Generic Trileptal Availability

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

TRILEPTAL (oxcarbazepine - suspension;oral)

  • Manufacturer: NOVARTIS
    Approval date: May 25, 2001
    Strength(s): 300MG/5ML [RLD] [AB]

TRILEPTAL (oxcarbazepine - tablet;oral)

  • Manufacturer: NOVARTIS
    Approval date: January 14, 2000
    Strength(s): 150MG [AB], 300MG [AB], 600MG [RLD] [AB]

Has a generic version of Trileptal been approved?

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

oxcarbazepine suspension;oral

  • Manufacturer: AMNEAL PHARMS
    Approval date: September 17, 2012
    Strength(s): 300MG/5ML [AB]
  • Manufacturer: RANBAXY
    Approval date: June 26, 2009
    Strength(s): 300MG/5ML [AB]
  • Manufacturer: ROXANE
    Approval date: October 3, 2012
    Strength(s): 300MG/5ML [AB]

oxcarbazepine tablet;oral

  • Manufacturer: APOTEX INC
    Approval date: April 9, 2008
    Strength(s): 150MG [AB], 300MG [AB], 600MG [AB]
  • Manufacturer: BRECKENRIDGE PHARM
    Approval date: January 11, 2008
    Strength(s): 150MG [AB], 300MG [AB], 600MG [AB]
  • Manufacturer: CADISTA PHARMS
    Approval date: January 25, 2010
    Strength(s): 150MG [AB], 300MG [AB], 600MG [AB]
  • Manufacturer: GLENMARK GENERICS
    Approval date: October 9, 2007
    Strength(s): 150MG [AB], 300MG [AB], 600MG [AB]
  • Manufacturer: ROXANE
    Approval date: October 9, 2007
    Strength(s): 150MG [AB], 300MG [AB], 600MG [AB]
  • Manufacturer: SUN PHARM INDS
    Approval date: October 9, 2007
    Strength(s): 150MG [AB], 300MG [AB], 600MG [AB]
  • Manufacturer: TARO
    Approval date: November 15, 2007
    Strength(s): 150MG [AB], 300MG [AB], 600MG [AB]

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

  • Oxacarbazepine film-coated tablets
    Patent 7,037,525
    Issued: May 2, 2006
    Inventor(s): Schlütermann; Burkhard
    Assignee(s): Novartis AG
    The invention relates to formulations, e.g. film-coated tablets containing oxcarbazepine and to processes for the production of said formulations. The film-coated tablets have a tablet core comprising a therapeutically effective dose of oxacarbazepine being in a finely ground form having a mean particle size of from 4 to 12 μm (median value), and a hydrophilic permeable outer coating.
    Patent expiration dates:
    • February 12, 2018
      ✓ 
      Patent use: METHOD OF TREATING SEIZURES
    • August 12, 2018
      ✓ 
      Pediatric exclusivity
  • Suspension comprising oxcarbazepine
    Patent 8,119,148
    Issued: February 21, 2012
    Inventor(s): Sigg; Juergen & Billington; Michael
    Assignee(s): Novartis Pharmaceuticals Corporation
    This invention provides a pharmaceutical composition in the form of a suspension comprising oxcarbazepine.
    Patent expiration dates:
    • December 19, 2020
      ✓ 
      Patent use: METHOD OF TREATING SEIZURES
      ✓ 
      Drug product
    • June 19, 2021
      ✓ 
      Pediatric exclusivity

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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