Colazal

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

COLAZAL (balsalazide disodium - capsule; oral)

• 
  Manufacturer: SALIX PHARMS
  
  Approval date: July 18, 2000
  
  Strength(s): 750MG ^[RLD][AB]

Has a generic version of Colazal been approved?

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

balsalazide disodium capsule; oral

• 
  Manufacturer: APOTEX INC
  
  Approval date: December 28, 2007
  
  Strength(s): 750MG ^[AB]


• 
  Manufacturer: MYLAN
  
  Approval date: December 28, 2007
  
  Strength(s): 750MG ^[AB]


• 
  Manufacturer: ROXANE
  
  Approval date: December 28, 2007
  
  Strength(s): 750MG ^[AB]

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

• 
  Formulations and uses of 2-hydroxy-5-phenylazobenzoic acid derivatives
  Patent 7,452,872
  Issued: November 18, 2008
  Inventor(s): Johnson; Lorin
  Assignee(s): Salix Pharmaceuticals, Inc.
  A method of increasing the bioavailability of balsalazide by administration of an oral dosage form with food is provided, as well as an article of manufacture comprising an oral dosage form of balsalazide in a suitable container and associated with printed labeling which describes the increased bioavailability of the medication in the container when taken with food.
  
  Patent expiration dates:
  
  
  • August 24, 2026
    
    ✓ 
    Patent use: TREATMENT OF ULCERATIVE COLITIS
  
  
  
  • February 24, 2027
    
    ✓ 
    Pediatric exclusivity
  
  



• 
  Formulations and uses of 2-hydroxy-5-phenylazobenzoic acid derivatives
  Patent 7,625,884
  Issued: December 1, 2009
  Inventor(s): Johnson; Lorin
  Assignee(s): Salix Pharmaceuticals, Ltd
  A method of increasing the bioavailability of balsalazide by administration of an oral dosage form with food is provided, as well as an article of manufacture comprising an oral dosage form of balsalazide in a suitable container and associated with printed labeling which describes the increased bioavailability of the medication in the container when taken with food.
  
  Patent expiration dates:
  
  
  • August 24, 2026
    
    ✓ 
    Patent use: TREATMENT OF ULCERATIVE COLITIS
  
  
  
  • February 24, 2027
    
    ✓ 
    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:
  • December 20, 2013 - ORPHAN DRUG EXCLUSIVITY
  
  
  • June 20, 2014 - PEDIATRIC EXCLUSIVITY
  
  

See also...

• Colazal Consumer Information (Wolters Kluwer)
• Colazal Consumer Information (Cerner Multum)
• Colazal Advanced Consumer Information (Micromedex)
• Colazal AHFS DI Monographs (ASHP)
• Balsalazide Consumer Information (Wolters Kluwer)
• Balsalazide Consumer Information (Cerner Multum)
• Balsalazide Advanced Consumer Information (Micromedex)
• Balsalazide Disodium AHFS DI Monographs (ASHP)