Low Dose ALKS 5461 — Competitive Intelligence Brief

Low Dose ALKS 5461 (Low Dose ALKS 5461) competitive landscape: 6 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: Opioid agonist-antagonist combination. Area: Pain Management / Opioid Use Disorder.

phase 3 Opioid agonist-antagonist combination Mu-opioid receptor (buprenorphine component); opioid receptor antagonism (samidorphan component) Pain Management / Opioid Use Disorder Small molecule

Target snapshot

Low Dose ALKS 5461 (Low Dose ALKS 5461) — Alkermes, Inc.. ALKS 5461 is a combination of buprenorphine and samidorphan that acts as a partial mu-opioid receptor agonist while blocking opioid-induced side effects through opioid antagonism.

Comparator set (6 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
Low Dose ALKS 5461 TARGET	Low Dose ALKS 5461	Alkermes, Inc.	phase 3	Opioid agonist-antagonist combination	Mu-opioid receptor (buprenorphine component); opioid receptor antagonism (samidorphan component)
Zubsolv sublingual tablets	Zubsolv sublingual tablets	Indivior Inc.	marketed	Opioid agonist-antagonist combination	Mu-opioid receptor (buprenorphine); opioid receptors (naloxone antagonism)
Buprenorphine, Naloxone Drug Combination	Buprenorphine, Naloxone Drug Combination	The University of Texas Health Science Center, Houston	marketed	Opioid agonist-antagonist combination	Mu-opioid receptor (buprenorphine as partial agonist; naloxone as antagonist)
Suboxone (SCH 000484)	Suboxone (SCH 000484)	Merck Sharp & Dohme LLC	marketed	Opioid agonist-antagonist combination	Mu-opioid receptor (buprenorphine); opioid receptors (naloxone)
Buprenorphine Naloxone	Buprenorphine Naloxone	Johns Hopkins University	marketed	Opioid agonist-antagonist combination	Mu-opioid receptor (buprenorphine as partial agonist; naloxone as antagonist)
NTX/BUP	NTX/BUP	Alkermes, Inc.	phase 3	Opioid agonist-antagonist combination	Mu-opioid receptor (μ-OR)
Oxycodone Naltrexone (a)	Oxycodone Naltrexone (a)	Elite Laboratories, Inc	phase 3	Opioid agonist-antagonist combination	Mu-opioid receptor (oxycodone agonist); opioid receptors (naltrexone antagonist)

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 agonist-antagonist combination class)

1. New York State Psychiatric Institute · 2 drugs in this class
2. Elite Laboratories, Inc · 2 drugs in this class
3. Alkermes, Inc. · 2 drugs in this class
4. Merck Sharp & Dohme LLC · 1 drug in this class
5. Orexo AB · 1 drug in this class
6. The University of Texas Health Science Center, Houston · 1 drug in this class
7. Indivior Inc. · 1 drug in this class
8. Johns Hopkins University · 1 drug in this class