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ROCALTROL

NDA

CALCITRIOL | N018044 | ESJAY PHARMA LLC

2 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

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

1 petition (1 open) from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Suitability Petition from Windels Marx Lane & Mittendorf, LLP FDA-2025-P-1154 Windels Marx Lane & Mittendorf, LLP filed this suitability petition pursuant to Section 505(j)(2)(C) of the FDC Act requesting that FDA declare Calcitriol Capsules in 0.75 mcg, 1 mcg, and 2 mcg strengths suitable for submission as an ANDA, based on the reference listed drug ROCALTROL Capsules approv	Suitability	2025-05-07	Open	Windels Marx Lane & Mittendorf

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

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part D Spending

CMS annual spending data for Rocaltrol (2023)

Total Spending

$37K

Total Claims

239

Beneficiaries

Avg Cost/Unit

$3.02

Spending Trend

$58K(2019)→$44K(2020)→$42K(2021)→$46K(2022)→$37K(2023)

YoY Change:+99.9%

5yr CAGR:+14.3%

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

API Supply Chain5 active DMFs2 inactive

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

TAPI NL BVCALCITRIOL USP

DMF 124171997

CARBOGEN AMCIS BVCALCITRIOL

DMF 140931999

CERBIOS PHARMA SACALCITRIOL

DMF 147182000

MICROBIOPHARM JAPAN CO LTDCALCITRIOL

DMF 151282000

FORMOSA LABORATORIES INCCALCITRIOL

DMF 182272005

DUPHAR BVInactiveCALCITRIOL

DMF 65471986

CATALENT PHARMA SOLUTIONS LLCInactiveCALCITRIOL 0.25 MCG SOFT GELATIN CAPSULES

DMF 169742003

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

Approval Letters

4 letters from Drugs@FDA

Date	Submission	Document
Mar 3, 2010	SUPPL -38	View Letter (PDF)
Jul 8, 2004	SUPPL -32	View Letter (PDF)
Jun 16, 2004	SUPPL -25	View Letter (PDF)
Feb 1, 2002	SUPPL -28	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 0.25MCG

RLDAB

0 patents0 exclusivities▴

CAPSULE;ORAL | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.

#002 — 0.5MCG

RLDAB

0 patents0 exclusivities▾

CAPSULE;ORAL | Approved: Approved Prior to Jan 1, 1982