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Generic Bethkis Availability

Last updated on Jan 11, 2023.

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

BETHKIS (tobramycin - solution;inhalation)

  • Manufacturer: CHIESI
    Approval date: October 12, 2012
    Strength(s): 300MG/4ML [RLD] [AN]

Has a generic version of Bethkis been approved?

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

tobramycin solution;inhalation

  • Manufacturer: MANKIND PHARMA
    Approval date: September 22, 2022
    Strength(s): 300MG/4ML [AN]
  • Manufacturer: TEVA PHARMS USA
    Approval date: June 26, 2019
    Strength(s): 300MG/4ML [AN]

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

  • Optimized formulation of tobramycin for aerosolization
    Patent 6,987,094
    Issued: January 17, 2006
    Inventor(s): Malvolti; Chiara & Garzia; Raffaella
    Assignee(s): Chiesi Farmaceutici S.p.A.

    The invention provides a tobramycin formulation for delivery by aerosolization in the form of additive-free, isotonic solution whose pH has been optimised to ensure adequate shelf-life at room temperature. Said formulation can be advantageously used for the treatment and prophylaxis of acute and chronic endobronchial infections, in particular those caused by the bacterium Pseudomonas aeruginosa associated to lung diseases such as cystic fibrosis.

    Patent expiration dates:

    • September 22, 2022
      ✓ 
      Drug product
  • Optimised formulation of tobramycin for aerosolization
    Patent 7,696,178
    Issued: April 13, 2010
    Inventor(s): Malvolti; Chiara & Garzia; Raffaella
    Assignee(s): Chiesi Farmaceutici S.p.A.

    The invention provides a tobramycin formulation for delivery by aerosolization in the form of additive-free, isotonic solution whose pH has been optimised to ensure adequate shelf-life at room temperature. Said formulation can be advantageously used for the treatment and prophylaxis of acute and chronic endobronchial infections, in particular those caused by the bacterium Pseudomonas aeruginosa associated to lung diseases such as cystic fibrosis.

    Patent expiration dates:

    • September 22, 2022
      ✓ 
      Drug product
  • Optimised formulation of tobramycin for aerosolization
    Patent 7,939,502
    Issued: May 10, 2011
    Inventor(s): Malvolti; Chiara & Garzia; Raffaella
    Assignee(s): Chiesi Farmaceutici S.p.A.

    The invention provides a tobramycin formulation for delivery by aerosolization in the form of additive-free, isotonic solution whose pH has been optimised to ensure adequate shelf-life at room temperature. Said formulation can be advantageously used for the treatment and prophylaxis of acute and chronic endobronchial infections, in particular those caused by the bacterium Pseudomonas aeruginosa associated to lung diseases such as cystic fibrosis.

    Patent expiration dates:

    • June 14, 2022
      ✓ 
      Patent use: MANAGEMENT OF CYSTIC FIBROSIS PATIENTS

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.
AN Solutions 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.

Further information

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

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