TRABECTEDIN - Generic Drug Details

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What are the generic drug sources for trabectedin and what is the scope of freedom to operate?

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^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up 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
Anturec Pharmaceuticals GmbH	Phase 3

See all TRABECTEDIN clinical trials

Generic filers with tentative approvals for TRABECTEDIN

Applicant	Application No.	Strength	Dosage Form
⤷ Sign Up	⤷ Sign Up	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

Anatomical Therapeutic Chemical (ATC) Classes for TRABECTEDIN

L01CX	Other plant alkaloids and natural products
L01C	PLANT ALKALOIDS AND OTHER NATURAL PRODUCTS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

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

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Glossary

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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	⤷ Sign Up	⤷ Sign Up			Y	⤷ Sign Up
>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

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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

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Country	Patent Number	Title	Estimated Expiration
China	102018714	Formulations	⤷ Sign Up
Slovenia	1658848		⤷ Sign Up
Russian Federation	2382647	КОМПОЗИЦИИ, СОДЕРЖАЩИЕ ЭКТИНЭСАЙДИН И ДИСАХАРИД (ECTEINASCIDIN AND DISACCHARIDE-CONTAINING COMPOSITIONS)	⤷ Sign Up
Uruguay	29183	FORMULACIONES	⤷ Sign Up
El Salvador	2006002283	FORMULACIONES	⤷ Sign Up
Brazil	PI0517238	formulações que compreendem ecteinascidina e um dissacarìdeo	⤷ Sign Up
Canada	2520979	FORMULATIONS (FORMULATIONS)	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

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