Viewing data from:

LOREEV XR

NDA

LORAZEPAM | N214826 | ALMATICA PHARMA LLC

4 strengths1 unique patent0 unique exclusivities

Patent Timeline

1 unique patent by expiration date

Active (1)Today

2027

2028

2029

2030

2031

2032

2033

2034

Today

8999393

Jan. 8, 2034

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

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.

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 4 NDCs

Highest NADAC/Unit

$14.26

per ea

Lowest NADAC/Unit

$14.23

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
52427065830LOREEV XR 1 MG CAPSULE	$14.26	EA	Brand	—	2026-06-17
52427066130LOREEV XR 1.5 MG CAPSULE	$14.24	EA	Brand	—	2026-06-17
52427066730LOREEV XR 3 MG CAPSULE	$14.23	EA	Brand	—	2026-06-17
52427066330LOREEV XR 2 MG CAPSULE	$14.23	EA	Brand	—	2026-06-17

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

VA Federal Supply Schedule

Government-negotiated contract prices | 8 NDCs (4 FSS, 4 Big4)

Lowest Price

$333.65

Highest Price

$426.07

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
52427-0663-30LOREEV 2MG XR CAP	$426.07	FSS	Almatica LLC.	07/14/2030
52427-0663-30LOREEV 2MG XR CAP	$333.65	Big4	Almatica LLC.	07/14/2030
52427-0658-30LOREEV 1MG XR CAP	$426.07	FSS	Almatica LLC.	07/14/2030
52427-0658-30LOREEV 1MG XR CAP	$333.65	Big4	Almatica LLC.	07/14/2030
52427-0661-30LOREEV 1.5MG XR CAP	$426.07	FSS	Almatica LLC.	07/14/2030
52427-0661-30LOREEV 1.5MG XR CAP	$333.66	Big4	Almatica LLC.	07/14/2030
52427-0667-30LOREEV 3MG XR CAP	$426.07	FSS	Almatica LLC.	07/14/2030
52427-0667-30LOREEV 3MG XR CAP	$333.65	Big4	Almatica LLC.	07/14/2030

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

Medicare Part D Spending

CMS annual spending data for Loreev XR (2024)

Total Spending

$2.2M

Total Claims

4,959

Beneficiaries

1,089

Avg Cost/Unit

$14.70

Spending Trend

$18K(2021)→$663K(2022)→$1.5M(2023)→$2.2M(2024)

YoY Change:-4.3%

5yr CAGR:+14.1%

Source: CMS Medicare Part D Spending by Drug (2024). 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 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

2 letters from Drugs@FDA

Date	Submission	Document
Jan 17, 2023	SUPPL -3	View Letter (PDF)
Aug 31, 2021	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (4)

Sort:

#001 — 1MG

RLD

1 patent0 exclusivities▴

CAPSULE, EXTENDED RELEASE;ORAL | Approved: Aug 27, 2021

Patents (1) · 1 use code

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
8999393	Jan 8, 2034	—	—	Yes		—

#002 — 2MG

RLD

1 patent0 exclusivities▾

CAPSULE, EXTENDED RELEASE;ORAL | Approved: Aug 27, 2021

#003 — 3MG

RLD

1 patent0 exclusivities▾

CAPSULE, EXTENDED RELEASE;ORAL | Approved: Aug 27, 2021

#004 — 1.5MG

RLD

1 patent0 exclusivities▾

CAPSULE, EXTENDED RELEASE;ORAL | Approved: Feb 16, 2022