Monday, October 24, 2016

Keppra XR


See also: Generic Keppra


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


KEPPRA XR (levetiracetam - tablet, extended release; oral)



  • Manufacturer: UCB INC

    Approval date: September 12, 2008

    Strength(s): 500MG [AB]


  • Manufacturer: UCB INC

    Approval date: February 12, 2009

    Strength(s): 750MG [RLD][AB]

Has a generic version of Keppra XR been approved?


A generic version of Keppra 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 Keppra XR and have been approved by the FDA:


levetiracetam tablet, extended release; oral



  • Manufacturer: ACTAVIS ELIZABETH

    Approval date: September 12, 2011

    Strength(s): 500MG [AB], 750MG [AB]


  • Manufacturer: ANCHEN PHARMS

    Approval date: October 4, 2011

    Strength(s): 500MG [AB], 750MG [AB]


  • Manufacturer: APOTEX INC

    Approval date: September 12, 2011

    Strength(s): 500MG [AB], 750MG [AB]


  • Manufacturer: LUPIN LTD

    Approval date: September 12, 2011

    Strength(s): 500MG [AB], 750MG [AB]


  • Manufacturer: MUTUAL PHARM CO INC

    Approval date: September 12, 2011

    Strength(s): 500MG [AB], 750MG [AB]


  • Manufacturer: MYLAN PHARMS INC

    Approval date: December 19, 2011

    Strength(s): 500MG [AB], 750MG [AB]


  • Manufacturer: PAR PHARM

    Approval date: September 12, 2011

    Strength(s): 500MG [AB], 750MG [AB]


  • Manufacturer: TEVA PHARMS

    Approval date: September 12, 2011

    Strength(s): 500MG [AB], 750MG [AB]


  • Manufacturer: WATSON LABS FLORIDA

    Approval date: September 12, 2011

    Strength(s): 500MG [AB], 750MG [AB]

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Keppra 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 formulation of levetiracetam
    Patent 7,858,122
    Issued: December 28, 2010
    Inventor(s): Kshirsagar; Rajesh & Joshi; Mayank & Raichandani; Yogesh
    Assignee(s): UCB Pharma S.A.
    An extended release pharmaceutical composition of Levetiracetam with once a day dosage regime and the process of preparing it. The extended release tablet of Levetiracetam is with the core comprising of Levetiracetam and water dispersible rate controlling polymer, and the tablet core is optionally functional coated comprising a combination of water non-dispersible and/or water dispersible polymer. It provides extended therapeutically effective plasma levels over a twenty four hour period with diminished incidences of neuropsychiatric adverse events by eliminating the troughs and peaks of drug concentration in a patients blood plasma, which comprises administering orally to a patient in need thereof, an extended release tablet that provides a peak blood plasma level of Levetiracetam in from about eight to about Sixteen hours. The core is prepared by Wet granulation, Dry granulation or Direct compression and optionally the tablet core is coated either in an coating pan or in and Fluidized bed system.
    Patent expiration dates:

    • September 17, 2028
      ✓ 
      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:
    • September 12, 2011 - NEW DOSAGE FORM

See also...

  • Keppra XR Extended-Release Tablets Consumer Information (Wolters Kluwer)
  • Keppra XR Consumer Information (Cerner Multum)
  • Keppra XR Advanced Consumer Information (Micromedex)
  • Levetiracetam Consumer Information (Wolters Kluwer)
  • Levetiracetam Extended-Release Tablets Consumer Information (Wolters Kluwer)
  • Levetiracetam Solution Consumer Information (Wolters Kluwer)
  • Levetiracetam Tablets Consumer Information (Wolters Kluwer)
  • Levetiracetam Consumer Information (Cerner Multum)
  • Levetiracetam Advanced Consumer Information (Micromedex)
  • Levetiracetam Intravenous Advanced Consumer Information (Micromedex)
  • Levetiracetam AHFS DI Monographs (ASHP)

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