SEMAGLUTIDE | N215256 | NOVO NORDISK INC
| Trial # | Patent | Type | Petitioner | Status | Filed | Decision |
|---|---|---|---|---|---|---|
| IPR2023-00722 | 8536122 | IPR | Mylan Pharmaceuticals Inc. et al. | Institution Denied | 2023-03-16 | 2023-10-02 |
| IPR2023-00723 | 8129343 | 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. | 2023-01-27 | Active | — | |
| 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 | Open | The WhiteOak Group |
Source: Regulations.gov. FDA citizen petitions matched by application number.
| Code | Date | Status |
|---|---|---|
| I-935 | Mar 8, 2027 | < 1 year |
| I-973 | Aug 15, 2028 | Active |
Novo Nordisk added semaglutide (Wegovy) NDA 215256 supplement 009 to the FDA products database.
New: New record
Novo Nordisk added semaglutide (WEGOVY) as a new product record (NDA 215256, strength 010) to Drugs@FDA.
New: New record
Orange Book patent listing for Wegovy (semaglutide) injection 2.4 mg, patent 12,569,543, removed from NDA 215256.
Old: Record existed
Novo removed U.S. Patent 12,569,543 from the Orange Book listing for Wegovy (semaglutide) NDA 215256.
Old: Record existed
Novo Nordisk removed U.S. Patent 12,569,543 from the Orange Book for Wegovy (semaglutide).
Old: Record existed
New: New record
Novo Nordisk added a new product record (semaglutide/Wegovy, NDA 215256, supplement 008) to the FDA database.
New: New record
Novo Nordisk added semaglutide (Wegovy) as a new product record (NDA 215256, supplement 011) in FDA regulatory databases.
New: New record
Novo Nordisk added semaglutide (WEGOVY) supplemental application 007 to the products table in Drugs@FDA.
New: New record
Novo Nordisk removed U.S. Patent 12,569,543 from the Orange Book listing for Wegovy (semaglutide) NDA 215256.
Old: Record existed
Orange Book patent 12569543 (covering semaglutide formulation or use) was removed from NDA 215256 for Wegovy (semaglutide).
Old: Record existed
Novo Nordisk removed U.S. Patent 12,569,543 from the Orange Book listing for Wegovy (semaglutide) NDA 215256.
Old: Record existed