MESALAMINE | N022301 | SALIX PHARMACEUTICALS INC
| Trial # | Patent | Type | Petitioner | Status | Filed | Decision |
|---|---|---|---|---|---|---|
| IPR2016-01409 | 8865688 | IPR | MycoNovo, Inc. et al. | Terminated | 2016-07-11 | — |
| IPR2016-01386 | 8865688 | IPR | Mylan Pharmaceuticals Inc. et al. | Terminated | 2016-07-08 | — |
| IPR2016-00297 | 8865688 | IPR | GeneriCo, LLC et al. | Final Written Decision | 2015-12-08 | — |
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
Salix Pharmaceuticals Inc. et al v. Novel Laboratories Inc. 4 patentsANDA 205841mesalamine | D. Del. | 2015-01-08 | Terminated 2017-07-31 | — |
| D. Del. | 2012-09-07 | Terminated 2014-09-16 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from US WorldMeds, LLC FDA-2019-P-3192 · 56 docket documents US WorldMeds, LLC filed this citizen petition requesting that the FDA revoke or restrict the marketing authorizations for certain mesalamine products, including brands such as Asacol HD, Apriso, Pentasa, and Lialda, due to alleged impurity concerns and manufacturing issues, and to require additional | Other | 2019-12-27 | Open | US WorldMeds, LLC |
Source: Regulations.gov. FDA citizen petitions matched by application number.
Highest NADAC/Unit
$0.4979
per ea
Lowest NADAC/Unit
$0.4979
per ea
Brand NDCs
0
Generic NDCs
1
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 00093922489MESALAMINE ER 0.375 GRAM CAP | $0.4979 | EA | Generic | — | 2026-06-17 |
Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.
| Patent # | Expiration | PED | Drug Substance | Drug Product | Use Code | Delist |
|---|---|---|---|---|---|---|
| 8865688 | May 1, 2030 | — | — | — | — |