June 2025 is the earliest predictable date that a generic Nucynta ER (tapentadol ER) product could become available. This date is when the first patent for the drug is set to expire. However, lawsuits or other patents for new uses of Nucynta ER may delay the manufacturing of a generic version beyond this date.
Can I Buy Generic Nucynta ER?
Nucynta® ER (tapentadol ER) is a prescription opioid analgesic. It is approved to treat moderate-to-severe pain that requires continuous, around-the-clock treatment. It is also approved to treat diabetic nerve pain that requires continuous, around-the-clock treatment. This drug is a strong, long-acting narcotic painkiller that should not be used to treat mild or short-term pain. It is a relatively new medication and is, therefore, not yet available in generic form.
Nucynta ER is made by Janssen Pharmaceuticals. It is protected from generic competition by a patent that has not yet expired.
When Will a Generic Version Be Available?
The first patent is set to expire in June 2025. This is the earliest predictable date that a generic version of Nucynta ER 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 new Nucynta ER uses. Once the patent expires, several companies may manufacture a generic version.
Is Tapentadol ER a Generic Nucynta ER?
No -- tapentadol ER is the active ingredient in Nucynta ER, 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 patents for the original medicine must have expired 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):
Nucynta ER [package insert]. Titusville, NJ: Janssen Pharmaceuticals, Inc.;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 6, 2011.
eMedTV serves only as an informational resource. This site does not dispense medical advice or advice of any kind.
Site users seeking medical advice about their specific situation should consult with their own physician. Click