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CARAC

NDA

FLUOROURACIL | N020985 | EXTROVIS AG

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

Para IV certification filed but no ANDA patent litigation cases (NOS 835) matched from PACER. Litigation may be pending or filed under a different caption.

Citizen Petitions

2 petitions (1 open) from Regulations.gov

Petition	Type	Filed	Status	Petitioner
CITIZEN PETITION from Caraco Pharmaceutical Laboratories, Ltd. FDA-2006-P-0271 Caraco Pharmaceutical Laboratories, Ltd. filed a citizen petition under Section 505(j)(2)(c) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA determine whether the reference listed drug Hydrochlorothiazide Tablets USP 100 mg (ANDA 85-022, held by IVAX Pharmaceuticals Inc.) was vol	Other	2008-11-17	Open	Caraco Pharmaceutical Laboratories
Caraco Pharmaceutical Laboratories, Ltd. - Citizen Petition FDA-2008-P-0411	505(q)	2008-07-20	Denied	—

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

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part D Spending

CMS annual spending data for Carac (2023)

Total Spending

$49K

Total Claims

Beneficiaries

Avg Cost/Unit

$82.37

Spending Trend

$307K(2019)→$146K(2020)→$106K(2021)→$104K(2022)→$49K(2023)

YoY Change:+2.3%

5yr CAGR:+1.6%

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

4 letters from Drugs@FDA

Date	Submission	Document
May 4, 2026	SUPPL -21	View Letter (PDF)
May 27, 2022	SUPPL -19	View Letter (PDF)
Dec 19, 2003	SUPPL -4	View Letter (PDF)
Oct 27, 2000	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 0.5%

RLD

0 patents0 exclusivities▴

CREAM;TOPICAL | Approved: Oct 27, 2000

No patent or exclusivity listings for this strength.