Details for Patent: 12,324,806
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Which drugs does patent 12,324,806 protect, and when does it expire?
Patent 12,324,806 protects ZEPZELCA and is included in one NDA.
This patent has thirty-six patent family members in twenty-one countries.
Summary for Patent: 12,324,806
| Title: | Method of treating SCLC and managing hepatotoxicity |
| Abstract: | Provided are methods for the treatment of SCLC patients by administering therapeutic amounts of lurbinectedin by intravenous infusion. Also provided are methods of treating cancer by administering lurbinectedin in combination with other anticancer drugs, in particular topoisomerase inhibitors. The invention further relates to the administration of lurbinectedin in combination with anti-emetic agents for effective control of symptoms related to nausea and vomiting, reduced lurbinectedin dosages to achieve a safer administration and an increase in the number of treatment cycles. Stable lyophilized formulations of lurbinectedin are also provided. |
| Inventor(s): | Carmen Kahatt, José María Fernandez, Salvador Fudio, Arturo Soto, Pilar Lardelli, Cristian Fernandez |
| Assignee: | Pharmamar SA |
| Application Number: | US18/448,122 |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for patent 12,324,806 |
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Patent Claim Types: see list of patent claims | Use; |
Drugs Protected by US Patent 12,324,806
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Patented / Exclusive Use | Submissiondate |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Jazz | ZEPZELCA | lurbinectedin | POWDER;INTRAVENOUS | 213702-001 | Jun 15, 2020 | RX | Yes | Yes | ⤷ Start Trial | ⤷ Start Trial | TREATING METASTATIC SCLC AFTER PLATINUM CHEMOTHERAPY WITH LURBINECTEDIN MONOTHERAPY BY REDUCING THE DOSE FOR GRADE ≥3 HEPATOTOXICITY FROM 3.2 TO 2.6 MG/M2 AND 2.6 TO 2.0 MG/M2 LURBINECTEDIN WITHIN 35 DAYS OF THE HIGHER DOSE IF HEPATOTOXICITY ≤GRADE 1 | ⤷ Start Trial | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Patented / Exclusive Use | >Submissiondate |
International Family Members for US Patent 12,324,806
| Country | Patent Number | Estimated Expiration | Supplementary Protection Certificate | SPC Country | SPC Expiration |
|---|---|---|---|---|---|
| Australia | 2020388196 | ⤷ Start Trial | |||
| Australia | 2025203941 | ⤷ Start Trial | |||
| Australia | 2025203950 | ⤷ Start Trial | |||
| Australia | 2025203954 | ⤷ Start Trial | |||
| >Country | >Patent Number | >Estimated Expiration | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration |
