SEMAGLUTIDE | N218316 | NOVO NORDISK INC
| Trial # | Patent | Type | Petitioner | Status | Filed | Decision |
|---|---|---|---|---|---|---|
| IPR2023-00723 | 8129343 | IPR | Mylan Pharmaceuticals Inc. et al. | Institution Denied | 2023-03-16 | 2023-10-02 |
| IPR2023-00722 | 8536122 | IPR | Mylan Pharmaceuticals Inc. et al. | Institution Denied | 2023-03-16 | 2023-10-02 |
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
| D.N.J. | 2026-06-04 | Terminated 2026-06-12 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Novo Nordisk Inc. FDA-2024-P-5378 · 9 docket documents Novo Nordisk Inc. filed a citizen petition requesting that the FDA add semaglutide products to the demonstrable difficulties for compounding lists under Federal Food, Drug, and Cosmetic Act sections 503A and 503B, citing formulation complexities, delivery mechanism differences, and public health ris | Other | 2024-11-19 | Open | Novo Nordisk Inc. |
Citizen Petition from Covington & Burling LLP on Behalf of Novo Nordisk Inc. FDA-2024-P-4937 · 4 docket documents Covington & Burling LLP, on behalf of Novo Nordisk Inc., filed this citizen petition requesting that the FDA exclude semaglutide from the 503B Bulks List, rescind the 503B Interim Policy in its entirety, and exclude semaglutide from Category 1 of the 503B Interim Policy. The petition argues that sem | Other | 2024-10-23 | Open | Novo Nordisk Inc. |
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
$43.51
per ea
Lowest NADAC/Unit
$43.36
per ea
Brand NDCs
4
Generic NDCs
0
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 00169441531WEGOVY 1.5 MG TABLET | $43.51 | EA | Brand | — | 2026-06-17 |
| 00169440431WEGOVY 4 MG TABLET | $43.49 | EA | Brand | — | 2026-06-17 |
| 00169440931WEGOVY 9 MG TABLET | $43.42 | EA | Brand | — | 2026-06-17 |
| 00169442531WEGOVY 25 MG TABLET | $43.36 | EA | Brand | — | 2026-06-17 |
Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.
| Code | Date | Status |
|---|---|---|
| I-935 | Mar 8, 2027 | < 1 year |
| NP | Dec 22, 2028 | Active |