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Generic Ciprodex Availability

Last updated on July 7, 2021.

Ciprodex is a brand name of ciprofloxacin/dexamethasone otic, approved by the FDA in the following formulation(s):

CIPRODEX (ciprofloxacin; dexamethasone - suspension/drops;otic)

  • Manufacturer: NOVARTIS
    Approval date: July 18, 2003
    Strength(s): 0.3%;0.1% [RLD] [AB]

Has a generic version of Ciprodex been approved?

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

CIPROFLOXACIN AND DEXAMETHASONE (ciprofloxacin; dexamethasone suspension/drops;otic)

  • Manufacturer: DR REDDYS LABS LTD
    Approval date: August 10, 2020
    Strength(s): 0.3%;0.1% [AB]

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

  • Method of treating middle ear infections
    Patent 8,846,650
    Issued: September 30, 2014
    Assignee(s): Novartis AG

    Aqueous suspension formulations containing dexamethasone and ciprofloxacin are disclosed for the treatment of middle ear infections in human patients having an open tympanic membrane.

    Patent expiration dates:

    • June 4, 2025
      ✓ 
      Patent use: TREATMENT OF ACUTE OTITIS MEDIA
      ✓ 
      Drug product
  • Method of treating middle ear infections
    Patent 9,149,486
    Issued: October 6, 2015
    Assignee(s): ALCON PHARMACEUTICALS LTD

    Aqueous suspension formulations containing dexamethasone and ciprofloxacin are disclosed for the treatment of middle ear infections in human patients having an open tympanic membrane.

    Patent expiration dates:

    • September 13, 2022
      ✓ 
      Patent use: TREATMENT OF ACUTE OTITIS MEDIA
      ✓ 
      Drug product
  • Method of treating middle ear infections
    Patent 9,345,714
    Issued: May 24, 2016
    Assignee(s): Alcon Pharmaceuticals Ltd.

    Aqueous suspension formulations containing dexamethasone and ciprofloxacin are disclosed for the treatment of middle ear infections in human patients having an open tympanic membrane.

    Patent expiration dates:

    • September 13, 2022
      ✓ 
      Patent use: TREATMENT OF ACUTE OTITIS MEDIA
      ✓ 
      Drug product
  • Method of treating middle ear infections
    Patent 9,402,805
    Issued: August 2, 2016
    Assignee(s): Alcon Pharmaceuticals Ltd.

    Aqueous suspension formulations containing dexamethasone and ciprofloxacin are disclosed for the treatment of middle ear infections in human patients having an open tympanic membrane.

    Patent expiration dates:

    • September 13, 2022
      ✓ 
      Patent use: TREATMENT OF ACUTE OTITIS MEDIA
      ✓ 
      Drug product
    • September 13, 2022
      ✓ 
      Patent use: TREATMENT OF ACUTE OTITIS EXTERNA
      ✓ 
      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.
AB Products meeting necessary bioequivalence requirements. Multisource drug products listed under the same heading (e.g. identical active ingredients, dosage form, and routes of administration) and having the same strength (see Therapeutic Equivalence-Related Terms, Pharmaceutical Equivalents) generally will be coded AB if a study is submitted demonstrating bioequivalence. In certain instances, a number is added to the end of the AB code to make a three character code (e.g. AB1, AB2, AB7). Three-character codes are assigned only in situations when more than one reference listed drug of the same strength has been designated under the same heading. Two or more reference listed drugs are generally selected only when there are at least two potential reference drug products which are not bioequivalent to each other. If a study is submitted that demonstrates bioequivalence to a specific listed drug product, the generic product will be given the same three-character code as the reference listed drug it was compared against.

Further information

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