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  1. pharmadog
  2. ›drugs
  3. ›DIAZEPAM
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DIAZEPAM

Marketedupdated 3mo ago
by Mylan Institutional Inc
Approved
community read0 votes

🐶 often sniffed alongside

top 2
  • tagApproval2 co-mentions · 1 sources
  • companyNavinta LLC1 co-mentions · 1 sources

indications

investigational
Epilepsy

all catalysts(1)

approval · 1
Nov 14, 2025
approval
9mo ago
DIAZEPAM — FDA approval
DIAZEPAM
→

Trials studying DIAZEPAM

  • phase1A Study to Assess the Time to Onset of Action of Staccato Alprazolam Versus Midazolam and Diazepam in Healthy Participantscompletedn=55
  • phase2Pharmacokinetics Study of VALTOCO® in Pediatric Subjects With Epilepsycompletedn=35
  • phase4Evaluating the Abuse Potential of NEURONTIN® When Taken Orally in Healthy Non-drug Dependent Participants With Sedative Drug Abuse Experiencecompletedn=52

Patent cliff

source: FDA Orange Book
first barrier falls
Jan 10, 2027
142 days

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

patents (21)

  • Oct 16, 2032method-of-use (U-4173)US 12324852
  • Oct 16, 2032method-of-use (U-4173)US 12324852
  • Oct 16, 2032method-of-use (U-4173)US 12324852
  • Jun 13, 2032method-of-use (U-4173)US 12337061
  • Jun 13, 2032method-of-use (U-4173)US 12337061
  • Jun 13, 2032method-of-use (U-4173)US 12337061
  • Mar 27, 2029formulationUS 112414142.6y
  • Mar 27, 2029formulationUS 112414142.6y
  • Mar 27, 2029formulationUS 112414142.6y
  • Mar 27, 2029formulationUS 117937862.6y
  • Mar 27, 2029formulationUS 117937862.6y
  • Mar 27, 2029formulationUS 117937862.6y
  • Mar 27, 2029formulationUS 122686642.6y
  • Mar 27, 2029formulationUS 122686642.6y
  • Mar 27, 2029formulationUS 122686642.6y
  • Mar 27, 2029formulationUS 125214002.6y
  • Mar 27, 2029formulationUS 125214002.6y
  • Mar 27, 2029formulationUS 125214002.6y
  • Mar 27, 2029formulationUS 88955462.6y
  • Mar 27, 2029formulationUS 88955462.6y
  • Mar 27, 2029formulationUS 88955462.6y

FDA exclusivities (6)

  • Apr 15, 2028NPPNew Product (3y)1.7y
  • Apr 15, 2028NPPNew Product (3y)1.7y
  • Apr 15, 2028NPPNew Product (3y)1.7y
  • Jan 10, 2027ODE-279Orphan Drug (7y)142d
  • Jan 10, 2027ODE-279Orphan Drug (7y)142d
  • Jan 10, 2027ODE-279Orphan Drug (7y)142d

News(0)

no news has mentioned this drug yet

brand
DIAZEPAM
generic
DIAZEPAM
indication
Alcohol Withdrawal Syndrome
phase
marketed
Data sources
openFDA · ClinicalTrials.gov
last refreshed 34m ago
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