There are currently no generic insulin products available. "Biologic" medications, such as insulin, are regulated by different laws and rules than most other medications. These laws prevent any generic versions of these medications from being manufactured in the United States. It is not clear when (or even if) generic versions of insulin will ever be available.
Is There a Generic Version of Insulin Available?
At this time, there are no generic insulin medications available. It does not matter if it is a brand-new type of insulin or one that has been around for decades -- current rules and regulations do not allow for the production or sale of generic insulin in the United States.
Why Isn't Generic Insulin Available?
Insulin is considered a "biologic" medication and is regulated by different rules and laws than most other medications. At this point, generic biologics, including generic insulin, 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.
Why Did My Insurance Make Me Switch Insulins?
You might wonder why your insurance company (or Medicaid or Medicare Part-D) made you switch your brand of insulin to another brand, especially when there are no generic versions available. Insurance companies can bargain with drug manufacturers to get special deals or rebates for medications. This helps to keep costs down. Some insurance companies will only cover certain brands of insulin for this reason. This is usually only a factor for the older insulins (for which there are several, nearly equivalent alternatives). If you are required to switch insulins, make sure to check your blood sugar levels more often until you know how the switch will affect you.
Written by/reviewed by: Kristi Monson, PharmD;Arthur Schoenstadt, MD
Last reviewed by: KristiMonson, PharmD;
List of references (click here):
See references for individual insulin products in eMedTV.com.
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 October 30, 2008.
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