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 five 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
AI Deep Research
Questions you can ask:
- What is the 5 year forecast for YONDELIS?
- What are the global sales for YONDELIS?
- What is Average Wholesale Price for YONDELIS?
Summary for YONDELIS
| International Patents: | 44 |
| US Patents: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases 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.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of YONDELIS is ⤷ Start Trial.
This potential generic entry date is based on patent 8,895,557.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
| 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 | 8,895,557*PED | ⤷ Start Trial | Y | ⤷ Start Trial | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
International Patents for YONDELIS
See the table below for patents covering YONDELIS around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| New Zealand | 554761 | Formulations comprising ecteinascidin and a disaccharide | ⤷ Start Trial |
| Austria | E368461 | ⤷ Start Trial | |
| Portugal | 1658848 | ⤷ Start Trial | |
| Hong Kong | 1091724 | Formulations comprising ecteinascidin and a disaccharide | ⤷ Start Trial |
| Taiwan | 200621256 | Formulations | ⤷ Start Trial |
| Jordan | 2464 | صيغ تحتوي على اكتيناسيدين وسكريات ثنائية (Formulations comprising ecteinascidin and a disaccharide.) | ⤷ Start Trial |
| Norway | 20072713 | ⤷ Start Trial | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
YONDELIS (Trabectedin): Investment Scenario, Market Dynamics, and Financial Trajectory
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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. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. 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.
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Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2026, www.DrugPatentWatch.com.
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