There are currently no generic Asacol HD (mesalamine) products licensed for sale. The earliest predictable date that a generic version could become available is November 2015. Until a generic becomes available, remember that there are no other mesalamine products that are equivalent to Asacol HD.
This medication is made by Warner Chilcott (US), LLC. It is currently under the protection of patents that prevent any generic Asacol HD from being manufactured in the United States.
When Will Generic Asacol HD Be Available?
The first patent for Asacol HD expired in August 2013. Yet, no generic versions are available. This suggests that another patent (which expires in November 2021) may still be protecting the drug against generic competition. However, a settlement between the manufacturer of Asacol HD and a generic manufacturer (Zydus Pharmaceuticals USA) will allow a generic version as early as November 2015.
Other circumstances could come up to extend or shorten the exclusivity period of the medication. This could include such things as lawsuits or other patents for specific Asacol HD uses. Once Asacol HD goes off patent, there may be several companies that will manufacture a generic Asacol HD drug.
Is Mesalamine a Generic Asacol HD?
No -- mesalamine is the active ingredient in Asacol HD (as well as several other medications) but is not a generic version of the medicine.
What can be confusing is that, oftentimes, the active ingredient of any 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 must make the product.
There are no other mesalamine products that are equivalent to Asacol HD, including the old Asacol (400 mg) tablets or Delzicol® capsules. It should also be noted that taking two regular-strength (400 mg) Asacol tablets or Delzicol capsules is not equivalent to taking one Asacol HD (800 mg) tablet, since the medications are absorbed differently.
Written by/reviewed by: Kristi Monson, PharmD;Arthur Schoenstadt, MD
Drug Store News. Warner Chilcott settles with Zydus over generic Asacol HD (December 11, 2013). DSN Web site. Available at: http://drugstorenews.com/article/warner-chilcott-settles-zydus-over-generic-asacol-hd. Accessed April 2, 2014.
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 December 2, 2013.
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