Mallinckrodt plc / Cadence Pharmaceuticals, Inc.

Acute pain in the hospital setting (postoperative)

$40.7B Global postoperative pain therapeutics market 2024

Disease Overview

Acute postoperative pain affects nearly all surgical inpatients and is treated with a multimodal regimen combining IV opioids, IV/oral non-opioids (acetaminophen, NSAIDs, ketamine, dexmedetomidine), and regional anesthetics. The clinical and policy push since the mid-2010s has been to reduce inpatient opioid exposure to limit dependence and adverse events, elevating non-opioid IV options.

Competitive Landscape

Ofirmev (IV acetaminophen) was launched by Cadence in 2011 as the first FDA-approved IV acetaminophen in the US, sold under license from Bristol-Myers Squibb's Perfalgan franchise. At the time of Mallinckrodt's $1.4B all-cash acquisition (Feb 2014, closed Mar 19, 2014), the IV non-opioid landscape included Pacira's Exparel (liposomal bupivacaine, launched 2012), generic IV ketorolac, IV ibuprofen (Caldolor, Cumberland), and IV opioids led by morphine, hydromorphone, and fentanyl. Ofirmev's differentiation was reproducible non-opioid central analgesia with formulary uptake at 2,350+ US hospitals and >2x revenue growth ($50.1M→$110.5M, 2012→2013), making it Mallinckrodt's anchor for a hospital specialty franchise alongside its controlled-substance generic base. Mallinckrodt sharply raised list price from $14.75 to $35.40 per vial in May 2014, drawing Senate pricing scrutiny. Generic IV acetaminophen entered the US market following the loss of patent exclusivity in late 2014 (Fresenius Kabi authorized generic, then multiple ANDA approvals from 2020 onward), eroding pricing power and shifting the franchise's economics.