DEXTROMETHORPHAN HYDROBROMIDE; QUINIDINE SULFATE | N021879 | OTSUKA AMERICA PHARMACEUTICAL INC
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
Otsuka America Pharmaceutical, Inc. et al v. Hetero Labs Limited et al 1 patentANDA 218426dextromethorphan hydrobromide and quinidine sulfate | D. Del. | 2025-05-27 | Active | — |
Avanir Pharmaceuticals Inc. et al v. Sandoz Inc. 3 patentsANDA 203538dextromethorphan hydrobromide/quinidine sulfate | D. Del. | 2013-05-30 | Terminated 2013-08-20 | — |
Avanir Pharmaceuticals Inc. v. Impax Laboratories Inc. 1 patentANDA 203061dextromethorphan hydrobromide/quinidine sulfate | D. Del. | 2012-10-08 | Terminated 2015-09-25 | — |
Avanir Pharmaceuticals Inc. et al v. Watson Pharmaceuticals Inc. et al 2 patentsANDA 203538dextromethorphan hydrobromide/quinidine sulfate | D. Del. | 2012-03-02 | Terminated 2015-09-25 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
| Patent # | Expiration | PED | Drug Substance | Drug Product | Use Code | Delist |
|---|---|---|---|---|---|---|
| 7659282 | Aug 13, 2026 | — | — | — | — |
Otsuka America Pharm replaced Avanir Pharms as the listed applicant for Nuedexta (dextromethorphan hydrobromide; quinidine sulfate) NDA 021879.
Old: AVANIR PHARMS
New: OTSUKA AMERICA PHARM
Otsuka America Pharmaceutical Inc. replaced Avanir Pharmaceuticals Inc. as the listed applicant for Nuedexta (dextromethorphan hydrobromide; quinidine sulfate) NDA 021879.
Old: AVANIR PHARMACEUTICALS INC
New: OTSUKA AMERICA PHARMACEUTICAL INC