Viewing data from:

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

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
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

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

Clinical Trials

99 trials from ClinicalTrials.gov, 3 active, 71 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Haloperidol and Lorazepam for Delirium in Patients With Advanced Cancer NCT01949662	Phase 2	Active	M.D. Anderson Cancer Center	93	2014-01 → 2028-01-01
Haloperidol and Lorazepam in Controlling Symptoms of Persistent Agitated Delirium in Patients With Advanced Cancer Undergoing Palliative Care NCT03743649	Phase 2/3	Active	M.D. Anderson Cancer Center	110	2019-07-17 → 2028-12-31
Optimization of Procedural Sedation Protocol Used for Dental Care Delivery in People With Mental Disability NCT02078336	Phase 4	Active	Universitaire Ziekenhuizen KU Leuven	40	2013-12 → 2025-07
Safety and Efficacy Evaluation Of Pregabalin (Lyrica) With Patients With Generalized Anxiety Disorder NCT00624780	Phase 4	Completed	Pfizer's Upjohn has merged with Mylan to form Viatris Inc.	615	2009-05 → 2012-04
Phase 1 Study to Characterize the Safety and Pharmacokinetics of Single Intravenous Dose of Lorazepam in Healthy Japanese Adult Subjects NCT01994668	Phase 1	Completed	Pfizer	8	2014-01 → 2014-02
Gabapentin for Alcohol Withdrawal Syndrome NCT03012815	Phase 4	Completed	Mayo Clinic	88	2017-02-01 → 2021-03-01
Effect of A Single Dose of Lorazepam on Salivary Cortisol Response in Children Undergoing Digestive Endoscopy:NCT03180632	Phase 2	Completed	St. Justine's Hospital	98	2017-06-28 → 2018-06-01
Treating Alcohol Withdrawal With Oral Baclofen NCT00597701	N/A	Completed	Essentia Health	79	2003-04 → 2008-02
Lorazepam for the Treatment of Status Epilepticus or Repetitive Status Epilepticus in Japan NCT02239380	Phase 3	Completed	Pfizer	26	2014-11 → 2016-08
A First In Human Study In Healthy People To Evaluate Safety, Toleration, Pharmacokinetics and Pharmacodynamics of Single Oral Doses Of PF-06372865 NCT01951144	Phase 1	Completed	Pfizer	45	2013-10 → 2014-07

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

VA Federal Supply Schedule

Government-negotiated contract prices | 6 NDCs (3 FSS, 3 Big4)

Lowest Price

$2268.67

Highest Price

$4829.85

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
00187-0064-01ATIVAN 1MG TAB	$3030.61	FSS	Bausch Health US, LLC	04/30/2026
00187-0064-01ATIVAN 1MG TAB	$3030.61	Big4	Bausch Health US, LLC	04/30/2026
00187-0063-01ATIVAN 0.5MG TAB	$2268.67	FSS	Bausch Health US, LLC	04/30/2026
00187-0063-01ATIVAN 0.5MG TAB	$2268.67	Big4	Bausch Health US, LLC	04/30/2026
00187-0065-01ATIVAN 2MG TAB	$4829.85	FSS	Bausch Health US, LLC	04/30/2026
00187-0065-01ATIVAN 2MG TAB	$4829.85	Big4	Bausch Health US, LLC	04/30/2026

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

Medicare Part D Spending

CMS annual spending data for Ativan (2024)

Total Spending

$22.6M

Total Claims

6,598

Beneficiaries

1,633

Avg Cost/Unit

$40.05

Spending Trend

$26.2M(2019)→$22.4M(2020)→$23.7M(2021)→$24.3M(2022)→$24.3M(2023)→$22.6M(2024)

YoY Change:-8.2%

5yr CAGR:+1.8%

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

Medicare Part B Spending

CMS physician-administered drug spending for Ativan (2024)

Total Spending

$13K

Total Claims

9,674

Beneficiaries

3,752

ASP Price

$1.21

Spending Trend

$22K(2019)→$19K(2020)→$16K(2021)→$13K(2022)→$17K(2023)→$13K(2024)

YoY Change:-2.0%

5yr CAGR:+12.0%

HCPCS: J2060 — Injection, lorazepam, 2 mg

Source: CMS Medicare Part B Spending by Drug (2024). Shows physician-administered drug costs.

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 LTDLORAZEPAM 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