ACTIQ® — Competitive Intelligence Brief

ACTIQ® (ACTIQ®) competitive landscape: 6 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: opioid analgesic. Area: Pain Management.

phase 2 opioid analgesic mu-opioid receptors Pain Management Small molecule

Target snapshot

ACTIQ® (ACTIQ®) — Cephalon. ACTIQ® delivers fentanyl, a potent opioid analgesic, directly to the oral mucosa for rapid absorption and pain relief.

Comparator set (6 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
ACTIQ® TARGET	ACTIQ®	Cephalon	phase 2	opioid analgesic	mu-opioid receptors
BENZHYDROCODONE	BENZHYDROCODONE		marketed	Opioid analgesic combination; full mu-opioid agonist with non-opioid analgesic	Mu-opioid receptors (primary); delta and kappa opioid receptors (secondary); central nervous system pain pathways	2018-01-01
Methadone Hydrochloride	METHADONE	Specgx Llc	marketed	Opioid Agonist	mu-opioid receptors, NMDA receptor	1947-01-01
ropivacaine,morphine chloride,epinephrine,ketorolac	ropivacaine,morphine chloride,epinephrine,ketorolac	Jose Antonio Bernia Gil	marketed	Multimodal analgesic combination (local anesthetic + opioid + NSAID + sympathomimetic)	Sodium channels (ropivacaine), mu-opioid receptors (morphine), alpha/beta-adrenergic receptors (epinephrine), cyclooxygenase 1 and 2 (ketorolac)
Bupivacaine-fentanyl-morphine elective group	Bupivacaine-fentanyl-morphine elective group	Conrad Arnfinn Bjørshol	marketed	Combination analgesic (local anesthetic + opioids)	Voltage-gated sodium channels (bupivacaine); mu-opioid receptors (fentanyl, morphine)
Bupivacaine with intrathecal morphine	Bupivacaine with intrathecal morphine	Centre Hospitalier Universitaire Vaudois	marketed	Local anesthetic with intrathecal opioid	Voltage-gated sodium channels (bupivacaine); mu-opioid receptors (morphine)
Rifaximin and loperamide	Rifaximin and loperamide	The University of Texas Health Science Center, Houston	marketed	Antibiotic + antidiarrheal combination	Bacterial RNA polymerase (rifaximin); mu-opioid receptors in the GI tract (loperamide)

Recent regulatory actions (last 90 days)

No regulatory actions in the last 90 days for this set.

Upcoming PDUFA dates (next 180 days)

No PDUFA dates in the next 180 days for this set.

Patent timeline (forward window)

No upcoming patent expiries for this set.

Sponsor landscape (opioid analgesic class)

1. · 1 drug in this class
2. Alza Corporation, DE, USA · 1 drug in this class
3. Cephalon · 1 drug in this class
4. INSYS Therapeutics Inc · 1 drug in this class