Oxycodone Naltrexone (a) — Competitive Intelligence Brief

Oxycodone Naltrexone (a) (Oxycodone Naltrexone (a)) competitive landscape: 6 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: Opioid agonist-antagonist combination. Area: Pain Management.

phase 3 Opioid agonist-antagonist combination Mu-opioid receptor (oxycodone agonist); opioid receptors (naltrexone antagonist) Pain Management Small molecule

Target snapshot

Oxycodone Naltrexone (a) (Oxycodone Naltrexone (a)) — Elite Laboratories, Inc. Oxycodone naltrexone is a combination of an opioid agonist (oxycodone) and an opioid antagonist (naltrexone) designed to provide analgesia while reducing opioid-related adverse effects and abuse potential.

Comparator set (6 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
Oxycodone Naltrexone (a) TARGET	Oxycodone Naltrexone (a)	Elite Laboratories, Inc	phase 3	Opioid agonist-antagonist combination	Mu-opioid receptor (oxycodone agonist); opioid receptors (naltrexone antagonist)
Buprenorphine Naloxone	Buprenorphine Naloxone	Johns Hopkins University	marketed	Opioid agonist-antagonist combination	Mu-opioid receptor (buprenorphine as partial agonist; naloxone as antagonist)
Zubsolv sublingual tablets	Zubsolv sublingual tablets	Indivior Inc.	marketed	Opioid agonist-antagonist combination	Mu-opioid receptor (buprenorphine); opioid receptors (naloxone antagonism)
Suboxone (SCH 000484)	Suboxone (SCH 000484)	Merck Sharp & Dohme LLC	marketed	Opioid agonist-antagonist combination	Mu-opioid receptor (buprenorphine); opioid receptors (naloxone)
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)
Buprenorphine/naloxone sublingual tablets	Buprenorphine/naloxone sublingual tablets	Orexo AB	phase 3	Opioid agonist-antagonist combination	Mu-opioid receptor (buprenorphine partial agonist; naloxone antagonist)
Low Bup/Nal Dose	Low Bup/Nal Dose	New York State Psychiatric Institute	phase 3	Opioid agonist-antagonist combination	Mu-opioid receptor (buprenorphine); opioid receptors (naloxone antagonism)

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