GLATIRAMER ACETATE | N020622 | TEVA PHARMACEUTICALS USA
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
Teva Pharmaceuticals USA Inc. et al v. Amneal Pharmaceuticals LLC 2 patentsANDA 207553glatiramer acetate | D. Del. | 2015-02-03 | Terminated 2017-01-31 | — |
TEVA PHARMACEUTICALS USA, INC. et al v. DR. REDDYS LABORATORIES, LTD. et al 1 patentglatiramer acetate | D.N.J. | 2015-01-22 | Terminated 2015-06-26 | — |
TEVA PHARMACEUTICALS USA, INC. et al v. SYNTHON PHARMACEUTICALS, INC. et al 2 patentsANDA 206873glatiramer acetate | NCMD | 2014-11-19 | Terminated 2015-02-12 | — |
Teva Pharmaceuticals USA Inc. et al v. Synthon Pharmaceuticals, Inc. et al 2 patentsANDA 206873glatiramer acetate | D. Del. | 2014-11-18 | Terminated 2017-01-31 | — |
Teva Pharmaceuticals USA Inc. et al v. Mylan Pharmaceuticals Inc. et al 2 patentsANDA 206936glatiramer acetate | D. Del. | 2014-10-06 | Terminated 2017-01-31 | — |
TEVA PHARMACEUTICALS USA, INC. et al v. DOCTOR REDDY'S LABORATORIES, LTD. et al 2 patentsANDA 206767, 206921glatiramer acetate | D.N.J. | 2014-09-11 | Terminated 2014-12-03 | — |
Teva Pharmaceuticals USA Inc. et al v. Dr Reddy's Laboratories Ltd et al. 2 patentsANDA 206767glatiramer acetate | D. Del. | 2014-09-10 | Terminated 2017-01-31 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition From Teva Pharmaceuticals FDA-2015-P-1050 Teva Pharmaceuticals filed this citizen petition submitting gene expression studies comparing Copaxone (glatiramer acetate) with Polimunol to support its research on establishing therapeutic equivalence standards for non-biological complex drugs. The petition presents mouse splenocyte and human mono | Other | 2015-04-01 | Denied | Teva Pharmaceuticals |
Citizen Petition From Teva Neuroscience FDA-2014-P-0933 Teva Neuroscience filed this citizen petition under section 505(q) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA establish specific approval requirements for ANDAs for glatiramer acetate generic products and reconsider its position on the adequacy of current bioequivalence stan | 505(q) | 2014-07-03 | Denied | Teva Neuroscience |
Citizen Petition from TEVA Pharmaceuticals FDA-2013-P-1641 Teva Pharmaceuticals filed a citizen petition on December 5, 2013, pursuant to sections 505(j) and 505(q) of the Federal Food, Drug, and Cosmetic Act, requesting that the FDA refrain from approving any abbreviated new drug application (ANDA) referencing Copaxone (glatiramer acetate injection) unless | 505(q) | 2013-12-12 | Denied | TEVA Pharmaceuticals |
Source: Regulations.gov. FDA citizen petitions matched by application number.
No patent or exclusivity listings for this strength.