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Tapentadol ER (CG5503) — Competitive Intelligence Brief

Tapentadol ER (CG5503) (Tapentadol ER (CG5503)) competitive landscape: 4 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: mu-opioid receptor agonist and norepinephrine reuptake inhibitor. Area: Pain.

phase 3 mu-opioid receptor agonist and norepinephrine reuptake inhibitor mu-opioid receptor, norepinephrine transporter Pain Small molecule Live · refreshed every 30 min

Target snapshot

Tapentadol ER (CG5503) (Tapentadol ER (CG5503)) — Johnson & Johnson Pharmaceutical Research & Development, L.L.C.. Tapentadol ER is a mu-opioid receptor agonist and norepinephrine reuptake inhibitor.

Comparator set (4 drugs)

Auto-detected by same drug class / molecular target / therapeutic area, ranked by phase + recency. Override with ?vs=slug1,slug2,….

DrugGenericSponsorPhaseClassTargetApproval / PDUFA
Tapentadol ER (CG5503) TARGET Tapentadol ER (CG5503) Johnson & Johnson Pharmaceutical Research & Development, L.L.C. phase 3 mu-opioid receptor agonist and norepinephrine reuptake inhibitor mu-opioid receptor, norepinephrine transporter
dexketoprofen trometamol + tramadol hydrochloride dexketoprofen trometamol + tramadol hydrochloride Kavaklıdere Umut Hospital marketed NSAID + opioid analgesic combination COX-1/COX-2 (dexketoprofen); mu-opioid receptor, norepinephrine transporter, serotonin transporter (tramadol)
Ropivacaine + Tramadol Ropivacaine + Tramadol Aga Khan University marketed Local anesthetic + opioid analgesic combination Voltage-gated sodium channels (ropivacaine); mu-opioid receptor, norepinephrine transporter, serotonin transporter (tramadol)
lidocaine+systemic tramadol lidocaine+systemic tramadol Bagcilar Training and Research Hospital phase 3 Local anesthetic and weak opioid agonist Mu-opioid receptor, Norepinephrine transporter
CG5503 IR; tapentadol CG5503 IR; tapentadol Johnson & Johnson Pharmaceutical Research & Development, L.L.C. phase 3 Mu-opioid receptor agonist and norepinephrine reuptake inhibitor Mu-opioid receptor (OPRM1); norepinephrine transporter (SLC6A2)

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 (mu-opioid receptor agonist and norepinephrine reuptake inhibitor class)

  1. Johnson & Johnson Pharmaceutical Research & Development, L.L.C. · 1 drug in this class

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Cite this brief

Drug Landscape (2026). Tapentadol ER (CG5503) — Competitive Intelligence Brief. https://druglandscape.com/ci/tapentadol-er-cg5503. Accessed 2026-05-16.

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