Generic Giazo Availability

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

GIAZO (balsalazide disodium - tablet;oral)

  • Manufacturer: SALIX PHARMS
    Approval date: February 3, 2012
    Strength(s): 1.1GM [RLD]

Has a generic version of Giazo been approved?

No. There is currently no therapeutically equivalent version of Giazo available in the United States.

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Giazo. 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 of balsalazide and its derivatives
    Patent 6,197,341
    Issued: March 6, 2001
    Inventor(s): Friess; Stefan & Heckenmuller; Harald & Szambien; Oliver
    The invention provides a unit formulation which comprises a 2-hydroxy-5-phenylazobenzoic acid derivative which is particularly sodium balsalazide dihydrate which formulation has a density of at least 0.9 mg/mm.sup.3 and its use in the treatment of gastrointestinal diseases.
    Patent expiration dates:
    • March 13, 2018
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      Patent use: TREATMENT OF MILDLY TO MODERATELY ACTIVE ULCERATIVE COLITIS IN MALE PATIENTS
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      Drug product
  • 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
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      Patent use: TREATMENT OF MILDLY TO MODERATELY ACTIVE ULCERATIVE COLITIS IN MALE PATIENTS
  • 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
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      Patent use: TREATMENT OF MILDLY TO MODERATELY ACTIVE ULCERATIVE COLITIS IN MALE PATIENTS
  • Formulations and uses of 2-hydroxy-5-phenylazobenzoic acid derivatives for the treatment of males
    Patent 8,497,256
    Issued: July 30, 2013
    Assignee(s): Salix Pharmaceuticals, Ltd
    The instant application provides methods and compositions for the treatment of male subjects having ulcerative colitis.
    Patent expiration dates:
    • June 23, 2031
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      Patent use: TREATMENT OF MILDLY TO MODERATELY ACTIVE ULCERATIVE COLITIS IN MALE PATIENTS

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:
    • February 3, 2015 - NEW DOSAGE FORM

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.
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