At this time, there are no generic Humulin R products licensed for sale. Insulin medications are considered "biologic" drugs, which are regulated by certain laws that prevent any generic versions from being manufactured in the United States. Until these laws change, no generic drug companies will be allowed to produce any generic Humulin R products.
An Overview of Generic Humulin R
Humulin® R (regular insulin) is a prescription diabetes medication. It is a short-acting form of insulin that is approved to treat both type 1 and type 2 diabetes. As a short-acting insulin, Humulin R 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. Standard U-100 Humulin R is available without a prescription, while concentrated U-500 Humulin R is available only with a prescription.
Humulin R is made by Hospira, Inc. and is marketed and distributed by Eli Lilly and Company. At this time, there are no generic versions of Humulin R (or any other insulins) available.
Why Isn't Generic Humulin R Available?
At this point, there are no generic insulin medications in the United States. Humulin 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 Humulin 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.
Is Regular Insulin the Same as Generic Humulin R?
No -- regular insulin is the active ingredient in Humulin R (as well as a few other insulins) but is not a generic version of it. What can be confusing is that, oftentimes, 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, the original medicine must have gone off patent, and another company besides the original manufacturer must make the product.
Written by/reviewed by: Kristi Monson, PharmD;Arthur Schoenstadt, MD
Last reviewed by: KristiMonson, PharmD;
List of references (click here):
Humulin R [package insert]. Indianapolis, IN: Lily USA, LLC;2013 March.
U-100 Humulin R [patient package insert]. Indianapolis, IN: Eli Lilly and Company;2007 April.
U-500 Humulin R [package insert]. Indianapolis, IN: Eli Lilly and Company;2007 September.
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 16, 2008.
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