Cumberland Pharmaceuticals Inc. (CPIX) announced that the Centers for Medicare & Medicaid Services has officially associated a reimbursement price with the permanent J‑code J1741 for its Caldolor® (ibuprofen) injection. The decision, made on December 8, 2025, makes Caldolor a covered, non‑opioid option for pain and fever management under Medicare and Medicaid, creating a new revenue stream for the company.
Prior to this announcement, Caldolor had not been included in the 2025 Medicare Outpatient Prospective Payment System ruling under the NOPAIN Act, because CMS cited a lack of explicit post‑operative use in the drug’s FDA‑approved indications. The new J‑code reimbursement therefore represents a significant regulatory win, removing a key barrier to adoption and positioning Caldolor alongside other reimbursable non‑opioid therapies.
The reimbursement is expected to accelerate Caldolor’s market penetration. In the third quarter of 2025, the company reported net revenues of $8.3 million, and year‑to‑date revenues reached $30.8 million, a 12 % increase over the same period in 2024. The new coverage is likely to boost sales in both adult and pediatric segments, as the drug’s expanded labeling now includes infants 3 months and older. While the specific reimbursement amount has not been disclosed, the association with a J‑code signals that providers can bill for the product, which should translate into higher utilization and revenue growth.
CEO A.J. Kazimi emphasized the strategic importance of the win: “With Caldolor now linked to an established reimbursement price, healthcare providers have a reimbursable non‑opioid alternative to help address pain management. This update supports providers in making clinically appropriate decisions while contributing to efforts to reduce opioid exposure and reinforces our commitment to improving access to Caldolor and ensuring patients receive the pain management they need.” The statement underscores the company’s focus on safer pain management and its broader specialty pharmacy strategy.
The announcement has been well received by the market, reflecting confidence in the company’s ability to capitalize on the new reimbursement channel and its ongoing efforts to expand non‑opioid offerings. The regulatory approval is a key milestone that strengthens Cumberland’s competitive position in a market increasingly driven by opioid‑safety initiatives.
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