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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

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

2 trials from ClinicalTrials.gov — 2 recruiting

Trial	Phase	Status	Sponsor	Enrollment	Dates
A Study to Test the Safety and Tolerability of Staccato Alprazolam in Study Participants 12 Years of Age and Older With Stereotypical Prolonged Seizures NCT05076617	Phase 3	By Invitation	UCB Biopharma SRL	300	2022-02-03 → 2028-11-30
A Study to Test the Efficacy and Safety of Staccato Alprazolam in Study Participants 12 Years of Age and Older With Stereotypical Prolonged Seizures NCT05077904	Phase 3	Recruiting	UCB Biopharma SRL	350	2021-12-07 → 2026-07-31

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

Medicare Part D Spending

CMS annual spending data for Xanax (2023)

Total Spending

$14.1M

Total Claims

21,326

Beneficiaries

3,445

Avg Cost/Unit

$7.82

Spending Trend

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

YoY Change:+6.7%

5yr CAGR:+5.9%

Source: CMS Medicare Part D Spending by Drug (2023). 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