Viewing data from:

SORILUX

NDA

CALCIPOTRIENE | N022563 | MAYNE PHARMA LLC

1 strength2 unique patents0 unique exclusivities

Patent Timeline

2 unique patents by expiration date

Expired (1)Active (1)Today

2027

2028

Today

8263580

May. 7, 2028

8629128

May. 26, 2026

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 Sorilux (2023)

Total Spending

$351K

Total Claims

202

Beneficiaries

100

Avg Cost/Unit

$14.80

Spending Trend

$1.2M(2019)→$855K(2020)→$646K(2021)→$416K(2022)→$351K(2023)

YoY Change:+0.3%

5yr CAGR:+3.8%

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

API Supply Chain9 active DMFs4 inactive

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

LEO PHARMA ASCALCIPOTRIENE HYDRATE DRUG SUBSTANCE

DMF 105141993

LEO PHARMA ASCALCIPOTRIENE CREAM

DMF 105151993

TAPI NL BVCALCIPOTRIENE USP

DMF 169582003

ALP PHARM BEIJING CO LTDCALCIPOTRIENE (CALCIPOTRIOL)

DMF 219432008

CERBIOS PHARMA SACALCIPOTRIENE ANHYDROUS

DMF 231032009

ALP PHARM BEIJING CO LTDCALCIPOTRIENE HYDRATE

DMF 272222013

CERBIOS PHARMA SACALCIPOTRIENE MONOHYDRATE

DMF 306152016

NANJING HERON PHARMACEUTICAL CO LTDCALCIPOTRIENE MONOHYDRATE

DMF 387432023

ANHUI HAOYUAN PHARMACEUTICAL CO LTDCALCIPOTRIENE

DMF 406922024

LEO PHARMA ASInactiveCALCIPOTRIENE DRUG SUBSTANCE

DMF 83081989

LEO PHARMA ASInactiveCALCIPOTRIENE OINTMENT

DMF 83121989

LEO PHARMA ASInactiveCALCIPOTRIENE SCALP SOLUTION

DMF 108391994

SAFC INCInactiveCALCIPOTRIENE

DMF 169282003

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

Approval Letters

5 letters from Drugs@FDA

Date	Submission	Document
Nov 8, 2019	SUPPL -8	View Letter (PDF)
Nov 8, 2019	SUPPL -7	View Letter (PDF)
Oct 2, 2012	SUPPL -2	View Letter (PDF)
Apr 25, 2011	SUPPL -1	View Letter (PDF)
Oct 13, 2010	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 0.005%

RLD

2 patents0 exclusivities▴

AEROSOL, FOAM;TOPICAL | Approved: Oct 6, 2010

Patents (2)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
8263580	May 7, 2028	—	—	Yes		—
8629128	May 26, 2026	—	—	Yes		—