GLATIRAMER ACETATE | A091646 | MYLAN PHARMACEUTICALS INC
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
MOMENTA PHARMACEUTICALS, INC. v. MYLAN PHARMACEUTICALS, INC. et al 2 patentsANDA 090218, 206921, 091646, 206936glatiramer acetate | W.D. Pa. | 2022-05-20 | Active | — |
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., 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 | — |
Source: Regulations.gov. FDA citizen petitions matched by application number.
Highest NADAC/Unit
$45.73
per ml
Lowest NADAC/Unit
$45.73
per ml
Brand NDCs
0
Generic NDCs
1
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 00378696093GLATIRAMER 20 MG/ML SYRINGE | $45.73 | ML | Generic | — | 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.