Lotemax (loteprednol) is protected by patents that prohibit a generic version of the drug from being manufactured. However, the first patent is set to expire in September 2012, which is the earliest predictable date that a generic Lotemax may be available. Loteprednol is the active ingredient in Lotemax, but it is not a generic version of the drug.
Can I Buy Generic Lotemax?
Lotemax® (loteprednol etabonate) is a prescription eye medication approved for the treatment of eye inflammation. Lotemax is a corticosteroid (often just known as a "steroid").
Lotemax is manufactured by Bausch & Lomb Incorporated. It is currently under the protection of patents that prevent any generic Lotemax from being manufactured in the United States.
When Will Generic Lotemax Be Available?
There are a few different patents for Lotemax, the first of which is set to expire in September 2012. This first patent was initially set to expire in March 2012, but the manufacturer was given a six-month extension for performing much-needed pediatric studies with the medication. This is the earliest predictable date that a generic version could become available.
However, there are other circumstances that could come up to extend or shorten this exclusivity period. This could include such things as lawsuits or other patents for specific Lotemax uses. Once the medication goes off-patent, there may be several companies that manufacture a generic Lotemax drug.
Is Loteprednol a Generic Lotemax?
No -- loteprednol etabonate is the active ingredient in Lotemax (as well as in Alrex®, a lower-strength loteprednol eye medication), but it is not a generic version of it. What can be confusing is that oftentimes, the active ingredient of a drug is 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 would make the product.
Written by/reviewed by: Kristi Monson, PharmD;Arthur Schoenstadt, MD
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 April 10, 2012.
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