METHYLPHENIDATE HYDROCHLORIDE | N021121 | JANSSEN PHARMACEUTICALS INC
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
Alza Corporation et al v. Amneal Pharmaceuticals of New York, LLC et al 2 patentsANDA 207515methylphenidate hydrochloride | D. Del. | 2016-10-07 | Terminated 2017-07-27 | — |
MYLAN PHARMACEUTICALS INC. v. JANSSEN PHARMACEUTICALS, INC. 2 patentsANDA 20-6726methylphenidate hydrochloride extended-release | E.D. Pa. | 2015-05-29 | Terminated 2015-10-16 | — |
| D.N.J. | 2014-06-16 | Terminated 2014-09-30 | — |
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Hydrochloride) Tablets (ANDA 040-306), which is listed as discontinued in the Orange Book, was voluntarily withdrawn for | Other | 2013-07-03 | Granted | — |
Source: Regulations.gov. FDA citizen petitions matched by application number.
Highest NADAC/Unit
$14.18
per ea
Lowest NADAC/Unit
$12.33
per ea
Brand NDCs
4
Generic NDCs
0
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 50458058701CONCERTA ER 54 MG TABLET | $14.18 | EA | Brand | $0.8326 | 2026-06-17 |
| 50458058601CONCERTA ER 36 MG TABLET | $13.05 | EA | Brand | $0.6842 | 2026-06-17 |
| 50458058801CONCERTA ER 27 MG TABLET | $12.65 | EA | Brand | $0.6404 | 2026-06-17 |
| 50458058501CONCERTA ER 18 MG TABLET | $12.33 | EA | Brand | $0.6192 | 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.