Lutetium lu 177 dotatate - Generic Drug Details
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What are the generic drug sources for lutetium lu 177 dotatate and what is the scope of freedom to operate?
Lutetium lu 177 dotatate
is the generic ingredient in one branded drug marketed by Aaa Usa Inc and is included in one NDA. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.Lutetium lu 177 dotatate has thirty-eight patent family members in fifteen countries.
One supplier is listed for this compound.
Summary for lutetium lu 177 dotatate
| International Patents: | 38 |
| US Patents: | 3 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 2 |
| Clinical Trials: | 19 |
| Patent Applications: | 14 |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for lutetium lu 177 dotatate |
| What excipients (inactive ingredients) are in lutetium lu 177 dotatate? | lutetium lu 177 dotatate excipients list |
| DailyMed Link: | lutetium lu 177 dotatate at DailyMed |
Recent Clinical Trials for lutetium lu 177 dotatate
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Novartis | Phase 2 |
| Merck Sharp & Dohme LLC | Phase 2 |
| Pashtoon M. Kasi | Phase 2 |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Aaa Usa Inc | LUTATHERA | lutetium lu 177 dotatate | SOLUTION;INTRAVENOUS | 208700-001 | Jan 26, 2018 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Aaa Usa Inc | LUTATHERA | lutetium lu 177 dotatate | SOLUTION;INTRAVENOUS | 208700-001 | Jan 26, 2018 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Aaa Usa Inc | LUTATHERA | lutetium lu 177 dotatate | SOLUTION;INTRAVENOUS | 208700-001 | Jan 26, 2018 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Aaa Usa Inc | LUTATHERA | lutetium lu 177 dotatate | SOLUTION;INTRAVENOUS | 208700-001 | Jan 26, 2018 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Aaa Usa Inc | LUTATHERA | lutetium lu 177 dotatate | SOLUTION;INTRAVENOUS | 208700-001 | Jan 26, 2018 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Aaa Usa Inc | LUTATHERA | lutetium lu 177 dotatate | SOLUTION;INTRAVENOUS | 208700-001 | Jan 26, 2018 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Aaa Usa Inc | LUTATHERA | lutetium lu 177 dotatate | SOLUTION;INTRAVENOUS | 208700-001 | Jan 26, 2018 | 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 |
International Patents for lutetium lu 177 dotatate
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Japan | 2022500355 | 安定な濃厚放射性核種錯体溶液 | ⤷ Sign Up |
| China | 117122707 | 联合疗法 (Combination therapy) | ⤷ Sign Up |
| Australia | 2022203683 | Stable, concentrated radionuclide complex solutions | ⤷ Sign Up |
| Israel | 280314 | תמיסות קומפלקס של רדיונוקליד יציבות ומורוכזות (Stable, concentrated radionuclide complex solutions) | ⤷ Sign Up |
| Japan | 2023107801 | 併用療法 (COMBINATION THERAPY) | ⤷ Sign Up |
| Israel | 313560 | תמיסות קומפלקס של רדיונוקליד יציבות ומורוכזות (Stable, concentrated radionuclide complex solutions) | ⤷ Sign Up |
| Japan | 2024038132 | 神経内分泌腫瘍の処置の方法 (METHOD OF TREATMENT OF NEUROENDOCRINE TUMORS) | ⤷ Sign Up |
| >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 | 2024C/528 | Belgium | ⤷ Sign Up | PRODUCT NAME: LUTETIUM (177LU) VIPIVOTIDE TETRAXETAN; AUTHORISATION NUMBER AND DATE: EU/1/22/1703 20221212 |
| 4095130 | LUC00352 | Luxembourg | ⤷ Sign Up | PRODUCT NAME: LUTETIUM (177LU) VIPIVOTIDE TETRAXETAN; AUTHORISATION NUMBER AND DATE: EU/1/22/1703 20221212 |
| 4095130 | 301281 | Netherlands | ⤷ Sign Up | PRODUCT NAME: LUTETIUM (177-LU)-VIPIVOTIDE TETRAXETAN; REGISTRATION NO/DATE: EU/1/22/1703, 20221212 |
| 4095130 | CA 2024 00027 | Denmark | ⤷ Sign Up | PRODUCT NAME: LUTETIUM (177LU) VIPIVOTIDETETRAXETAN; REG. NO/DATE: EU/1/22/1703 20221212 |
| 4095130 | 122024000038 | Germany | ⤷ Sign Up | PRODUCT NAME: (177LU)LUTETIUMVIPIVOTIDTETRAXETAN; REGISTRATION NO/DATE: EU/1/22/1703 20221209 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
