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 three patents protecting this compound. Additional information is available in the individual branded drug profile pages.Lutetium lu 177 dotatate has thirty-seven patent family members in fifteen countries.
One supplier is listed for this compound.
Summary for LUTETIUM LU 177 DOTATATE
| International Patents: | 37 |
| 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 |
|---|---|
| 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 | ⤷ 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 | 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 | 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 |
|---|---|---|---|
| Australia | 2018433575 | Stable, concentrated radionuclide complex solutions | ⤷ Sign Up |
| Mexico | 2021000805 | SOLUCIONES DE COMPLEJOS DE RADIONUCLIDOS ESTABLES Y CONCENTRADAS. (STABLE, CONCENTRATED RADIONUCLIDE COMPLEX SOLUTIONS.) | ⤷ Sign Up |
| South Korea | 20240033296 | 안정한 농축 방사성 핵종 복합체 용액 (STABLE CONCENTRATED RADIONUCLIDE COMPLEX SOLUTIONS) | ⤷ Sign Up |
| China | 112955188 | 治疗神经内分泌肿瘤的方法 (METHOD OF TREATMENT OF NEUROENDOCRINE TUMORS) | ⤷ Sign Up |
| Israel | 280314 | תמיסות קומפלקס של רדיונוקליד יציבות ומורוכזות (Stable, concentrated radionuclide complex solutions) | ⤷ Sign Up |
| Brazil | 112021001148 | soluções estáveis de complexo de radionuclídeo concentrado | ⤷ Sign Up |
| >Country | >Patent Number | >Title | >Estimated Expiration |
