Details for Patent: 12,622,921
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Which drugs does patent 12,622,921 protect, and when does it expire?
Patent 12,622,921 protects TEPYLUTE and is included in one NDA.
This patent has nine patent family members in eight countries.
Summary for Patent: 12,622,921
| Title: | Stable formulations comprising thiotepa |
| Abstract: | The present disclosure provides pharmaceutical compositions comprising thiotepa and one selected from PEG, such as PEG400 or PEG600, and DMSO, and optionally water or an aqueous saline solution and thiosulfate. The composition is free or substantially free of impurities. Also provided is a method for treating cancer in a subject, or myeloablation prior to bone marrow transplantation using the composition. A method for enhancing the stability of a thiotepa formulation is also contemplated. |
| Inventor(s): | Sharon Cunningham, Orlaith RYAN, Johannes Jan Platteeuw |
| Assignee: | Shorla Pharma Ltd |
| Application Number: | US17/897,839 |
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Patent Claim Types: see list of patent claims | Use; Composition; Formulation; |
Drugs Protected by US Patent 12,622,921
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Patented / Exclusive Use | Submissiondate |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Shorla | TEPYLUTE | thiotepa | SOLUTION;INTRAVENOUS | 216984-001 | Jun 25, 2024 | RX | Yes | Yes | ⤷ Start Trial | ⤷ Start Trial | TREATMENT OF ADENOCARCINOMA OF THE BREAST OR OVARY | ⤷ Start Trial | ||||
| Shorla | TEPYLUTE | thiotepa | SOLUTION;INTRAVENOUS | 216984-002 | Feb 26, 2025 | RX | Yes | Yes | ⤷ Start Trial | ⤷ Start Trial | TREATMENT OF ADENOCARCINOMA OF THE BREAST OR OVARY | ⤷ 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 12,622,921
| Country | Patent Number | Estimated Expiration | Supplementary Protection Certificate | SPC Country | SPC Expiration |
|---|---|---|---|---|---|
| Australia | 2023220025 | ⤷ Start Trial | |||
| Canada | 3244102 | ⤷ Start Trial | |||
| China | 119053320 | ⤷ Start Trial | |||
| European Patent Office | 4479024 | ⤷ Start Trial | |||
| Japan | 2025506736 | ⤷ Start Trial | |||
| South Korea | 20240141334 | ⤷ Start Trial | |||
| >Country | >Patent Number | >Estimated Expiration | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration |
