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NDA

FLUDARABINE PHOSPHATE | N022273 | SANOFI AVENTIS US 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

500 trials from ClinicalTrials.gov — 18 recruiting, 95 active, 383 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Provision of TCRγδ T Cells and Memory T Cells Plus Selected Use of Blinatumomab in Naïve T-cell Depleted Haploidentical Donor Hematopoietic Cell Transplantation for Hematologic Malignancies Relapsed or Refractory Despite Prior Transplantation NCT02790515	Phase 2	Active	St. Jude Children's Research Hospital	170	2016-07-14 → 2026-07-01
T Cell Depleted Allogeneic Hematopoietic Stem Cell Transplantation Conditioned With a Reduced Intensity Regimen in Patients With Hematologic Malignancies and Aplastic Anemia NCT03531736	Phase 1	Active	Memorial Sloan Kettering Cancer Center	17	2018-05-09 → 2027-05
Infusion of Expanded Cord Blood Cells in Addition to Single Cord Blood Transplant in Treating Patients With Acute Leukemia, Chronic Myeloid Leukemia, or Myelodysplastic Syndromes NCT03399773	Phase 2	Active	Fred Hutchinson Cancer Center	31	2022-05-10 → 2027-04-02
TCRαβ-depleted Progenitor Cell Graft With Additional Memory T-cell DLI, Plus Selected Use of Blinatumomab, in Naive T-cell Depleted Haploidentical Donor Hematopoietc Cell Transplantation for Hematologic Malignancies NCT03849651	Phase 2	Active	St. Jude Children's Research Hospital	69	2019-01-31 → 2027-12-31
A Safety And Efficacy Study Of HLA-G- Targeted CAR-T Cells IVS-3001 In Subjects With Previously Treated Advanced HLA-G-Positive Solid Tumors NCT05672459	Phase 1/2	Active	M.D. Anderson Cancer Center	31	2023-06-21 → 2028-12-29
Combination Chemotherapy, Total Body Irradiation, and Donor Blood Stem Cell Transplant in Treating Patients With Secondary Myelofibrosis NCT03118492	Phase 1	Active	City of Hope Medical Center	22	2017-06-21 → 2027-04-29
Study of KTE-X19 in Adult Japanese Participants With Relapsed/Refractory Mantle Cell Lymphoma or Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia NCT06253663	Phase 2	Active	Kite, A Gilead Company	25	2024-03-18 → 2027-07
Optimizing PTCy Dose and Timing NCT03983850	Phase 1/2	Active	National Cancer Institute (NCI)	105	2019-07-09 → 2026-10-26
A Trial of Epigenetic Priming in Patients With Newly Diagnosed Acute Myeloid Leukemia NCT03164057	Phase 2	Active	St. Jude Children's Research Hospital	206	2017-06-15 → 2027-06
Ibrutinib, Fludarabine Phosphate, Cyclophosphamide, and Obinutuzumab in Treating Patients With Chronic Lymphocytic Leukemia NCT02629809	Phase 2	Active	M.D. Anderson Cancer Center	81	2016-03-18 → 2028-03-31

Source: ClinicalTrials.gov. Trials matched by ingredient name; data refreshed each weekday and may lag the registry.

API Supply Chain6 active DMFs6 inactive

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

TAPI NL BVFLUDARABINE PHOSPHATE

DMF 157422001

ZHEJIANG HISUN PHARMACEUTICAL CO LTDFLUDARABINE PHOSPHATE USP

DMF 168072003

HUBEI BIOCAUSE HEILEN PHARMACEUTICAL CO LTDFludarabine Phosphate Drug Substance

DMF 210472007

EXPLORA LABORATORIES SAFLUDARABINE PHOSPHATE

DMF 230062009

HUBEI BIOCAUSE HEILEN PHARMACEUTICAL CO LTDFLUDARABINE PHOSPHATE DRUG SUBSTANCE

DMF 345092020

BIOCARE PHARMACEUTICAL LTDFLUDARABINE PHOSPHATE (REFINED)

DMF 351732020

ASH STEVENS INCInactiveFLUDARABINE PHOSPHATE

DMF 82411989

BAYER SCHERING PHARMA AGInactiveFLUDARABINE PHOSPHATE

DMF 149242000

ASH STEVENS INCInactiveFLUDARABINE PHOSPHATE (ASP)

DMF 155422001

RELIABLE BIOPHARMACEUTICAL LLCInactiveFLUDARABINE PHOSPHATE

DMF 171362004

EUTICALS SPAInactiveFLUDARABINE PHOSPHATE

DMF 173742004

AXITEC CO LTDInactiveFLUDARABINE PHOSPHATE USP, NON-STERILE BULK DRUG

DMF 196142006

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

Approval Letters

2 letters from Drugs@FDA

Date	Submission	Document
Nov 24, 2009	SUPPL -1	View Letter (PDF)
Dec 29, 2008	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 10MG

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Dec 18, 2008

No patent or exclusivity listings for this strength.