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

2 petitions (1 open) from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from Buchanan Ingersoll & Rooney PC FDA-2025-P-0431 · 4 docket documents Buchanan Ingersoll & Rooney PC filed this citizen petition under 21 C.F.R. § 10.30 requesting that the FDA maintain and strictly apply the product-specific guidance for chlorambucil tablets to all pending and future ANDAs for chlorambucil 2 mg tablets, ensuring they contain results of an in vivo bio	505(q)	2025-02-13	Open	Buchanan Ingersoll & Rooney PC
Citizen Petition from Buchanan Ingersoll & Rooney PC FDA-2025-P-0026 · 4 docket documents Buchanan Ingersoll & Rooney PC filed this citizen petition under 21 C.F.R. § 10.30 requesting that the FDA maintain and strictly apply the current product-specific guidance for chlorambucil tablets to all pending and future ANDAs for chlorambucil, particularly 2 mg tablets, to ensure they contain re	505(q)	2025-01-02	Withdrawn	Buchanan Ingersoll & Rooney PC

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

Clinical Trials

48 trials from ClinicalTrials.gov, 4 active, 26 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
A Study of the Combination of Ibrutinib Plus Venetoclax Versus Chlorambucil Plus Obinutuzumab for the First-line Treatment of Participants With Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL)NCT03462719	Phase 3	Active	Janssen Research & Development, LLC	211	2018-04-17 → 2029-04-05
Study of Acalabrutinib Versus Chlorambucil Plus Rituximab in Adult Subjects With Previously Untreated Chronic Lymphocytic Leukemia NCT04075292	Phase 3	Active	AstraZeneca	155	2020-01-20 → 2027-01-01
Phase II Study of Chlorambucil and Subcutaneous Rituximab in Patients With Extranodal MALT Lymphoma NCT01808599	Phase 2	Active	International Extranodal Lymphoma Study Group (IELSG)	112	2013-12 → 2028-09
Acalabrutinib, Obinutuzumab and Chlorambucil in Treatment naïve CLL NCT02475681	Phase 3	Active	Acerta Pharma BV	535	2015-06-26 → 2025-09-30
Combination Chemotherapy in Treating Patients With Advanced Hodgkin's Disease NCT00003421	Phase 3	Completed	Medical Research Council	800	1998-06 → 2005-11
CLL11: A Study of Obinutuzumab (RO5072759 [GA101]) With Chlorambucil in Patients With Previously Untreated Chronic Lymphocytic Leukemia (Stage 2)NCT02053610	Phase 3	Completed	Hoffmann-La Roche	787	2009-12-31 → 2017-08-23
A Study of MabThera (Rituximab) Plus Chlorambucil in Patients With Previously Untreated Chronic Lymphocytic Leukemia.NCT00738374	Phase 2	Completed	Hoffmann-La Roche	97	2008-11-03 → 2013-01-14
Treatment of Mantle Cell Lymphoma at Diagnosis for Patients Under 65 Years NCT00285389	Phase 2	Completed	French Innovative Leukemia Organisation	39	2002-02 → 2008-12
An Expanded Access, Open-Label Study of Obinutuzumab (GA101) Plus Chlorambucil in Patients With Previously Untreated Chronic Lymphocytic Leukemia NCT01868893	Phase 2	Completed	Genentech, Inc.	20	2013-08 → 2014-01
Chlorambucil or Fludarabine as First-Line Therapy in Treating Patients With Previously Untreated Waldenström Macroglobulinemia, Splenic Lymphoma, or Lymphoplasmacytic Lymphoma NCT00608374	Phase 3	Completed	Taunton and Somerset Hospital	400	2006-06 → 2013-01

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

Medicare Part D Spending

CMS annual spending data for Leukeran (2024)

Total Spending

$16.9M

Total Claims

876

Beneficiaries

183

Avg Cost/Unit

$536.85

Spending Trend

$5.5M(2019)→$3.6M(2020)→$2.8M(2021)→$5.0M(2022)→$6.8M(2023)→$16.9M(2024)

YoY Change:+13.5%

5yr CAGR:+13.5%

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

Date	Submission	Document
Nov 3, 2011	SUPPL -32	View Letter (PDF)
Apr 28, 2010	SUPPL -30	View Letter (PDF)
May 25, 2005	SUPPL -29	View Letter (PDF)
Nov 25, 2003	SUPPL -28	View Letter (PDF)
Jul 24, 2001	SUPPL -21	View Letter (PDF)
Jul 24, 2001	SUPPL -23	View Letter (PDF)
Jul 24, 2001	SUPPL -22	View Letter (PDF)
Jun 20, 2001	SUPPL -24	View Letter (PDF)

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.