Generic Cedax Availability

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

CEDAX (ceftibuten dihydrate - capsule;oral)

  • Manufacturer: PERNIX THERAP
    Approval date: December 20, 1995
    Strength(s): EQ 400MG BASE [RLD]

CEDAX (ceftibuten dihydrate - for suspension;oral)

  • Manufacturer: PERNIX THERAP
    Approval date: December 20, 1995
    Strength(s): EQ 90MG BASE/5ML [RLD]

Has a generic version of Cedax been approved?

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

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

  • Stable hydrated cephalosporin dry powder for oral suspension formulation
    Patent 5,599,557
    Issued: February 4, 1997
    Inventor(s): Johnson; Donald A. & Wearley; Lorraine & Galeos; Rebecca & Sequeira; Joel A.
    Assignee(s): Schering Corporation
    A dry hydrated cephalosporin, e.g. ceftibuten having about 7 to 14% by weight of water, powder formulation, pharmaceutical compositions in the form of an oral suspension dosage form and a method of making the dry powder formulations are disclosed.
    Patent expiration dates:
    • February 4, 2014
      ✓ 
      Patent use: TREATMENT OF COMMUNITY ACQUIRED PNEUMONIA, ACUTE EXACERBATION OF CHRONIC BRONCHITIS, AND ACUTE BACTERIAL SINUSITIS CAUSED BY SUSCEPTIBLE STRAINS OF DESIGNATED MICROORGANISMS IN PATIENTS 18 YEARS AND OLDER.
      ✓ 
      Drug product
    • February 4, 2014
      ✓ 
      Patent use: METHOD OF TREATING BACTERIAL INFECTIONS
      ✓ 
      Drug product

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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