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Last Updated: January 19, 2022

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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 October 23, 2022. This may change due to patent challenges or generic licensing.

There is one Paragraph IV patent challenge for this drug. This may lead to patent invalidation or a license for generic production.

Indicators of Generic Entry

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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: 31
Clinical Trials: 50
Patent Applications: 3,534
Drug Prices: Drug price information for YONDELIS
What excipients (inactive ingredients) are in YONDELIS?YONDELIS excipients list
DailyMed Link:YONDELIS at DailyMed
Drug patent expirations by year for YONDELIS
Drug Prices for YONDELIS

See drug prices for YONDELIS

DrugPatentWatch® Estimated Generic Entry Opportunity Date for YONDELIS
Generic Entry Date for YONDELIS*:
Constraining patent/regulatory exclusivity:
FOR THE TREATMENT OF PATIENTS WITH UNRESECTABLE OR METASTATIC LIPOSARCOMA OR LEIOMYOSARCOMA WHO RECEIVED A PRIOR ANTHRACYCLINE-CONTAINING REGIMEN
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
Rain Therapeutics Inc.Phase 3
M.D. Anderson Cancer CenterPhase 1
Janssen Scientific Affairs, LLCPhase 1

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 NDA Submissiondate
YONDELIS POWDER;INTRAVENOUS trabectedin 207953 2020-04-23

US Patents and Regulatory Information for YONDELIS

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

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

This potential generic entry date is based on FOR THE TREATMENT OF PATIENTS WITH UNRESECTABLE OR METASTATIC LIPOSARCOMA OR LEIOMYOSARCOMA WHO RECEIVED A PRIOR ANTHRACYCLINE-CONTAINING REGIMEN.

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 it Free
Patent Expiration: ⤷  Try it Free

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: ⤷  Try it Free

INFORMATION ADDED TO SECTION 8.4 OF THE LABELING TO DESCRIBE THE RESULTS FROM PEDIATRIC STUDIES
Exclusivity Expiration: ⤷  Try it Free

PEDIATRIC EXCLUSIVITY
Exclusivity Expiration: ⤷  Try it Free

PEDIATRIC EXCLUSIVITY
Exclusivity Expiration: ⤷  Try it Free

PEDIATRIC EXCLUSIVITY
Exclusivity Expiration: ⤷  Try it Free

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

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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.