Hycamtin

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

HYCAMTIN (topotecan hydrochloride - capsule; oral)

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

HYCAMTIN (topotecan hydrochloride - injectable; injection)

• 
  Manufacturer: GLAXOSMITHKLINE
  
  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: ACTAVIS TOTOWA
  
  Approval date: December 2, 2010
  
  Strength(s): EQ 4MG BASE/VIAL ^[AP]


• 
  Manufacturer: APP PHARMS
  
  Approval date: November 29, 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 ONCOL
  
  Approval date: November 29, 2010
  
  Strength(s): EQ 4MG BASE/VIAL ^[AP]


• 
  Manufacturer: SAGENT PHARMS
  
  Approval date: January 26, 2011
  
  Strength(s): EQ 4MG BASE/VIAL ^[AP]


• 
  Manufacturer: THREE RIVERS PHARMS
  
  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: 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.

• 
  Treatment of ovarian cancer
  Patent 5,674,872
  Issued: October 7, 1997
  Inventor(s): Johnson; Randall Keith
  Assignee(s): SmithKline Beecham Corporation
  A method of treating ovarian cancer in a human afflicted therewith which comprises administering to such human an effective amount of a compound of the water soluble camptothecin analog class.
  
  Patent expiration dates:
  
  
  • October 7, 2014
    
    ✓ 
    Patent use: TREATMENT OF METASTATIC CARCINOMA OF THE OVARY AFTER FAILURE OF INITIAL OR SUBSEQUENT CHEMOTHERAPY
  
  
  
  • April 7, 2015
    
    ✓ 
    Pediatric exclusivity
  
  

Related Exclusivities

Exclusivity is exclusive marketing rights granted by the FDA upon approval of a drug and can run concurrently with a patent or not. Exclusivity is a statutory provision and is granted to an NDA applicant if statutory requirements are met.

• Exclusivity expiration dates:
  • October 11, 2010 - NEW DOSAGE FORM
  
  

See also...

• Hycamtin Consumer Information (Wolters Kluwer)
• Hycamtin Capsules Consumer Information (Wolters Kluwer)
• Hycamtin Consumer Information (Cerner Multum)
• Hycamtin Advanced Consumer Information (Micromedex)
• Hycamtin Intravenous Advanced Consumer Information (Micromedex)
• Hycamtin AHFS DI Monographs (ASHP)
• Topotecan Consumer Information (Wolters Kluwer)
• Topotecan Capsules Consumer Information (Wolters Kluwer)
• Topotecan Consumer Information (Cerner Multum)
• Topotecan Advanced Consumer Information (Micromedex)
• Topotecan Intravenous Advanced Consumer Information (Micromedex)
• Topotecan Hydrochloride AHFS DI Monographs (ASHP)