LIRAGLUTIDE | N022341 | NOVO NORDISK INC
| Trial # | Patent | Type | Petitioner | Status | Filed | Decision |
|---|---|---|---|---|---|---|
| IPR2022-00657 | 8114833 | IPR | Fresenius Kabi USA, LLC | Terminated-Settled | 2022-03-03 | 2022-09-08 |
| IPR2020-01252 | 8114833 | IPR | Pfizer Inc. | Terminated-Settled | 2020-07-22 | — |
| IPR2020-00324 | 8114833 | IPR | Pfizer Inc. et al. | Terminated-Settled | 2019-12-19 | — |
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
| D.N.J. | 2024-01-19 | Terminated 2024-07-29 | — | |
Novo Nordisk Inc. et al v. Orbicular Pharmaceutical Technologies Pvt. Ltd. 2 patentsANDA 217590Liraglutide Recombinant Solution Injection | D. Del. | 2023-02-17 | Terminated 2024-04-11 | — |
Novo Nordisk Inc. et al v. Hikma Pharmaceuticals USA Inc. 4 patentsANDA 215503Liraglutide | D. Del. | 2021-12-21 | Terminated 2023-01-17 | — |
| D.N.J. | 2020-06-04 | Terminated 2020-08-04 | — | |
| D. Del. | 2020-06-03 | Terminated 2022-03-23 | — | |
| WVND | 2019-08-22 | Terminated 2019-09-23 | — | |
| D. Del. | 2019-08-20 | Terminated 2021-04-06 | — | |
Novo Nordisk Inc. et al v. Teva Pharmaceuticals USA, Inc. 5 patentsANDA 210084Liraglutide Recombinant Solution Injection | D. Del. | 2017-03-03 | Terminated 2019-03-18 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Novo Nordisk Inc. FDA-2018-P-3401 Novo Nordisk, Inc. filed this citizen petition on September 5, 2018, requesting that the FDA refrain from receiving for review any ANDA or 505(b)(2) NDA referencing its liraglutide products VICTOZA, SAXENDA, or XULTOPHY until FDA publishes final guidance on abbreviated new drug applications for high | 505(q) Stay Request | 2018-09-10 | Denied | Novo Nordisk Inc. |
Citizen Petition from Novo Nordisk Inc FDA-2017-P-6029 Novo Nordisk Inc. filed this citizen petition requesting that the FDA refrain from approving any ANDA for a liraglutide product referencing VICTOZA, SAXENDA, or XULTOPHY without comparative clinical data, and similarly refrain from approving any 505(b)(2) application referencing these drugs unless t | 505(q) | 2017-10-06 | Denied | Novo Nordisk Inc |
Source: Regulations.gov. FDA citizen petitions matched by application number.