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 |
|---|---|---|---|---|
NOVO NORDISK INC. et al v. RIO BIOPHARMACEUTICALS, INC. 17 patentsANDA 218240, 218241liraglutide | D.N.J. | 2024-02-05 | Terminated 2024-09-17 | — |
| D.N.J. | 2024-01-19 | Terminated 2024-07-29 | — | |
| D. Del. | 2023-10-20 | Terminated 2023-12-21 | — | |
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 | — | |
| N.D. W. Va. | 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 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. |
Citizen Petition from Novo Nordisk Inc. FDA-2018-P-3401 · 10 docket documents 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 · 30 docket documents 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 |
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
$87.84
per ml
Lowest NADAC/Unit
$33.42
per ml
Brand NDCs
2
Generic NDCs
2
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 00169406013VICTOZA 3-PAK 18 MG/3 ML PEN | $87.84 | ML | Brand | $33.42 | 2026-06-17 |
| 00169406012VICTOZA 2-PAK 18 MG/3 ML PEN | $87.73 | ML | Brand | $37.92 | 2026-06-17 |
| 00480366720LIRAGLUTIDE 2-PAK 18 MG/3 ML | $37.92 | ML | Generic | — | 2026-06-17 |
| 00480366722LIRAGLUTIDE 3-PAK 18 MG/3 ML | $33.42 | ML | Generic | — | 2026-06-17 |
Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.