At this time, there are certain laws that prevent any generic Novolin R (regular insulin) 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. It is important to understand that while regular insulin is the "generic name" for Novolin R, it is not a generic version of the medicine.
Generic Novolin R: An Overview
Novolin® R (regular insulin) is a prescription diabetes medication. It is a short-acting form of insulin used primarily to control the rise in blood sugar after meals. It comes in the form of an injection and can also be administered intravenously (by IV). Like other brands of regular insulin, Novolin R is available without a prescription.
Novolin R is made by Novo Nordisk. At this time, there are no generic versions of Novolin R (or any other insulins) available.
Isn't Regular Insulin a Generic for Novolin R?
No -- regular insulin is the active ingredient in Novolin R (as well as a few other insulins), but it is not a generic version of Novolin R. Often, the active ingredient of a 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, another company (besides the original manufacturer) receives approval from the United States Food and Drug Administration to make and sell a generic version of a product.
Why Isn't Generic Novolin R Available?
At this point, there are no generic insulin medications available in the United States. Novolin R is considered a "biologic" medication and is regulated by different rules and laws than most other medications. At this point, generic biologics, including generic Novolin R, 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):
Novolin R [package insert]. Princeton, NJ: Novo Nordisk, Inc.;2013 March.
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 August 25, 2008.
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