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Generic Hycamtin Availability

Last updated on May 11, 2023.

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

HYCAMTIN (topotecan hydrochloride - capsule;oral)

  • Manufacturer: NOVARTIS
    Approval date: October 11, 2007
    Strength(s): EQ 0.25MG BASE [RLD], EQ 1MG BASE [RLD]

HYCAMTIN (topotecan hydrochloride - injectable;injection)

  • Manufacturer: NOVARTIS
    Approval date: May 28, 1996
    Strength(s): EQ 4MG BASE/VIAL [RLD] [AP]

Has a generic version of Hycamtin been approved?

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

topotecan hydrochloride injectable;injection

  • Manufacturer: ACCORD HLTHCARE
    Approval date: June 26, 2013
    Strength(s): EQ 4MG BASE/VIAL [AP]
  • Manufacturer: ACTAVIS TOTOWA
    Approval date: December 2, 2010
    Strength(s): EQ 4MG BASE/VIAL [AP]
  • Manufacturer: DR REDDYS LABS LTD
    Approval date: March 9, 2011
    Strength(s): EQ 4MG BASE/VIAL [AP]
  • Manufacturer: FRESENIUS KABI USA
    Approval date: November 29, 2010
    Strength(s): EQ 4MG BASE/VIAL [AP]
  • Manufacturer: NOVAST LABS
    Approval date: November 30, 2016
    Strength(s): EQ 4MG BASE/VIAL [AP]
  • Manufacturer: SAGENT PHARMS
    Approval date: January 26, 2011
    Strength(s): EQ 4MG BASE/VIAL [AP]
  • Manufacturer: TEYRO LABS
    Approval date: December 1, 2010
    Strength(s): EQ 4MG BASE/VIAL [AP]

Note: No generic formulation of the following product is available.

  • topotecan hydrochloride - capsule;oral

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Hycamtin. 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: Generic Drug FAQ.

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.

  • Compound, corresponding compositions, preparation and/or treatment methods
    Patent 8,158,645
    Issued: April 17, 2012
    Inventor(s): Dell'Orco; Philip C. & Diederich; Ann Marie & Su; Qiaogong & Wood; Jeffery Lee
    Assignee(s): GlaxoSmithKline LLC

    Disclosed is a novel crystalline form of topotecan monohydrochloride pentahydrate, which is a pentahydrate of 10-[(dimethylamino)methyl]-4-ethyl-4,9-dihydroxy-1H-pyrano[3′,4′:6,7]indolizino[1,2-b]quinoline-3,14(4H,12H)dione monohydrochloride, corresponding pharmaceutical compositions, methods preparation and/or use thereof to treat anti-viral and/or cancer-related diseases.

    Patent expiration dates:

    • December 10, 2024
      ✓ 
      Drug product

Glossary

Term Definition
Drug Patent A 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 Exclusivity Exclusivity 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.
RLD A 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.
AP Injectable 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.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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