Viewing data from:

LEUKERAN

NDA

CHLORAMBUCIL | N010669 | WAYLIS THERAPEUTICS LLC

1 strength0 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 Leukeran (2023)

Total Spending

$14.3M

Total Claims

1,401

Beneficiaries

268

Avg Cost/Unit

$321.41

Spending Trend

$5.5M(2019)→$3.6M(2020)→$2.8M(2021)→$5.0M(2022)→$14.3M(2023)

YoY Change:+372.1%

5yr CAGR:+89.6%

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

API Supply Chain1 active DMF

1 active API supplier hold Drug Master Files for this ingredient. Limited supplier base — potential supply chain risk.

BIOPHORE INDIA PHARMACEUTICALS PVT LTDCHLORAMBUCIL

DMF 289562015

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

Approval Letters

8 letters from Drugs@FDA

Source: Drugs@FDA application documents.

Products (1)

#002 — 2MG

RLD

0 patents0 exclusivities▴

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

No patent or exclusivity listings for this strength.