The earliest date that a generic version of Quillivant XR (methylphenidate ER oral suspension) could become available is in 2029, when the first patent for the drug expires. Although methylphenidate is sometimes called the "generic name" of Quillivant XR, it is simply the active ingredient in the medication and not a generic version of it.
Quillivant XR is made by Tris Pharma, Inc., and distributed by NextWave Pharmaceuticals, Inc., a subsidiary of Pfizer, Inc. The drug is currently protected by patents and exclusivity rights that prevent any generic Quillivant XR from being manufactured in the United States.
When Will a Generic Version Be Available?
The first patent for Quillivant XR is set to expire in March 2029. This is the earliest predictable date that a generic version could become available.
However, other circumstances could come up to delay or shorten this exclusivity period. This could include things such as lawsuits or other patents for new Quillivant XR uses. Once the patents and exclusivity rights expire, several companies may begin manufacturing a generic Quillivant XR drug.
Is Methylphenidate the Same as Generic Quillivant XR?
No -- methylphenidate is the active ingredient in Quillivant XR, 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 June 10, 2013.
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