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 · 3 docket documents 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FDA formally determine that Namenda (memantine hydrochloride) tablets in 5 mg and 10 mg streng | 505(q) | 2014-10-01 | Withdrawn | Sean Mahoney Upsher-Smith Laboratories Inc |
Citizen Petition From Apotex Corp. FDA-2014-P-0099 · 3 docket documents Apotex Corp. filed a citizen petition under Section 505 of the Federal Food, Drug, and Cosmetic Act requesting that the FDA refuse to receive any abbreviated new drug applications for memantine hydrochloride extended release capsules unless the bioequivalence studies are conducted using a crossover | 505(q) | 2014-01-31 | Denied | Apotex Corp. |
Lachman Consultant Services, Inc. - Citizen Petition FDA-2007-P-0191 · 3 docket documents Lachman Consultant Services, Inc. filed this citizen petition on behalf of a client requesting that the FDA Commissioner determine whether Namenda (memantine hydrochloride) Tablets in 15 mg and 20 mg strengths, approved under NDA 21-487 by Forest Laboratories, were voluntarily withdrawn from sale fo | 505(q) | 2008-06-26 | Denied | — |
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 | — | — | — |