EN3409 — Competitive Intelligence Brief

EN3409 (EN3409) competitive landscape: 6 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: Partial mu-opioid receptor agonist. Area: Pain Management / Opioid Use Disorder.

phase 3 Partial mu-opioid receptor agonist Mu-opioid receptor (μ-OR) Pain Management / Opioid Use Disorder Small molecule

Target snapshot

EN3409 (EN3409) — BioDelivery Sciences International. EN3409 is a buprenorphine formulation designed to provide sustained opioid receptor agonism with reduced abuse potential through a specialized delivery technology.

Comparator set (6 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
EN3409 TARGET	EN3409	BioDelivery Sciences International	phase 3	Partial mu-opioid receptor agonist	Mu-opioid receptor (μ-OR)
Injectable buprenorphine	Injectable buprenorphine	University of California, San Francisco	marketed	Partial mu-opioid receptor agonist	Mu-opioid receptor (OPRM1)
Subutex, Buprenorphine Hydrochloride, SCH 28444	Subutex, Buprenorphine Hydrochloride, SCH 28444	Indivior Inc.	marketed	Partial mu-opioid receptor agonist	Mu-opioid receptor (μ-OR)
Buprenorphine (Experimental)	Buprenorphine (Experimental)	University of Alabama at Birmingham	marketed	Partial mu-opioid receptor agonist	Mu-opioid receptor (μ-OR)
TM buprenorphine	TM buprenorphine	Indivior Inc.	marketed	Partial mu-opioid receptor agonist	Mu-opioid receptor (OPRM1)
Injectable subcutaneous buprenorphine	Injectable subcutaneous buprenorphine	VA Office of Research and Development	marketed	Partial mu-opioid receptor agonist	Mu-opioid receptor (μ-OR)
Immediate Release Sublingual Buprenorphine	Immediate Release Sublingual Buprenorphine	Royal Victoria Hospital, Canada	marketed	Partial mu-opioid receptor agonist	Mu-opioid receptor (μ-OR)

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 (Partial mu-opioid receptor agonist class)

1. Indivior Inc. · 3 drugs in this class
2. New York State Psychiatric Institute · 3 drugs in this class
3. Orexo AB · 2 drugs in this class
4. BioDelivery Sciences International · 2 drugs in this class
5. King's College London · 1 drug in this class
6. Merck Sharp & Dohme LLC · 1 drug in this class
7. Mundipharma (China) Pharmaceutical Co. Ltd · 1 drug in this class
8. NYU Langone Health · 1 drug in this class
9. National Institute on Drug Abuse (NIDA) · 1 drug in this class
10. Purdue Pharma LP · 1 drug in this class