There are no patents preventing companies from making a generic Azactam (aztreonam injection) product. However, at this time, there is only a generic version of the powder form of Azactam. This generic Azactam has been studied by the FDA and determined to be equivalent to the brand-name version of the drug, although it may contain different inactive ingredients.
Azactam® (aztreonam injection) is a prescription antibiotic approved to treat several different types of bacterial infections. It is classified as a monobactam antibiotic. Azactam is normally given as an injection into a vein (an intravenous, or IV, injection) or a muscle (an intramuscular, or IM, injection).
Azactam is supplied in two forms -- in regular single-use vials that contain the medication in powder form and in single-use plastic containers that contain the medicine as a premixed solution. Azactam in powder form must be diluted with liquid to make a solution for injection. Because the plastic containers are already in solution (liquid) form, they do not need to be diluted.
Regular Azactam powder is made by Bristol Myers Squib Company. Premix Azactam in plastic containers is made by Baxter Healthcare Corporation for Bristol Myers Squib Company.
Neither of these medications is protected by patents. However, only Azactam in powder form is currently available as a generic.
Generic Azactam is available in the following strengths:
- Aztreonam 1 gram per vial
- Aztreonam 2 grams per vial.
Generic Azactam is made by APP Pharmaceuticals, a division of Fresenius Kabi USA, and by Bedford Laboratories.
All generic medications must undergo certain tests to compare them to brand-name medications. The U.S. Food and Drug Administration (FDA) then looks at these tests to decide if the generics are equivalent to the brand-name medications and assigns each generic a rating.
An "AP" rating means that the FDA has determined that a generic injectable medication is equivalent to a brand-name injectable medication. All of the generic Azactam versions currently available have an "AP" rating, meaning they should be equivalent to Azactam.
However, generic medications are allowed to have different inactive ingredients than the brand-name medication. This might include fillers, dyes, or other ingredients that may cause problems for people with allergies or sensitivities.