Wednesday, July 8, 2026

Drug profile · INN

fentanyl citrate

fentanyl citrate (FENTANYL CITRATE) is a mu opioid receptor agonist. Route of administration: transmucosal. Current US regulatory status: approved.

FDA: approved
US status approved
Patents linked 4
Pipeline programs 30
News articles 0
Drug details — fentanyl citrate
US status
approved
Class
Route
TRANSMUCOSAL
Patents
4
Programs
30
Data quality
0.84

Quick answer

fentanyl citrate (FENTANYL CITRATE) is a mu opioid receptor agonist. Route of administration: transmucosal. Current US regulatory status: approved.

Key facts

INN fentanyl citrate
Brand FENTANYL CITRATE
Mechanism Mu opioid receptor agonist
Target Mu-type opioid receptor
Route TRANSMUCOSAL
Formulation FILM

Mechanism of action

Mu opioid receptor agonist

Primary target: Mu-type opioid receptor

Approval history

Authority Status Date
FDA approved

Pipeline programs

  1. ACTIQ (Oral transmucosal fentanyl citrate) Phase 3 · Teva Pharma · Breakthrough Pain
  2. APHP211044 Phase 3 · PARItec · urgency, limb injuries
  3. Fentanyl Buccal Tablet Phase 3 · Teva Pharma · Chronic Pain
  4. Fentanyl Buccal Tablets Phase 3 · Teva Pharma · Pain
  5. Fentanyl Buccal Tablets Compared With Immediate-Release Oxycodone Phase 3 · Teva Pharma · Chronic Pain
  6. HSK3486-309 Phase 3 · Anaxis Pharma · General anaesthesia
  7. Intranasal Fentanyl Spray (INFS) Phase 3 · Takeda · Break Through Pain
  8. ORAVESCENT Fentanyl Citrate Phase 3 · Teva Pharma · Chronic Low Back Pain

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

Related patents

  1. CA 3046406

    PRODUIT DE REMPLACEMENT DE FACTEUR DE COAGULATION SANGUINE POUR UTILISATION DANS LE TRAITEMENT PROPHYLACTIQUE OU THERAPEUTIQUE DES HEMORRAGIES

    Expires Wed Aug 11 2038 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  2. US 8653107

    Fentanyl composition for nasal administration

    Expires Mon Feb 13 2034 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  3. EP 2599478

    Transdermales therapeutisches System zur Verabreichung von Fentanyl oder einem Analogstoff davon

    Expires Tue May 31 2033 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  4. CA 2784005

    SYSTEMES DE VEHICULES NANOPARTICULAIRES A BASE DE POLY (ACIDE DL-LACTIQUE - CO - GLYCOLIQUE) (PLGA) POUR THERAPIE PHOTODYNAMIQUE (PDT)

    Expires Wed Jun 11 2031 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

Frequently asked questions

What is fentanyl citrate?

fentanyl citrate (FENTANYL CITRATE) is a mu opioid receptor agonist. Route of administration: transmucosal. Current US regulatory status: approved.

What is the brand name for fentanyl citrate?

FENTANYL CITRATE is a marketed brand name for fentanyl citrate. Check FDA Drugs@FDA for the current US label holder and prescribing information.

What is the US approval status of fentanyl citrate?

fentanyl citrate 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.