BRIVARACETAM | A214501 | ZYDUS PHARMACEUTICALS USA INC
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
UCB, Inc. et al v. Annora Pharma Private Limited et al 3 patentsANDA 214831, 214875, 214848, 214918, 214880, 214922, 214924, 214921, 214501brivaracetam | D. Del. | 2020-07-24 | Terminated 2023-09-12 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
No patent or exclusivity listings for this strength.
Zydus Pharmaceuticals' brivaracetam product (NDA 214501, supplement 005) received an AB therapeutic equivalence rating, indicating bioequivalence to the reference product.
New: AB
Zydus Pharmaceuticals' brivaracetam product (NDA 214501) changed status from discontinued to active prescription drug.
Old: DISCN
New: RX
Zydus Pharmaceuticals reactivated brivaracetam (BRIVARACETAM) from discontinued status to prescription drug status under NDA 214501.
Old: DISCN
New: RX
Zydus Pharmaceuticals' brivaracetam NDA 214501, supplement 002, received a therapeutic equivalence code of AB, indicating it is therapeutically equivalent to the reference product.
New: AB
Zydus Pharmaceuticals' brivaracetam NDA 214501 supplement 004 changed status from discontinued to active prescription drug.
Old: DISCN
New: RX
Zydus Pharmaceuticals' brivaracetam NDA 214501, Supplement 004 received an AB therapeutic equivalence rating.
New: AB
Zydus Pharmaceuticals' brivaracetam product (NDA 214501, supplement 003) status changed from discontinued to active prescription drug.
Old: DISCN
New: RX
Zydus Pharmaceuticals' brivaracetam product received an AB therapeutic equivalence rating, indicating therapeutic equivalence to the reference-listed drug.
New: AB
Zydus Pharmaceuticals' brivaracetam application (NDA 214501) transitioned from discontinued status to an active prescription drug product.
Old: DISCN
New: RX
Zydus Pharma's brivaracetam NDA 214501 abbreviated application 003 received an AB therapeutic equivalence code.
New: AB