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  2. ›drugs
  3. ›Narcan
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naloxone hydrochloride

Marketedupdated 3mo ago
by Emergent Devices Inc
Approved
community read0 votes

🐶 often sniffed alongside

top 8
  • tagApproval662 co-mentions · 280 sources
  • drugSUBOXONE454 co-mentions · 227 sources
  • drugBUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE454 co-mentions · 227 sources
  • drugSUBLOCADE454 co-mentions · 227 sources
  • drugbuprenorphine ER454 co-mentions · 227 sources
  • drugbuprenorphine454 co-mentions · 227 sources
  • drugBRIXADI454 co-mentions · 227 sources
  • drugBUPRENORPHINE HYDROCHLORIDE454 co-mentions · 227 sources

Small molecule drug with a maximum clinical stage of Approval (across all indications), with 3 approved and 4 investigational indications.

all catalysts(15)

approval · 15
Jul 11, 2001
approval
25y ago
NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE (NALOXONE HYDROCHLORIDE) — FDA approval
naloxone hydrochloride
→
Jan 7, 2015
approval
12y ago
NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE (NALOXONE HYDROCHLORIDE) — FDA approval
naloxone hydrochloride
→
Apr 20, 2017
approval
9y ago
NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE (NALOXONE HYDROCHLORIDE) — FDA approval
naloxone hydrochloride
→
Apr 20, 2017
approval
9y ago
NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE (NALOXONE HYDROCHLORIDE) — FDA approval
naloxone hydrochloride
→
Sep 18, 2018
approval
8y ago
NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE (NALOXONE HYDROCHLORIDE) — FDA approval
naloxone hydrochloride
→
Sep 20, 2018
approval
8y ago
NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE (NALOXONE HYDROCHLORIDE) — FDA approval
naloxone hydrochloride
→
Oct 9, 2019
approval
7y ago
NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE (NALOXONE HYDROCHLORIDE) — FDA approval
naloxone hydrochloride
→
Mar 4, 2021
approval
5y ago
NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE (NALOXONE HYDROCHLORIDE) — FDA approval
naloxone hydrochloride
→
Jan 3, 2024
approval
3y ago
NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE (NALOXONE HYDROCHLORIDE) — FDA approval
naloxone hydrochloride
→
Jan 3, 2024
approval
3y ago
NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE (NALOXONE HYDROCHLORIDE) — FDA approval
naloxone hydrochloride
→
Apr 19, 2024
approval
$SCNX0.3314-4.08%
2y ago
REZENOPY (NALOXONE HYDROCHLORIDE) — FDA approval
naloxone hydrochloride
→
Oct 31, 2024
approval
2y ago
NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE (NALOXONE HYDROCHLORIDE) — FDA approval
naloxone hydrochloride
→
Jan 23, 2026
approval
7mo ago
NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE (NALOXONE HYDROCHLORIDE) — FDA approval
naloxone hydrochloride
→
Jan 23, 2026
approval
7mo ago
NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE (NALOXONE HYDROCHLORIDE) — FDA approval
naloxone hydrochloride
→
Apr 9, 2026
approval
$SCNX0.3314-4.08%
4mo ago
REZENOPY (NALOXONE HYDROCHLORIDE) — FDA approval
naloxone hydrochloride
→
view all 15 catalysts →

Trials studying naloxone hydrochloride

  • phase1Pharmacokinetics (PK) and Safety of Multiple Doses of Intranasal Naloxone in Healthy Adultscompletedn=24
  • phase2A Phase 2 Safety, Tolerability, PK, and Efficacy Study of CS-1103 Following Fentanyl Challenge With Naloxone Blockadenot yet recruitingn=16
  • phase1Pharmacodynamic Evaluation of Intranasal Nalmefenecompletedn=84
  • phase4A Phase 4 Clinical Study to Investigate the Efficacy and Safety of Naloxone HCI IV in Patients With Strokecompletedn=446
  • phase4Clinical Outcomes From Nalmefenewithdrawn

Patent cliff

source: FDA Orange Book
first barrier falls
Dec 12, 2026
119 days

Earliest of all listed patents + FDA exclusivities. Generic / biosimilar entry typically only becomes possible AFTER both patent and exclusivity barriers expire.

patents (61)

  • Jun 14, 2041formulationUS 11571518
  • Feb 5, 2041method-of-use (U-4397)US 12514854
  • May 24, 2039formulationUS 11027072
  • Mar 20, 2035formulationUS 10220158
  • Mar 20, 2035formulationUS 10220158
  • Aug 26, 2034formulationUS 10722510
  • Aug 26, 2034formulationUS 10973814
  • Aug 26, 2034formulationUS 11135155
  • Aug 26, 2034formulationUS 11617713
  • Aug 26, 2034formulationUS 11628139
  • Aug 26, 2034formulationUS 11975096
  • Aug 26, 2034formulationUS 12414915
  • Jul 18, 2034formulationUS 9517307
  • Jul 18, 2034formulationUS 9517307
  • May 11, 2032method-of-use (U-3671)US 11020343
  • May 11, 2032formulationUS 11806428
  • May 11, 2032method-of-use (U-3671)US 12458591
  • Feb 4, 2032formulationUS 8627816
  • Feb 4, 2032formulationUS 8627816
  • May 24, 2031method-of-use (U-2476)US 101437924.8y
  • May 24, 2031method-of-use (U-2476)US 101437924.8y
  • May 24, 2031method-of-use (U-2476)US 101439724.8y
  • Feb 28, 2031method-of-use (U-1907)US 103222394.5y
  • Feb 28, 2031method-of-use (U-1907)US 103222394.5y
  • Feb 28, 2031method-of-use (U-1907)US 103222394.5y
  • Feb 28, 2031formulationUS 89399434.5y
  • Feb 28, 2031formulationUS 89399434.5y
  • Feb 28, 2031formulationUS 89399434.5y
  • Feb 28, 2031formulationUS 90220224.5y
  • Feb 28, 2031formulationUS 90220224.5y
  • Feb 28, 2031formulationUS 90220224.5y
  • Feb 28, 2031formulationUS 94748694.5y
  • Feb 28, 2031formulationUS 94748694.5y
  • Feb 28, 2031formulationUS 94748694.5y
  • Feb 28, 2031formulationUS 98148384.5y
  • Nov 2, 2029formulationUS 80213443.2y
  • Nov 2, 2029formulationUS 80213443.2y
  • Apr 10, 2029formulationUS 82266102.7y
  • Apr 10, 2029formulationUS 82266102.7y
  • Nov 25, 2028formulationUS 82315732.3y
  • Nov 25, 2028formulationUS 82315732.3y
  • Oct 30, 2028formulationUS 77491942.2y
  • Oct 30, 2028formulationUS 77491942.2y
  • Mar 12, 2028formulationUS 79470171.6y
  • Mar 12, 2028formulationUS 79470171.6y
  • May 23, 2027formulationUS 9724471281d
  • May 23, 2027formulationUS 9724471281d
  • Feb 27, 2027formulationUS 8206360196d
  • Feb 27, 2027formulationUS 8206360196d
  • Feb 20, 2027formulationUS 9238108189d
  • Feb 20, 2027formulationUS 9238108189d
  • Dec 12, 2026formulationUS 11590286119d
  • Dec 12, 2026formulationUS 11590286119d
  • Jun 25, 2026formulationUS 10960155
  • Jun 25, 2026formulationUS 10960155
  • Jun 10, 2026formulationUS 7731686
  • Jun 1, 2026formulationUS 7731686
  • Mar 31, 2026formulationUS 8926594
  • Mar 31, 2026formulationUS 8926594
  • Feb 1, 2026formulationUS 9278182
  • Feb 1, 2026formulationUS 9278182

FDA exclusivities (2)

  • Apr 19, 2027NPNP247d
  • Mar 7, 2026NPNP

News(5)

  • Narcan maker Emergent BioSolutions eliminates top R&D role in sweeping restructuring
    Two and a half years into his tenure as Emergent BioSolutions CEO, Joseph Papa is executing another round of restructuring to align the business with “current business realities.”
    fiercebiotech · 9d ago
  • Syphilis spreads while researchers contend with federal constraints and a drug shortage
    At the San Diego-Tijuana border, syphilis spreads while researchers contend with federal constraints and a drug shortage.
    stat · 14d ago
  • Trump administration will bring special ed to HHS
    Infant mortality rate dips, OTC naloxone options rise, and other health news from Morning Rounds
    stat · 1mo ago
  • FDA Broadens Access to Over-the-Counter Naloxone Nasal Spray for Opioid Overdose
    The U.S. Food and Drug Administration (FDA) today approved another over-the-counter (OTC) intranasal naloxone product, Rextovy, a 4 milligram (mg) naloxone hydrochloride nasal spray for the emergen…
    fda_press · 1mo ago
  • Are Republicans turning against medications for treating opioid addiction?
    Federal actions and proposals have reignited debate over methadone and buprenorphine, worrying addiction experts and patient groups.
    stat · 2mo ago
brand
Narcan
generic
naloxone hydrochloride
MOA
12.1 Mechanism of Action Naloxone hydrochloride is an opioid antagonist that antagonizes opioid effects by competing for the same receptor sites. Naloxone hydrochloride reverses the effects of opioids, including respiratory depression, sedation, and hypotension. It can also reverse the psychotomimetic and dysphoric effects of agonist-antagonists such as pentazocine.
indication
Acute Opioid Overdosage
phase
marketed
Data sources
openFDA · ClinicalTrials.gov
last refreshed 6m ago
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