Thursday, 18 August 2011

Keppra


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: INNOPHARMA LLC

    Approval date: August 5, 2011

    Strength(s): 500MG/5ML (100MG/ML) [AP]


  • Manufacturer: NEXUS PHARMS

    Approval date: May 26, 2010

    Strength(s): 500MG/5ML (100MG/ML) [AP]


  • Manufacturer: PHARMAFORCE

    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]

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: APOTEX

    Approval date: August 5, 2011

    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: LUPIN LTD

    Approval date: October 17, 2011

    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: 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: BIOKEY

    Approval date: November 5, 2010

    Strength(s): 500MG [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: COBALT LABS INC

    Approval date: January 15, 2009

    Strength(s): 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 DRUGS LTD

    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: 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: 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: SOLCO HLTHCARE

    Approval date: February 10, 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

    Approval date: January 15, 2009

    Strength(s): 1GM [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:
    • September 19, 2010 - PEDIATRIC EXCLUSIVITY

See also...

  • Keppra Consumer Information (Drugs.com)
  • Keppra Consumer Information (Wolters Kluwer)
  • Keppra Solution Consumer Information (Wolters Kluwer)
  • Keppra Tablets Consumer Information (Wolters Kluwer)
  • Keppra Consumer Information (Cerner Multum)
  • Keppra Advanced Consumer Information (Micromedex)
  • Keppra Intravenous Advanced Consumer Information (Micromedex)
  • Keppra AHFS DI Monographs (ASHP)
  • 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)

No comments:

Post a Comment