Generic Eloxatin Availability

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

ELOXATIN (oxaliplatin - injectable;iv (infusion))

  • Manufacturer: SANOFI AVENTIS US
    Approval date: January 31, 2005
    Strength(s): 50MG/10ML (5MG/ML) [RLD] [AP], 100MG/20ML (5MG/ML) [RLD] [AP]
  • Manufacturer: SANOFI AVENTIS US
    Approval date: November 17, 2006
    Strength(s): 200MG/40ML (5MG/ML) [RLD]

Has a generic version of Eloxatin been approved?

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

oxaliplatin injectable;iv (infusion)

  • Manufacturer: EBEWE PHARMA
    Approval date: August 7, 2009
    Strength(s): 50MG/10ML (5MG/ML) [AP], 100MG/20ML (5MG/ML) [AP]
  • Manufacturer: FRESENIUS KABI ONCOL
    Approval date: June 10, 2010
    Strength(s): 50MG/10ML (5MG/ML) [AP], 100MG/20ML (5MG/ML) [AP]
  • Manufacturer: HOSPIRA WORLDWIDE
    Approval date: August 7, 2009
    Strength(s): 50MG/10ML (5MG/ML) [AP], 100MG/20ML (5MG/ML) [AP]
  • Manufacturer: ONCO THERAPIES LTD
    Approval date: August 7, 2012
    Strength(s): 50MG/10ML (5MG/ML) [AP], 100MG/20ML (5MG/ML) [AP]
  • Manufacturer: SANDOZ
    Approval date: January 24, 2011
    Strength(s): 50MG/10ML (5MG/ML) [AP], 100MG/20ML (5MG/ML) [AP]
  • Manufacturer: SUN PHARMA GLOBAL
    Approval date: April 8, 2014
    Strength(s): 50MG/10ML (5MG/ML) [AP], 100MG/20ML (5MG/ML) [AP]

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

  • Platinum compound and process of preparing same
    Patent 5,290,961
    Issued: March 1, 1994
    Inventor(s): Okamoto; Koji & Hoshi; Yuko & Nakanishi; Chihiro
    Assignee(s): Tanaka Kikinzoku Kogyo K.K.
    Disclosed herein are a platinum compound employed as raw material of medicines having carcinostatic effects, and a process of preparing the platinum compound. The platinum compound (I) substantially free from impurities can be prepared through a reaction between the corresponding dihalogen compound and an organic dibasic acid employing an iodine compound utilizing the difference of solubilities between the desired compound and the iodine compounds.
    Patent expiration dates:
    • July 12, 2013
      ✓ 
      Pediatric exclusivity
  • Cis oxalato (trans 1-1,2-cyclohexanediamine) PT(II) having optically high purity
    Patent 5,338,874
    Issued: August 16, 1994
    Inventor(s): Nakanishi; Chihiro & Ohnishi; Yuko & Ohnishi; Junji & Taniuchi; Junichi & Okamoto; Koji & Tozawa; Takeshi
    Assignee(s): Tanaka Kikinzoku Kogyo K.K.
    Disclosed herein is cis-oxalato (trans-1-1,2-cyclohexanediamine) Pt(II) optically high purity. Because of its complete optical purity, the compound is effective as raw material of such a medicine as a carcinostatic agent. The complete optical purity of the above compound may be proved by comparing the respective melting points of the cis-oxalato (trans-1-1,2-cyclohexanediamine).
    Patent expiration dates:
    • October 7, 2013
      ✓ 
      Pediatric exclusivity
  • Cis-oxalato(trans-1-1,2-cyclohexanediamine) Pt(II) complex having high optical purity and process of preparing same
    Patent 5,420,319
    Issued: May 30, 1995
    Inventor(s): Okamoto; Koji & Nakanishi; Chihiro & Taniuchi; Junichi & Ohnishi; Junji & Komoda; Yasunobu
    Assignee(s): Tanaka Kikinzoku Kogyo K.K.
    Disclosed is cis-oxalato(trans-1-1,2-cyclohexanediamine) Pt(II) complex having high optical purity and no toxicity and exhibiting anticancer performance, as shown in the below Formula. Cis-oxalato(trans-1-1,2-cyclohexanediamine) Pt(II) complex of the invention possesses high optical purity or 99.94% or more e.e. and a melting point of 198.3.degree. to 199.7.degree. C. The complex is synthesized employing as starting material trans-1-1,2-cyclohexamediamine or a derivative of the trans-1-1,2-cyclohexanediamine optically resoluted by means of a high performance liquid chromatography. ##STR1##
    Patent expiration dates:
    • August 9, 2016
      ✓ 
      Drug substance
    • February 9, 2017
      ✓ 
      Pediatric exclusivity
  • Pharmaceutically stable preparation of oxaliplatinum
    Patent 5,716,988
    Issued: February 10, 1998
    Inventor(s): Ibrahim; Houssam & Mauvernay; Rolland-Yves
    Assignee(s): Debiopharm S.A.
    A pharmaceutically stable oxaliplatinum preparation for parenteral administration comprises an aqueous solution of oxaliplatinum, in a concentration of 1 to 5 mg/ml, and with a pH in the range of 4.5 to 6. The aqueous oxaliplatinum solution is advantageously provided as a ready-to-use preparation in a sealed container.
    Patent expiration dates:
    • August 7, 2015
      ✓ 
      Drug product
    • February 7, 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.
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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