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MYLERAN

NDA

BUSULFAN | N009386 | 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

1 petition (1 open) from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Suitability Petition from Foley & Lardner LLP FDA-2022-P-1940 · 3 docket documents Foley & Lardner LLP submitted this petition under 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act and 21 CFR § 314.93 requesting that the FDA Commissioner determine that an ANDA may be submitted for Busulfan Injection, USP 5 mg/mL, a formulation that differs from the reference listed drug B	Suitability	2022-08-18	Open	Foley & Lardner LLP

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

Clinical Trials

401 trials from ClinicalTrials.gov — 15 recruiting, 23 active, 224 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
International Randomised Phase III Clinical Trial in Children With Acute Myeloid Leukaemia NCT02724163	Phase 3	Active	University of Birmingham	700	2016-04 → 2032-12
Study of Intensity Modulated Total Marrow Irradiation (IM-TMI) in Addition to Fludarabine/Busulfan Conditioning for Allogeneic Transplantation in High Risk AML and Myelodysplastic Syndromes NCT03121014	Phase 2	Active	University of Illinois at Chicago	38	2017-04-24 → 2026-04
ß-Thalassemia Major With Autologous CD34+ Hematopoietic Progenitor Cells Transduced With TNS9.3.55 a Lentiviral Vector Encoding the Normal Human ß-Globin Gene NCT01639690	Phase 1	Active	San Rocco Therapeutics	10	2012-07 → 2027-07
Busulfan, Fludarabine Phosphate, and Post-Transplant Cyclophosphamide in Treating Patients With Blood Cancer Undergoing Donor Stem Cell Transplant NCT02861417	Phase 2	Active	M.D. Anderson Cancer Center	204	2016-08-05 → 2026-08-31
A Trial of Treatments to Assess the Effects on Outcome of Adults With AML and MDS Undergoing Allogeneic SCT NCT04217278	Phase 2/3	Active	University of Birmingham	333	2020-01-27 → 2026-05
Trial Evaluating MGTA-456 in Patients With High-Risk Malignancy NCT03674411	Phase 2	Active	Masonic Cancer Center, University of Minnesota	22	2019-01-02 → 2026-12-01
Optimizing PTCy Dose and Timing NCT03983850	Phase 1/2	Active	National Cancer Institute (NCI)	105	2019-07-09 → 2026-10-26
Venetoclax and Sequential Busulfan, Cladribine, and Fludarabine Phosphate Before Donor Stem Cell Transplant in Treating Patients With Acute Myelogenous Leukemia or Myelodysplastic Syndrome NCT02250937	Phase 2	Active	M.D. Anderson Cancer Center	116	2014-10-27 → 2027-10-31
Allogeneic Hematopoietic Stem Cell Transplant for Patients With Primary Immune Deficiencies NCT01652092	N/A	Active	Masonic Cancer Center, University of Minnesota	57	2012-09-04 → 2026-12
Pilot Study of Reduced-Intensity Hematopoietic Stem Cell Transplant of DOCK8 Deficiency NCT01176006	Phase 2	Active	National Cancer Institute (NCI)	70	2010-10-05 → 2028-10-31

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

Medicare Part D Spending

CMS annual spending data for Myleran (2024)

Total Spending

$177K

Total Claims

Beneficiaries

—

Avg Cost/Unit

$278.18

Spending Trend

$92K(2023)→$177K(2024)

YoY Change:+4.2%

5yr CAGR:+4.2%

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

API Supply Chain6 active DMFs3 inactive

6 active API suppliers hold Drug Master Files for this ingredient.

CHEMPACIFIC CORPBUSULFAN DRUG SUBSTANCE

DMF 211262007

APICORE US LLCBUSULFAN USP

DMF 239242010

EMCURE PHARMACEUTICALS LTDBUSULFAN USP

DMF 254332011

SHILPA PHARMA LIFESCIENCES LTDBUSULFAN USP

DMF 254912011

ARTHUR GROUP LLCBUSULFAN

DMF 256672012

FARMABIOS SPABUSULFAN

DMF 259332012

FRESENIUS KABI ONCOLOGY LTDInactiveBUSULFAN

DMF 243852010

EUTICALS SPAInactiveBUSULFAN

DMF 253932011

EXCELLA GMBH AND CO KGInactiveBUSULFAN

DMF 270062013

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

Approval Letters

3 letters from Drugs@FDA

Date	Submission	Document
Jan 9, 2004	SUPPL -23	View Letter (PDF)
May 16, 2003	SUPPL -21	View Letter (PDF)
Jan 23, 2003	SUPPL -19	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 2MG

RLD

0 patents0 exclusivities▴

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

No patent or exclusivity listings for this strength.