There are currently no generic Istalol products available. The earliest possible date that a generic version of the medication could become available is November 2018, when the first patent for Istalol expires. Although timolol is the active ingredient in Istalol, it is not a generic version of the medication. Other timolol eye drops are not equivalent to Istalol.
Is a Generic Version of Istalol Available?
Istalol® (timolol maleate) is a prescription eye drop approved for the treatment of glaucoma and high eye pressure. It belongs to a group of medications known as beta blockers and is used just once a day.
Istalol is made by Bausch & Lomb Pharmaceuticals, Inc., and is marketed and distributed by ISTA Pharmaceuticals, Inc. It is currently under the protection of a patent that prevents any generic Istalol from being manufactured in the United States.
When Will Generic Istalol Be Available?
The first patent for Istalol currently expires in November 2018. This is the earliest predictable date that a generic version of Istalol could become available.
However, there are other circumstances that could come up to extend or shorten the exclusivity period of Istalol. This could include such things as lawsuits or other patents for specific Istalol uses. Once Istalol goes off patent, there may be several companies that manufacture a generic Istalol drug.
Is Timolol a Generic Istalol?
No -- timolol is the active ingredient in Istalol, but it is not a generic version of Istalol. Other timolol eye drops (including generic timolol and other brand-name products) are not equivalent to Istalol.
Istalol is uniquely formulated in such a way that provides superior absorption of the medication into the eye. This allows for once-daily dosing (unlike other timolol drops), without a high risk for blurring (unlike timolol gel-forming drops). If you would like to use a generic timolol eye drop, ask your healthcare provider about switching. However, keep in mind that such products are not equivalent to Istalol.
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 30, 2009.
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