LURBINECTEDIN - Generic Drug Details
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What are the generic sources for lurbinectedin and what is the scope of patent protection?
Lurbinectedin
is the generic ingredient in one branded drug marketed by Jazz and is included in one NDA. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.Lurbinectedin has thirty-two patent family members in twenty-three countries.
One supplier is listed for this compound.
Summary for LURBINECTEDIN
International Patents: | 32 |
US Patents: | 1 |
Tradenames: | 1 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 32 |
Clinical Trials: | 36 |
Patent Applications: | 184 |
What excipients (inactive ingredients) are in LURBINECTEDIN? | LURBINECTEDIN excipients list |
DailyMed Link: | LURBINECTEDIN at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for LURBINECTEDIN
Generic Entry Date for LURBINECTEDIN*:
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 LURBINECTEDIN
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
PharmaMar | Phase 2/Phase 3 |
Stand Up To Cancer | Phase 1/Phase 2 |
Children's Hospital of Philadelphia | Phase 1/Phase 2 |
Pharmacology for LURBINECTEDIN
Drug Class | Alkylating Drug |
Mechanism of Action | Alkylating Activity |
Anatomical Therapeutic Chemical (ATC) Classes for LURBINECTEDIN
Paragraph IV (Patent) Challenges for LURBINECTEDIN
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
ZEPZELCA | Powder for Injection | lurbinectedin | 4 mg/vial | 213702 | 5 | 2024-06-17 |
US Patents and Regulatory Information for LURBINECTEDIN
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Jazz | ZEPZELCA | lurbinectedin | POWDER;INTRAVENOUS | 213702-001 | Jun 15, 2020 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
Jazz | ZEPZELCA | lurbinectedin | POWDER;INTRAVENOUS | 213702-001 | Jun 15, 2020 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Jazz | ZEPZELCA | lurbinectedin | POWDER;INTRAVENOUS | 213702-001 | Jun 15, 2020 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
International Patents for LURBINECTEDIN
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Poland | 218295 | ⤷ Sign Up | |
Hungary | 229779 | Ecteinascidin analogues, their use in the preparation of a medicament for treatment of cancer and pharmaceutical compositions containing the compounds | ⤷ Sign Up |
European Patent Office | 1806349 | ⤷ Sign Up | |
Austria | 374777 | ⤷ Sign Up | |
South Korea | 20040032150 | ⤷ Sign Up | |
>Country | >Patent Number | >Title | >Estimated Expiration |
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