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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

18 trials from ClinicalTrials.gov, 4 active, 7 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Dabrafenib and Trametinib Followed by Ipilimumab and Nivolumab or Ipilimumab and Nivolumab Followed by Dabrafenib and Trametinib in Treating Patients With Stage III-IV BRAFV600 Melanoma NCT02224781	Phase 3	Active	National Cancer Institute (NCI)	267	2015-09-08 → 2026-12-19
Testing Two Different Treatment Schedules of Dabrafenib and Trametinib for Skin Cancer Which Has Spread NCT02196181	Phase 2	Active	National Cancer Institute (NCI)	280	2014-09-19 → 2027-03-15
A Trial of Dabrafenib, Trametinib and Hydroxychloroquine for Patients With Recurrent LGG or HGG With a BRAF Aberration NCT04201457	Phase 1/2	Active	Pediatric Brain Tumor Consortium	57	2020-01-17 → 2026-03-31
Dabrafenib Combined With Trametinib After Radiation Therapy in Treating Patients With Newly-Diagnosed High-Grade Glioma NCT03919071	Phase 2	Active	National Cancer Institute (NCI)	58	2020-02-20 → 2027-09-30
Vaccine Therapy With or Without Imiquimod in Treating Patients Who Have Undergone Surgery for Stage II, Stage III, or Stage IV Melanoma NCT00118313	Phase 1	Completed	Craig L Slingluff, Jr	—	2004-11-04 → 2006-07-28
Phase 1 Safety Study of Dimethyl Sulfoxide Cryopreserved Platelets NCT02078284	Phase 1	Completed	U.S. Army Medical Research and Development Command	28	2014-11-05 → 2016-07-17
Dabrafenib and Trametinib in People With BRAF V600E Mutation Positive Lesions in Erdheim Chester Disease NCT02281760	Phase 2	Completed	National Human Genome Research Institute (NHGRI)	9	2014-11-01 → 2018-08-29
Botulin-A Toxin Instillations and Overactive Bladder NCT00583219	Phase 1/2	Completed	Mayo Clinic	25	2006-03 → 2008-05
Melatonin Cream Against Acute Radiation Dermatitis in Patients With Early Breast Cancer NCT03716583	Phase 2	Completed	Dennis Bregner Zetner	48	2019-04-30 → 2021-01-31
Trametinib in Treating Patients With Recurrent or Progressive Low-Grade Ovarian Cancer or Peritoneal Cavity Cancer NCT02101788	Phase 2/3	Completed	National Cancer Institute (NCI)	260	2014-04-11 → 2025-10-27

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

VA Federal Supply Schedule

Government-negotiated contract prices | 2 NDCs (1 FSS, 1 Big4)

Lowest Price

$522.42

Highest Price

$631.96

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
67457-0177-50RIMSO-50	$631.96	FSS	Mylan Institutional LLC	09/28/2028
67457-0177-50RIMSO-50	$522.42	Big4	Mylan Institutional LLC	09/28/2028

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

Medicare Part D Spending

CMS annual spending data for Rimso-50 (2024)

Total Spending

$568K

Total Claims

349

Beneficiaries

105

Avg Cost/Unit

$13.75

Spending Trend

$661K(2019)→$646K(2020)→$712K(2021)→$584K(2022)→$591K(2023)→$568K(2024)

YoY Change:-0.5%

5yr CAGR:+2.3%

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

Medicare Part B Spending

CMS physician-administered drug spending for Rimso-50 (2024)

Total Spending

$3.7M

Total Claims

5,614

Beneficiaries

701

ASP Price

$695.76

Spending Trend

$4.2M(2019)→$3.9M(2020)→$3.9M(2021)→$3.6M(2022)→$3.4M(2023)→$3.7M(2024)

YoY Change:+5.7%

5yr CAGR:+6.0%

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

Source: CMS Medicare Part B Spending by Drug (2024). 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.