Viewing data from:

RIMSO-50

NDA

DIMETHYL SULFOXIDE | N017788 | MYLAN INSTITUTIONAL LLC

1 strength0 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

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

1 trial from ClinicalTrials.gov, 1 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
3TR (Taxonomy, Treatment, Targets and Remission) Systemic Lupus Erythematosus Study Protocol 2 NCT05747651	—	Completed	University Hospital, Brest	6	2023-03-27 → 2025-10-08

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

Medicare Part D Spending

CMS annual spending data for Rimso-50 (2023)

Total Spending

$591K

Total Claims

368

Beneficiaries

105

Avg Cost/Unit

$13.83

Spending Trend

$661K(2019)→$646K(2020)→$712K(2021)→$584K(2022)→$591K(2023)

YoY Change:+7.7%

5yr CAGR:+3.1%

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

Medicare Part B Spending

CMS physician-administered drug spending for Rimso-50 (2023)

Total Spending

$3.4M

Total Claims

5,415

Beneficiaries

730

ASP Price

—

HCPCS: J1212 — Injection, dmso, dimethyl sulfoxide, 50%, 50 ml

Source: CMS Medicare Part B Spending by Drug (2023). Shows physician-administered drug costs.

API Supply Chain1 active DMF5 inactive

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

GAYLORD CHEMICAL CO LLCDIMETHYL SULFOXIDE (DMSO), USP GRADE

DMF 127061997

NATIONAL CANCER INSTITUTEInactiveDIMETHYL SULFOXIDE

DMF 8041964

ARAPAHOE CHEMICALS INC DIV SYNTEX LABORATORIES INCInactiveDIMETHYL SULFOXIDE

DMF 10671967

RESEARCH INDUSTRIES CORPInactiveDIMETHYL SULFOXIDE (DMSO)

DMF 25511975

SIGMA FOOD AND DRUG DIV SIGMA ALDRIDGE CORPInactiveDIMETHYL SULFOXIDE

DMF 41381981

SHOWA INDUSTRY CO LTDInactiveDIMETHYL SULFOXIDE (DMSO-P)

DMF 52361984

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

Products (1)

#001 — 50%

RLD

0 patents0 exclusivities▴

SOLUTION;INTRAVESICAL | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.