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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Questions you can ask:
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Summary for YONDELIS
International Patents: | 44 |
US Patents: | 1 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 43 |
Clinical Trials: | 51 |
Patent Applications: | 2,415 |
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 |
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
Sponsor | Phase |
---|---|
Westfälische Wilhelms-Universität Münster | Phase 3 |
Anturec Pharmaceuticals GmbH | Phase 3 |
Rain Therapeutics Inc. | Phase 3 |
Pharmacology for YONDELIS
Drug Class | Alkylating Drug |
Mechanism of Action | Alkylating 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 ⤷ Sign Up.
This potential generic entry date is based on patent ⤷ Sign Up.
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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 | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
>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 |
---|---|---|---|
China | 102018714 | Formulations | ⤷ Sign Up |
Slovenia | 1658848 | ⤷ Sign Up | |
Russian Federation | 2382647 | КОМПОЗИЦИИ, СОДЕРЖАЩИЕ ЭКТИНЭСАЙДИН И ДИСАХАРИД (ECTEINASCIDIN AND DISACCHARIDE-CONTAINING COMPOSITIONS) | ⤷ Sign Up |
Uruguay | 29183 | FORMULACIONES | ⤷ Sign Up |
El Salvador | 2006002283 | FORMULACIONES | ⤷ Sign Up |
Brazil | PI0517238 | formulações que compreendem ecteinascidina e um dissacarìdeo | ⤷ Sign Up |
Canada | 2520979 | FORMULATIONS (FORMULATIONS) | ⤷ Sign Up |
>Country | >Patent Number | >Title | >Estimated Expiration |