Wednesday, July 8, 2026

Drug profile · INN

tapentadol hydrochloride

tapentadol hydrochloride (TAPENTADOL HYDROCHLORIDE) is a mu opioid receptor agonist. Associated with COLLEGIUM PHARMACEUTICAL, INC. Route of administration: oral. Current US regulatory status: approved.

FDA: approved
US status approved
Patents linked 8
Pipeline programs 0
News articles 0
Drug details — tapentadol hydrochloride
US status
approved
Class
Route
ORAL
Patents
8
Programs
0
Data quality
0.89

Quick answer

tapentadol hydrochloride (TAPENTADOL HYDROCHLORIDE) is a mu opioid receptor agonist. Associated with COLLEGIUM PHARMACEUTICAL, INC. Route of administration: oral. Current US regulatory status: approved.

Key facts

INN tapentadol hydrochloride
Brand TAPENTADOL HYDROCHLORIDE
Mechanism Mu opioid receptor agonist
Target Mu-type opioid receptor
Route ORAL
Formulation TABLET, EXTENDED RELEASE

Mechanism of action

Mu opioid receptor agonist

Primary target: Mu-type opioid receptor

Approval history

Authority Status Date
FDA approved

Related & competitor drugs

  1. alvimopan Mu opioid receptor antagonist
  2. loperamide hydrochloride Mu opioid receptor agonist
  3. methadone hydrochloride Mu opioid receptor agonist
  4. morphine sulfate Mu opioid receptor agonist
  5. oxycodone Mu opioid receptor agonist
  6. oxycodone hydrochloride Mu opioid receptor agonist
  1. US 10525053

    Abuse-deterrent pharmaceutical compositions of opioids and other drugs

    Expires Mon Jan 02 2040 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  2. US 9592200

    Abuse-deterrent pharmaceutical compositions of opioids and other drugs

    Expires Mon Mar 09 2037 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  3. US 9248195

    Abuse-deterrent pharmaceutical compositions of opioids and other drugs

    Expires Mon Jan 28 2036 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  4. US 9044398

    Abuse-deterrent pharmaceutical compositions of opiods and other drugs

    Expires Mon May 28 2035 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  5. US 8840928

    Tamper-resistant pharmaceutical compositions of opioids and other drugs

    Expires Mon Sep 18 2034 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  6. US 8557291

    Abuse-deterrent pharmaceutical compositions of opioids and other drugs

    Expires Mon Oct 10 2033 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  7. US 8512751

    Pharmaceutical compositions for sleep disorders

    Expires Mon Aug 15 2033 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  8. US 7399488

    Abuse-deterrent pharmaceutical compositions of opiods and other drugs

    Expires Mon Jul 10 2028 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

Frequently asked questions

What is tapentadol hydrochloride?

tapentadol hydrochloride (TAPENTADOL HYDROCHLORIDE) is a mu opioid receptor agonist. Associated with COLLEGIUM PHARMACEUTICAL, INC. Route of administration: oral. Current US regulatory status: approved.

What is the brand name for tapentadol hydrochloride?

TAPENTADOL HYDROCHLORIDE is a marketed brand name for tapentadol hydrochloride. Check FDA Drugs@FDA for the current US label holder and prescribing information.

What is the US approval status of tapentadol hydrochloride?

tapentadol hydrochloride has approved status in the United States according to our Drugs@FDA-derived records. Verify on the official FDA label before clinical or commercial decisions.