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PARAPLATIN

NDA

CARBOPLATIN | N019880 | CORDEN PHARMA LATINA SPA

3 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

3 trials from ClinicalTrials.gov — 1 recruiting, 2 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
A Study to Assess Adverse Events and Change in Disease Activity of Multiple Treatment Combinations With Intravenous Mirvetuximab Soravtansine in Adult Participants With Ovarian Cancer NCT07059845	Phase 2	Recruiting	AbbVie	400	2025-11-13 → 2029-01
Trial Evaluating Feasibility and Quality of Life of Second Look Laparoscopy With Hyperthermic Intraperitoneal Chemotherapy NCT04415944	Phase 2	Completed	Wake Forest University Health Sciences	10	2021-05-20 → 2026-01-23
Pembrolizumab and Carboplatin for the Treatment of Recurrent Ovarian, Fallopian Tube, or Primary Peritoneal Cancer NCT04387227	Phase 2	Completed	University of Washington	22	2021-03-18 → 2026-06-01

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

API Supply Chain11 active DMFs7 inactive

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

VERANOVA LPCARBOPLATIN

DMF 71451987

HERAEUS PRECIOUS METALS GMBH AND CO KGCARBOPLATIN USP

DMF 151472000

STREM CHEMICALS INCCARBOPLATIN (USP)

DMF 159382002

SUN PHARMACEUTICAL INDUSTRIES LTDCARBOPLATIN USP

DMF 166642003

TAPI NL BVCARBOPLATIN

DMF 176592004

LAURUS LABS LTDCARBOPLATIN USP DRUG SUBSTANCE

DMF 219182008

QILU PHARMACEUTICAL CO LTDCARBOPLATIN USP

DMF 242012010

UMICORE ARGENTINA SACARBOPLATIN

DMF 280472014

KUNMING GUIYAN PHARMACEUTICAL CO LTDCARBOPLATIN DRUG SUBSTANCE

DMF 291002015

HETERO LABS LTDCARBOPLATIN USP

DMF 291672015

KUNMING GUIYAN PHARMACEUTICAL CO LTDCARBOPLATIN

DMF 417312025

LACHEMA BRNOInactiveCARBOPLATIN

DMF 95411992

PLIVA-LACHEMA ASInactiveCARBOPLATIN

DMF 162802002

INSTITUTE DRUG TECHNOLOGY AUSTRALIA LTDInactiveCARBOPLATIN

DMF 167092003

CIPLA LTDInactiveCARBOPLATIN USP

DMF 169162003

QILU PHARMACEUTICAL CO LTDInactiveCARBOPLATIN (NON-STERILE API)

DMF 236062010

FRESENIUS KABI ONCOLOGY LTDInactiveCARBOPLATIN

DMF 239952010

MAC CHEM PRODUCTS INDIA PVT LTDInactiveCARBOPLATIN USP

DMF 260292012

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

Approval Letters

2 letters from Drugs@FDA

Date	Submission	Document
Nov 12, 2010	SUPPL -20	View Letter (PDF)
Feb 14, 2002	SUPPL -11	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — 50MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: Mar 3, 1989

No patent or exclusivity listings for this strength.

#002 — 150MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Mar 3, 1989

#003 — 450MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Mar 3, 1989