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LUTATHERA Drug Profile
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When do Lutathera patents expire, and what generic alternatives are available?
Lutathera is a drug marketed by Aaa Usa Inc and is included in one NDA.
The generic ingredient in LUTATHERA is lutetium dotatate lu-177. There are four drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the lutetium dotatate lu-177 profile page.
Summary for LUTATHERA
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Clinical Trials: | 11 |
| Drug Prices: | Drug price information for LUTATHERA |
| DailyMed Link: | LUTATHERA at DailyMed |
Generic Entry Opportunity Date for LUTATHERA
Generic Entry Date for LUTATHERA*:
Constraining patent/regulatory exclusivity:
TREATMENT OF SOMATOSTATIN RECEPTOR-POSITIVE GASTROENTEROPANCREATIC NEUROENDOCRINE TUMORS (GEP-NETS) INCLUDING FOREGUT, MIDGUT, AND HINDGUT NEUROENDOCRINE TUMORS IN ADULTS NDA:
Dosage:
SOLUTION;INTRAVENOUS |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Recent Clinical Trials for LUTATHERA
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| M.D. Anderson Cancer Center | Phase 2 |
| Advanced Accelerator Applications | Phase 2 |
| King's College Hospital NHS Trust | Phase 2 |
US Patents and Regulatory Information for LUTATHERA
| 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 dotatate lu-177 | SOLUTION;INTRAVENOUS | 208700-001 | Jan 26, 2018 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Aaa Usa Inc | LUTATHERA | lutetium dotatate lu-177 | SOLUTION;INTRAVENOUS | 208700-001 | Jan 26, 2018 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
