There are currently no generic forms of Lantus (insulin glargine) approved in the United States. Lantus is considered a "biologic" medication, and rules and regulations prevent manufacturers from making any generic biologics. Also, patents currently prohibit generic Lantus from being manufactured. The first patent should expire in May 2010, but it is not known when (or if) a generic version of Lantus will become available.
Lantus is made by sanofi-aventis. At this time, generic Lantus has not been approved in the United States.
When Will Generic Lantus Be Available?
This is a difficult question to answer. There are at least two major obstacles preventing generic Lantus from becoming available. First, Lantus is considered a "biologic" medication and is, therefore, under different rules and laws than most other medications. At this point, generic biologics, including generic Lantus, are not allowed to be manufactured in the United States. Currently, legislation is under way that may change the laws concerning generic biologics (including insulin), but it is not clear when (or even if) this may happen.
Second, several unexpired patents protect the drug. The first of these patents already expired in May 2010. Other additional patents that expire at a later date may continue to protect Lantus from generic competition.
Is Insulin Glargine the Same as Generic Lantus?
No -- insulin glargine is the active ingredient in Lantus, but it 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):
Lantus [package insert]. Bridgewater, NJ: sanofi-aventis U.S. LLC;2007 March.
sanofi-aventis U.S. Dear pharmacist letter (10/13/2010). e-Pharm/alert Web site. Available at: http://whatcounts.jobson.com/dm?id=BB7B0E5EB06376216C292FADCE98C4CD. Accessed October 21, 2010.
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 27, 2010.
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