Viewing data from:

RAYALDEE

NDA

CALCIFEDIOL | N208010 | EIRGEN PHARMA LTD

1 strength16 unique patents0 unique exclusivities

Patent Timeline

16 unique patents by expiration date

Expiring < 1yr (3)Active (13)Today

2027

2028

2029

2030

2031

2032

2033

2034

Today

Apr. 25, 2028

Jul. 19, 2028

Aug. 27, 2028

Apr. 25, 2028

Feb. 2, 2027

Apr. 25, 2028

Apr. 25, 2028

Mar. 14, 2034

Apr. 25, 2028

Feb. 2, 2027

Feb. 2, 2027

Mar. 14, 2034

Mar. 14, 2034

Apr. 25, 2028

Mar. 14, 2034

Sep. 7, 2030

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

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part D Spending

CMS annual spending data for Rayaldee (2023)

Total Spending

$41.5M

Total Claims

29,444

Beneficiaries

4,889

Avg Cost/Unit

$41.68

Spending Trend

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

YoY Change:+4.1%

5yr CAGR:+3.3%

Source: CMS Medicare Part D Spending by Drug (2023). 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)

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		—