TIRZEPATIDE | N217806 | ELI LILLY AND CO
| Trial # | Patent | Type | Petitioner | Status | Filed | Decision |
|---|---|---|---|---|---|---|
| IPR2025-01024 | 9474780 | IPR | Empower Clinic Services, LLC. (d/b/a Empower Pharmacy) | Discretionary Denial | 2025-05-22 | 2025-10-10 |
| IPR2025-01346 | 9474780 | IPR | BPI Labs, LLC et al. | Discretionary Denial | 2025-08-04 | 2025-12-11 |
| Code | Date | Status |
|---|---|---|
| I-958 | Dec 20, 2027 | Active |
| M-82 | Oct 18, 2027 | Active |
| NCE | May 13, 2027 | < 1 year |
| NP | Nov 8, 2026 | < 1 year |
Eli Lilly obtained new chemical entity exclusivity for Zepbound (tirzepatide) autoinjector formulation under NDA 217806, providing five years of regulatory exclusivity from approval.
New: New record
Eli Lilly's Zepbound (tirzepatide) autoinjector received a new regulatory exclusivity designation (M-82 code) for NDA 217806.
New: New record
Eli Lilly added patent 12629404 to the Orange Book listing for Zepbound (tirzepatide) autoinjector under NDA 217806.
New: New record
Eli Lilly added U.S. Patent 12,629,404 to the Orange Book for Zepbound (tirzepatide) autoinjector formulation under NDA 217806.
New: New record
Eli Lilly added U.S. Patent 12,616,740 to the Orange Book for Zepbound (tirzepatide) autoinjector formulation under NDA 217806.
New: New record
Eli Lilly added U.S. Patent 12,616,740 to the Orange Book for Zepbound (tirzepatide) autoinjector formulation under NDA 217806.
New: New record
Eli Lilly added patent 12616740 to the Orange Book for Zepbound (tirzepatide) autoinjector formulation under NDA 217806.
New: New record
Eli Lilly added U.S. Patent 12,616,740 to the Orange Book for Zepbound (tirzepatide) autoinjector, NDA 217806.
New: New record
Eli Lilly added U.S. Patent 12,629,404 to the Orange Book for Zepbound (tirzepatide) autoinjector formulation.
New: New record
Eli Lilly added patent 12616740 to the Orange Book for Zepbound (tirzepatide) autoinjector formulation under NDA 217806.
New: New record
Eli Lilly added U.S. Patent 12,616,740 to the Orange Book listing for Zepbound (tirzepatide) autoinjector formulation under NDA 217806.
New: New record
Eli Lilly added U.S. Patent 12,616,740 to the Orange Book for Zepbound (tirzepatide) autoinjector formulation under NDA 217806.
New: New record
Eli Lilly added patent 12,616,740 to the Orange Book listing for Zepbound (tirzepatide) autoinjector formulation (NDA 217806).
New: New record
Eli Lilly added patent 12,629,404 to the Orange Book for Zepbound (tirzepatide) autoinjector formulation (NDA 217806).
New: New record
Eli Lilly added U.S. Patent 12,616,740 to the Orange Book for Zepbound (tirzepatide) autoinjector formulation under NDA 217806.
New: New record
Eli Lilly added patent 12629404 to the Orange Book for Zepbound (tirzepatide) autoinjector formulation.
New: New record
Eli Lilly added U.S. Patent 12,616,740 to the Orange Book for Zepbound (tirzepatide) autoinjector, NDA 217806.
New: New record
Eli Lilly added patent 12616740 to the Orange Book for Zepbound (tirzepatide) autoinjector formulation under NDA 217806.
New: New record
Eli Lilly added U.S. Patent 12,616,740 to the Orange Book for Zepbound (tirzepatide) autoinjector formulation under NDA 217806.
New: New record
Eli Lilly's Zepbound (tirzepatide) autoinjector gained metabolite exclusivity (M-82) for NDA 217806, Supplement 014.
New: New record
Eli Lilly's tirzepatide autoinjector formulation (Zepbound) gained orphan drug exclusivity designation (I-958) for NDA 217806.
New: New record
Eli Lilly added a 180-day pediatric exclusivity code (I-958) to tirzepatide (Zepbound autoinjector) for NDA 217806, supplement 013.
New: New record
Eli Lilly's Zepbound (tirzepatide) autoinjector formulation gained a new regulatory exclusivity designation (M-82) under NDA 217806.
New: New record
Eli Lilly's Zepbound (tirzepatide) autoinjector formulation gained new chemical entity exclusivity under NDA 217806, supplemental application 015.
New: New record
New: New record
New: New record
New: New record
New: New record
New: New record
New: New record
New: New record
New: New record
New: New record
New: New record
New: New record
New: New record
Eli Lilly's Zepbound (tirzepatide) autoinjector received new chemical entity exclusivity upon approval under NDA 217806.
New: New record
Eli Lilly's Zepbound (tirzepatide) autoinjector formulation received a new regulatory exclusivity designation (M-82) for NDA 217806, Supplement 013.
New: New record
Eli Lilly's Zepbound (tirzepatide) autoinjector gained new chemical entity (NCE) exclusivity upon NDA 217806 approval, providing five years of regulatory exclusivity from Jan 2024.
New: New record
New: New record
New: New record
New: New record
New: New record
New: New record
Eli Lilly listed patent 12629404 for Zepbound (tirzepatide) autoinjector formulation in FDA Orange Book under NDA 217806.
New: New record
Eli Lilly added U.S. Patent No. 12,616,740 to the Orange Book listing for Zepbound (tirzepatide) autoinjector formulation (NDA 217806).
New: New record
Eli Lilly's Zepbound (tirzepatide) autoinjector formulation (NDA 217806, supplement 016) received new chemical entity exclusivity designation.
New: New record
Eli Lilly's Zepbound (tirzepatide) autoinjector received new chemical entity exclusivity designation in connection with NDA 217806.
New: New record
Eli Lilly's Zepbound (tirzepatide) autoinjector formulation received new chemical entity (NCE) exclusivity designation for NDA 217806, supplement 024.
New: New record
Eli Lilly's Zepbound (tirzepatide) autoinjector formulation received metabolite exclusivity (M-82) upon approval of NDA 217806, Supplement 017.
New: New record