You’re using a public version of DrugPatentWatch with 5 free searches available | Register to unlock more free searches. CREATE FREE ACCOUNT

Last Updated: April 16, 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

International Patents:	44
US Patents:	1
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	4
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	43
Clinical Trials:	96
Patent Applications:	5,711
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for trabectedin
What excipients (inactive ingredients) are in trabectedin?	trabectedin excipients list
DailyMed Link:	trabectedin at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for trabectedin

Generic Entry Date for trabectedin^: ⤷ Try a Trial* Constraining patent/regulatory exclusivity: ⤷ Try a Trial 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

Sponsor	Phase
Alliance for Clinical Trials in Oncology	Phase 2/Phase 3
National Cancer Institute (NCI)	Phase 2/Phase 3
Westfälische Wilhelms-Universität Münster	Phase 3

See all trabectedin clinical trials

Generic filers with tentative approvals for TRABECTEDIN

Applicant	Application No.	Strength	Dosage Form
⤷ Try a Trial	⤷ Try a Trial	1MG	INJECTABLE;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 Class	Alkylating Drug
Mechanism of Action	Alkylating 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

+ Get email alerts for changes to this table

Glossary

Subscribe to access the full database, or 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
Janssen Prods	YONDELIS	trabectedin	POWDER;INTRAVENOUS	207953-001	Oct 23, 2015		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial			Y	⤷ 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

Subscribe to access the full database, or Try a Trial
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

International Patents for trabectedin

Subscribe to access the full database, or Try a Trial
Country	Patent Number	Title	Estimated Expiration
Taiwan	I296523		⤷ Try a Trial
Guatemala	200500314	FORMULACIONES	⤷ Try a Trial
Germany	602005001833		⤷ Try a Trial
Japan	4268163		⤷ Try a Trial
New Zealand	554761	Formulations comprising ecteinascidin and a disaccharide	⤷ Try a Trial
Panama	8650801	COMPOSICIONES Y FORMULACIONES DE ECTEINASCIDINA, COMO LA ECTEINASCIDINA 743	⤷ Try a Trial
South Korea	20070091121	FORMULATIONS COMPRISING ECTEINASCIDIN AND A DISACCHARIDE	⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

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

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.