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ATIVAN

NDA

LORAZEPAM | N017794 | BAUSCH HEALTH US LLC

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

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

1 trial from ClinicalTrials.gov — 1 recruiting

Trial	Phase	Status	Sponsor	Enrollment	Dates
Effect of IE Glasses on MRI Patient Outcomes NCT07660952	N/A	Not Yet Recruiting	Baptist Health South Florida	300	2026-07-01 → 2027-07-01

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

Medicare Part D Spending

CMS annual spending data for Lorazepam* (2023)

Total Spending

$63.4M

Total Claims

8,044,242

Beneficiaries

1,805,689

Avg Cost/Unit

$0.16

Spending Trend

$26.2M(2019)→$66.8M(2019)→$67.2M(2020)→$22.4M(2020)→$23.7M(2021)→$69.7M(2021)→$62.0M(2022)→$24.3M(2022)→$24.3M(2023)→$63.4M(2023)

YoY Change:+6.6%

5yr CAGR:+2.4%

Source: CMS Medicare Part D Spending by Drug (2023). Shows gross drug cost under Part D.

API Supply Chain8 active DMFs4 inactive

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

CAMBREX PROFARMACO MILANO SRLLORAZEPAM

DMF 45171982

FIS FABBRICA ITALIANA SINTETICI SPALORAZEPAM

DMF 50271983

EVONIK OPERATIONS GMBHLORAZEPAM

DMF 50411983

RL FINE CHEM PVT LTDLORAZEPAM

DMF 190062005

CENTAUR PHARMACEUTICALS PVT LTDLORAZEPAM USP

DMF 224602009

MALLADI DRUGS AND PHARMACEUTICALS LTDLORAZEPAM

DMF 232472009

KALINTIS HEALTHCARE PVT LTDLORAZEPAM USP

DMF 352992020

STHREE CHEMICALS PRIVATE LIMITEDLORAZEPAM USP

DMF 407542024

SANDOZ LTD PHARMACEUTICAL DIV CHEMICAL DEVELOPMENTInactiveLORAZEPAM

DMF 57471985

SUN PHARMACEUTICAL INDUSTRIES LTDInactiveLORAZEPAM USP

DMF 151562000

CIPLA LTDInactiveLORAZEPAM USP

DMF 177652004

TEVA PHARMACEUTICAL INDUSTRIES LTDInactiveLORAZEPAM

DMF 192682006

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

Approval Letters

4 letters from Drugs@FDA

Date	Submission	Document
Jan 17, 2023	SUPPL -49	View Letter (PDF)
Feb 9, 2021	SUPPL -48	View Letter (PDF)
Dec 22, 2016	SUPPL -44	View Letter (PDF)
Apr 25, 2007	SUPPL -35	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — 0.5MG

RLDAB

0 patents0 exclusivities▴

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

No patent or exclusivity listings for this strength.

#002 — 1MG

RLDAB

0 patents0 exclusivities▾

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

#003 — 2MG

RLDAB

0 patents0 exclusivities▾

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