METHYLPHENIDATE | N205489 | NEOS THERAPEUTICS INC
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
Neos Therapeutics, Inc. et al v. Teva Pharmaceuticals USA, Inc. 3 patentsANDA 210924methylphenidate | D. Del. | 2017-12-13 | Terminated 2019-01-02 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition form MD Pharmaceutical Inc. FDA-1992-P-0169 · 3 docket documents MD Pharmaceutical Inc., a generic drug manufacturer, filed a citizen petition under Section 505(j)(2)(C) of the Federal Food, Drug and Cosmetic Act and 21 CFR 314.93 requesting that the FDA issue a finding that an abbreviated new drug application is suitable for Methylphenidate Hydrochloride Extende | Other | 2017-05-02 | Open | — |
Tedor Pharma Inc. - Citizen Petition FDA-2013-P-0303 · 4 docket documents Tedor Pharma Inc filed this citizen petition on March 6, 2013, pursuant to 21 CFR §314.161, requesting that the FDA determine whether UCB Inc's Metadate ER 10 mg (Methylphenidate Hydrochloride) Tablets (ANDA 040-306), which is listed as discontinued in the Orange Book, was voluntarily withdrawn for | Other | 2013-07-03 | Granted | — |
Exhibit E A Comparison of Once Daily Extended-Release Methylphenidate Formula... FDA-2005-P-0120 · 26 docket documents | Other | 2012-04-12 | Partially Denied | — |
UCB, Inc. - Letter FDA-2004-P-0290 · 7 docket documents UCB, Inc. submitted general correspondence on June 23, 2011 regarding NDA 21-259 for Metadate CD (methylphenidate HCl, USP) extended-release capsules in strengths of 10 mg through 60 mg, providing updated regulatory contact information in response to an FDA request related to a prior citizen petitio | Other | 2011-07-18 | Partially Denied | — |
Source: Regulations.gov. FDA citizen petitions matched by application number.
Highest NADAC/Unit
$18.04
per ea
Lowest NADAC/Unit
$17.95
per ea
Brand NDCs
3
Generic NDCs
0
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 70165020030COTEMPLA XR-ODT 17.3 MG TABLET | $18.04 | EA | Brand | — | 2026-04-01 |
| 70165010030COTEMPLA XR-ODT 8.6 MG TABLET | $17.99 | EA | Brand | — | 2026-04-01 |
| 70165030030COTEMPLA XR-ODT 25.9 MG TABLET | $17.95 | EA | Brand | — | 2026-04-01 |
Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.