Opioid Nucynta Gets Six-Month Extension of Exclusivity – Generic Options to Hold

Posted on by myMatrixx
Pharmacist looking at prescriptions

On June 13, 2024, Collegium Pharmaceutical, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted pediatric exclusivity for opioid medications Nucynta® and Nucynta® ER. This adds to the 2023 exclusivity granted for Nucynta for New Patient Population in pediatrics.

The 2024 FDA grant for pediatric use extends the brand exclusivity of the opioids an additional six months: January 3, 2027, for Nucynta and December 27, 2025, for Nucynta ER.

Nucynta is approved to manage short term (acute) pain in adults and children 6 years of age and older who weigh at least 88 pounds (40 kg).

Nucynta ER is approved for the management of severe and persistent pain in adults that requires an extended treatment period with a daily opioid analgesic.

While not one of the most heavily prescribed opioids in the MyMatrixx book of business, the additional brand exclusivity delays the industry from releasing generic versions of these medications to the market.

Generic Medications Deliver Same Care for Less Money

Generic medicines are clinically effective alternatives to brand medications. They have the same active ingredient as brand-name medicines and work in the same way. The drugs may look different and contain different non-active ingredients such as fillers and binders.

A generic medication is approved via an abbreviated new drug application by which a generic manufacturer must demonstrate that the generic medication performs the same in the body as the brand name drug regarding dosage, safety, effectiveness, strength, stability, and quality.

A reduction in research cost means that a generic medication can be sold at substantial discounts compared to the brand medication, despite having the same therapeutic effect. Generic alternatives typically cost 80-85% less than their brand-name equivalents according to estimates from the FDA.

The MyMatrixx clinical team will continue to monitor the status of the Nucynta medications and when generic alternatives may be available. For any questions you may have, please reach out to your Clinical Account Executive or Clinical@myMatrixx.com