Viewing data from:

YONDELIS

NDA

TRABECTEDIN | N207953 | JANSSEN PRODUCTS LP

1 strength1 unique patent0 unique exclusivities

Patent Timeline

1 unique patent by expiration date

Active (1)TodayPED (+6 mo)

2027

2028

Today

8895557

Jul. 7, 2028

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

1 case on OB patents (1 active) from PACER

Case	Court	Filed	Status	Judge
Janssen Products, L.P. et al v. EVER Valinject GmbH et al 2:2025cv01867 2 patentstrabectedin (ecteinascidin 743, ET-743)	D.N.J.	2025-03-14	Active	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

1 trial from ClinicalTrials.gov

Trial	Phase	Status	Sponsor	Enrollment	Dates
Phase II Decentralized Pragmatic Trial of Adjuvant Doxorubicin - Trabectedin Chemotherapy in uLMS NCT07076186	Phase 2	Suspended	M.D. Anderson Cancer Center	48	2025-10-02 → 2029-12-02

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

Medicare Part D Spending

CMS annual spending data for Yondelis (2023)

Total Spending

$578K

Total Claims

Beneficiaries

Avg Cost/Unit

$3362.91

Spending Trend

$237K(2019)→$258K(2020)→$372K(2021)→$110K(2022)→$578K(2023)

YoY Change:+4.4%

5yr CAGR:+1.4%

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 Yondelis (2023)

Total Spending

$12.2M

Total Claims

1,389

Beneficiaries

346

ASP Price

—

HCPCS: J9352 — Injection, trabectedin, 0.1 mg

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

API Supply Chain6 active DMFs1 inactive

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

PHARMA MAR SATRABECTEDIN

DMF 217552008

MSN LABORATORIES PRIVATE LTDTRABECTEDIN

DMF 343112019

APICORE LLCTRABECTEDIN

DMF 358282021

SHANGHAI HAOYUAN CHEMEXPRESS CO LTDTRABECTEDIN (HM-326A_42)

DMF 367242022

BRIGHTGENE BIO-MEDICAL TECHNOLOGY CO LTDTRABECTEDIN

DMF 391652023

EXTROVIS AGTRABECTEDIN

DMF 395112024

JANSSEN PHARMACEUTICA NVInactiveTRABECTEDIN (R279741)

DMF 220202008

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

Approval Letters

7 letters from Drugs@FDA

Date	Submission	Document
Dec 31, 2025	SUPPL -9	View Letter (PDF)
Jun 4, 2020	SUPPL -6	View Letter (PDF)
Dec 30, 2018	SUPPL -5	View Letter (PDF)
Jul 6, 2018	SUPPL -4	View Letter (PDF)
May 19, 2017	SUPPL -3	View Letter (PDF)
Jul 22, 2016	SUPPL -1	View Letter (PDF)
Oct 23, 2015	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 1MG/VIAL

RLD

1 patent0 exclusivities▴

POWDER;INTRAVENOUS | Approved: Oct 23, 2015

Patents (1)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
8895557	Jan 7, 2028PED: Jul 7, 2028	PED	—	Yes	—	—