Generic Zofran Availability

See also: Generic Zofran ODT

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

ZOFRAN (ondansetron hydrochloride - injectable;injection)

  • Manufacturer: GLAXOSMITHKLINE
    Approval date: January 4, 1991
    Strength(s): EQ 2MG BASE/ML [RLD] [AP]

ZOFRAN (ondansetron hydrochloride - solution;oral)

  • Manufacturer: GLAXOSMITHKLINE
    Approval date: January 24, 1997
    Strength(s): EQ 4MG BASE/5ML [RLD] [AA]

ZOFRAN (ondansetron hydrochloride - tablet;oral)

  • Manufacturer: GLAXOSMITHKLINE
    Approval date: December 31, 1992
    Strength(s): EQ 4MG BASE [AB], EQ 8MG BASE [AB]
  • Manufacturer: GLAXOSMITHKLINE
    Approval date: August 27, 1999
    Strength(s): EQ 24MG BASE [RLD] [AB]

Has a generic version of Zofran been approved?

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

ondansetron hydrochloride injectable;injection

  • Manufacturer: AGILA SPECLTS
    Approval date: April 23, 2008
    Strength(s): EQ 2MG BASE/ML [AP]
  • Manufacturer: AUROBINDO PHARMA LTD
    Approval date: December 21, 2012
    Strength(s): EQ 2MG BASE/ML [AP]
  • Manufacturer: BEDFORD
    Approval date: December 26, 2006
    Strength(s): EQ 2MG BASE/ML [AP]
  • Manufacturer: CLARIS LIFESCIENCES
    Approval date: February 22, 2013
    Strength(s): EQ 2MG BASE/ML [AP]
  • Manufacturer: EMCURE PHARMS
    Approval date: April 16, 2010
    Strength(s): EQ 2MG BASE/ML [AP]
  • Manufacturer: FRESENIUS KABI USA
    Approval date: December 26, 2006
    Strength(s): EQ 2MG BASE/ML [AP]
  • Manufacturer: GLAND PHARMA LTD
    Approval date: September 25, 2009
    Strength(s): EQ 2MG BASE/ML [AP]
  • Manufacturer: GLAND PHARMA LTD
    Approval date: June 15, 2012
    Strength(s): EQ 2MG BASE/ML [AP]
  • Manufacturer: HIKMA FARMACEUTICA
    Approval date: December 26, 2006
    Strength(s): EQ 2MG BASE/ML [AP]
  • Manufacturer: HIKMA MAPLE
    Approval date: December 26, 2006
    Strength(s): EQ 2MG BASE/ML [AP]
  • Manufacturer: HOSPIRA
    Approval date: December 26, 2006
    Strength(s): EQ 2MG BASE/ML [AP]
  • Manufacturer: HOSPIRA
    Approval date: January 19, 2007
    Strength(s): EQ 2MG BASE/ML [AP]
  • Manufacturer: LANNETT
    Approval date: August 5, 2010
    Strength(s): EQ 2MG BASE/ML [AP]
  • Manufacturer: LUITPOLD
    Approval date: November 18, 2008
    Strength(s): EQ 2MG BASE/ML [AP]
  • Manufacturer: SANDOZ
    Approval date: June 27, 2007
    Strength(s): EQ 2MG BASE/ML [AP]
  • Manufacturer: SUN PHARM INDS (IN)
    Approval date: December 26, 2006
    Strength(s): EQ 2MG BASE/ML [AP]
  • Manufacturer: TEVA
    Approval date: November 22, 2006
    Strength(s): EQ 2MG BASE/ML [AP]
  • Manufacturer: WOCKHARDT
    Approval date: December 26, 2006
    Strength(s): EQ 2MG BASE/ML [AP]

ondansetron hydrochloride solution;oral

  • Manufacturer: AMNEAL PHARMS
    Approval date: January 31, 2011
    Strength(s): EQ 4MG BASE/5ML [AA]
  • Manufacturer: APOTEX
    Approval date: June 25, 2007
    Strength(s): EQ 4MG BASE/5ML [AA]
  • Manufacturer: AUROBINDO PHARMA
    Approval date: November 28, 2007
    Strength(s): EQ 4MG BASE/5ML [AA]
  • Manufacturer: ROXANE
    Approval date: December 26, 2006
    Strength(s): EQ 4MG BASE/5ML [AA]
  • Manufacturer: SILARX
    Approval date: January 27, 2011
    Strength(s): EQ 4MG BASE/5ML [AA]
  • Manufacturer: TARO
    Approval date: November 30, 2007
    Strength(s): EQ 4MG BASE/5ML [AA]

ondansetron hydrochloride tablet;oral

  • Manufacturer: APOTEX
    Approval date: June 25, 2007
    Strength(s): EQ 4MG BASE [AB], EQ 8MG BASE [AB]
  • Manufacturer: AUROBINDO PHARMA
    Approval date: July 31, 2007
    Strength(s): EQ 4MG BASE [AB], EQ 8MG BASE [AB], EQ 24MG BASE [AB]
  • Manufacturer: DR REDDYS LABS LTD
    Approval date: December 26, 2006
    Strength(s): EQ 4MG BASE [AB], EQ 8MG BASE [AB], EQ 24MG BASE [AB]
  • Manufacturer: GLENMARK GENERICS
    Approval date: June 25, 2007
    Strength(s): EQ 4MG BASE [AB], EQ 8MG BASE [AB], EQ 24MG BASE [AB]
  • Manufacturer: IPCA LABS LTD
    Approval date: January 23, 2014
    Strength(s): EQ 4MG BASE [AB], EQ 8MG BASE [AB]
  • Manufacturer: MYLAN
    Approval date: June 25, 2007
    Strength(s): EQ 4MG BASE [AB], EQ 8MG BASE [AB], EQ 24MG BASE [AB]
  • Manufacturer: NATCO PHARMA LTD
    Approval date: June 25, 2007
    Strength(s): EQ 4MG BASE [AB], EQ 8MG BASE [AB]
  • Manufacturer: PLIVA HRVATSKA DOO
    Approval date: June 25, 2007
    Strength(s): EQ 4MG BASE [AB], EQ 8MG BASE [AB], EQ 24MG BASE [AB]
  • Manufacturer: SANDOZ
    Approval date: June 25, 2007
    Strength(s): EQ 4MG BASE [AB], EQ 8MG BASE [AB], EQ 24MG BASE [AB]
  • Manufacturer: SUN PHARM INDS (IN)
    Approval date: June 25, 2007
    Strength(s): EQ 4MG BASE [AB], EQ 8MG BASE [AB]
  • Manufacturer: TEVA
    Approval date: June 25, 2007
    Strength(s): EQ 4MG BASE [AB], EQ 8MG BASE [AB], EQ 24MG BASE [AB]

ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE (ondansetron hydrochloride injectable;injection)

  • Manufacturer: AGILA SPECLTS
    Approval date: April 23, 2008
    Strength(s): EQ 2MG BASE/ML [AP]
  • Manufacturer: AUROBINDO PHARMA LTD
    Approval date: December 21, 2012
    Strength(s): EQ 2MG BASE/ML [AP]
  • Manufacturer: BD RX
    Approval date: July 19, 2013
    Strength(s): EQ 2MG BASE/ML [AP]
  • Manufacturer: BEDFORD LABS
    Approval date: December 26, 2006
    Strength(s): EQ 2MG BASE/ML [AP]
  • Manufacturer: CLARIS LIFESCIENCES
    Approval date: February 22, 2013
    Strength(s): EQ 2MG BASE/ML [AP]
  • Manufacturer: EMCURE PHARMS LTD
    Approval date: January 3, 2013
    Strength(s): EQ 2MG BASE/ML [AP]
  • Manufacturer: FRESENIUS KABI USA
    Approval date: December 26, 2006
    Strength(s): EQ 2MG BASE/ML [AP]
  • Manufacturer: HIKMA FARMACEUTICA
    Approval date: December 26, 2006
    Strength(s): EQ 2MG BASE/ML [AP]
  • Manufacturer: HIKMA MAPLE
    Approval date: December 26, 2006
    Strength(s): EQ 2MG BASE/ML [AP]
  • Manufacturer: HOSPIRA
    Approval date: December 26, 2006
    Strength(s): EQ 2MG BASE/ML [AP]
  • Manufacturer: LUITPOLD
    Approval date: November 18, 2008
    Strength(s): EQ 2MG BASE/ML [AP]
  • Manufacturer: SANDOZ
    Approval date: June 27, 2007
    Strength(s): EQ 2MG BASE/ML [AP]
  • Manufacturer: SUN PHARM INDS LTD
    Approval date: December 26, 2006
    Strength(s): EQ 2MG BASE/ML [AP]
  • Manufacturer: TARO PHARMS IRELAND
    Approval date: March 21, 2008
    Strength(s): EQ 2MG BASE/ML [AP]
  • Manufacturer: TEVA
    Approval date: November 22, 2006
    Strength(s): EQ 2MG BASE/ML [AP]
  • Manufacturer: WOCKHARDT
    Approval date: December 26, 2006
    Strength(s): EQ 2MG BASE/ML [AP]

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

  • Oral compositions containing ondansetron
    Patent 5,854,270
    Issued: December 29, 1998
    Inventor(s): Gambhir; Renu
    Assignee(s): Glaxo Wellcome Inc.
    The invention relates to a liquid composition for oral administration comprising ondansetron or a pharmaceutically acceptable derivative thereof, a sweetener and one or more pharmaceutically acceptable excipients. The sweetener comprises one or more polyhydric alcohols and the pH of the combination lies in the range 2.0 to 5.0. Methods for the manufacture of such compositions and for their use in the treatment of conditions mediated through the action of 5-hydroxytryptamine (5 HT) at 5 HT.sub.3 receptors are also included.
    Patent expiration dates:
    • November 20, 2015
      ✓ 
      Patent use: RELIEF OF NAUSEA AND VOMITING
      ✓ 
      Drug product
    • May 20, 2016
      ✓ 
      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.
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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