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NIPENT

NDA

PENTOSTATIN | N020122 | HOSPIRA INC

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

46 trials from ClinicalTrials.gov, 6 active, 31 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Nonmyeloablative Peripheral Blood Mobilized Hematopoietic Precursor Cell Transplantation for Sickle Cell Disease and Beta-thalassemia in People With Higher Risk of Transplant Failure NCT02105766	Phase 2	Active	National Heart, Lung, and Blood Institute (NHLBI)	56	2014-04-21 → 2027-12-31
Nonmyeloablative Haploidentical Peripheral Blood Mobilized Hematopoietic Precursor Cell Transplantation for Sickle Cell Disease NCT03077542	Phase 1/2	Active	National Heart, Lung, and Blood Institute (NHLBI)	57	2017-04-06 → 2026-08-31
A Blood Stem Cell Transplant for Sickle Cell Disease NCT03249831	Phase 1	Active	City of Hope Medical Center	3	2019-01-04 → 2027-01-25
Randomized Phase II Trial of Rituximab With Either Pentostatin or Bendamustine for Multiply Relapsed or Refractory Hairy Cell Leukemia NCT01059786	Phase 2	Active	National Cancer Institute (NCI)	69	2010-07-01 → 2031-06-30
Allogeneic Hematopoietic Cell Transplantation for Disorders of T-cell Proliferation and/or Dysregulation NCT03663933	Phase 2	Active	National Cancer Institute (NCI)	71	2018-09-04 → 2030-04-03
A Study to Evaluate Axatilimab Versus Best Available Therapy in Participants With Chronic Graft Versus Host Disease After at Least 2 Prior Lines of Systemic Therapy NCT06821542	Phase 3	Active	Incyte Corporation	9	2025-06-04 → 2032-11-30
Phase II Trial of Pentostatin in Steroid Refractory Acute Graft Versus Host Disease NCT00201786	Phase 2	Completed	Ohio State University Comprehensive Cancer Center	8	2003-07 → 2013-07
Pentostatin, Cyclophosphamide, and Rituximab in Treating Patients With Previously Untreated Chronic Lymphocytic Leukemia NCT00541034	Phase 2	Completed	Memorial Sloan Kettering Cancer Center	49	2005-05 → 2016-01
Pentostatin, Cyclophosphamide, Rituximab, and Mitoxantrone in Treating Patients With Chronic Lymphocytic Leukemia or Other Low-Grade B-Cell Cancer NCT00546377	Phase 1/2	Completed	Memorial Sloan Kettering Cancer Center	50	2005-07 → 2014-05
Pentostatin, Cyclophosphamide, and Rituximab in Treating Patients With Chronic Lymphocytic Leukemia or Other B-cell Cancers NCT00003658	Phase 2	Completed	Memorial Sloan Kettering Cancer Center	60	1998-09 → 2005-10

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

VA Federal Supply Schedule

Government-negotiated contract prices | 2 NDCs (1 FSS, 1 Big4)

Lowest Price

$1954.06

Highest Price

$2542.52

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
00409-0801-01PENTOSTATIN 10MG/MANNITOL 50MG/VIL INJ	$1954.06	Big4	Pfizer Inc.	06/30/2029
00409-0801-01PENTOSTATIN 10MG/MANNITOL 50MG/VIL INJ	$2542.52	FSS	Pfizer Inc.	06/30/2029

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

Medicare Part B Spending

CMS physician-administered drug spending for Nipent (2024)

Total Spending

$424K

Total Claims

167

Beneficiaries

ASP Price

$2421.93

Spending Trend

$824K(2019)→$627K(2020)→$618K(2021)→$394K(2022)→$781K(2023)→$424K(2024)

YoY Change:+2.8%

5yr CAGR:+6.3%

HCPCS: J9268 — Injection, pentostatin, 10 mg

Source: CMS Medicare Part B Spending by Drug (2024). Shows physician-administered drug costs.

API Supply Chain2 active DMFs

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

CHEMPACIFIC CORPPENTOSTATIN

DMF 182352005

MATRIX PHARMACORP PRIVATE LTDPENTOSTATIN

DMF 248622011

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 4, 2025	SUPPL -21	View Letter (PDF)
Oct 29, 2019	SUPPL -15	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 10MG/VIAL

RLDAP

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: Oct 11, 1991

No patent or exclusivity listings for this strength.