Tramadol (Ultram®) — Competitive Intelligence Brief

Tramadol (Ultram®) (Tramadol (Ultram®)) competitive landscape: 6 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: Opioid analgesic. Area: Pain management.

phase 3 Opioid analgesic Opioid receptors Pain management Small molecule

Target snapshot

Tramadol (Ultram®) (Tramadol (Ultram®)) — Esteve Pharmaceuticals, S.A.. Tramadol is a centrally acting opioid analgesic that works by binding to opioid receptors in the brain and spinal cord, reducing pain perception.

Comparator set (6 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
Tramadol (Ultram®) TARGET	Tramadol (Ultram®)	Esteve Pharmaceuticals, S.A.	phase 3	Opioid analgesic	Opioid receptors
SAMIDORPHAN L-MALATE	SAMIDORPHAN L-MALATE		marketed	Atypical Antipsychotic [EPC]	dopamine and serotonin type 2 (5HT2) receptors, opioid receptors	2021-01-01
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
NALBUPHINE HYDROCHLORIDE	NALBUPHINE HYDROCHLORIDE		marketed		kappa opioid receptors, mu opioid receptors	1979-01-01
Methadone Hydrochloride	METHADONE	Specgx Llc	marketed	Opioid Agonist	mu-opioid receptors, NMDA receptor	1947-01-01
Norco 5milligram-325milligram Tablet	Norco 5milligram-325milligram Tablet	Wake Forest University Health Sciences	marketed	Opioid analgesic combination	Opioid receptors (mu, delta, kappa); COX inhibition (acetaminophen)
Naloxone Hydrochloride	Naloxone Hydrochloride	Pfizer Inc.	marketed	Mixed opioid agonist-antagonist with opioid antagonist	Opioid receptors (mu, kappa)

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)

• 2026-06-25 — Naloxone Hydrochloride · 10960155 · Formulation · US
• 2026-12-12 — Naloxone Hydrochloride · 11590286 · Formulation · US
• 2027-02-20 — Naloxone Hydrochloride · 9238108 · Formulation · US
• 2027-02-27 — Naloxone Hydrochloride · 8206360 · Formulation · US
• 2027-05-23 — Naloxone Hydrochloride · 9724471 · Formulation · US
• 2028-03-12 — Naloxone Hydrochloride · 7947017 · Formulation · US
• 2028-10-30 — Naloxone Hydrochloride · 7749194 · Formulation · US
• 2028-11-25 — Naloxone Hydrochloride · 8231573 · Formulation · US
• 2029-04-10 — Naloxone Hydrochloride · 8226610 · Formulation · US
• 2029-11-02 — Naloxone Hydrochloride · 8021344 · Formulation · US
• 2031-02-28 — Naloxone Hydrochloride · 9814838 · Formulation · US
• 2031-02-28 — Naloxone Hydrochloride · 9474869 · Formulation · US
• 2031-02-28 — Naloxone Hydrochloride · 8939943 · Formulation · US
• 2031-02-28 — Naloxone Hydrochloride · 10322239 · Method of Use · US
• 2031-02-28 — Naloxone Hydrochloride · 9022022 · Formulation · US
• 2031-05-24 — Naloxone Hydrochloride · 10143972 · Method of Use · US
• 2031-05-24 — Naloxone Hydrochloride · 10143792 · Method of Use · US
• 2032-02-04 — Naloxone Hydrochloride · 8627816 · Formulation · US
• 2032-05-11 — Naloxone Hydrochloride · 12458591 · Method of Use · US
• 2032-05-11 — Naloxone Hydrochloride · 11806428 · Formulation · US
• 2032-05-11 — Naloxone Hydrochloride · 11020343 · Method of Use · US
• 2034-07-18 — Naloxone Hydrochloride · 9517307 · Formulation · US
• 2034-08-26 — Naloxone Hydrochloride · 11135155 · Formulation · US
• 2034-08-26 — Naloxone Hydrochloride · 11617713 · Formulation · US
• 2034-08-26 — Naloxone Hydrochloride · 11628139 · Formulation · US
• 2034-08-26 — Naloxone Hydrochloride · 10973814 · Formulation · US
• 2034-08-26 — Naloxone Hydrochloride · 10722510 · Formulation · US
• 2034-08-26 — Naloxone Hydrochloride · 11975096 · Formulation · US
• 2034-08-26 — Naloxone Hydrochloride · 12414915 · Formulation · US
• 2035-03-20 — Naloxone Hydrochloride · 10220158 · Formulation · US

Sponsor landscape (Opioid analgesic class)

1. Alza Corporation, DE, USA · 3 drugs in this class
2. Labopharm Inc. · 3 drugs in this class
3. University of Rochester · 3 drugs in this class
4. Purdue Pharma LP · 3 drugs in this class
5. Institute of Child Health · 2 drugs in this class
6. London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's · 2 drugs in this class
7. Fujian Cancer Hospital · 2 drugs in this class
8. Children's Hospital of Fudan University · 2 drugs in this class
9. AdventHealth · 2 drugs in this class
10. Danish University of Pharmaceutical Sciences · 2 drugs in this class