Time limited offer for new users ▶ Get up to 3 months free

Serving leading biopharmaceutical companies globally:

Harvard Business School
Express Scripts
Medtronic
McKesson
Johnson and Johnson
Merck

Last Updated: February 2, 2023

YONDELIS Drug Patent Profile


✉ Email this page to a colleague

« Back to Dashboard

▶ Start for $1
Remove trial restrictions


When do Yondelis patents expire, and when can generic versions of Yondelis launch?

Yondelis is a drug marketed by Janssen Prods and is included in one NDA. There is one patent protecting this drug and one Paragraph IV challenge.

This drug has forty-four patent family members in thirty-six countries.

The generic ingredient in YONDELIS is trabectedin. There are four drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the trabectedin profile page.

DrugPatentWatch® Generic Entry Outlook for Yondelis

Yondelis was eligible for patent challenges on October 23, 2019.

There have been two patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

There is one tentative approval for the generic drug (trabectedin), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

< Available with Subscription >

  Sign up for a Free Trial

Drug patent expirations by year for YONDELIS
Drug Prices for YONDELIS

See drug prices for YONDELIS

Recent Clinical Trials for YONDELIS

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Anturec Pharmaceuticals GmbHPhase 3
Westfälische Wilhelms-Universität MünsterPhase 3
Rain Therapeutics Inc.Phase 3

See all YONDELIS clinical trials

Pharmacology for YONDELIS
Drug Class Alkylating Drug
Mechanism of ActionAlkylating Activity
Paragraph IV (Patent) Challenges for YONDELIS
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
YONDELIS Powder for Injection trabectedin 1 mg/vial 207953 2 2020-04-23

US Patents and Regulatory Information for YONDELIS

YONDELIS is protected by one US patents and two FDA Regulatory Exclusivities.

Patents protecting YONDELIS

Pharmaceutical formulations of ecteinascidin compounds
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

FDA Regulatory Exclusivity protecting YONDELIS

FOR THE TREATMENT OF PATIENTS WITH UNRESECTABLE OR METASTATIC LIPOSARCOMA OR LEIOMYOSARCOMA WHO RECEIVED A PRIOR ANTHRACYCLINE-CONTAINING REGIMEN
Exclusivity Expiration: See Plans and Pricing

PEDIATRIC EXCLUSIVITY
Exclusivity Expiration: See Plans and Pricing

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Janssen Prods YONDELIS trabectedin POWDER;INTRAVENOUS 207953-001 Oct 23, 2015 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Janssen Prods YONDELIS trabectedin POWDER;INTRAVENOUS 207953-001 Oct 23, 2015 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Janssen Prods YONDELIS trabectedin POWDER;INTRAVENOUS 207953-001 Oct 23, 2015 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

EU/EMA Drug Approvals for YONDELIS

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Pharma Mar S.A. Yondelis trabectedin EMEA/H/C/000773
Yondelis is indicated for the treatment of patients with advanced soft-tissue sarcoma, after failure of anthracyclines and ifosfamide, or who are unsuited to receive these agents. Efficacy data are based mainly on liposarcoma and leiomyosarcoma patients.Yondelis in combination with pegylated liposomal doxorubicin (PLD) is indicated for the treatment of patients with relapsed platinum-sensitive ovarian cancer.
Authorised no no no 2007-09-17
Pharma Mar S.A. Yondelis trabectedin EMEA/H/C/000464
Yondelis is indicated for the treatment of patients with advanced soft tissue sarcoma, having failed antracyclines and ifosfamide, or having failed ifosfamide and unsuitable to receive antracyclines/ifosfamide.
Refused no no no 2004-09-07
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for YONDELIS

See the table below for patents covering YONDELIS around the world.

Country Patent Number Title Estimated Expiration
Russian Federation 2007119724 КОМПОЗИЦИИ, СОДЕРЖАЩИЕ ЭКТИНЭСАЙДИН И ДИСАХАРИД See Plans and Pricing
Panama 8650801 COMPOSICIONES Y FORMULACIONES DE ECTEINASCIDINA, COMO LA ECTEINASCIDINA 743 See Plans and Pricing
Croatia P20070374 See Plans and Pricing
Cyprus 1107773 See Plans and Pricing
European Patent Office 1658848 Compositions contenant d'ecteinascidin et undisaccharide (Formulations comprising ecteinascidin and a disaccharide) See Plans and Pricing
Argentina 051653 FORMULACIONES See Plans and Pricing
El Salvador 2006002283 FORMULACIONES See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Moodys
McKesson
Dow
AstraZeneca
Baxter
Harvard Business School

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.