Currently, exclusivity rights prevent the manufacturing of any generic versions of Supprelin LA (histrelin implant). These exclusivity rights are scheduled to expire in May 2014, which would be the earliest date that a generic version could become available. However, lawsuits or other patents for new uses of the drug may delay the manufacturing of a generic Supprelin LA implant.
Can I Buy Generic Supprelin LA?
Supprelin® LA (histrelin implant) is a prescription medication approved for use in children with central precocious puberty, a condition that causes puberty to start too early. It is a synthetic (manufactured) form of gonadotropin-releasing hormone (GnRH), a hormone found naturally in the body that helps regulate the production of other hormones.
Supprelin LA is manufactured by Endo Pharmaceuticals Solutions, Inc. The medication is protected from generic competition by exclusivity rights that have not yet expired.
When Will a Generic Version Be Available?
Endo Pharmaceuticals holds the exclusive rights to market Supprelin LA in the United States until May 2014. This is the earliest predictable date that a generic version could become available.
However, other circumstances could come up to extend or shorten this exclusivity period. This could include such things as lawsuits or other patents for specific Supprelin LA uses. Once the drug goes off-patent, there may be several companies that manufacture a generic Supprelin LA drug.
Is Histrelin a Generic Supprelin LA?
No -- histrelin is the active ingredient in Supprelin LA, but it is 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 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
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 1, 2011.
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