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
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*:
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
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 |
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
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 | ⤷ 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
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 |
---|---|---|---|
Peru | 20060925 | COMPOSICION FARMACEUTICA QUE COMPRENDE ECTEINASCIDINA Y UN DISACARIDO | ⤷ Sign Up |
Israel | 182776 | COMPOSITIONS CONTAINING ECTEINASCIDIN AND A DISACCHARIDE | ⤷ Sign Up |
Argentina | 110986 | COMPOSICIONES DE ECTEINASCIDINA, FORMULACIONES LIOFILIZADAS, MÉTODO DE PREPARACIÓN Y USO | ⤷ Sign Up |
Norway | 328035 | ⤷ Sign Up | |
South Korea | 101188691 | ⤷ Sign Up | |
>Country | >Patent Number | >Title | >Estimated Expiration |
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