The Current Manufacturer: Protega Pharmaceuticals
Protega Pharmaceuticals Inc. is the manufacturer and rights holder of Roxybond, a Schedule II controlled substance. This privately held specialty pharmaceutical company is focused on developing medications with abuse-deterrent properties to combat the opioid crisis. Protega's proprietary SentryBond technology is the innovative feature that distinguishes Roxybond, an immediate-release oxycodone, from other opioid formulations. The company has received multiple FDA approvals for Roxybond, initially for 5mg, 15mg, and 30mg tablets in 2017, and later for a 10mg tablet in 2024.
Protega's approach centers on creating drugs that maintain their intended therapeutic effect when taken correctly but are more difficult to manipulate for misuse. The SentryBond technology uses inactive excipients to make the tablet resistant to common methods of manipulation, such as crushing, dissolving, and injecting. While these features reduce the potential for certain types of abuse, it is crucial to remember that abuse of any opioid, including Roxybond, is still possible.
A Timeline of Development and Ownership
The manufacturing rights to Roxybond have evolved over time, starting with its initial development and moving through a commercialization partnership before landing with Protega Pharmaceuticals.
Inspirion Delivery Sciences
The development of Roxybond and its underlying abuse-deterrent technology, SentryBond, began with Inspirion Delivery Sciences LLC. This company specialized in creating pharmaceutical products with controlled-release and abuse-deterrent features. Inspirion was the original assignee of the patent covering the abuse-deterrent composition.
The Role of Daiichi Sankyo
Following its initial FDA approval in 2017, Inspirion entered into a license and co-marketing agreement with Daiichi Sankyo, Inc., for the U.S. commercialization of Roxybond. Daiichi Sankyo, a major global pharmaceutical company, initially supported the launch of the medication. However, as the opioid crisis intensified and litigation against opioid manufacturers increased, Daiichi Sankyo decided to end its collaboration with Inspirion in 2019.
Transition to Protega Pharmaceuticals
After Daiichi Sankyo's departure, Protega Pharmaceuticals took over the commercialization of Roxybond. The transition consolidated the manufacturing, marketing, and commercial efforts under a single, specialty pharmaceutical company dedicated to advancing abuse-deterrent technologies. This change ensured the continued availability of Roxybond while also allowing Protega to continue its focus on innovation in the field.
What is Roxybond's SentryBond Technology?
Roxybond is formulated with Protega's SentryBond technology to make it more difficult to misuse through common methods of abuse. The technology works by creating physicochemical properties that make the tablet resistant to manipulation.
Here are some of the key features of SentryBond technology:
- Resists Physical Manipulation: The tablet is designed to be hard to crush or pulverize, preventing abusers from turning it into a powder for snorting.
- Resists Chemical Extraction: The inactive ingredients make it difficult to dissolve the tablet in common solvents, thwarting chemical attempts to extract the oxycodone for injection.
- Preserves Oral Bioavailability: When taken as intended (orally, intact), the abuse-deterrent technology does not interfere with the immediate-release delivery of the oxycodone, ensuring proper pain management.
Authorized Generic Versions
As of September 2025, an authorized generic version of Roxybond is available. This generic product is an important development in expanding access to this abuse-deterrent formulation. An authorized generic is produced by the brand company and marketed under a private label, so it is identical to the brand-name product in every aspect, including its active and inactive ingredients and appearance.
Ohemo Life Sciences Inc. markets the authorized generic version of oxycodone hydrochloride tablets, which is bioequivalent to Roxybond.
Comparing Roxybond and its Authorized Generic
| Feature | Roxybond (Brand Name) | Authorized Generic (Oxycodone HCl) |
|---|---|---|
| Manufacturer | Protega Pharmaceuticals | Ohemo Life Sciences Inc. |
| Abuse-Deterrent Technology | SentryBond™ | Identical SentryBond™ technology |
| Appearance | Identical appearance | Identical appearance |
| Active Ingredient | Oxycodone Hydrochloride | Oxycodone Hydrochloride |
| Inactive Ingredients | Same inactive ingredients | Same inactive ingredients |
| FDA Status | Approved as a brand-name drug with abuse-deterrent labeling | Approved as an authorized generic |
| Cost | Typically higher | Often more affordable |
Conclusion: The Evolving Landscape of Opioid Manufacturing
The question of Who makes Roxybond? leads to a more nuanced understanding of the opioid market and the pharmaceutical industry's response to the public health crisis. Protega Pharmaceuticals now manufactures this abuse-deterrent opioid, which was originally developed by Inspirion Delivery Sciences with early commercialization by Daiichi Sankyo. By integrating technologies like SentryBond, the pharmaceutical industry attempts to mitigate the potential for abuse. The availability of an authorized generic from Ohemo Life Sciences Inc. further expands access to this specific formulation. However, it is essential for both prescribers and patients to remember that abuse-deterrent features do not eliminate all risks associated with opioid use, including addiction, misuse, and respiratory depression. Therefore, strict prescribing practices and patient monitoring remain critical for safe pain management. For more detailed information on abuse-deterrent opioids and other drug-related data, the U.S. Food and Drug Administration offers comprehensive resources.
