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Last Updated: September 27, 2022

Trabectedin - Generic Drug Details


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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
Recent Clinical Trials for trabectedin

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

SponsorPhase
National Cancer Institute (NCI)Phase 2/Phase 3
Rain Therapeutics Inc.Phase 3
Humanitas Hospital, ItalyPhase 2

See all trabectedin clinical trials

Generic filers with tentative approvals for TRABECTEDIN
Applicant Application No. Strength Dosage Form
See Plans and PricingSee Plans and Pricing1MGINJECTABLE;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 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 See Plans and Pricing See Plans and Pricing See Plans and Pricing
Janssen Prods YONDELIS trabectedin POWDER;INTRAVENOUS 207953-001 Oct 23, 2015 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Janssen Prods YONDELIS trabectedin POWDER;INTRAVENOUS 207953-001 Oct 23, 2015 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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

International Patents for trabectedin

Country Patent Number Title Estimated Expiration
Croatia P20070374 See Plans and Pricing
Jordan 2464 صيغ تحتوي على اكتيناسيدين وسكريات ثنائية (Formulations comprising ecteinascidin and a disaccharide.) See Plans and Pricing
Argentina 110986 COMPOSICIONES DE ECTEINASCIDINA, FORMULACIONES LIOFILIZADAS, MÉTODO DE PREPARACIÓN Y USO See Plans and Pricing
Taiwan I296523 See Plans and Pricing
South Korea 101188691 See Plans and Pricing
Taiwan 200621256 Formulations See Plans and Pricing
Portugal 1658848 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

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