Tacrolimus (Prograf®, Protopic®) is a prescription medicine approved in oral and injectable forms (Prograf) to prevent organ rejection after a kidney, heart, or liver transplant. It is also available as an ointment (Protopic), which is licensed to treat moderate-to-severe symptoms of atopic dermatitis.
The oral version of tacrolimus is available in generic form and comes in several strengths. However, the intravenous injection and the ointment are not available in generic forms. The injectable form is protected by exclusivity rights that are not set to expire until March 2013. Tacrolimus ointment is currently protected by patents, which prevent generic competition until September 2014.
When the patents and exclusivity rights expire, companies may choose to make a generic version of the ointment and intravenous injections.
(For more information on generic tacrolimus, click Generic Prograf and Generic Protopic. These articles take a closer look at the generic versions of tacrolimus, including when they may become available in ointment and injectable forms.)
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 March 8, 2012.
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