Even though there are no patents or exclusivity rights protecting Mustargen (mechlorethamine) from generic competition, a generic version of this drug is not available at this time. It is possible that the demand for this chemotherapy drug is so small that it would not be profitable for a company to manufacture a generic version.
Can I Buy Generic Mustargen?
Mustargen® (mechlorethamine) is a prescription chemotherapy medicine. It belongs to a general group of chemotherapy medicines known as alkylating agents.
Mustargen is manufactured by Baxter Oncology GmbH for Lundbeck, Inc. At this time, the medication is not available in generic form.
When Will a Generic Version Be Available?
Mustargen is an older medicine; it was approved by the U.S. Food and Drug Administration (FDA) before 1982. The medication is not protected from generic competition by patents or exclusivity rights. Normally, when a medication is no longer protected by patents, generic manufacturers begin to make generic versions of the medication. However, at this time, no generic manufacturer is making a generic version of Mustargen.
It is not entirely clear why a generic version of this drug is not being made. It could be that the demand for the medicine is too small for a generic manufacturer to profit from making a generic version. Because it is unclear why a generic manufacturer has not chosen to make a generic form of Mustargen, it is difficult to predict when, or even if, a generic version will become available.
Is Mechlorethamine a Generic Mustargen?
No -- mechlorethamine is the active ingredient in Mustargen, not a generic version 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, 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
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 28, 2012.
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