Trial	Phase	Status	Sponsor	Enrollment	Dates
Prevention and Treatment With Calcifediol of COVID-19 Induced Acute Respiratory Syndrome NCT04366908	Phase 2	Completed	Maimónides Biomedical Research Institute of Córdoba	517	2020-05-07 → 2022-04-19
Safety and Efficacy of CTAP101 to Treat Secondary Hyperparathyroidism in Stage 3 or 4 CKD and Vitamin D Insufficiency NCT01651000	Phase 3	Completed	OPKO IP Holdings II, Inc.	213	2012-09 → 2014-07
Dose Finding Study in Physically Frail Elderly to Measure 25(OH) Vitamin D Levels After Supplementation With Hy.D Calcifediol 25 SD/S and Vitamin D3 NCT01868945	Phase 1	Completed	dsm-firmenich Switzerland AG	59	2013-04 → 2014-06
Effects of Vitamin D3 Versus 25OHD3 on Mineral Metabolism and Immune Function NCT02091219	Early Phase 1	Completed	University of California, Los Angeles	35	2014-06 → 2019-12-07
Safety and Efficacy of CTAP101 to Treat Secondary Hyperparathyroidism in Stage 3 or 4 CKD and Vitamin D Insufficiency NCT01704079	Phase 3	Completed	OPKO IP Holdings II, Inc.	216	2012-11 → 2014-09
To Test the Effect of Calcifediol Hy.D Supplementation on Muscle Function and Bone Quality in Younger Postmenopausal Women With Osteopenia NCT02527668	Phase 2	Completed	dsm-firmenich Switzerland AG	150	2015-09 → 2018-12
Extension Study of CTAP101-CL-3001 or CTAP101-CL-3002 NCT02282813	Phase 3	Completed	OPKO Health, Inc.	298	2013-04 → 2015-05
Efficacy and Safety of Paricalcitol in the Reduction of Secondary Hyperparathyroidism After Kidney Transplantation.NCT01939977	Phase 4	Completed	Fundación Senefro	148	2014-01 → 2015-12
Effect of CTAP101 Capsules on Ca/iPTH in Advanced Breast/Prostate Cancer Patients Treated With Denosumab/Zoledronic Acid NCT02274623	Phase 1	Completed	OPKO Health, Inc.	33	2014-12 → 2017-03-17
The Effect of Calcifediol (Hy.D 25 SD/S) and Vitamin D3 on Muscle Strength in a Frail Elderly Population NCT02349282	N/A	Completed	Wageningen University	78	2014-12 → 2015-12

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

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 1 NDC

Highest NADAC/Unit

$41.30

per ea

Lowest NADAC/Unit

$41.30

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
70301100201RAYALDEE ER 30 MCG CAP (HARD)	$41.30	EA	Brand	—	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 | 1 NDC (1 FSS)

Lowest Price

$926.59

Highest Price

$926.59

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
70301-1002-01RAYALDEE 30MCG CAP, SA	$926.59	FSS	OPKO Pharmaceuticals, LLC	09/29/2028

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

Medicare Part D Spending

CMS annual spending data for Rayaldee (2024)

Total Spending

$42.8M

Total Claims

31,494

Beneficiaries

5,248

Avg Cost/Unit

$40.58

Spending Trend

$45.9M(2019)→$61.3M(2020)→$39.6M(2021)→$36.1M(2022)→$41.5M(2023)→$42.8M(2024)

YoY Change:-2.6%

5yr CAGR:+2.4%

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

API Supply Chain2 active DMFs1 inactive

2 active API suppliers hold Drug Master Files for this ingredient. Limited supplier base — potential supply chain risk.

CARBOGEN AMCIS BVCALCIFEDIOL

DMF 219632008

FORMOSA LABORATORIES INCCALCIFEDIOL

DMF 336402019

SOLVAY DUPHAR BVInactiveCALCIFEDIOL

DMF 123861997

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

Approval Letters

3 letters from Drugs@FDA

Date	Submission	Document
Feb 22, 2024	SUPPL -13	View Letter (PDF)
Dec 20, 2019	SUPPL -5	View Letter (PDF)
Jun 21, 2016	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 0.03MG

RLD

16 patents0 exclusivities▴

CAPSULE, EXTENDED RELEASE;ORAL | Approved: Jun 17, 2016

Patents (16) · 15 use codes

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
8207149	Apr 25, 2028	—	—	—		—
8361488	Jul 19, 2028	—	—	Yes	—	—
8426391	Aug 27, 2028	—	—	—		—
8778373	Apr 25, 2028	—	—	—		—
8906410	Feb 2, 2027	—	—	Yes	—	—
9408858	Apr 25, 2028	—	—	—		—
9498486	Apr 25, 2028	—	—	—		—
9861644	Mar 14, 2034	—	—	Yes	—	—
9925147	Apr 25, 2028	—	—	Yes		—
9943530	Feb 2, 2027	—	—	—		—
10213442	Feb 2, 2027	—	—	Yes	—	—
10300078	Mar 14, 2034	—	—	Yes	—	—
10357502	Mar 14, 2034	—	—	Yes	—	—
11154509	Apr 25, 2028	—	—	—		—
11253528	Mar 14, 2034	—	—	Yes	—	—
11801253	Sep 7, 2030	—	—	Yes		—