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Generic Kitabis Pak Availability

Kitabis Pak is a brand name of tobramycin, approved by the FDA in the following formulation(s):

KITABIS PAK (tobramycin - solution;inhalation)

  • Manufacturer: PULMOFLOW INC
    Approval date: December 2, 2014
    Strength(s): 300MG/5ML [AN]

Has a generic version of Kitabis Pak been approved?

Yes. The following products are equivalent to Kitabis Pak:

tobramycin solution;inhalation

  • Manufacturer: AKORN INC
    Approval date: May 28, 2014
    Strength(s): 300MG/5ML [AN]
  • Manufacturer: AMNEAL PHARMS
    Approval date: July 13, 2015
    Strength(s): 300MG/5ML [AN]
  • Manufacturer: LUPIN ATLANTIS
    Approval date: March 22, 2017
    Strength(s): 300MG/5ML [AN]
  • Manufacturer: TEVA PHARMS USA
    Approval date: October 10, 2013
    Strength(s): 300MG/5ML [AN]

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Kitabis Pak. 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 FAQs.

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.
ANSolutions and powders for aerosolization. Uncertainty regarding the therapeutic equivalence of aerosolized products arises primarily because of differences in the drug delivery system. Solutions and powders intended for aerosolization that are marketed for use in any of several delivery systems are considered to be pharmaceutically and therapeutically equivalent and are coded AN. Those products that are compatible only with a specific delivery system or those products that are packaged in and with a specific delivery system are coded BN, unless they have met an appropriate bioequivalence standard. Solutions or suspensions in a specific delivery system will be coded AN if the bioequivalence standard is based upon in vitro methodology, if bioequivalence needs to be demonstrated by in vivo methodology then the drug products will be coded AB.
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