lutetium lu-177 dotatate - Profile
What are the generic drug sources for lutetium lu-177 dotatate and what is the scope of patent protection?
Lutetium lu-177 dotatate
is the generic ingredient in three branded drugs marketed by Curium, Lantheus Medical, and Aaa Usa Inc, and is included in three NDAs. There are nine patents protecting this compound. Additional information is available in the individual branded drug profile pages.Paragraph IV (Patent) Challenges for LUTETIUM LU-177 DOTATATE
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| LUTATHERA | Injection | lutetium lu-177 dotatate | 10 mCi/mL | 208700 | 1 | 2023-11-13 |
US Patents and Regulatory Information for lutetium lu-177 dotatate
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Curium | BEXLUTRY | lutetium lu-177 dotatate | SOLUTION;INTRAVENOUS | 218525-001 | Sep 14, 2026 | RX | Yes | Yes | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Lantheus Medical | BRAVNETSA | lutetium lu-177 dotatate | SOLUTION;INTRAVENOUS | 217060-001 | Sep 21, 2026 | AP | RX | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | |||
| Aaa Usa Inc | LUTATHERA | lutetium lu-177 dotatate | SOLUTION;INTRAVENOUS | 208700-001 | Jan 26, 2018 | AP | RX | Yes | Yes | 12,415,003*PED | ⤷ Start Trial | Y | ⤷ Start Trial | ||
| Aaa Usa Inc | LUTATHERA | lutetium lu-177 dotatate | SOLUTION;INTRAVENOUS | 208700-001 | Jan 26, 2018 | AP | RX | Yes | Yes | 12,144,873*PED | ⤷ Start Trial | Y | ⤷ Start Trial | ||
| Aaa Usa Inc | LUTATHERA | lutetium lu-177 dotatate | SOLUTION;INTRAVENOUS | 208700-001 | Jan 26, 2018 | AP | RX | Yes | Yes | 12,151,003*PED | ⤷ Start Trial | Y | ⤷ Start Trial | ||
| Aaa Usa Inc | LUTATHERA | lutetium lu-177 dotatate | SOLUTION;INTRAVENOUS | 208700-001 | Jan 26, 2018 | AP | RX | Yes | Yes | 12,491,272*PED | ⤷ Start Trial | Y | ⤷ Start Trial | ||
| Aaa Usa Inc | LUTATHERA | lutetium lu-177 dotatate | SOLUTION;INTRAVENOUS | 208700-001 | Jan 26, 2018 | AP | RX | Yes | Yes | 10,596,278*PED | ⤷ Start Trial | Y | ⤷ Start Trial | ||
| >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 lutetium lu-177 dotatate
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Argentina | 119655 | ⤷ Start Trial | |
| Australia | 2018433575 | ⤷ Start Trial | |
| Australia | 2022203683 | ⤷ Start Trial | |
| Australia | 2024201217 | ⤷ Start Trial | |
| Australia | 2025202231 | ⤷ Start Trial | |
| Australia | 2025204901 | ⤷ Start Trial | |
| Australia | 2025220852 | ⤷ Start Trial | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for lutetium lu-177 dotatate
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 4095130 | 202440024 | Slovenia | ⤷ Start Trial | PRODUCT NAME: LUTETIUM (177LU) VIPIVOTIDE TETRAXETAN; NATIONAL AUTHORISATION NUMBER: EU/1/22/1703; DATE OF NATIONAL AUTHORISATION: 20221209; AUTHORITY FOR NATIONAL AUTHORISATION: EU |
| 4095130 | 2490022-7 | Sweden | ⤷ Start Trial | PRODUCT NAME: LUTETIUM (177LU) VIPIVOTIDE TETRAXETAN; REG. NO/DATE: EU/1/22/1703 20221212 |
| 4095130 | CA 2024 00027 | Denmark | ⤷ Start Trial | PRODUCT NAME: LUTETIUM (177LU) VIPIVOTIDETETRAXETAN; REG. NO/DATE: EU/1/22/1703 20221212 |
| 4095130 | 2024C/528 | Belgium | ⤷ Start Trial | PRODUCT NAME: LUTETIUM (177LU) VIPIVOTIDE TETRAXETAN; AUTHORISATION NUMBER AND DATE: EU/1/22/1703 20221212 |
| 4095130 | 301281 | Netherlands | ⤷ Start Trial | PRODUCT NAME: LUTETIUM (177-LU)-VIPIVOTIDE TETRAXETAN; REGISTRATION NO/DATE: EU/1/22/1703, 20221212 |
| 4095130 | C04095130/01 | Switzerland | ⤷ Start Trial | PRODUCT NAME: LUTETIUM (177LU) VIPIVOTID TETRAXETAN; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 68684 24.02.2023 |
| 4095130 | 23/2024 | Austria | ⤷ Start Trial | PRODUCT NAME: LUTETIUM (177LU) VIPIVOTIDE TETRAXETAN; REGISTRATION NO/DATE: EU/1/22/1703 (MITTEILUNG) 20221212 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
