At this time, a generic version of Coartem (artemether/lumefantrine) is not available. Novartis Pharmaceuticals Corporation holds the exclusive rights to market this medication until October 2014. This is the earliest possible date that a generic version of the drug could become available. However, Coartem may be protected by certain other exclusivity rights until April 2016.
Can I Buy Generic Coartem?
Coartem® (artemether/lumefantrine) is a prescription medication licensed to treat uncomplicated, or mild, malaria. It is a combination of two antimalarial medicines: artemether and lumefantrine.
This medication is made by Novartis Pharmaceuticals Corporation. It is protected from generic competition by patents and exclusivity rights that have not yet expired.
When Will a Generic Version Be Available?
The first patent for Coartem currently expires in October 2014. This is the earliest predictable date that a generic version could become available. However, the drug may also be protected by "orphan drug exclusivity" until April 2016. Orphan drugs are medications that are approved for rare conditions; the manufacturers of such drugs are given incentives in the form of extended protection from competition.
There are also other circumstances that could come up to extend or shorten this exclusivity period. This could include such things as lawsuits or other patents for specific Coartem uses. Once the drug goes off-patent, there may be several companies that manufacture a generic Coartem drug.
Are Artemether and Lumefantrine a Generic Coartem?
No -- artemether and lumefantrine are the active ingredients in Coartem, not generic versions of it. What can be confusing is that the active ingredient of a drug is often 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 would make the product.
Written by/reviewed by: Kristi Monson, PharmD;Arthur Schoenstadt, MD
Last reviewed by: KristiMonson, PharmD;
List of references (click here):
Coartem [package insert]. East Hanover, NJ: Novartis Pharmaceuticals Corporation;2012 August.
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 8, 2010.
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