Generic Keppra Availability

See also: Generic Keppra XR

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

KEPPRA (levetiracetam - injectable; iv (infusion))

  • Manufacturer: UCB INC
    Approval date: July 31, 2006
    Strength(s): 500MG/5ML (100MG/ML) [RLD] [AP]

KEPPRA (levetiracetam - solution; oral)

  • Manufacturer: UCB INC
    Approval date: July 15, 2003
    Strength(s): 100MG/ML [RLD] [AA]

KEPPRA (levetiracetam - tablet; oral)

  • Manufacturer: UCB INC
    Approval date: November 30, 1999
    Strength(s): 250MG [AB], 500MG [AB], 750MG [AB]
  • Manufacturer: UCB INC
    Approval date: January 6, 2006
    Strength(s): 1GM [RLD] [AB]

Has a generic version of Keppra been approved?

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

levetiracetam injectable; iv (infusion)

  • Manufacturer: FRESENIUS KABI USA
    Approval date: May 26, 2010
    Strength(s): 500MG/5ML (100MG/ML) [AP]
  • Manufacturer: LUITPOLD
    Approval date: January 31, 2012
    Strength(s): 500MG/5ML (100MG/ML) [AP]
  • Manufacturer: SUN PHARM INDS LTD
    Approval date: June 16, 2010
    Strength(s): 500MG/5ML (100MG/ML) [AP]
  • Manufacturer: X GEN PHARMS
    Approval date: August 5, 2011
    Strength(s): 500MG/5ML (100MG/ML) [AP]

levetiracetam solution; oral

  • Manufacturer: ACTAVIS MID ATLANTIC
    Approval date: January 15, 2009
    Strength(s): 100MG/ML [AA]
  • Manufacturer: AMNEAL PHARMS
    Approval date: October 27, 2009
    Strength(s): 100MG/ML [AA]
  • Manufacturer: AUROBINDO PHARM
    Approval date: January 15, 2009
    Strength(s): 100MG/ML [AA]
  • Manufacturer: CYPRESS PHARM
    Approval date: January 16, 2009
    Strength(s): 100MG/ML [AA]
  • Manufacturer: HETERO LABS LTD III
    Approval date: February 28, 2013
    Strength(s): 100MG/ML [AA]
  • Manufacturer: HI-TECH PHARMACAL
    Approval date: February 28, 2012
    Strength(s): 100MG/ML [AA]
  • Manufacturer: LUPIN LTD
    Approval date: October 17, 2011
    Strength(s): 100MG/ML [AA]
  • Manufacturer: ORIT LABS LLC
    Approval date: May 9, 2013
    Strength(s): 100MG/ML [AA]
  • Manufacturer: ROXANE
    Approval date: January 15, 2009
    Strength(s): 100MG/ML [AA]
  • Manufacturer: SILARX
    Approval date: April 3, 2009
    Strength(s): 100MG/ML [AA]
  • Manufacturer: TARO
    Approval date: February 10, 2009
    Strength(s): 100MG/ML [AA]
  • Manufacturer: TOLMAR
    Approval date: January 15, 2009
    Strength(s): 100MG/ML [AA]
  • Manufacturer: TRIS PHARMA INC
    Approval date: September 30, 2010
    Strength(s): 100MG/ML [AA]
  • Manufacturer: VINTAGE PHARMS
    Approval date: April 11, 2012
    Strength(s): 100MG/ML [AA]
  • Manufacturer: WOCKHARDT
    Approval date: March 3, 2010
    Strength(s): 100MG/ML [AA]

levetiracetam tablet; oral

  • Manufacturer: ACCORD HLTHCARE
    Approval date: February 14, 2011
    Strength(s): 1GM [AB], 250MG [AB], 500MG [AB], 750MG [AB]
  • Manufacturer: AJANTA PHARMA
    Approval date: June 14, 2011
    Strength(s): 1GM [AB], 250MG [AB], 500MG [AB], 750MG [AB]
  • Manufacturer: APOTEX INC
    Approval date: March 13, 2009
    Strength(s): 1GM [AB], 250MG [AB], 500MG [AB], 750MG [AB]
  • Manufacturer: AUROBINDO PHARMA
    Approval date: January 15, 2009
    Strength(s): 1GM [AB], 250MG [AB], 500MG [AB], 750MG [AB]
  • Manufacturer: BOCA PHARMA
    Approval date: March 20, 2009
    Strength(s): 250MG [AB], 500MG [AB], 750MG [AB]
  • Manufacturer: BRECKENRIDGE PHARM
    Approval date: August 18, 2011
    Strength(s): 1GM [AB], 250MG [AB], 500MG [AB], 750MG [AB]
  • Manufacturer: DR REDDYS LABS LTD
    Approval date: January 15, 2009
    Strength(s): 1GM [AB], 250MG [AB], 500MG [AB], 750MG [AB]
  • Manufacturer: HETERO LABS LTD III
    Approval date: October 8, 2010
    Strength(s): 1GM [AB], 250MG [AB], 500MG [AB], 750MG [AB]
  • Manufacturer: INVAGEN PHARMS
    Approval date: January 15, 2009
    Strength(s): 250MG [AB], 500MG [AB], 750MG [AB]
  • Manufacturer: LOTUS PHARM CO LTD
    Approval date: November 5, 2010
    Strength(s): 500MG [AB]
  • Manufacturer: LUPIN
    Approval date: January 15, 2009
    Strength(s): 1GM [AB], 250MG [AB], 500MG [AB], 750MG [AB]
  • Manufacturer: METHAPHARM
    Approval date: July 28, 2010
    Strength(s): 1GM [AB], 250MG [AB], 500MG [AB], 750MG [AB]
  • Manufacturer: MYLAN
    Approval date: November 4, 2008
    Strength(s): 250MG [AB], 500MG [AB], 750MG [AB]
  • Manufacturer: MYLAN
    Approval date: December 8, 2009
    Strength(s): 1GM [AB]
  • Manufacturer: ORCHID HLTHCARE
    Approval date: January 15, 2009
    Strength(s): 250MG [AB], 500MG [AB], 750MG [AB]
  • Manufacturer: ORCHID HLTHCARE
    Approval date: August 5, 2010
    Strength(s): 1GM [AB]
  • Manufacturer: PRINSTON INC
    Approval date: February 10, 2009
    Strength(s): 1GM [AB], 250MG [AB], 500MG [AB], 750MG [AB]
  • Manufacturer: ROXANE
    Approval date: January 15, 2009
    Strength(s): 1GM [AB], 250MG [AB], 500MG [AB], 750MG [AB]
  • Manufacturer: SANDOZ
    Approval date: January 15, 2009
    Strength(s): 1GM [AB], 250MG [AB], 500MG [AB], 750MG [AB]
  • Manufacturer: TARO
    Approval date: February 1, 2010
    Strength(s): 1GM [AB], 250MG [AB], 500MG [AB], 750MG [AB]
  • Manufacturer: TEVA PHARMS
    Approval date: January 15, 2009
    Strength(s): 1GM [AB], 250MG [AB], 500MG [AB], 750MG [AB]
  • Manufacturer: TORRENT PHARMS
    Approval date: January 15, 2009
    Strength(s): 1GM [AB], 250MG [AB], 500MG [AB], 750MG [AB]
  • Manufacturer: VINTAGE PHARMS
    Approval date: December 14, 2010
    Strength(s): 1GM [AB], 250MG [AB], 500MG [AB], 750MG [AB]
  • Manufacturer: WATSON LABS INC
    Approval date: January 15, 2009
    Strength(s): 1GM [AB], 250MG [AB], 500MG [AB], 750MG [AB]
  • Manufacturer: WOCKHARDT
    Approval date: January 15, 2009
    Strength(s): 1GM [AB], 250MG [AB], 500MG [AB], 750MG [AB]
  • Manufacturer: ZYDUS PHARMS USA INC
    Approval date: April 29, 2009
    Strength(s): 1GM [AB], 250MG [AB]

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

There are no current U.S. patents associated with Keppra.

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:
    • December 16, 2014 - NEW PATIENT POPULATION
    • June 16, 2015 - PEDIATRIC EXCLUSIVITY

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.
AAProducts in conventional dosage forms not presenting bioequivalence problems. Products coded as AA contain active ingredients and dosage forms that are not regarded as presenting either actual or potential bioequivalence problems or drug quality or standards issues. However, all oral dosage forms must, nonetheless, meet an appropriate in vitro bioequivalence standard that is acceptable to the Agency in order to be approved.
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.
APInjectable aqueous solutions and, in certain instances, intravenous non-aqueous solutions. It should be noted that even though injectable (parenteral) products under a specific listing may be evaluated as therapeutically equivalent, there may be important differences among the products in the general category, Injectable; Injection. For example, some injectable products that are rated therapeutically equivalent are labeled for different routes of administration. In addition, some products evaluated as therapeutically equivalent may have different preservatives or no preservatives at all. Injectable products available as dry powders for reconstitution, concentrated sterile solutions for dilution, or sterile solutions ready for injection are pharmaceutical alternative drug products. They are not rated as therapeutically equivalent (AP) to each other even if these pharmaceutical alternative drug products are designed to produce the same concentration prior to injection and are similarly labeled. Consistent with accepted professional practice, it is the responsibility of the prescriber, dispenser, or individual administering the product to be familiar with a product's labeling to assure that it is given only by the route(s) of administration stated in the labeling.
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