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.
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
Summary for YONDELIS
International Patents: | 44 |
US Patents: | 1 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 36 |
Clinical Trials: | 51 |
Patent Applications: | 3,828 |
Drug Prices: | Drug price information for YONDELIS |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for YONDELIS |
What excipients (inactive ingredients) are in YONDELIS? | YONDELIS excipients list |
DailyMed Link: | YONDELIS at DailyMed |


Recent Clinical Trials for YONDELIS
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Anturec Pharmaceuticals GmbH | Phase 3 |
Westfälische Wilhelms-Universität Münster | Phase 3 |
Rain Therapeutics Inc. | Phase 3 |
Pharmacology for YONDELIS
Drug Class | Alkylating Drug |
Mechanism of Action | Alkylating Activity |
Anatomical Therapeutic Chemical (ATC) Classes for YONDELIS
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 |