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Last Updated: April 24, 2024

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YONDELIS Drug Patent Profile


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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.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be July 7, 2028. This may change due to patent challenges or generic licensing.

There have been three 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

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  Try a Trial

Drug patent expirations by year for YONDELIS
Drug Prices for YONDELIS

See drug prices for YONDELIS

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for YONDELIS
Generic Entry Date for YONDELIS*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
POWDER;INTRAVENOUS

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for YONDELIS

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

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

See all YONDELIS clinical trials

Pharmacology for YONDELIS
Drug ClassAlkylating 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.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of YONDELIS is ⤷  Try a Trial.

This potential generic entry date is based on patent ⤷  Try a Trial.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting YONDELIS

Pharmaceutical formulations of ecteinascidin compounds
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

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 ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
>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

When does loss-of-exclusivity occur for YONDELIS?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Patent: 1653
Estimated Expiration: ⤷  Try a Trial

Patent: 0986
Estimated Expiration: ⤷  Try a Trial

Australia

Patent: 05227421
Estimated Expiration: ⤷  Try a Trial

Austria

Patent: 68461
Estimated Expiration: ⤷  Try a Trial

Brazil

Patent: 0517238
Estimated Expiration: ⤷  Try a Trial

Canada

Patent: 20979
Estimated Expiration: ⤷  Try a Trial

China

Patent: 23794
Estimated Expiration: ⤷  Try a Trial

Patent: 2018714
Estimated Expiration: ⤷  Try a Trial

Croatia

Patent: 0070374
Estimated Expiration: ⤷  Try a Trial

Cyprus

Patent: 07773
Estimated Expiration: ⤷  Try a Trial

Denmark

Patent: 58848
Estimated Expiration: ⤷  Try a Trial

El Salvador

Patent: 06002283
Estimated Expiration: ⤷  Try a Trial

European Patent Office

Patent: 58848
Estimated Expiration: ⤷  Try a Trial

Germany

Patent: 2005001833
Estimated Expiration: ⤷  Try a Trial

Guatemala

Patent: 0500314
Estimated Expiration: ⤷  Try a Trial

Honduras

Patent: 05029978
Estimated Expiration: ⤷  Try a Trial

Hong Kong

Patent: 91724
Estimated Expiration: ⤷  Try a Trial

Israel

Patent: 2776
Estimated Expiration: ⤷  Try a Trial

Japan

Patent: 68163
Estimated Expiration: ⤷  Try a Trial

Patent: 06124393
Estimated Expiration: ⤷  Try a Trial

Jordan

Patent: 64
Estimated Expiration: ⤷  Try a Trial

Malaysia

Patent: 9049
Estimated Expiration: ⤷  Try a Trial

Mexico

Patent: 05011650
Estimated Expiration: ⤷  Try a Trial

New Zealand

Patent: 4761
Estimated Expiration: ⤷  Try a Trial

Norway

Patent: 8035
Estimated Expiration: ⤷  Try a Trial

Patent: 072713
Estimated Expiration: ⤷  Try a Trial

Panama

Patent: 50801
Estimated Expiration: ⤷  Try a Trial

Peru

Patent: 060925
Estimated Expiration: ⤷  Try a Trial

Patent: 100089
Estimated Expiration: ⤷  Try a Trial

Poland

Patent: 58848
Estimated Expiration: ⤷  Try a Trial

Portugal

Patent: 58848
Estimated Expiration: ⤷  Try a Trial

Russian Federation

Patent: 82647
Estimated Expiration: ⤷  Try a Trial

Patent: 07119724
Estimated Expiration: ⤷  Try a Trial

Serbia

Patent: 510
Estimated Expiration: ⤷  Try a Trial

Slovenia

Patent: 58848
Estimated Expiration: ⤷  Try a Trial

South Africa

Patent: 0703450
Estimated Expiration: ⤷  Try a Trial

South Korea

Patent: 1188691
Estimated Expiration: ⤷  Try a Trial

Patent: 070091121
Estimated Expiration: ⤷  Try a Trial

Spain

Patent: 90844
Estimated Expiration: ⤷  Try a Trial

Taiwan

Patent: 96523
Estimated Expiration: ⤷  Try a Trial

Patent: 0621256
Estimated Expiration: ⤷  Try a Trial

Ukraine

Patent: 032
Estimated Expiration: ⤷  Try a Trial

Uruguay

Patent: 183
Estimated Expiration: ⤷  Try a Trial

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

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

Country Patent Number Title Estimated Expiration
Norway 20072713 ⤷  Try a Trial
Japan 4268163 ⤷  Try a Trial
Germany 602005001833 ⤷  Try a Trial
Canada 2520979 FORMULATIONS (FORMULATIONS) ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

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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.