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ZINACEF

NDA

CEFUROXIME SODIUM | N050558 | PAI HOLDINGS LLC DBA PHARMACEUTICAL ASSOCIATES INC

3 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

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part D Spending

CMS annual spending data for Cefuroxime Sodium* (2023)

Total Spending

$6K

Total Claims

Beneficiaries

Avg Cost/Unit

$2.49

Spending Trend

$11K(2019)→$11K(2020)→$13K(2021)→$3K(2022)→$6K(2023)

YoY Change:+121.3%

5yr CAGR:+15.2%

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

API Supply Chain5 active DMFs9 inactive

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

ACS DOBFAR SPACEFUROXIME SODIUM (STERILE BULK)

DMF 132051998

FARMABIOS SPACEFUROXIME SODIUM STERILE USP

DMF 187222005

GLAXOSMITHKLINE LLCCEFUROXIME SODIUM

DMF 244112011

NECTAR LIFESCIENCES LTDCEFUROXIME SODIUM USP (STERILE) DRUG SUBSTANCE

DMF 246272011

STERILE INDIA PVT LTDCEFUROXIME SODIUM USP (STERILE)

DMF 299832016

ELI LILLY AND COInactiveCEFUROXIME SODIUM

DMF 136751998

FARMABIOS SRLInactiveCEFUROXIME SODIUM STERILE

DMF 141371999

FRESENIUS KABI ANTI INFECTIVES SRLInactiveCEFUROXIME SODIUM STERILE

DMF 155502001

FARMABIOS SPAInactiveCEFUROXIME SODIUM (INTERMEDIATE)

DMF 163252002

WOCKHARDT LTDInactiveCEFUROXIME SODIUM (STERILE)

DMF 166492003

AUROBINDO PHARMA LTDInactiveCEFUROXIME SODIUM

DMF 185302005

AUROBINDO PHARMA LTDInactiveCEFUROXIME SODIUM (STERILE) USP

DMF 188852005

ORCHID CHEMICALS AND PHARMACEUTICALS LTDInactiveCEFUROXIME SODIUM (STERILE)

DMF 203312007

ZHUHAI UNITED LABORATORIES CO LTDInactiveCEFUROXIME SODIUM USP

DMF 261142012

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

Approval Letters

6 letters from Drugs@FDA

Date	Submission	Document
May 18, 2021	SUPPL -76	View Letter (PDF)
May 17, 2021	SUPPL -76	View Letter (PDF)
Feb 12, 2020	SUPPL -75	View Letter (PDF)
Sep 29, 2014	SUPPL -69	View Letter (PDF)
Jul 31, 2007	SUPPL -67	View Letter (PDF)
May 26, 2004	SUPPL -57	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#002 — EQ 750MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

INJECTABLE;INTRAMUSCULAR, INTRAVENOUS | Approved: Oct 19, 1983

No patent or exclusivity listings for this strength.

#003 — EQ 1.5GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Oct 19, 1983

#004 — EQ 7.5GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Oct 23, 1986