TIRZEPATIDE | N215866 | ELI LILLY AND CO
| Trial # | Patent | Type | Petitioner | Status | Filed | Decision |
|---|---|---|---|---|---|---|
| IPR2025-01346 | 9474780 | IPR | BPI Labs, LLC et al. | Discretionary Denial | 2025-08-04 | 2025-12-11 |
| IPR2025-01024 | 9474780 | IPR | Empower Clinic Services, LLC. (d/b/a Empower Pharmacy) | Discretionary Denial | 2025-05-22 | 2025-10-10 |
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Charles Ludlam FDA-2024-P-1223 · 5 docket documents Charles Ludlam filed this citizen petition requesting that the FDA require additional clinical trials and modify product labels for tirzepatide (Mounjaro/Zepbound) and semaglutide (Ozempic/Wegovy) to address lean muscle mass loss, ideal goal weight setting, and weight loss maintenance strategies, ci | Other | 2024-03-13 | Open | Charles Ludlam |
Source: Regulations.gov. FDA citizen petitions matched by application number.
Highest NADAC/Unit
$538.67
per ml
Lowest NADAC/Unit
$538.48
per ml
Brand NDCs
6
Generic NDCs
0
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 00002150680MOUNJARO 2.5 MG/0.5 ML PEN | $538.67 | ML | Brand | — | 2026-06-17 |
| 00002149580MOUNJARO 5 MG/0.5 ML PEN | $538.63 | ML | Brand | — | 2026-06-17 |
| 00002148480MOUNJARO 7.5 MG/0.5 ML PEN | $538.63 | ML | Brand | — | 2026-06-17 |
| 00002147180MOUNJARO 10 MG/0.5 ML PEN | $538.62 | ML | Brand | — | 2026-06-17 |
| 00002146080MOUNJARO 12.5 MG/0.5 ML PEN | $538.48 | ML | Brand | — | 2026-06-17 |
| 00002145780MOUNJARO 15 MG/0.5 ML PEN | $538.48 | ML | Brand | — | 2026-06-17 |
Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.
| Code | Date | Status |
|---|---|---|
| NCE | May 13, 2027 | < 1 year |
| NPP | Dec 19, 2028 | Active |