Drugs Home > Generic Tobramycin Inhalation Solution
Unexpired patents currently prevent any company from making a generic version of tobramycin inhalation solution. The earliest predictable date generic versions could become available is in October 2014 (when Tobi's patent expires) and September 2022 (when Bethkis's patent expires). Tobramycin is sometimes called the "generic name" of Tobi and Bethkis, but it's simply the active ingredient in the medications -- not a generic version.
There are currently a couple of tobramycin inhalation solution medications available: Bethkis and Tobi. Bethkis is made by Catalent Pharma Solutions, LLC, for Cornerstone Therapeutics, Inc. Tobi is made by Novartis Pharmaceuticals Corporation. Both medications are protected by patents that prevent any generic versions from being manufactured in the United States.
When Will a Generic Version Be Available?
The first patent for Bethkis expires in September 2022 and the patent for Tobi expires in October 2014. These are the earliest predictable dates that a generic version of the medicines could become available.
However, other circumstances could come up to delay or shorten this exclusivity period for each medication. This could include things such as lawsuits or other patents for new uses. Once the patents expire, several companies may begin manufacturing generic versions of Tobi and Bethkis.
Is Tobramycin Inhalation Solution a Generic Bethkis or Tobi?
No -- tobramycin is the active ingredient in Bethkis and Tobi, not a generic version. What can be confusing is that the active ingredient of a drug is often referred to as the "generic name." The generic name is different from a generic version of a medicine.
In order for there to be a generic version of a medicine, the original medicine must have gone off-patent, and another company besides the original manufacturer must make the product.
Written by/reviewed by: Kristi Monson, PharmD;Arthur Schoenstadt, MD
Last reviewed by: KristiMonson, PharmD;
List of references (click here):
Tobi [package insert]. East Hanover, NJ: Novartis Pharmaceuticals Corporation;2009 November.
Food and Drug Administration, Center for Drug Evaluation and Research. Electronic orange book: approved drug products with therapeutic equivalence evaluations. FDA Web site. Available at: http://www.fda.gov/cder/ob/. Accessed June 13, 2013.
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