LEVOKETOCONAZOLE | N214133 | STRONGBRIDGE DUBLIN LTD
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
XERIS PHARMACEUTICALS, INC. et al v. NOVITIUM PHARMA, LLC et al 4 patentsANDA 221336levoketoconazole | D.N.J. | 2026-06-04 | Active | — |
XERIS PHARMACEUTICALS, INC. et al v. SANDOZ INC. et al 5 patentsANDA 220804, 220935levoketoconazole | D.N.J. | 2026-03-20 | Terminated 2026-06-08 | — |
XERIS PHARMACEUTICALS, INC. et al v. SOMERSET THERAPEUTICS, LLC et al 5 patentsANDA 221137, 220357levoketoconazole | D.N.J. | 2026-02-26 | Active | Julien Xavier Neals |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Petition from Lachman Consultant Services, Inc. FDA-2026-P-8250 Lachman Consultant Services, Inc. filed a citizen petition requesting that the FDA make a determination of suitability regarding an unspecified drug product or formulation, seeking regulatory guidance on the product's eligibility for development or approval through established FDA mechanisms. | Suitability | 2026-07-28 | Open | Lachman Consultant Services, Inc. |
Source: Regulations.gov. FDA citizen petitions matched by application number.
| Code | Date | Status |
|---|---|---|
| NCE* | Dec 30, 2026 | < 1 year |
| ODE-385 | Dec 30, 2028 | Active |