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 patent protection?
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 two patents protecting this compound. Additional information is available in the individual branded drug profile pages.Lutetium lu 177 dotatate has thirty-three patent family members in fifteen countries.
One supplier is listed for this compound.
Summary for LUTETIUM LU 177 DOTATATE
International Patents: | 33 |
US Patents: | 2 |
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 |
---|---|
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 | ⤷ 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 | |||
>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 |
---|---|---|---|
China | 117122707 | 联合疗法 (Combination therapy) | ⤷ Try a Trial |
Singapore | 11202100645X | STABLE, CONCENTRATED RADIONUCLIDE COMPLEX SOLUTIONS | ⤷ Try a Trial |
Japan | 2023117417 | 安定な濃厚放射性核種錯体溶液 (STABLE, CONCENTRATED RADIONUCLIDE COMPLEX SOLUTIONS) | ⤷ Try a Trial |
Taiwan | 202019489 | Stable, concentrated radionuclide complex solutions | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |