You’re using a public version of DrugPatentWatch with 1 free search available | Register to unlock more free searches. CREATE FREE ACCOUNT

Serving leading biopharmaceutical companies globally:

Merck
Baxter
Dow
Moodys
Mallinckrodt
McKesson

Last Updated: February 22, 2024

Trabectedin - Generic Drug Details


✉ Email this page to a colleague

« Back to Dashboard


What are the generic drug sources for trabectedin and what is the scope of patent protection?

Trabectedin is the generic ingredient in one branded drug marketed by Janssen Prods and is included in one NDA. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

Trabectedin has forty-four patent family members in thirty-six countries.

There are four drug master file entries for trabectedin. One supplier is listed for this compound. There is one tentative approval for this compound.

Summary for trabectedin
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for trabectedin
Generic Entry Date for trabectedin*:
Constraining patent/regulatory exclusivity:
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 trabectedin

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Alliance for Clinical Trials in OncologyPhase 2/Phase 3
National Cancer Institute (NCI)Phase 2/Phase 3
Westfälische Wilhelms-Universität MünsterPhase 3

See all trabectedin clinical trials

Generic filers with tentative approvals for TRABECTEDIN
Applicant Application No. Strength Dosage Form
⤷  Try a Trial⤷  Try a Trial1MGINJECTABLE;INJECTION

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for trabectedin
Drug ClassAlkylating Drug
Mechanism of ActionAlkylating Activity
Paragraph IV (Patent) Challenges for TRABECTEDIN
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 trabectedin

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 a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Janssen Prods YONDELIS trabectedin POWDER;INTRAVENOUS 207953-001 Oct 23, 2015 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>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 trabectedin

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

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Mallinckrodt
AstraZeneca
Dow
Baxter
Boehringer Ingelheim
Colorcon

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.