Viewing data from:

XANAX

NDA

ALPRAZOLAM | N018276 | UPJOHN US 2 LLC

4 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

Para IV certification filed but no ANDA patent litigation cases (NOS 835) matched from PACER. Litigation may be pending or filed under a different caption.

Citizen Petitions

3 petitions from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from Justice for Jake FDA-2018-P-0673 · 5 docket documents Justice for Jake filed this petition requesting that alprazolam be rescheduled from Schedule IV to Schedule II under the Controlled Substances Act, citing data showing alprazolam's involvement in approximately one-third of opioid overdose deaths and 125,000 annual hospital visits. The petitioner ask	Other	2018-02-12	Partially Denied	Justice for Jake
Citizen Petition from Emily Robin et al FDA-2010-P-0091 · 6 docket documents Emily Robin and other individuals who experienced adverse reactions to benzodiazepines filed this petition requesting that the FDA amend labeling for all FDA-approved benzodiazepines, including Ativan (lorazepam), Xanax (alprazolam), Klonopin (clonazepam), and Valium (diazepam), to standardize warni	Other	2010-03-01	Denied	Emily Robin et al
Citizen Petition from Beckloff Associates FDA-2006-P-0339 · 4 docket documents Beckloff Associates filed this citizen petition regarding Trade Name® (alprazolam orally disintegrating tablets), seeking regulatory action to address dependence and withdrawal concerns associated with the drug. The petition requests that the FDA implement mechanisms such as modifications to prescri	Other	2009-03-24	Denied	Beckloff Associates

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

Clinical Trials

73 trials from ClinicalTrials.gov, 57 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Mechanisms of Hypoglycemia Associated Autonomic Dysfunction Question 2 NCT00574639	Early Phase 1	Completed	University of Maryland, Baltimore	14	2007-07 → 2016-06
Assessment of Effect of Rapastinel on Driving Performance NCT03814733	Phase 1	Completed	Naurex, Inc, an affiliate of Allergan plc	107	2018-11-05 → 2019-04-03
Inpatient, Dose-Ranging Study of Staccato Alprazolam in Epilepsy With Predictable Seizure Pattern NCT03478982	Phase 2	Completed	Engage Therapeutics, Inc.	156	2018-03-16 → 2020-01-04
A Study of the Abuse Potential of Lasmiditan in Participants Who Are Recreational Drug Users NCT03286218	Phase 1	Completed	Eli Lilly and Company	96	2017-09-15 → 2017-11-20
A Study To Evaluate The Abuse Potential Of Single Oral Doses Of Dimebon (Latrepirdine) In Healthy Recreational Polydrug Users NCT00975481	Phase 1	Completed	Pfizer	36	2009-10 → 2010-02
Pharmacokinetics Of Alprazolam Sublingual Tablet Versus Conventional Tablet NCT01256151	Phase 1	Completed	Pfizer's Upjohn has merged with Mylan to form Viatris Inc.	28	2011-01 → 2011-05
Bioequivalence Trial of Alprazolam 2 mg Tablets NCT01745575	Phase 1	Completed	GlaxoSmithKline	26	2010-03-28 → 2010-04-05
Licorice Botanical Dietary Supplements - Metabolism and Safety in Women NCT03948243	Phase 1	Completed	University of Illinois at Chicago	19	2019-04-01 → 2022-04-22
Staccato Alprazolam and Photoparoxysmal Response NCT02351115	Phase 2	Completed	Nova Pneuma Inc.	5	2015-01 → 2016-07
A Relative Bioavailability Study of 2 mg Alprazolam OD Tablets Under Non-Fasting Conditions NCT01188057	Phase 1	Completed	Actavis Inc.	40	2006-07 → 2006-08

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

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 25 NDCs (14 brand, 11 generic)

Highest NADAC/Unit

$15.93

per ea

Lowest NADAC/Unit

$0.0225

per ea

Brand NDCs

Generic NDCs

Avg Brand: $8.58

Avg Generic: $0.0283

100% less

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
00009009401XANAX 2 MG TABLET	$15.93	EA	Brand	$0.0479	2026-06-17
58151045501XANAX 2 MG TABLET	$15.93	EA	Brand	$0.0479	2026-06-17
58151045401XANAX 1 MG TABLET	$9.37	EA	Brand	$0.0246	2026-06-17
00009009004XANAX 1 MG TABLET	$9.37	EA	Brand	$0.0246	2026-06-17
00009009001XANAX 1 MG TABLET	$9.37	EA	Brand	$0.0246	2026-06-17
58151045405XANAX 1 MG TABLET	$9.37	EA	Brand	$0.0246	2026-06-17

Showing 6 of 25 NDCs.

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

VA Federal Supply Schedule

Government-negotiated contract prices | 50 NDCs (25 FSS, 25 Big4)

Lowest Price

$0.90

Highest Price

$2350.27

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
59762-3719-04ALPRAZOLAM 0.25MG TABLETS	$21.23	FSS	Mylan Pharmaceuticals, Inc.	12/31/2027
59762-3719-04ALPRAZOLAM 0.25MG TABLETS	$11.99	Big4	Mylan Pharmaceuticals, Inc.	12/31/2027
59762-3720-01ALPRAZOLAM 0.5MG TABLETS	$2.69	FSS	Mylan Pharmaceuticals, Inc.	12/31/2027
59762-3720-01ALPRAZOLAM 0.5MG TABLETS	$1.50	Big4	Mylan Pharmaceuticals, Inc.	12/31/2027
00009-0094-01XANAX 2MG TAB	$799.23	FSS	Mylan Specialty L.P.	01/14/2027
00009-0094-01XANAX 2MG TAB	$799.23	Big4	Mylan Specialty L.P.	01/14/2027

Showing 6 of 50 NDCs.

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

Medicare Part D Spending

CMS annual spending data for Xanax (2024)

Total Spending

$13.4M

Total Claims

20,242

Beneficiaries

3,271

Avg Cost/Unit

$7.78

Spending Trend

$16.2M(2019)→$16.6M(2020)→$15.6M(2021)→$14.6M(2022)→$14.1M(2023)→$13.4M(2024)

YoY Change:-0.5%

5yr CAGR:+4.3%

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

API Supply Chain8 active DMFs9 inactive

7 active API suppliers hold Drug Master Files for this ingredient.

CAMBREX PROFARMACO MILANO SRLALPRAZOLAM

DMF 70941987

FERMION OYALPRAZOLAM

DMF 90431991

PH HEALTH LTDALPRAZOLAM DRUG SUBSTANCE

DMF 180752005

MATRIX PHARMACORP PRIVATE LTDALPRAZOLAM USP

DMF 182142005

MALLADI DRUGS AND PHARMACEUTICALS LTDALPRAZOLAM

DMF 204482007

CENTAUR PHARMACEUTICALS PVT LTDALPRAZOLAM USP

DMF 208272007

RL FINE CHEM PVT LTDALPRAZOLAM

DMF 334172019

MATRIX PHARMACORP PRIVATE LTDALPRAZOLAM USP (FORM-III)

DMF 408612025

CIPLA LTDInactiveALPRAZOLAM USP

DMF 80601989

ZAMBON SPAInactiveALPRAZOLAM

DMF 88601990

DIOSYNTH BVInactiveALPRAZOLAM

DMF 91281991

FINE CHEMICALS CORPInactiveALPRAZOLAM

DMF 93431991

LAKE CHEMICALS PRIVATE LTDInactiveALPRAZOLAM

DMF 218282008

ALP PHARM BEIJING CO LTDInactiveALPRAZOLAM USP (DRUG SUBSTANCE, NON-STERILE)

DMF 219492008

QILU TIANHE PHARMACEUTICAL CO LTDInactiveALPRAZOLAM USP (NON STERILE API)

DMF 220362008

NOVUS FINE CHEMICALS LLCInactiveALPRAZOLAM (CIV)

DMF 231932009

APOTEX PHARMACHEM INDIA PVT LTDInactiveALPRAZOLAM USP

DMF 250742011

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

Approval Letters

8 letters from Drugs@FDA

Date	Submission	Document
Feb 1, 2023	SUPPL -59	View Letter (PDF)
Mar 2, 2021	SUPPL -55	View Letter (PDF)
Feb 9, 2021	SUPPL -58	View Letter (PDF)
Dec 22, 2016	SUPPL -52	View Letter (PDF)
Aug 26, 2011	SUPPL -45	View Letter (PDF)
Jun 3, 2011	SUPPL -44	View Letter (PDF)
Apr 7, 2004	SUPPL -38	View Letter (PDF)
Apr 7, 2004	SUPPL -39	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (4)

Sort:

#001 — 0.25MG

RLDAB

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.

#002 — 0.5MG

RLDAB

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Approved Prior to Jan 1, 1982

#003 — 1MG

RLDAB

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Approved Prior to Jan 1, 1982

#004 — 2MG

RLDAB

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Nov 27, 1985