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-four patent family members in fifteen countries.
One supplier is listed for this compound.
Summary for LUTETIUM LU 177 DOTATATE
| International Patents: | 34 |
| 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 |
| 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 |
|---|---|
| Merck Sharp & Dohme LLC | Phase 2 |
| Pashtoon M. Kasi | Phase 2 |
| GI Research Foundation | 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 | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Aaa Usa Inc | LUTATHERA | lutetium lu 177 dotatate | SOLUTION;INTRAVENOUS | 208700-001 | Jan 26, 2018 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Aaa Usa Inc | LUTATHERA | lutetium lu 177 dotatate | SOLUTION;INTRAVENOUS | 208700-001 | Jan 26, 2018 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Aaa Usa Inc | LUTATHERA | lutetium lu 177 dotatate | SOLUTION;INTRAVENOUS | 208700-001 | Jan 26, 2018 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a 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 |
|---|---|---|---|
| Australia | 2022203683 | Stable, concentrated radionuclide complex solutions | ⤷ Try a Trial |
| Japan | 2021531306 | 神経内分泌腫瘍の処置の方法 | ⤷ Try a Trial |
| Australia | 2024201217 | Stable, concentrated radionuclide complex solutions | ⤷ Try a Trial |
| Japan | 2022500355 | 安定な濃厚放射性核種錯体溶液 | ⤷ Try a Trial |
| Singapore | 11202100645X | STABLE, CONCENTRATED RADIONUCLIDE COMPLEX SOLUTIONS | ⤷ Try a Trial |
| Argentina | 119655 | SOLUCIONES DE COMPLEJOS DE RADIONÚCLIDOS ESTABLES Y CONCENTRADAS | ⤷ Try a Trial |
| >Country | >Patent Number | >Title | >Estimated Expiration |
