SEMAGLUTIDE | N209637 | NOVO NORDISK INC
| Trial # | Patent | Type | Petitioner | Status | Filed | Decision |
|---|---|---|---|---|---|---|
| IPR2022-00657 | 8114833Delisted | IPR | Fresenius Kabi USA, LLC | Terminated-Settled | 2022-03-03 | 2022-09-08 |
| IPR2020-01252 | 8114833Delisted | IPR | Pfizer Inc. | Terminated-Settled | 2020-07-22 | — |
| IPR2020-00324 | 8114833Delisted | IPR | Pfizer Inc. et al. | Terminated-Settled | 2019-12-19 | — |
| 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 |
| IPR2023-00724 | 10335462 | IPR | Mylan Pharmaceuticals Inc. et al. | Terminated-Settled | 2023-03-16 | 2025-01-10 |
| IPR2024-00009 | 10335462 | IPR | DR. REDDY'S LABORATORIES, INC. et al. | Terminated-Settled | 2023-10-20 | 2025-01-10 |
| IPR2024-00107 | 10335462 | IPR | Sun Pharmaceutical Industries Ltd. et al. | Terminated-Settled | 2023-11-02 | 2025-01-10 |
| IPR2024-00631 | 10335462 | IPR | Apotex Inc. et al. | Terminated-Settled | 2024-03-01 | 2025-01-10 |
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
| D. Del. | 2024-07-01 | Terminated 2024-10-02 | — | |
| D. Del. | 2022-08-05 | Terminated 2024-12-13 | — | |
Novo Nordisk A/S et al v. Sun Pharmaceutical Industries Ltd. et al 2 patentsANDA 216478semaglutide | D. Del. | 2022-03-04 | Terminated 2024-10-16 | — |
Novo Nordisk Inc. et al v. Rio Biopharmaceuticals, Inc. et al 5 patentsANDA 216305semaglutide | D. Del. | 2022-03-04 | Terminated 2024-12-13 | — |
| D. Del. | 2022-03-04 | Terminated 2024-01-10 | — | |
Novo Nordisk Inc. et al v. Dr. Reddy's Laboratories Ltd. et al 10 patentsANDA 216417semaglutide | D. Del. | 2022-03-04 | Terminated 2024-10-16 | — |
Novo Nordisk Inc. et al v. Aurobindo Pharma USA, Inc. et al 20 patentsANDA 216954semaglutide | D. Del. | 2022-03-04 | Terminated 2022-03-28 | — |
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 |
Citizen Petition from Foley & Lardner LLP on behalf of Adventapharma DWC-LLC FDA-2025-P-3481 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 r | 505(q) | 2025-09-04 | Denied | Foley & Lardner LLP on behalf of Adventapharma DWC-LLC |
Source: Regulations.gov. FDA citizen petitions matched by application number.
| Patent # | Expiration | PED | Drug Substance | Drug Product | Use Code | Delist |
|---|---|---|---|---|---|---|
| RE46363 | Aug 3, 2026 | — | — | Yes | — | Delisted |
| 8129343 | Dec 5, 2031 | — | Yes | Yes | — | |
| 8536122 | Mar 20, 2026 | — | Yes | Yes | — | |
| 8920383 | Jul 17, 2026 | — | — | Yes | — | Delisted |
| 9108002 | Jan 20, 2026 | — | — | Yes | — | Delisted |
| 9132239 | Feb 1, 2032 | — | — | Yes | — | Delisted |
| 9457154 | Sep 29, 2027 | — | — | Yes | — | Delisted |
| 9616180 | Jan 20, 2026 | — | — | Yes | — | Delisted |
| 9687611 | Feb 27, 2027 | — | — | Yes | — | Delisted |
| 9775953 | Jul 17, 2026 | — | — | Yes | — | Delisted |
| 9861757 | Jan 20, 2026 | — | — | Yes | — | Delisted |
| 10220155 | Jul 17, 2026 | — | — | Yes | — | Delisted |
| 10335462 | Jun 21, 2033 | — | — | — | — | |
| 10357616 | Jan 20, 2026 | — | — | Yes | — | Delisted |
| 10376652 | Jan 20, 2026 | — | — | Yes | — | Delisted |
| 11097063 | Jul 17, 2026 | — | — | Yes | — | Delisted |
| Code | Date | Status |
|---|---|---|
| I-961 | Jan 28, 2028 | Active |
Novo Nordisk added a new product record (NDA 209637, supplement 005) for Ozempic (semaglutide) in Drugs@FDA.
New: New record
Novo Nordisk added semaglutide (Ozempic) as a new product record under NDA 209637, supplement 006.
New: New record
Novo added semaglutide (Ozempic) supplemental application 007 to the FDA database.
New: New record