Viewing data from:

HALCION

NDA

TRIAZOLAM | N017892 | PFIZER INC

3 strengths0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

1 petition (1 open) from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from Daniel F. Kripke, MD (The Weston Firm) FDA-2015-P-3959 · 6 docket documents Dr. Daniel F. Kripke filed this citizen petition under 21 C.F.R. § 10.30 requesting that the FDA take multiple administrative actions regarding hypnotic drugs including zolpidem, temazepam, eszopiclone, zaleplon, triazolam, flurazepam, quazepam, and barbiturates such as pentobarbital, amobarbital, a	Other	2015-12-16	Open	Daniel F. Kripke, MD (The Weston Firm)

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

13 trials from ClinicalTrials.gov — 1 recruiting, 10 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Measurement of the Hippocampal Theta Rhythm From the Outer Ear Canal NCT03954483	N/A	Recruiting	University of Manitoba	42	2023-10-16 → 2027-10-01
A Study to Evaluate the Clinical Efficacy, Safety and Tolerability of ARX-F03 Sublingual Sufentanil/Triazolam NanoTab™ in Patients Undergoing an Elective Abdominal Liposuction Procedure NCT00894699	Phase 2	Completed	Talphera, Inc	40	2009-06 → 2009-09
Effectiveness of GABA Agonists in Reducing the Reinforcing Effects of Cocaine NCT00218166	Phase 2	Completed	National Institute on Drug Abuse (NIDA)	78	2001-08 → 2005-05
Behavioral and Subjective Efficacy of Ramelteon in Subjects With a History of Polydrug Abuse NCT00671632	Phase 2	Completed	Takeda	14	2003-06 → 2003-12
Physiological, Behavioral and Subjective Effects of Drugs (GHB)NCT00058955	Phase 1	Completed	Orphan Medical	20	2003-08 → 2005-03
A Study to Determine Whether an Oral Drops Formulation of Triazolam is Bioequivalent to a Tablet Formulation in Healthy Subjects NCT01421043	Phase 1	Completed	Pfizer	34	2011-09 → 2011-10
A Study to Assess the Pharmacokinetics, Safety, and Tolerability of Intranasally Administered Esketamine in Healthy Participants NCT01780259	Phase 1	Completed	Janssen Research & Development, LLC	58	2012-12 → 2013-05
Oral Versus Intravenous Sedation for Ocular Procedures NCT03246724	Phase 4	Completed	Boston Medical Center	327	2017-10-16 → 2019-11-30
Next-Day Residual Effects of Gabapentin, Diphenhydramine and Triazolam on Simulated Driving Performance in Normal Volunteers NCT01888497	Phase 3	Completed	Pfizer's Upjohn has merged with Mylan to form Viatris Inc.	59	2013-07-29 → 2013-12-14
Comparison of Triazolam and Midazolam for Anxiolysis During Dental Treatment in the Pediatric Patient NCT03360123	N/A	Completed	University of Pittsburgh	4	2018-01-26 → 2018-04-11

Source: ClinicalTrials.gov. Trials matched by ingredient name.

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 3 NDCs

Highest NADAC/Unit

$0.3501

per ea

Lowest NADAC/Unit

$0.3397

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
59762371803TRIAZOLAM 0.25 MG TABLET	$0.3501	EA	Generic	—	2026-06-17
59762371809TRIAZOLAM 0.25 MG TABLET	$0.3501	EA	Generic	—	2026-06-17
59762371709TRIAZOLAM 0.125 MG TABLET	$0.3397	EA	Generic	—	2026-06-17

Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.

VA Federal Supply Schedule

Government-negotiated contract prices | 10 NDCs (5 FSS, 5 Big4)

Lowest Price

$22.57

Highest Price

$596.01

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
59762-3717-09TRIAZOLAM 0.125MG TAB	$125.63	FSS	Mylan Pharmaceuticals, Inc.	12/31/2027
59762-3717-09TRIAZOLAM 0.125MG TAB	$22.57	Big4	Mylan Pharmaceuticals, Inc.	12/31/2027
00009-0017-55HALCION TAB 0.25MG REV NUMBER UD	$596.01	FSS	Pfizer Inc.	06/30/2029
00009-0017-55HALCION TAB 0.25MG REV NUMBER UD	$463.59	Big4	Pfizer Inc.	06/30/2029
00009-0017-58HALCION 0.25MG TAB	$58.13	FSS	Pfizer Inc.	06/30/2029
00009-0017-58HALCION 0.25MG TAB	$43.66	Big4	Pfizer Inc.	06/30/2029

Showing 6 of 10 NDCs.

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

Medicare Part D Spending

CMS annual spending data for Halcion (2024)

Total Spending

$41K

Total Claims

202

Beneficiaries

Avg Cost/Unit

$5.59

Spending Trend

$133K(2019)→$109K(2020)→$96K(2021)→$37K(2022)→$42K(2023)→$41K(2024)

YoY Change:-9.0%

5yr CAGR:+0.5%

Source: CMS Medicare Part D Spending by Drug (2024). Shows gross drug cost under Part D.

API Supply Chain2 active DMFs5 inactive

2 active API suppliers hold Drug Master Files for this ingredient. Limited supplier base — potential supply chain risk.

CAMBREX PROFARMACO MILANO SRLTRIAZOLAM

DMF 87041990

CENTAUR PHARMACEUTICALS PRIVATE LTDTRIAZOLAM USP

DMF 359222021

DIOSYNTH BVInactiveTRIAZOLAM

DMF 86241990

ZAMBON SPAInactiveTRIAZOLAM

DMF 88591990

ORION CORP LTDInactiveTRIAZOLAM

DMF 92001991

FINE CHEMICALS CORPInactiveTRIAZOLAM

DMF 93421991

PHARMACIA AND UPJOHN SUB PFIZER INCInactiveTRIAZOLAM USP MICRONIZED

DMF 243142010

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

9 letters from Drugs@FDA

Date	Submission	Document
Jan 17, 2023	SUPPL -57	View Letter (PDF)
Oct 28, 2021	SUPPL -56	View Letter (PDF)
Feb 9, 2021	SUPPL -55	View Letter (PDF)
Oct 10, 2019	SUPPL -50	View Letter (PDF)
Feb 14, 2019	SUPPL -54	View Letter (PDF)
Dec 22, 2016	SUPPL -49	View Letter (PDF)
Sep 23, 2014	SUPPL -47	View Letter (PDF)
Feb 14, 2008	SUPPL -38	View Letter (PDF)
Jul 6, 2003	SUPPL -34	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — 0.25MG

RLDAB

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Nov 15, 1982

No patent or exclusivity listings for this strength.

#002 — 0.5MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Nov 15, 1982

#003 — 0.125MG

RLDAB

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Apr 26, 1985