LUTETIUM LU 177 DOTATATE | N208700 | ADVANCED ACCELERATOR APPLICATIONS USA INC
| Trial # | Patent | Type | Petitioner | Status | Filed | Decision |
|---|---|---|---|---|---|---|
| PGR2021-00003 | 10596276 | PGR | Evergreen Theragnostics, Inc. | Institution Denied | 2020-10-02 | — |
| PGR2021-00001 | 10596278 | PGR | Evergreen Theragnostics, Inc. | Institution Denied | 2020-10-02 | — |
| PGR2021-00002 | 10596278 | PGR | Evergreen Theragnostics, Inc. | Institution Denied | 2020-10-02 | — |
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
Advanced Accelerator Applications USA, Inc. et al v. Curium US LLC et al 4 patentslutetium Lu 177 dotatate | D. Del. | 2025-09-16 | Active | — |
| D. Del. | 2024-10-17 | Active | — | |
| D. Del. | 2024-01-25 | Active | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Advanced Accelerator Applications USA, Inc., A Novartis... FDA-2024-P-1871 · 11 docket documents Advanced Accelerator Applications USA, Inc., which holds the new drug application for Lutathera (lutetium Lu 177 dotatate), petitions the FDA Commissioner to require that any abbreviated new drug application under section 505(j) or new drug application under section 505(b)(2) referencing Lutathera d | 505(q) | 2024-04-16 | Partially Denied | Advanced Accelerator Applications USA, Inc., A Novartis Company |
Source: Regulations.gov. FDA citizen petitions matched by application number.
| Patent # | Expiration | PED | Drug Substance | Drug Product | Use Code | Delist |
|---|---|---|---|---|---|---|
| 10596276 | Jul 25, 2038PED: Jan 25, 2039 | PED | — | Yes | — | — |
| 10596278 | Jul 25, 2038PED: Jan 25, 2039 | PED | — | Yes | — | — |
| 11904027 | Jul 25, 2038PED: Jan 25, 2039 | PED | — | Yes | — | — |
| 12144873 | Jul 25, 2038PED: Jan 25, 2039 | PED | — | — | — | |
| 12151003 | Jul 25, 2038PED: Jan 25, 2039 | PED | — | Yes | — | |
| 12161732 | Jul 25, 2038PED: Jan 25, 2039 | PED | — | Yes | — | |
| 12168063 | Jul 25, 2038PED: Jan 25, 2039 | PED | — | Yes | — | |
| 12415003 | Jul 25, 2038PED: Jan 25, 2039 | PED | — | — | — | |
| 12491272 | Jul 25, 2038PED: Jan 25, 2039 | PED | — | — | — |
| Code | Date | Status |
|---|---|---|
| NPP | Apr 23, 2027 | < 1 year |
| ODE-479 | Apr 23, 2031 | Active |
| PED | Oct 23, 2027 | Active |
| PED | Oct 23, 2031 | Active |