Viewing data from:

XANAX XR

NDA

ALPRAZOLAM | N021434 | 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

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

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part D Spending

CMS annual spending data for Xanax XR (2023)

Total Spending

$295K

Total Claims

415

Beneficiaries

Avg Cost/Unit

$11.84

Spending Trend

$303K(2019)→$316K(2020)→$390K(2021)→$348K(2022)→$295K(2023)

YoY Change:+7.1%

5yr CAGR:+4.4%

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 -22	View Letter (PDF)
Mar 2, 2021	SUPPL -18	View Letter (PDF)
Feb 9, 2021	SUPPL -21	View Letter (PDF)
Dec 22, 2016	SUPPL -16	View Letter (PDF)
Aug 26, 2011	SUPPL -7	View Letter (PDF)
Jun 3, 2011	SUPPL -6	View Letter (PDF)
Jun 30, 2004	ORIG -1	View Letter (PDF)
Apr 7, 2004	SUPPL -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (4)

Sort:

#001 — 0.5MG

RLDAB

0 patents0 exclusivities▴

TABLET, EXTENDED RELEASE;ORAL | Approved: Jan 17, 2003

No patent or exclusivity listings for this strength.

#002 — 1MG

RLDAB

0 patents0 exclusivities▾

TABLET, EXTENDED RELEASE;ORAL | Approved: Jan 17, 2003

#003 — 2MG

RLDAB

0 patents0 exclusivities▾

TABLET, EXTENDED RELEASE;ORAL | Approved: Jan 17, 2003

#004 — 3MG

RLDAB

0 patents0 exclusivities▾

TABLET, EXTENDED RELEASE;ORAL | Approved: Jan 17, 2003