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FLUOROURACIL

NDA

FLUOROURACIL | N012209 | SPECTRUM PHARMACEUTICALS INC

2 strengths0 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

13 trials from ClinicalTrials.gov — 9 recruiting, 2 active, 2 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
A Phase I/II, Dose Finding and Optimization Study of [177Lu]Lu-NeoB in Combination With Capecitabine in Patients With GRPR+, ER+, HER2- Metastatic Breast Cancer After Progression on Previous Endocrine Therapy in Combination With a CDK4/6 Inhibitor.NCT06247995	Phase 1/2	Active	Novartis Pharmaceuticals	20	2024-08-14 → 2031-09-09
Can we Save the Rectum by Watchful Waiting or TransAnal Surgery Following (Chemo)Radiotherapy Versus Total Mesorectal Excision for Early REctal Cancer?NCT02945566	Phase 2/3	Active	University of Birmingham	380	2017-06-14 → 2028-08
A Study of Trastuzumab Rezetecan in Combination With Adebrelimab Versus Investigator's Choice of Therapy in Subjects With Residual Triple Negative Breast Cancer NCT07679360	Phase 3	Not Yet Recruiting	Suzhou Suncadia Biopharmaceuticals Co., Ltd.	1,000	2026-07 → 2032-12
Tislelizumab in Combination With Bevacizumab and Capecitabine in Advanced Solid Tumors With Evaluation in Immunotherapy-Resistant and Central Nervous System Disease NCT07681297	Phase 1/2	Not Yet Recruiting	National University Hospital, Singapore	154	2026-08 → 2028-08
Sacituzumab Tirumotecan (MK-2870) Plus Pembrolizumab Versus TPC in TNBC Who Did Not Achieve pCR (MK-2870-012)NCT06393374	Phase 3	Recruiting	Merck Sharp & Dohme LLC	1,530	2024-06-24 → 2037-12-14
SBRT + PD-1 Monoclonal Antibody in Unresectable Colorectal Liver Metastases NCT06794086	Phase 3	Recruiting	Jun Huang	24	2025-04-10 → 2027-01-20
Active Surveillance vs Adjuvant Chemoradiotherapy for Locally Resected Intermediate-Risk T1 Rectal Cancer NCT07669298	N/A	Recruiting	Medical University of Gdansk	480	2026-06-14 → 2037-06
A Phase II Study of Adjuvant Durvalumab Combined With GEMOX/GC Chemotherapy Followed by Lenvatinib Versus Capecitabine in Biliary Tract Cancer.NCT07679399	Phase 2	Recruiting	Peking Union Medical College Hospital	222	2025-06-01 → 2027-06-01
Randomizing Two Radiotherapy Boost Options to Avoid Rectal Cancer Surgery NCT03051464	Phase 2/3	Recruiting	Sir Mortimer B. Davis - Jewish General Hospital	131	2017-04-25 → 2030-01
Efficacy and Safety of Postoperative Concurrent Chemoradiotherapy for Extrahepatic Cholangiocarcinoma and Gallbladder Carcinoma: A Multicenter Prospective Phase II Study NCT07636824	Phase 2	Recruiting	Cancer Institute and Hospital, Chinese Academy of Medical Sciences	92	2026-06-16 → 2029-05-30

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

Medicare Part D Spending

CMS annual spending data for Fluorouracil* (2023)

Total Spending

$52.8M

Total Claims

575,539

Beneficiaries

500,442

Avg Cost/Unit

$2.40

Spending Trend

$40.1M(2019)→$48.8M(2020)→$52.4M(2021)→$55.0M(2022)→$52.8M(2023)

YoY Change:-14.7%

5yr CAGR:-5.3%

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

API Supply Chain4 active DMFs3 inactive

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

AMCOL HEALTH AND BEAUTY SOLUTIONS INCFLUOROURACIL IN MICROSPONGE® POLYMER (FLUROURACIL IN METHYL METHACRYLATE/DIMETHACRYLATE CROSSPOLYMER)

DMF 127381997

NANTONG JINGHUA PHARMACEUTICAL CO LTDFLUOROURACIL USP

DMF 184782005

IMCD SWITZERLAND AGFLUOROURACIL

DMF 217742008

FUJIAN SOUTH PHARMACEUTICAL CO LTDFLUOROURACIL

DMF 409392024

ANDARD MOUNT INTERNATIONAL LTDInactiveFLUOROURACIL

DMF 60981985

TEIKOKU CHEM INDUSTRYInactiveFLUOROURACIL

DMF 71791987

NANTONG GENERAL PHARMACEUTICAL FACTORYInactiveFLUOROURACIL

DMF 178322004

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Aug 2, 2016	SUPPL -40	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 500MG/10ML (50MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.

#002 — 2.5GM/50ML (50MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Jul 29, 2016