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CALCIUM GLUCONATE

NDA

CALCIUM GLUCONATE | N208418 | FRESENIUS KABI USA LLC

5 strengths1 unique patent0 unique exclusivities

Patent Timeline

1 unique patent by expiration date

Active (1)Today

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Today

10130646

Jul. 25, 2037

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

3 cases on OB patents (2 active) from PACER

Case	Court	Filed	Status	Judge
HQ Specialty Pharma Corp. et al v. Cipla Ltd. et al 1:2025cv01236 1 patentANDA 217891calcium gluconate in sodium chloride	D. Del.	2025-10-07	Active	—
HQ Specialty Pharma Corp. et al v. Sagent Pharmaceuticals 1:2025cv01227 1 patentANDA 219619calcium gluconate in sodium chloride	D. Del.	2025-10-03	Active	—
HQ Specialty Pharma Corp. et al v. Amneal Pharmaceuticals LLC 1:2023cv01135 1 patentANDA 217174calcium gluconate in sodium chloride	D. Del.	2023-10-11	Terminated 2025-08-12	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

18 trials from ClinicalTrials.gov — 12 recruiting, 5 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Coronary Artery Calcium Score in HIV Mexican Population (The CACsHIVMex Study)NCT07662161	—	Not Yet Recruiting	Instituto Mexicano del Seguro Social	384	2026-07-01 → 2030-07
Morphology in Oral Rare Syndromes & Artificial Intelligence for Clinical Diagnosis NCT07666269	N/A	Not Yet Recruiting	University Hospital, Bordeaux	240	2026-09-01 → 2028-03-01
Project HOPE (Hypertension Outreach Through Partnership and Engagement)NCT07681726	—	Not Yet Recruiting	Johns Hopkins University	150	2026-09-01 → 2027-04-30
Comparative Efficacy of Different Dentin Occluding Toothpaste Technologies NCT07664592	Phase 3	Not Yet Recruiting	Colgate Palmolive	132	2026-06-29 → 2026-09-30
Antibacterial Efficacy of Bioceramic and Calcium Hydroxide Intracanal Medicaments NCT07671326	N/A	Recruiting	Medipol University	24	2025-10-15 → 2026-12
Elucidating the Minimal Effective Dose of Prunes for Bone Health in Postmenopausal Women NCT06184646	N/A	Recruiting	San Diego State University	200	2024-03-15 → 2028-12
Comparison of MI Paste Plus and Resin Infiltration in White Spot Lesions Following Orthodontic Treatment NCT05733676	N/A	Recruiting	University of Alberta	62	2023-05-30 → 2028-10-01
Natural History Study of Parathyroid Disorders NCT04969926	—	Recruiting	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	3,000	2021-11-30 → 2031-01-22
ShockFast Intravascular Lithotripsy Device for Treatment of Calcified Coronary Lesions NCT07407738	N/A	Recruiting	Shunmei Medical	120	2026-02-16 → 2026-11-01
Pediatric Safety Follow-up Study of Prior Treatment With Romosozumab for Osteogenesis Imperfecta NCT07366086	Phase 3	Recruiting	Amgen	71	2026-03-18 → 2028-04-19

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

Medicare Part D Spending

CMS annual spending data for Calcium Gluconate (2023)

Total Spending

$67K

Total Claims

630

Beneficiaries

Avg Cost/Unit

$0.44

Spending Trend

$60K(2019)→$41K(2020)→$84K(2021)→$87K(2022)→$67K(2023)

YoY Change:+281.7%

5yr CAGR:+34.0%

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

API Supply Chain16 active DMFs1 inactive

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

GLOBAL CALCIUM PRIVATE LTDCALCIUM GLUCONATE MONOHYDRATE FOR INJECTION

DMF 294322015

TOMITA PHARMACEUTICAL CO LTDCALCIUM GLUCONATE MONOHYDRATE USP

DMF 316902017

ZHEJIANG RUIBANG LABORATORIESCALCIUM GLUCONATE FOR INJECTION

DMF 347482021

VASA PHARMACHEM PVT LTDCALCIUM GLUCONATE IP/BP/EP/USP

DMF 359402021

RAKS PHARMA PVT LTDCALCIUM GLUCONATE MONOHYDRATE USP

DMF 369382022

EXTROVIS AGCALCIUM GLUCONATE

DMF 372132023

ZYDUS LIFESCIENCES LTDCALCIUM GLUCONATE MONOHYDRATE USP

DMF 389692023

JIANGXI YBN PHARMACEUTICAL CO LTDCALCIUM GLUCONATE AND ZINC GLUCONATE

DMF 394332024

BIOPHORE INDIA PHARMACEUTICALS PVT LTDCALCIUM GLUCONATE MONOHYDRATE

DMF 396012024

HOSTER LABS PRIVATE LTDCALCIUM GLUCONATE MONOHYDRATE

DMF 400312024

MUBY CHEM PRIVATE LTDCALCIUM GLUCONATE MONOHYDRATE USP

DMF 411422025

GLOBAL CALCIUM PRIVATE LTDCALCIUM GLUCONATE USP (FOR INJECTION) MONOHYDRATE

DMF 424202025

JIANGXI XINGANJIANG PHARMACEUTICAL CO LTDCALCIUM GLUCONATE FOR INJECTION

DMF 425222025

JIANGXI XINGANJIANG PHARMACEUTICAL CO LTDCALCIUM GLUCONATE FOR ORAL USE

DMF 425232025

STHREE CHEMICALS PRIVATE LTDCALCIUM GLUCONATE USP

DMF 427052025

CIPLA LTDCALCIUM GLUCONATE MONOHYDRATE USP

DMF 428272025

PURAC BIOCHEM BVInactiveCALCIUM GLUCONATE

DMF 84381990

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

Approval Letters

4 letters from Drugs@FDA

Date	Submission	Document
Oct 18, 2022	SUPPL -13	View Letter (PDF)
Dec 30, 2021	SUPPL -11	View Letter (PDF)
Jun 22, 2021	SUPPL -7	View Letter (PDF)
Jun 16, 2017	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (5)

Sort:

#001 — 1GM/10ML (100MG/ML)

RLDAP

0 patents0 exclusivities▴

SOLUTION;INTRAVENOUS | Approved: Jun 15, 2017

No patent or exclusivity listings for this strength.

#002 — 5GM/50ML (100MG/ML)

RLDAP

0 patents0 exclusivities▾

SOLUTION;INTRAVENOUS | Approved: Jun 15, 2017

#003 — 10GM/100ML (100MG/ML)

RLDAP

0 patents0 exclusivities▾

SOLUTION;INTRAVENOUS | Approved: Jun 15, 2017

#004 — 1GM/50ML (20MG/ML)

RLD

1 patent0 exclusivities▾

SOLUTION;INTRAVENOUS | Approved: Jun 17, 2021

#005 — 2GM/100ML (20MG/ML)

RLD

1 patent0 exclusivities▾

SOLUTION;INTRAVENOUS | Approved: Jun 17, 2021