Viewing data from:

PHOSLO

NDA

CALCIUM ACETATE | N019976 | FRESENIUS MEDICAL CARE RENAL THERAPIES GROUP LLC

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

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
ROXANE LABORATORIES, INC. v. NOVEL LABORATORIES, INC. et al 2:2015cv05618 2 patentsANDA 20-7525, 77-728calcium acetate	D.N.J.	2015-07-17	Terminated 2018-09-18	—

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

Citizen Petitions

4 petitions (2 open) from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Beckloff Associates - Citizen Petition FDA-2006-P-0327 · 6 docket documents Beckloff Associates filed this citizen petition on behalf of a client requesting that the FDA determine whether PhosLo (calcium acetate) Tablets and Capsules, both containing 169 mg calcium equivalent and approved under NDA Nos. 019-976 and 021-160 respectively, were withdrawn from sale for safety o	505(q)	2009-01-15	Open	—
Beckloff Associates, Inc. - Citizen Pettition FDA-2008-P-0175 · 3 docket documents Beckloff Associates, Inc. filed this citizen petition requesting that the FDA declare Calcium Acetate Oral Solution, 667 mg/5 mL, suitable for submission as an ANDA under Section 505(j)(2)(c) of the Federal Food, Drug and Cosmetic Act, using PhosLo (calcium acetate) Tablets, 667 mg, approved under N	505(q)	2008-11-13	Withdrawn	—
Citizen Petition from Lachman Consultant Services, Inc. FDA-2006-P-0445 · 6 docket documents Lachman Consultant Services, Inc., on behalf of a client, filed a citizen petition requesting that the FDA determine whether Phoslo (calcium acetate) Tablets, equivalent to 169 mg calcium, approved under NDA 19-976, were voluntarily withdrawn from sale for safety or effectiveness reasons, as the inn	505(q)	2008-06-24	Open	Lachman Consultant Services, Inc.
Citizen Petition from Lachman Consultant Services, Inc. FDA-2006-P-0446 · 4 docket documents Lachman Consultant Services, Inc. filed this petition on behalf of an unnamed client requesting that the FDA determine whether Phoslo (calcium acetate) Capsules equivalent to 169 mg calcium, approved under NDA 21-160, was voluntarily withdrawn from sale for reasons of safety or effectiveness, as the	505(q)	2008-06-24	Withdrawn	Lachman Consultant Services, Inc.

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

Clinical Trials

500 trials from ClinicalTrials.gov, 24 active, 476 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Neoadjuvant RCT Versus CT for Patients With Locally Advanced, Potentially Resectable Adenocarcinoma of the GEJ NCT04375605	Phase 3	Active	Universitätsmedizin Mannheim	342	2020-06-03 → 2025-12
Vitamin D3 With Chemotherapy and Bevacizumab in Treating Patients With Advanced or Metastatic Colorectal Cancer NCT04094688	Phase 3	Active	Alliance for Clinical Trials in Oncology	455	2019-10-29 → 2026-07-01
Combination Chemotherapy With or Without Atezolizumab in Treating Patients With Stage III Colon Cancer and Deficient DNA Mismatch Repair NCT02912559	Phase 3	Active	National Cancer Institute (NCI)	712	2017-10-16 → 2026-12-18
Comparing Two Treatment Combinations, Gemcitabine and Nab-Paclitaxel With 5-Fluorouracil, Leucovorin, and Liposomal Irinotecan for Older Patients With Pancreatic Cancer That Has Spread NCT04233866	Phase 2	Active	ECOG-ACRIN Cancer Research Group	176	2020-08-26 → 2026-12-31
Imatinib Mesylate and Combination Chemotherapy in Treating Patients With Newly Diagnosed Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia NCT03007147	Phase 3	Active	Children's Oncology Group	475	2017-08-08 → 2027-09-30
Circulating Tumor DNA Testing in Predicting Treatment for Patients With Stage IIA Colon Cancer After Surgery NCT04068103	Phase 2/3	Active	NRG Oncology	635	2019-12-16 → 2026-06-21
Testing the Use of the Usual Chemotherapy Before and After Surgery for Removable Pancreatic Cancer NCT04340141	Phase 3	Active	Alliance for Clinical Trials in Oncology	358	2020-10-13 → 2030-11-01
Blinatumomab in Treating Younger Patients With Relapsed B-cell Acute Lymphoblastic Leukemia NCT02101853	Phase 3	Active	National Cancer Institute (NCI)	669	2014-12-17 → 2026-09-16
The Role of Serotonin in Compulsive Behavior in Humans: Underlying Brain Mechanisms NCT04336228	Phase 4	Active	Rigshospitalet, Denmark	46	2020-04-01 → 2027-12-31
A Study to Investigate Blinatumomab in Combination With Chemotherapy in Patients With Newly Diagnosed B-Lymphoblastic Leukemia NCT03914625	Phase 3	Active	National Cancer Institute (NCI)	6,720	2019-07-03 → 2027-09-30

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

API Supply Chain6 active DMFs1 inactive

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

NIACET BVCALCIUM ACETATE

DMF 189972005

VASA PHARMACHEM PVT LTDCALCIUM ACETATE

DMF 225502009

SUVEN LIFE SCIENCES LTDCALCIUM ACETATE USP

DMF 227522009

MACCO ORGANIQUES INCCALCIUM ACETATE

DMF 291662015

GLOBAL CALCIUM PRIVATE LTDCALCIUM ACETATE USP

DMF 356342021

LUOYANG LONGMEN PHARMACEUTICAL CO LTDCALCIUM ACETATE

DMF 426662025

FORMOSA LABORATORIES INCInactiveCALCIUM ACETATE USP

DMF 237352010

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

Approval Letters

2 letters from Drugs@FDA

Date	Submission	Document
Mar 2, 2004	SUPPL -6	View Letter (PDF)
Nov 4, 2002	SUPPL -5	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 667MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Dec 10, 1990

No patent or exclusivity listings for this strength.