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SODIUM ACETATE

NDA

SODIUM ACETATE | N018893 | HOSPIRA 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

1 trial from ClinicalTrials.gov — 1 recruiting

Trial	Phase	Status	Sponsor	Enrollment	Dates
177Lu-DOTA-EB-TATE in Adult Patients With Metastatic, Radioactive Iodine Non-Responsive Oncocytic (Hurthle-Cell) Thyroid Cancer NCT06991738	Phase 1/2	Not Yet Recruiting	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	18	2026-07-07 → 2032-08-01

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

Medicare Part D Spending

CMS annual spending data for Sodium Acetate (2023)

Total Spending

$51K

Total Claims

540

Beneficiaries

Avg Cost/Unit

$0.13

Spending Trend

$11K(2019)→$9K(2020)→$14K(2021)→$25K(2022)→$51K(2023)

YoY Change:+35.0%

5yr CAGR:+23.9%

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

API Supply Chain7 active DMFs4 inactive

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

MERCK KGAASODIUM ACETATE TRIHYDRATE

DMF 238022010

AVANTOR PERFORMANCE MATERIALS LLCSODIUM ACETATE TRIHYDRATE

DMF 277522014

MACCO ORGANIQUES INCSODIUM ACETATE ANHYDROUS

DMF 278442013

VM CHEMICALSSODIUM ACETATE TRIHYDRATE BP

DMF 290392015

MACCO ORGANIQUES INCSODIUM ACETATE TRIHYDRATE

DMF 330292018

LUOYANG LONGMEN PHARMACEUTICAL CO LTDSODIUM ACETATE TRIHYDRATE

DMF 426652025

EMNAR PHARMA PRIVATE LTDSODIUM ACETATE

DMF 428822025

NIACET CORPInactiveSODIUM ACETATE ANHYDROUS, USP GRADE

DMF 66541986

CARDINAL HEALTH 414 LLCInactiveSODIUM ACETATE C-11 INJECTION

DMF 245602011

SIEMENS MOLECULAR IMAGING INCInactiveSODIUM ACETATE C11 INJECTION

DMF 263522012

MERCK KGAAInactiveSODIUM ACETATE ANHYDROUS

DMF 319262017

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Mar 10, 2003	SUPPL -17	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — 40MEQ/20ML (2MEQ/ML)

RLDAP

0 patents0 exclusivities▴

SOLUTION;INTRAVENOUS | Approved: May 4, 1983

No patent or exclusivity listings for this strength.

#002 — 100MEQ/50ML (2MEQ/ML)

RLDAP

0 patents0 exclusivities▾

SOLUTION;INTRAVENOUS | Approved: Sep 2, 2014

#003 — 200MEQ/100ML (2MEQ/ML)

RLDAP

0 patents0 exclusivities▾

SOLUTION;INTRAVENOUS | Approved: Sep 2, 2014