MEMANTINE HYDROCHLORIDE | N022525 | ABBVIE INC
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
Allergan Sales LLC et al v. Macleods Pharmaceuticals, Ltd. et al 4 patentsANDA 206310memantine hydrochloride | D. Del. | 2017-06-02 | Terminated 2018-04-05 | — |
Forest Laboratories LLC et al v. Accord Healthcare Inc. et al 7 patentsANDA 207688memantine hydrochloride | D. Del. | 2015-10-09 | Terminated 2016-01-21 | — |
Forest Laboratories, LLC et al v. Lupin Limited et al 7 patentsANDA 206028, 205784, 205783, 205365memantine hydrochloride | D. Del. | 2014-08-15 | Terminated 2018-03-30 | — |
Forest Laboratories Inc. et al v. Apotex Corp. et al 7 patentsANDA 206135, 203293, 205784, 205783, 205813memantine hydrochloride | D. Del. | 2014-02-14 | Terminated 2016-02-16 | — |
Forest Laboratories Inc. et al v. Teva Pharmaceuticals USA Inc. 8 patentsANDA 205808, 205940, 205905memantine hydrochloride | D. Del. | 2014-01-31 | Terminated 2016-07-26 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Sean Mahoney Upsher-Smith Laboratories Inc FDA-2014-P-1483 Upsher-Smith Laboratories, Inc. filed this citizen petition pursuant to sections 505(j) and 505(w) of the Federal Food, Drug, and Cosmetic Act and 21 C.F.R. sections 314.122 and 314.161 requesting that the FDA formally determine that Namenda (memantine hydrochloride) tablets in 5 mg and 10 mg streng | 505(q) | 2014-10-01 | Withdrawn | Sean Mahoney Upsher-Smith Laboratories Inc |
Source: Regulations.gov. FDA citizen petitions matched by application number.
| Patent # | Expiration | PED | Drug Substance | Drug Product | Use Code | Delist |
|---|---|---|---|---|---|---|
| 8039009 | Mar 24, 2029PED: Sep 24, 2029 | PED | — | — | — |