixture comprising topiramate throughout its core; and wherein the coating includes one or more release controlling agent(s).
    Patent expiration dates:
    • March 19, 2033
      ✓ 
      Drug product
  • Extended-release topiramate capsules
    Patent 9,101,545
    Issued: August 11, 2015
    Assignee(s): UPSHER-SMITH LABORATORIES, INC.
    An extended-release topiramate capsule that includes a capsule shell containing a single population of coated particles; wherein each coated particle includes a core and a coating thereon; wherein each particle core includes a homogeneous mixture comprising topiramate throughout its core; and wherein the coating includes one or more release controlling agent(s).
    Patent expiration dates:
    • March 19, 2033
      ✓ 
      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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