Although the patents for Novolin N (NPH insulin) have expired, the medication is not available as a generic. Novolin N is a "biologic" drug that is regulated by different rules and laws than most other drugs. Generic biologics, including generic Novolin N, are not allowed to be manufactured in the United States at this time.
An Overview of Generic Novolin N
Novolin® N (NPH insulin) is an intermediate-acting form of insulin used to help control blood sugar. It is available without a prescription. In comparison with regular human insulin, Novolin N starts working more slowly, produces a lower (and later) peak, and has a longer duration of action.
Novolin N is made by Novo Nordisk. Although the patents for Novolin N have long expired, there are no generic versions of Novolin N (or any other insulins) available.
Currently, there are no generic insulin medications allowed in the United States. Novolin N 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 N, 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 NPH Insulin the Same as Generic Novolin N?
No -- NPH insulin is the active ingredient in Novolin N (as well as various 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):
Novolin N [package insert]. Princeton, NJ: Novo Nordisk, Inc.;2013 March.
Novo Nordisk. Dear healthcare provider letter: important insulin delivery device information: discontinuation of several insulin delivery devices (June 2009). FDA Web site. Available at: http://www.fda.gov/downloads/Drugs/DrugSafety/DrugShortages/UCM177158.pdf. Accessed August 21, 2009.
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 11, 2008.
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