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

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part D Spending

CMS annual spending data for Loreev XR (2023)

Total Spending

$1.5M

Total Claims

3,032

Beneficiaries

660

Avg Cost/Unit

$15.36

Spending Trend

$18K(2021)→$663K(2022)→$1.5M(2023)

YoY Change:+7.4%

5yr CAGR:+24.6%

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

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)

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