There are currently certain laws that prevent any generic NovoLog (insulin aspart) products from being manufactured in the United States. Legislation is underway that may change the laws concerning generic biologics (including insulin), but it is not clear when this may happen. Another reason why generic NovoLog is not available is because the patent for NovoLog does not expire until October 2014.
Generic NovoLog: An Overview
NovoLog® (insulin aspart) is a prescription diabetes medication. It is a rapid-acting form of insulin that is approved to treat both type 1 and type 2 diabetes. As a rapid-acting insulin, NovoLog is used primarily to control the rise in blood sugar that occurs after meals. It is also used in insulin pumps and can be given by IV. Compared to regular human insulin, NovoLog is designed to work more quickly, produce a higher peak, and have a shorter duration of action.
NovoLog is made by Novo Nordisk, Inc. At this time, there are no generic versions of NovoLog (or any other insulins) available.
Why Isn't Generic NovoLog Available?
There are at least two major obstacles preventing generic NovoLog from becoming available. First, NovoLog is protected by several unexpired patents, the first of which is currently set to expire in October 2014. These patents prevent any generic NovoLog from being sold in the United States.
Second, NovoLog is considered a "biologic" medication and is under different rules and laws than most other medications. At this point, generic biologics, including generic NovoLog, are not allowed to be manufactured in the United States. Currently, legislation is underway that may change the laws concerning generic biologics (including insulin), but it is not clear when (or even if) this may happen.
Written by/reviewed by: Kristi Monson, PharmD;Arthur Schoenstadt, MD
Last reviewed by: KristiMonson, PharmD;
List of references (click here):
NovoLog [package insert]. Plainsboro, NJ: Novo Nordisk;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 May 6, 2008.
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