GLATIRAMER ACETATE | N020622 | TEVA PHARMACEUTICALS USA
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
| D. Del. | 2017-05-24 | Terminated 2019-03-29 | — | |
Teva Pharmaceuticals USA, Inc. et al v. Mylan Pharmaceuticals Inc. et al 2 patentsglatiramer acetate | D. Del. | 2017-03-10 | Terminated 2017-12-11 | — |
| D.N.J. | 2017-01-13 | Terminated 2017-05-23 | — | |
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 | M.D.N.C. | 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 · 12 docket documents 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 Probiomed S.A. de C.V. Mexico FDA-2014-P-2301 · 4 docket documents Probiomed S.A. de C.V. Mexico filed this citizen petition on December 26, 2014, requesting that the FDA revise defamatory information about PROBIOGLA-r (glatiramer acetate injection) contained in Teva Pharmaceutical Industries Ltd.'s citizen petition filed under Docket No. FDA-2014-P-0933, which sou | 505(q) | 2014-12-29 | Denied | Probiomed S.A. de C.V. Mexico |
Citizen Petition From Teva Neuroscience FDA-2014-P-0933 · 17 docket documents 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 · 7 docket documents 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 |
Teva Pharmaceutical Industries Ltd - Citizen Petition FDA-2013-P-1128 · 3 docket documents Teva Pharmaceutical Industries Ltd. filed this citizen petition pursuant to 21 C.F.R. § 10.30 and 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 referencing Copaxone (glatiramer acetate injec | 505(q) Stay Request | 2013-11-27 | Withdrawn | — |
Teva Pharmaceutical Industries Ltd - Citizen Petition FDA-2012-P-0555 · 3 docket documents Teva Pharmaceutical Industries Ltd. filed this citizen petition on June 4, 2012, pursuant to 21 C.F.R. §10.30 and sections 505(b)(2) 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 | 505(q) | 2012-06-07 | Denied | — |
Teva Pharmaceutical Industries Ltd., Teva Neuroscience, Inc. - Citizen Petition FDA-2010-P-0642 · 6 docket documents Teva Pharmaceutical Industries Ltd. and Teva Neuroscience, Inc. filed this citizen petition under 21 C.F.R. § 10.30 and sections 505(j) and 505(q) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA refuse to approve any ANDA for a generic version of Copaxone (glatiramer acetate inje | 505(q) | 2010-12-17 | Denied | — |
Peptimmune, Inc. - Citizen Petition FDA-2010-P-0531 · 3 docket documents Peptimmune, Inc. filed this citizen petition on October 1, 2010, pursuant to Federal Food, Drug and Cosmetic Act sections 505(b) and 505(i), requesting that the FDA not approve any Abbreviated New Drug Application or 505(b)(2) application for a generic version of Copaxone (glatramer acetate injectio | 505(q) | 2010-10-25 | Denied | — |
Source: Regulations.gov. FDA citizen petitions matched by application number.
Highest NADAC/Unit
$541.07
per ml
Lowest NADAC/Unit
$230.20
per ml
Brand NDCs
2
Generic NDCs
0
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 68546032512COPAXONE 40 MG/ML SYRINGE | $541.07 | ML | Brand | $95.42 | 2026-06-17 |
| 68546031730COPAXONE 20 MG/ML SYRINGE | $230.20 | ML | Brand | $45.73 | 2026-06-17 |
Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.
No patent or exclusivity listings for this strength.