METHYLNALTREXONE BROMIDE | N208271 | SALIX PHARMACEUTICALS INC
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
BAUSCH HEALTH COMPANIES INC. et al v. ACTAVIS LABORATORIES FL, INC. et al 8 patentsANDA 209615methylnaltrexone bromide | D.N.J. | 2019-06-13 | Terminated 2021-03-19 | — |
VALEANT PHARMACEUTICALS INTERNATIONAL, INC. et al v. ACTAVIS LABORATORIES FL, INC. et al 7 patentsANDA 209615methylnaltrexone bromide | D.N.J. | 2017-12-08 | Terminated 2018-04-18 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Petition from Wishmen Lifesciences Private Limited FDA-2025-P-6022 Wishmen Lifesciences Private Limited submitted a suitability petition on November 10, 2025, pursuant to Section 505(j)(2)(C) of the FDC Act and 21 C.F.R. § 314.93, requesting that the FDA declare Methylnaltrexone Bromide Tablets at 450 mg strength suitable for submission as an ANDA, based on the RLD | Suitability | 2025-11-12 | Open | Wishmen Lifesciences Private Limited |
Source: Regulations.gov. FDA citizen petitions matched by application number.