Generic Asacol is not expected to become available until at least July 2013, when the patent for Asacol expires. However, certain circumstances -- such as other patents for specific uses of Asacol or lawsuits -- could come up to extend this date past 2013. Do not buy any generic Asacol drug until an approved generic is available.
Asacol is manufactured by Procter & Gamble Pharmaceuticals and is currently protected by a patent that prevents any generic Asacol from being manufactured. Yet, search the Internet for "generic Asacol" and you will find a number of companies selling it. The fact is that these medicines are fake, substandard, and potentially dangerous. You should not buy any generic Asacol until there is an approved generic available.
When Will There Be a Generic Asacol?
The patent for Asacol currently expires in July 2013. This is the earliest possible date that a generic version of Asacol could become available. However, there are other circumstances that could come up to extend the exclusivity period of Asacol beyond 2013. These circumstances could include things such as other patents for specific Asacol uses or lawsuits. Once Asacol goes off patent, there may be several companies that will begin manufacturing a generic Asacol drug.
Is Mesalamine a Generic Asacol?
The answer is no. Mesalamine is the active ingredient in Asacol (and several other medicines) but is not a generic version of the medication. What can be confusing is that, oftentimes, the active ingredient of any drug is referred to as its "generic name." The generic name of a drug is different from a generic version of it. 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 have made the product.
Written by/reviewed by: Kristi Monson, PharmD;Arthur Schoenstadt, MD
Last reviewed by: KristiMonson, PharmD;
List of references (click here):
Asacol [package insert]. Rockaway, NJ: Warner Chilcott (US), LLC;2013 October.
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 July 1, 2013.
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