Viewing data from:

FOSRENOL

NDA

LANTHANUM CARBONATE | N021468 | TAKEDA PHARMACEUTICALS USA INC

4 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

Para IV certification filed but no ANDA patent litigation cases (NOS 835) matched from PACER. Litigation may be pending or filed under a different caption.

Citizen Petitions

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Shire Development Inc. (Shire) - Citizen Petition FDA-2010-P-0309 · 7 docket documents Shire Development Inc. filed this citizen petition under sections 505(j) and 505(q) requesting that the FDA require all abbreviated new drug applications and 505(b)(2) new drug applications for generic or follow-on formulations of Fosrenol (lanthanum carbonate) oral chewable tablets to include chara	505(q)	2010-07-08	Partially Denied	—

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

Clinical Trials

37 trials from ClinicalTrials.gov, 31 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
The Pharmacokinetics of Rocaltrol When Administered Alone or in Combination With Fosrenol or Renvela in Healthy Volunteers NCT00925704	Phase 1	Completed	Shire	41	2009-06-01 → 2009-07-31
Phosphate Lowering in CKD Trial NCT02209636	Phase 4	Completed	VA Office of Research and Development	66	2014-09-15 → 2019-12-20
Chewed vs. Crushed Lanthanum Carbonate in Hemodialysis Patients NCT00660530	Phase 2	Completed	University of Illinois at Chicago	11	2008-01 → 2009-11
Efficacy and Safety of Fosrenol in Treating Elevated Serum Phosphate Levels in Adults With End Stage Renal Disease NCT00160121	Phase 4	Completed	Shire	2,500	2005-01-10 → 2005-12-13
A Double Blind Randomized Placebo Trial of Maintenance of Normal Serum Phosphorus in CKD NCT00785629	N/A	Completed	Denver Nephrologists, P.C.	148	2009-02 → 2011-07
Open Study of BAY77-1931 (Lanthanum Carbonate) in Continuous Ambulatory Peritoneal Dialysis Patients NCT01518387	Phase 3	Completed	Bayer	43	2006-01 → 2006-07
Efficacy and Safety of Lanthanum Carbonate and Sevelamer Hydrochloride in Patients Receiving Haemodialysis for End Stage Renal Disease NCT00151918	Phase 3	Completed	Shire	48	2005-01-07 → 2005-08-22
Efficacy and Safety of Lanthanum Carbonate in Reducing Serum Phosphorus Levels in Subjects With Stage 3 and 4 Chronic Kidney Disease NCT00234702	Phase 2	Completed	Shire	84	2006-01-11 → 2007-06-01
Efficacy and Tolerability of Treatment With Lanthanum Carbonate in Patients With End Stage Renal Disease Receiving Dialysis NCT00151931	Phase 3	Completed	Shire	456	2004-05-11 → 2006-01-12
Long-term Treatment on BAY77-1931 (Lanthanum Carbonate) to Measure Lanthanum Concentrations in Bone NCT00767637	Phase 2	Completed	Bayer	14	2005-06 → 2008-10

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

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 2 NDCs

Highest NADAC/Unit

$3.25

per ea

Lowest NADAC/Unit

$3.00

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
66993042485LANTHANUM CARB 1,000 MG TB CHW	$3.25	EA	Generic	—	2026-06-17
66993042285LANTHANUM CARB 500 MG TAB CHEW	$3.00	EA	Generic	—	2026-06-17

Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.

VA Federal Supply Schedule

Government-negotiated contract prices | 3 NDCs (3 FSS)

Lowest Price

$710.82

Highest Price

$710.82

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
54092-0252-90FOSRENOL 500MG CHEWABLE TABLET	$710.82	FSS	Takeda Pharmaceuticals America, Inc.	08/14/2026
54092-0253-90FOSRENOL 750MG CHEWABLE TAB	$710.82	FSS	Takeda Pharmaceuticals America, Inc.	08/14/2026
54092-0254-90FOSRENOL 1000MG CHEWABLE TAB	$710.82	FSS	Takeda Pharmaceuticals America, Inc.	08/14/2026

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

Medicare Part D Spending

CMS annual spending data for Fosrenol (2024)

Total Spending

$5.3M

Total Claims

3,262

Beneficiaries

1,090

Avg Cost/Unit

$11.44

Spending Trend

$6.9M(2019)→$6.7M(2020)→$5.7M(2021)→$5.2M(2022)→$5.8M(2023)→$5.3M(2024)

YoY Change:-9.7%

5yr CAGR:-1.6%

Source: CMS Medicare Part D Spending by Drug (2024). Shows gross drug cost under Part D.

API Supply Chain12 active DMFs3 inactive

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

MATRIX PHARMACORP PRIVATE LTDLANTHANUM CARBONATE

DMF 219582008

NATCO PHARMA LTDLANTHANUM CARBONATE DIHYDRATE

DMF 220502008

EXCELLA GMBH AND CO KGLANTHANUM CARBONATE

DMF 220942008

UNIMARK REMEDIES LTDLANTHANUM CARBONATE OCTAHYDRATE

DMF 232542009

SYMED LABS LTDLANTHANUM CARBONATE

DMF 282172014

MATRIX PHARMACORP PRIVATE LTDLANTHANUM CARBONATE (PROCESS 2)

DMF 334082018

ALKEM LABORATORIES LTDLANTHANUM CARBONATE OCTAHYDRATE

DMF 352982020

SOLARA ACTIVE PHARMA SCIENCES LTDLANTHANUM CARBONATE TETRAHYDRATE

DMF 370172022

SOLARA ACTIVE PHARMA SCIENCES LTDLANTHANUM CARBONATE OCTAHYDRATE

DMF 370182022

ZENJI PHARMACEUTICALS (SUZHOU) LTDLANTHANUM CARBONATE

DMF 370582023

ZHEJIANG GUOBANG PHARMACEUTICAL CO LTDLANTHANUM CARBONATE

DMF 393212023

ZENJI PHARMACEUTICALS (RIZHAO) LTDLANTHANUM CARBONATE

DMF 429572025

JOHNSON MATTHEY INCInactiveLANTHANUM CARBONATE

DMF 127221997

BOEHRINGER INGELHEIM CHEMICALS INCInactiveLANTHANUM CARBONATE HYDRATE

DMF 187862005

SIGNA SA DE CVInactiveLANTHANUM CARBONATE HYDRATE

DMF 280082014

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

Approval Letters

15 letters from Drugs@FDA

Date	Submission	Document
Sep 3, 2024	SUPPL -25	View Letter (PDF)
Dec 13, 2023	SUPPL -24	View Letter (PDF)
May 11, 2023	SUPPL -26	View Letter (PDF)
May 12, 2020	SUPPL -23	View Letter (PDF)
Dec 7, 2018	SUPPL -21	View Letter (PDF)
Feb 26, 2016	SUPPL -20	View Letter (PDF)
Sep 26, 2014	SUPPL -19	View Letter (PDF)
Nov 5, 2012	SUPPL -18	View Letter (PDF)
Sep 7, 2011	SUPPL -16	View Letter (PDF)
Apr 29, 2011	SUPPL -15	View Letter (PDF)
Apr 29, 2011	SUPPL -14	View Letter (PDF)
Oct 28, 2008	SUPPL -11	View Letter (PDF)
Apr 11, 2008	SUPPL -10	View Letter (PDF)
Mar 23, 2006	SUPPL -5	View Letter (PDF)
Oct 29, 2004	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (4)

Sort:

#001 — EQ 250MG BASE

0 patents0 exclusivities▴

TABLET, CHEWABLE;ORAL | Approved: Oct 26, 2004

No patent or exclusivity listings for this strength.

#002 — EQ 500MG BASE

RLDAB

0 patents0 exclusivities▾

TABLET, CHEWABLE;ORAL | Approved: Oct 26, 2004

#003 — EQ 750MG BASE

RLDAB

0 patents0 exclusivities▾

TABLET, CHEWABLE;ORAL | Approved: Nov 23, 2005

#004 — EQ 1GM BASE

RLDAB

0 patents0 exclusivities▾

TABLET, CHEWABLE;ORAL | Approved: Nov 23, 2005