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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
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 |
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
| Sponsor | Phase |
|---|---|
| Rain Therapeutics Inc. | Phase 3 |
| M.D. Anderson Cancer Center | Phase 1 |
| Janssen Scientific Affairs, LLC | Phase 1 |
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 | 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 |
International Patents for YONDELIS
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Croatia | P20070374 | ⤷ Try it Free |
| Panama | 8650801 | ⤷ Try it Free |
| Japan | 2006124393 | ⤷ Try it Free |
| Russian Federation | 2382647 | ⤷ Try it Free |
| Germany | 602005001833 | ⤷ Try it Free |
| Australia | 2005227421 | ⤷ Try it Free |
| Ukraine | 91032 | ⤷ Try it Free |
| >Country | >Patent Number | >Estimated Expiration |
