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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

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

15 trials from ClinicalTrials.gov — 10 recruiting, 3 active, 1 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
RRx-001 for Reducing Oral Mucositis in Patients Receiving Chemotherapy and Radiation for Head and Neck Cancer NCT05966194	Phase 2	Active	EpicentRx, Inc.	216	2024-04-02 → 2027-10-01
Perioperative Pembrolizumab (MK-3475) Plus Cystectomy or Perioperative Pembrolizumab Plus Enfortumab Vedotin Plus Cystectomy Versus Cystectomy Alone in Participants Who Are Cisplatin-ineligible or Decline Cisplatin With Muscle-invasive Bladder Cancer (MK-3475-905/KEYNOTE-905/EV-303)NCT03924895	Phase 3	Active	Merck Sharp & Dohme LLC	595	2019-07-24 → 2027-12-15
Testing the Addition of a New Anti-Cancer Drug, Triapine, to the Usual Chemotherapy Treatment (Cisplatin) During Radiation Therapy for Advanced-stage Cervical and Vaginal Cancers NCT02466971	Phase 3	Active	National Cancer Institute (NCI)	450	2016-05-10 → 2026-07-14
APG-157 in Locally Advanced Head and Neck Squamous Cell Carcinoma NCT07667296	Phase 3	Not Yet Recruiting	Aveta Biomics, Inc.	826	2026-07 → 2032-12
A Study of Radiation Therapy and Cemiplimab With or Without Fianlimab In People With Bladder Cancer NCT07414992	Phase 2	Not Yet Recruiting	Memorial Sloan Kettering Cancer Center	44	2026-07 → 2028-03
MRG003 Plus Toripalimab Versus Toripalimab as Neoadjuvant Therapy for PD-L1-Positive, Resectable, Locally Advanced Head and Neck Squamous Cell Carcinoma NCT07677475	Phase 2	Not Yet Recruiting	Dongguan People's Hospital	65	2026-06-30 → 2029-06-30
Integrated Early-CARE for Head & Neck Cancer.NCT07671573	N/A	Not Yet Recruiting	Portuguese Oncology Institute, Coimbra	64	2026-10-01 → 2028-03-31
Individualized Primary Clinical Target Volume Based on Margin Expansion for Nasopharyngeal Carcinoma NCT07661771	Phase 3	Not Yet Recruiting	Sun Yat-sen University	568	2026-07-01 → 2034-06-30
A Phase II Study of AK146D1 in Combination With AK112 in Advanced Non-Small Cell Lung Cancer NCT07669779	Phase 2	Not Yet Recruiting	Akeso	348	2026-06-30 → 2029-05-30
Efficacy and Safety Evaluation of VS-101 in Combination With Chemoradiotherapy in Patients With Head and Neck Cancer NCT06959082	Phase 2	Recruiting	VSPharmTech Co.,Ltd.	30	2026-06 → 2027-06

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

Medicare Part D Spending

CMS annual spending data for Cisplatin (2023)

Total Spending

$28K

Total Claims

512

Beneficiaries

210

Avg Cost/Unit

$0.32

Spending Trend

$33K(2019)→$22K(2020)→$29K(2021)→$38K(2022)→$28K(2023)

YoY Change:-10.8%

5yr CAGR:+0.5%

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

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