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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

4 petitions from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Sheppard Mullin Richter & Hampton LLP - Citizen Petition FDA-2012-P-0994 · 3 docket documents Sheppard Mullin Richter & Hampton LLP filed this ANDA suitability petition under Section 505(j)(2)(C) requesting FDA approval to submit an Abbreviated New Drug Application for Sodium Acetate Injection, USP 2 mEq/mL in a 100 mL glass vial, which differs from the reference listed drug (Hospira's Sodiu	Other	2012-09-25	Withdrawn	—
Sheppard Mullin Richter & Hampton LLP - Citizen Petition FDA-2012-P-0989 · 3 docket documents Sheppard Mullin Richter & Hampton LLP filed this ANDA suitability petition on September 13, 2012, requesting FDA approval under Section 505(j)(2)(C) to develop an ANDA for Sodium Acetate Injection, USP 2 mEq/mL in a 20 mL glass vial, which differs from the referenced listed drug (a plastic container	Other	2012-09-19	Withdrawn	—
Sheppard, Mullin, Richter & Hampton LLP - Citizen Petition FDA-2012-P-0982 · 3 docket documents Sheppard Mullin Richter & Hampton LLP filed this ANDA suitability petition under Section 505(j)(2)(C) of the Federal Food, Drug and Cosmetic Act seeking FDA approval to submit an Abbreviated New Drug Application for Sodium Acetate Injection, USP at a higher strength of 4 mEq/mL in a 50 mL glass vial	Other	2012-09-17	Withdrawn	—
APP Pharmaceuticals, LLC - Citizen Petition FDA-2009-P-0107 · 4 docket documents APP Pharmaceuticals, LLC submitted this ANDA suitability petition under section 505(j)(2)(C) of the Federal Food, Drug and Cosmetic Act to request permission to file an ANDA for Sodium Acetate Injection, USP increasing the strength from 40 mEq (2 mEq/mL) in a 20 mL partial-fill vial to 200 mEq (4 mE	Other	2009-02-26	Granted	—

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

Clinical Trials

500 trials from ClinicalTrials.gov, 21 active, 478 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
IoN- Is Ablative Radio-iodine Necessary for Low Risk Differentiated Thyroid Cancer Patients NCT01398085	Phase 2/3	Active	University College, London	504	2012-06-26 → 2031-03
Intravenous Estrogen in Kidney Transplant Study NCT03663543	Phase 1/2	Active	University of Pennsylvania	30	2016-08-26 → 2027-05-01
The HeLiX (Hemorrhage During Liver Resection: traneXamic Acid) Trial NCT02261415	Phase 3	Active	Sunnybrook Health Sciences Centre	1,386	2014-11 → 2027-08
Angiotensin-(1-7) and Energy Expenditure in Human Obesity NCT03777215	Early Phase 1	Active	Amy Arnold	30	2019-09-26 → 2026-12
Combination Chemotherapy With or Without Bortezomib in Treating Younger Patients With Newly Diagnosed T-Cell Acute Lymphoblastic Leukemia or Stage II-IV T-Cell Lymphoblastic Lymphoma NCT02112916	Phase 3	Active	National Cancer Institute (NCI)	847	2014-10-04 → 2026-09-16
Sunitinib Malate or Valproic Acid in Preventing Metastasis in Patients With High-Risk Uveal Melanoma NCT02068586	Phase 2	Active	Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University	210	2014-11-19 → 2026-12-31
Optical Tissue Identification for Myocardial Architecture NCT04017975	Phase 2	Active	Aditya Kaza	70	2019-12-20 → 2023-09
Blinatumomab and Combination Chemotherapy or Dasatinib, Prednisone, and Blinatumomab in Treating Older Patients With Acute Lymphoblastic Leukemia NCT02143414	Phase 2	Active	National Cancer Institute (NCI)	53	2015-06-30 → 2027-01-26
VSV-hIFNbeta-NIS With or Without Ruxolitinib Phosphate in Treating Stage IV or Recurrent Endometrial Cancer NCT03120624	Phase 1	Active	Mayo Clinic	34	2017-09-15 → 2028-01-01
Vaccine Therapy in Treating Patients With Newly Diagnosed Advanced Colon Polyps NCT02134925	Phase 2	Active	National Cancer Institute (NCI)	110	2014-06-23 → 2027-03-09

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

Medicare Part D Spending

CMS annual spending data for Sodium Acetate (2024)

Total Spending

$44K

Total Claims

501

Beneficiaries

Avg Cost/Unit

$0.10

Spending Trend

$11K(2019)→$12K(2020)→$15K(2021)→$25K(2022)→$51K(2023)→$44K(2024)

YoY Change:-26.6%

5yr CAGR:-2.3%

Source: CMS Medicare Part D Spending by Drug (2024). 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