SEMAGLUTIDE | N215256 | 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 |
|---|---|---|---|---|
Novo Nordisk Inc. et al v. Sun Pharmaceutical Industries Ltd. et al 1 patentANDA 217962semaglutide | D. Del. | 2025-06-20 | Active | — |
| D. Del. | 2025-03-10 | Active | — | |
| D. Del. | 2024-09-05 | Active | — | |
Novo Nordisk Inc. et al v. Sun Pharmaceutical Industries Ltd. et al 1 patentANDA 217962semaglutide | D. Del. | 2024-09-05 | Active | — |
| D. Del. | 2024-01-12 | Terminated 2025-03-21 | — | |
Novo Nordisk Inc. et al v. Sun Pharmaceutical Industries Ltd. et al 5 patentsANDA 217962semaglutide | D. Del. | 2023-12-21 | Active | — |
| D. Del. | 2023-01-27 | Terminated 2024-01-16 | — | |
| WVND | 2023-01-27 | Terminated 2023-11-01 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Petition from The WhiteOak Group, LLC (on behalf of Hybio Pharmac... FDA-2025-P-7376 The WhiteOak Group, LLC, on behalf of Hybio Pharmaceutical Co., Ltd., filed this suitability petition under Section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act and 21 CFR 314.93 requesting that FDA declare Semaglutide Injection in five strengths (1 mg/1.5 mL, 2 mg/1.5 mL, 4 mg/3 mL, 6.8 | Suitability | 2025-12-29 | Partially Denied | Hybio Pharmaceutical Co., Ltd. |
Citizen Petition from Foley & Lardner, LLP on behalf of Adventapharma DWC-LLC FDA-2025-P-3368 Foley & Lardner LLP on behalf of Adventapharma DWC-LLC filed this citizen petition under 21 CFR 10.30 requesting that the FDA refrain from approving any ANDA for generic semaglutide injection (Ozempic, NDA N209637) unless the generic product includes a pen injector functionally equivalent to the ref | 505(q) | 2025-08-27 | Withdrawn | Adventapharma DWC-LLC |
Citizen Petition from Wiley Rein LLP FDA-2025-P-3239 Wiley Rein LLP filed this citizen petition on behalf of an unnamed client on August 19, 2025, requesting that the FDA Commissioner take regulatory action to address public health risks associated with large-scale production and distribution of compounded semaglutide preparations. The petitioner requ | Other | 2025-08-20 | Withdrawn | Wiley Rein LLP |
Citizen Petition from Foley & Lardner, LLP FDA-2025-P-3103 Foley & Lardner, LLP filed this citizen petition on behalf of an unnamed client requesting that the FDA refrain from approving Abbreviated New Drug Applications (ANDAs) for generic semaglutide injection referencing the reference listed drug Ozempic (N209637) unless the generic product includes a pen | 505(q) | 2025-08-14 | Withdrawn | Foley & Lardner, LLP |
Citizen Petition from Novo Nordisk Inc. FDA-2024-P-5378 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 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 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 |
Citizen Petition from Physicians Committee for Responsible Medicine FDA-2023-P-2507 The Physicians Committee for Responsible Medicine filed this citizen petition requesting that the Food and Drug Administration Commissioner require manufacturers of glucagon-like peptide-1 receptor agonists, including semaglutide, to include labeling disclosing that low-fat plant-based diets have co | Other | 2023-06-21 | Open | Physicians Committee for Responsible Medicine |
Citizen Petition from Novo Nordisk Inc. FDA-2017-P-6029 Novo Nordisk Inc. filed a citizen petition requesting that FDA establish weight-based dosing guidance for semaglutide and similar GLP-1 receptor agonists to improve pediatric treatment efficacy and safety, along with potential updates to existing NDA labeling to reflect the proposed dosing recommend | Other | 2018-09-06 | Denied | Novo Nordisk Inc. |
Source: Regulations.gov. FDA citizen petitions matched by application number.
Highest NADAC/Unit
$653.33
per ml
Lowest NADAC/Unit
$435.57
per ml
Brand NDCs
5
Generic NDCs
0
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 00169452514WEGOVY 0.25 MG/0.5 ML PEN | $653.33 | ML | Brand | — | 2026-10-21 |
| 00169450514WEGOVY 0.5 MG/0.5 ML PEN | $653.30 | ML | Brand | — | 2026-10-21 |
| 00169450114WEGOVY 1 MG/0.5 ML PEN | $653.07 | ML | Brand | — | 2026-10-21 |
| 00169452414WEGOVY 2.4 MG/0.75 ML PEN | $435.57 | ML | Brand | — | 2026-10-21 |
| 00169451714WEGOVY 1.7 MG/0.75 ML PEN | $435.57 | ML | Brand | — | 2026-10-21 |
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 |
| I-973 | Aug 15, 2028 | Active |