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YONDELIS Drug Profile
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Which patents cover Yondelis, and what generic alternatives are available?
Yondelis is a drug marketed by Janssen Prods and is included in one NDA. There is one patent protecting this drug.
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.
US ANDA Litigation and Generic Entry Outlook for Yondelis
Yondelis was eligible for patent challenges on October 23rd, 2019.
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be October 23rd, 2022. This may change due to patent challenges or generic licensing.
Summary for YONDELIS
| International Patents: | 44 |
| US Patents: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 25 |
| Clinical Trials: | 45 |
| Patent Applications: | 11 |
| Drug Prices: | Drug price information for YONDELIS |
| DailyMed Link: | YONDELIS at DailyMed |
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 |
|---|---|
| M.D. Anderson Cancer Center | Phase 1 |
| Sarcoma Oncology Research Center, LLC | Phase 2 |
| Janssen Scientific Affairs, LLC | Phase 1 |
Pharmacology for YONDELIS
| Drug Class | Alkylating Drug |
| Mechanism of Action | Alkylating Activity |
Synonyms for YONDELIS
| 114899-77-3 |
| 87541-EP2298780A1 |
| 87541-EP2305689A1 |
| AC-27767 |
| AC1L33FK |
| AKOS025401985 |
| AN-5365 |
| C39H43N3O11S |
| CAS-114899-77-3 |
| CCRIS 8133 |
| CHEBI:84050 |
| CHEMBL450449 |
| CS-1608 |
| DB05109 |
| DSSTox_CID_26880 |
| DSSTox_GSID_46880 |
| DSSTox_RID_81984 |
| DTXSID2046880 |
| Ect 743 |
| Ecteinascidin |
| ecteinascidin 743 |
| Ecteinascidin 743;ET-743;Ecteinascidin |
| Ecteinascidin 743|||ET-743|||Yondelis|||NSC-684766 |
| Ecteinascidine 743 |
| Et 743 |
| ET-743 |
| ET743 |
| GTPL2774 |
| HY-50936 |
| ID0YZQ2TCP |
| LS-146121 |
| NCGC00181159-01 |
| NCGC00181159-02 |
| NSC 648766 |
| NSC 684766 |
| NSC-684766 |
| PKVRCIRHQMSYJX-AIFWHQITSA-N |
| SCHEMBL12119916 |
| Tox21_112762 |
| Tox21_113236 |
| Trabectedin |
| Trabectedin [INN] |
| Trabectedin [USAN:INN:BAN] |
| UNII-ID0YZQ2TCP |
| X5006 |
| Z-3121 |
| ZINC150338708 |
US Patents and Regulatory Information for YONDELIS
| 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 | Start Trial | Start Trial | Y | Start Trial | |||
| Janssen Prods | YONDELIS | trabectedin | POWDER;INTRAVENOUS | 207953-001 | Oct 23, 2015 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Janssen Prods | YONDELIS | trabectedin | POWDER;INTRAVENOUS | 207953-001 | Oct 23, 2015 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Janssen Prods | YONDELIS | trabectedin | POWDER;INTRAVENOUS | 207953-001 | Oct 23, 2015 | RX | Yes | Yes | Start Trial | Start Trial | 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
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| New Zealand | 554761 | Start Trial |
| Japan | 4268163 | Start Trial |
| Slovenia | 1658848 | Start Trial |
| El Salvador | 2006002283 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
