Generic Camptosar Availability

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

CAMPTOSAR (irinotecan hydrochloride - injectable;injection)

  • Manufacturer: PFIZER INC
    Approval date: June 14, 1996
    Strength(s): 40MG/2ML (20MG/ML) [RLD] [AP], 100MG/5ML (20MG/ML) [RLD] [AP]
  • Manufacturer: PFIZER INC
    Approval date: August 5, 2010
    Strength(s): 300MG/15ML (20MG/ML) [RLD]

Has a generic version of Camptosar been approved?

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

irinotecan hydrochloride injectable;injection

  • Manufacturer: ACCORD HLTHCARE
    Approval date: November 21, 2008
    Strength(s): 40MG/2ML (20MG/ML) [AP], 100MG/5ML (20MG/ML) [AP]
  • Manufacturer: ACTAVIS TOTOWA
    Approval date: February 27, 2008
    Strength(s): 40MG/2ML (20MG/ML) [AP], 100MG/5ML (20MG/ML) [AP]
  • Manufacturer: AKORN
    Approval date: September 16, 2009
    Strength(s): 40MG/2ML (20MG/ML) [AP], 100MG/5ML (20MG/ML) [AP]
  • Manufacturer: BEDFORD LABS
    Approval date: December 24, 2008
    Strength(s): 40MG/2ML (20MG/ML) [AP], 100MG/5ML (20MG/ML) [AP]
  • Manufacturer: CIPLA LTD
    Approval date: February 20, 2008
    Strength(s): 40MG/2ML (20MG/ML) [AP], 100MG/5ML (20MG/ML) [AP]
  • Manufacturer: DR REDDYS LABS LTD
    Approval date: April 15, 2010
    Strength(s): 40MG/2ML (20MG/ML) [AP], 100MG/5ML (20MG/ML) [AP]
  • Manufacturer: EBEWE PHARMA
    Approval date: November 12, 2009
    Strength(s): 40MG/2ML (20MG/ML) [AP], 100MG/5ML (20MG/ML) [AP]
  • Manufacturer: EMCURE PHARMS LTD
    Approval date: February 14, 2012
    Strength(s): 40MG/2ML (20MG/ML) [AP], 100MG/5ML (20MG/ML) [AP]
  • Manufacturer: FRESENIUS KABI ONCOL
    Approval date: February 27, 2008
    Strength(s): 40MG/2ML (20MG/ML) [AP], 100MG/5ML (20MG/ML) [AP]
  • Manufacturer: FRESENIUS KABI USA
    Approval date: February 27, 2008
    Strength(s): 40MG/2ML (20MG/ML) [AP], 100MG/5ML (20MG/ML) [AP]
  • Manufacturer: HIKMA FARMACEUTICA
    Approval date: December 20, 2010
    Strength(s): 40MG/2ML (20MG/ML) [AP], 100MG/5ML (20MG/ML) [AP]
  • Manufacturer: HISUN PHARM HANGZHOU
    Approval date: January 28, 2009
    Strength(s): 40MG/2ML (20MG/ML) [AP], 100MG/5ML (20MG/ML) [AP]
  • Manufacturer: HOSPIRA
    Approval date: February 27, 2008
    Strength(s): 40MG/2ML (20MG/ML) [AP], 100MG/5ML (20MG/ML) [AP]
  • Manufacturer: JIANGSU HENGRUI MED
    Approval date: December 16, 2011
    Strength(s): 40MG/2ML (20MG/ML) [AP], 100MG/5ML (20MG/ML) [AP]
  • Manufacturer: MUSTAFA NEVZAT ILAC
    Approval date: May 13, 2011
    Strength(s): 40MG/2ML (20MG/ML) [AP], 100MG/5ML (20MG/ML) [AP]
  • Manufacturer: PLIVA LACHEMA
    Approval date: October 31, 2008
    Strength(s): 100MG/5ML (20MG/ML) [AP], 40MG/2ML (20MG/ML) [AP]
  • Manufacturer: SUN PHARMA GLOBAL
    Approval date: April 21, 2008
    Strength(s): 40MG/2ML (20MG/ML) [AP], 100MG/5ML (20MG/ML) [AP]
  • Manufacturer: TEVA PHARMS USA
    Approval date: February 27, 2008
    Strength(s): 40MG/2ML (20MG/ML) [AP], 100MG/5ML (20MG/ML) [AP]

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

  • Method for treating cancer using camptothecin derivatives and 5-fluorouracil
    Patent 6,403,569
    Issued: June 11, 2002
    Inventor(s): Wolf R.; Achterrath
    Assignee(s): Aventis Pharma S.A.
    A combination therapy for treating cancer including administering at least one camptothecin derivative in conjunction with another anticancer agent. The combination therapy is preferably used as a first-line therapy for treating metastatic colorectal cancer and preferably involves administration of a combination of CPT-11, 5-fluorouracil and folinic acid, according to specific infusional treatment schedules which show therapeutic synergy in the treatment of cancer.
    Patent expiration dates:
    • April 28, 2020
      ✓ 
      Patent use: USE IN COMBINATION WITH 5-FLUOROURACIL AND LEUCOVORIN FOR THE TREATMENT OF METASTATIC COLORECTAL CANCER WHERE THE DOSE OF LEUCOVORIN IS AT LEAST 200MG PER SQUARE METER
    • October 28, 2020
      ✓ 
      Pediatric exclusivity
  • Method for treating cancer using camptothecin derivatives and 5-fluorouracil
    Patent 6,794,370
    Issued: September 21, 2004
    Inventor(s): Wolf R.; Achterrath
    Assignee(s): Aventis Pharma S.A.
    A combination therapy for treating cancer including administering at least one camptothecin derivative in conjunction with another anticancer agent. The combination therapy is preferably used as a first-line therapy for treating metastatic colorectal cancer and preferably involves administration of a combination of CPT-11, 5-fluorouracil and folinic acid, according to specific infusional treatment schedules which show therapeutic synergy in the treatment of cancer.
    Patent expiration dates:
    • May 1, 2020
      ✓ 
      Patent use: USE OF IRINOTECAN IN COMBINATION WITH 5-FLUOROURACIL AND LEUCOVORIN FOR THE TREATMENT OF METASTATIC COLRECTAL CANCER
    • November 1, 2020
      ✓ 
      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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