LIRAGLUTIDE | N206321 | 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 |
|---|---|---|---|---|
Novo Nordisk Inc. et al v. Orbicular Pharmaceutical Technologies Pvt. Ltd., et al., 18 patentsANDA 217234liraglutide recombinant | D. Del. | 2022-06-24 | Terminated 2024-04-11 | — |
Novo Nordisk Inc. et al v. Teva Pharmaceuticals, Inc. et al 17 patentsANDA 214568liraglutide recombinant | D. Del. | 2021-12-21 | Terminated 2023-09-25 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Covington & Burling LLP on behalf of Novo Nordisk Inc. FDA-2024-P-5966 · 4 docket documents Covington & Burling LLP on behalf of Novo Nordisk Inc. filed this citizen petition pursuant to 21 C.F.R. § 10.30 requesting that the FDA publish a notice excluding liraglutide from the 503B Bulks List, rescind the 503B Interim Policy in its entirety, and exclude liraglutide from Category 1 of the 50 | Other | 2025-01-02 | Open | Novo Nordisk Inc. |
Public Citizen Health Research Group - Citizen Petition FDA-2012-P-0404 · 4 docket documents Public Citizen Health Research Group filed this citizen petition in April 2012 pursuant to sections 355(e) of the Federal Food, Drug, and Cosmetic Act and 21 C.F.R. 10.30, requesting that the FDA immediately remove liraglutide (Victoza) from the market because known increased risks of thyroid cancer | Other | 2012-05-02 | Denied | — |
Source: Regulations.gov. FDA citizen petitions matched by application number.
Highest NADAC/Unit
$87.17
per ml
Lowest NADAC/Unit
$87.17
per ml
Brand NDCs
1
Generic NDCs
0
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 00169280015SAXENDA 18 MG/3 ML PEN | $87.17 | ML | Brand | $63.18 | 2026-06-17 |
Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.