Generic Zofran ODT Availability

See also: Generic Zofran

Zofran ODT is a brand name of ondansetron, approved by the FDA in the following formulation(s):

ZOFRAN ODT (ondansetron - tablet, orally disintegrating; oral)

Has a generic version of Zofran ODT been approved?

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

ondansetron tablet, orally disintegrating; oral

  • Manufacturer: AUROBINDO PHARMA
    Approval date: April 12, 2010
    Strength(s): 4MG [AB], 8MG [AB]
  • Manufacturer: BARR
    Approval date: June 25, 2007
    Strength(s): 4MG [AB], 8MG [AB]
  • Manufacturer: GLENMARK GENERICS
    Approval date: June 27, 2007
    Strength(s): 4MG [AB], 8MG [AB]
  • Manufacturer: MYLAN
    Approval date: June 25, 2007
    Strength(s): 4MG [AB], 8MG [AB]
  • Manufacturer: RANBAXY
    Approval date: February 24, 2011
    Strength(s): 4MG [AB], 8MG [AB]
  • Manufacturer: SANDOZ
    Approval date: August 13, 2007
    Strength(s): 4MG [AB], 8MG [AB]
  • Manufacturer: SUN PHARM INDS
    Approval date: August 2, 2007
    Strength(s): 4MG [AB], 8MG [AB]
  • Manufacturer: TEVA
    Approval date: June 25, 2007
    Strength(s): 4MG [AB], 8MG [AB]

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

  • Freeze-dried compositions
    Patent 5,955,488
    Issued: September 21, 1999
    Inventor(s): Winterborn; Ian Keith
    Assignee(s): Glaxo Wellcome Inc.
    The invention relates to a freeze-dried dosage form for oral administration capable of being rapidly disintegrated in the mouth comprising ondansetron in the form of its free base or a pharmaceutically acceptable solvate thereof and one or more pharmaceutically acceptable excipients. Methods for the manufacture of such compositions and for their use in the treatment of conditions mediated through the action of 5-hydroxytryptamine (5HT) at 5HT.sub.3 receptors are also described.
    Patent expiration dates:
    • November 14, 2015
    • May 14, 2016
      ✓ 
      Pediatric exclusivity
  • Ondansetron freeze-dried dosage form compositions for oral administration
    Patent 6,063,802
    Issued: May 16, 2000
    Inventor(s): Winterborn; Ian Keith
    Assignee(s): Glaxco Wellcome Inc.
    The invention relates to a freeze-dried dosage form for oral administration capable of being rapidly disintegrated in the mouth comprising ondansetron in the form of its free base or a pharmaceutically acceptable solvate thereof and one or more pharmaceutically acceptable excipients. Methods for the manufacture of such compositions and for their use in the treatment of conditions mediated through the action of 5-hydroxytryptamine (5HT) at 5HT.sub.3 receptors are also described.
    Patent expiration dates:
    • November 14, 2015
    • May 14, 2016
      ✓ 
      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.
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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