EPHEDRINE SULFATE | N213407 | NEXUS PHARMACEUTICALS LLC
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
NEXUS PHARMACEUTICALS, LLC v. SABA ILAC SANAYI VE TICARET A.S. 4 patentsANDA 218622ephedrine sulfate | D.N.J. | 2025-08-26 | Active | — |
Nexus Pharmaceuticals, LLC v. Hikma Pharmaceuticals USA Inc. et al 3 patentsANDA 217721ephedrine sulfate | D. Del. | 2025-01-06 | Terminated 2026-01-28 | — |
| D. Del. | 2023-05-19 | Terminated 2024-03-08 | — | |
NEXUS PHARMACEUTICALS, INC. v. SOMERSET PHARMA, LLC 2 patentsANDA 218113ephedrine sulfate | D.N.J. | 2023-03-03 | Terminated 2024-12-24 | — |
| D.N.J. | 2022-09-23 | Terminated 2025-03-18 | — | |
| D. Del. | 2022-09-21 | Active | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Nexus Pharmaceutical Inc. FDA-2022-P-2998 · 6 docket documents Nexus Pharmaceuticals, Inc. submitted a citizen petition on November 23, 2022 under 21 C.F.R. § 10.30 requesting that FDA finalize its September 2019 proposal to exclude ephedrine sulfate from the 503B Bulks List and rescind the 503B Interim Policy, arguing that FDA's own approval of EMERPHED® demon | Other | 2022-11-25 | Partially Denied | Nexus Pharmaceutical Inc. |
Citizen Petition from Nexus Pharmaceuticals Inc. FDA-2021-P-0358 · 4 docket documents Nexus Pharmaceuticals, Inc. filed this citizen petition under 21 C.F.R. § 10.30 requesting that the FDA retain and strengthen its guidance on compounded drugs that are essentially copies of approved drugs under section 503B of the Federal Food, Drug, and Cosmetic Act, specifically requesting that th | Other | 2021-04-08 | Open | Nexus Pharmaceuticals Inc. |
Source: Regulations.gov. FDA citizen petitions matched by application number.