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PLATINOL

NDA

CISPLATIN | N018057 | HQ SPECIALTY PHARMA CORP

4 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

Para IV certification filed but no ANDA patent litigation cases (NOS 835) matched from PACER. Litigation may be pending or filed under a different caption.

Citizen Petitions

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition A from PHARMACHEMIE B.V. FDA-1988-P-0242 · 9 docket documents Pharmachemie B.V., a Netherlands-based pharmaceutical manufacturer, filed an ANDA Suitability Petition under section 505(j)(2)(C) of the Federal Food, Drug and Cosmetic Act requesting approval to submit an Abbreviated New Drug Application for Cisplatin Injection 0.5 mg/mL in 20 mL vials, which would	Other	2017-06-28	Withdrawn	—

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

Clinical Trials

500 trials from ClinicalTrials.gov, 105 active, 394 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Novel Combination Therapy in the Treatment of Relapsed and Refractory Aggressive B-Cell Lymphoma NCT02436707	Phase 2	Active	Canadian Cancer Trials Group	129	2015-10-27 → 2026-12-31
A Study to Assess a PI3Kδ Inhibitor (IOA-244) in Patients With Metastatic Cancers NCT04328844	Phase 1	Active	iOnctura	210	2020-02-25 → 2027-03
Cisplatin, Nab-Paclitaxel, and Cetuximab (CACTUX) in Patients With Incurable Head and Neck Squamous Cell Carcinoma NCT02270814	Phase 2	Active	Washington University School of Medicine	74	2015-02-02 → 2026-05-15
PD-1 Inhibitor and Chemotherapy With Concurrent Irradiation at Varied Tumour Sites in Advanced Non-small Cell Lung Cancer NCT03774732	Phase 3	Active	UNICANCER	327	2018-01-24 → 2026-12-22
Platinum in Treating Patients With Residual Triple-Negative Breast Cancer Following Neoadjuvant Chemotherapy NCT02445391	Phase 3	Active	ECOG-ACRIN Cancer Research Group	415	2015-10-20 → 2031-03-29
A Study of Two Dosing Schedules of Atezolizumab in Combination With Gemcitabine and Cisplatin as First-Line Treatment for Metastatic Bladder Cancer NCT03093922	Phase 2	Active	Memorial Sloan Kettering Cancer Center	32	2017-03-22 → 2027-03
A Study of Novel Anti-cancer Agents in Patients With Previously Untreated NSCLC NCT03819465	Phase 1	Active	AstraZeneca	175	2018-12-27 → 2026-07-01
Paclitaxel, Carboplatin and Cetuximab (PCC) With Cetuximab, Docetaxel, Cisplatin and Fluorouracil (C-TPF) in Previously Untreated Patients With Locally Advanced Head and Neck Squamous Cell Carcinoma NCT01154920	Phase 2	Active	M.D. Anderson Cancer Center	128	2010-07-09 → 2027-12-31
Study of Pembrolizumab Given Prior to Surgery and in Combination With Radiotherapy Given Post-surgery for Advanced Head and Neck Squamous Cell Carcinoma (MK-3475-689)NCT03765918	Phase 3	Active	Merck Sharp & Dohme LLC	714	2018-12-17 → 2026-09-10
Gemcitabine Hydrochloride and Cisplatin With or Without Veliparib or Veliparib Alone in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer NCT01585805	Phase 2	Active	National Cancer Institute (NCI)	83	2012-05-15 → 2027-03-09

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

VA Federal Supply Schedule

Government-negotiated contract prices | 2 NDCs (2 FSS)

Lowest Price

$0.93

Highest Price

$198.90

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
44567-0511-01CISPLATIN 200MG/200ML INJ	$0.93	FSS	WG Critical Care, LLC	06/14/2029
44567-0530-01CISPLATIN 50MG/100ML INJ	$198.90	FSS	WG Critical Care, LLC	06/14/2029

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

Medicare Part D Spending

CMS annual spending data for Cisplatin (2024)

Total Spending

$37K

Total Claims

764

Beneficiaries

249

Avg Cost/Unit

$0.30

Spending Trend

$33K(2019)→$22K(2020)→$29K(2021)→$38K(2022)→$26K(2023)→$37K(2024)

YoY Change:-6.2%

5yr CAGR:-0.7%

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 Cisplatin (2024)

Total Spending

$720K

Total Claims

28,889

Beneficiaries

6,086

ASP Price

$3.36

Spending Trend

$570K(2019)→$514K(2020)→$462K(2021)→$480K(2022)→$519K(2023)→$720K(2024)

YoY Change:+53.9%

5yr CAGR:+15.9%

HCPCS: J9060 — Injection, cisplatin, powder or solution, 10 mg

Source: CMS Medicare Part B Spending by Drug (2024). Shows physician-administered drug costs.

API Supply Chain6 active DMFs6 inactive

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

HERAEUS PRECIOUS METALS GMBH AND CO KGCISPLATIN USP

DMF 66621986

VERANOVA LPCISPLATIN

DMF 96011992

LAURUS LABS LTDCISPLATIN USP DRUG SUBSTANCE

DMF 219172008

QILU PHARMACEUTICAL CO LTDCISPLATIN (NON STERILE API)

DMF 239852010

UMICORE ARGENTINA SACISPLATIN

DMF 280462014

HETERO LABS LTDCISPLATIN USP

DMF 288012014

ENGELHARD MINERALS AND CHEMICAL CORPInactiveCISPLATIN

DMF 40981981

PLANTEX LTD CHEMICAL AND PHARMACEUTICAL WORKSInactiveCISPLATIN

DMF 48241983

SOCIETE FRANCAISE D'ORGANOInactiveCISPLATIN

DMF 51891983

TAMILNADU DADHA PHARMACEUTICALInactiveCISPLATIN

DMF 79651989

INSTITUTE DRUG TECHNOLOGY AUSTRALIA LTDInactiveCISPLATIN DRUG SUBSTANCE

DMF 108981994

DEGUSSA AG WERK RADEBEULInactiveCISPLATIN

DMF 120121996

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

Approval Letters

6 letters from Drugs@FDA

Date	Submission	Document
Feb 27, 2019	SUPPL -89	View Letter (PDF)
Feb 27, 2015	SUPPL -83	View Letter (PDF)
Jan 3, 2012	SUPPL -81	View Letter (PDF)
Aug 31, 2011	SUPPL -80	View Letter (PDF)
Sep 7, 2010	SUPPL -79	View Letter (PDF)
Nov 8, 2002	SUPPL -76	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (4)

Sort:

#002 — 50MG/VIAL

RLD

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Approved Prior to Jan 1, 1982

#004 — 1MG/ML

RLDAP

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Nov 8, 1988

#001 — 10MG/VIAL

RLD

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.

#003 — 0.5MG/ML

RLD

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Jul 18, 1984