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Generic Keppra XR Availability

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: BOCA PHARMA
    Approval date: May 25, 2012
    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: ROUSES POINT PHARMS
    Approval date: August 27, 2012
    Strength(s): 500MG [AB], 750MG [AB]
  • Manufacturer: TEVA PHARMS
    Approval date: September 12, 2011
    Strength(s): 500MG [AB], 750MG [AB]
  • Manufacturer: TORRENT PHARMS LTD
    Approval date: May 29, 2012
    Strength(s): 500MG [AB], 750MG [AB]
  • Manufacturer: VINTAGE PHARMS LLC
    Approval date: July 20, 2012
    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

See also...

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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