METHYLPHENIDATE | N021514 | NOVEN PHARMACEUTICALS INC
| 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 | — |
Citizen Petition From Noven Pharmaceuticals, Inc. FDA-2013-P-1710 · 4 docket documents Noven Pharmaceuticals, Inc. filed a citizen petition under section 505(q) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA refuse to approve any abbreviated new drug application for a generic version of Daytrana (methylphenidate transdermal system) unless the applicant demonstrate | 505(q) | 2014-01-24 | Denied | Noven Pharmaceuticals, Inc. |
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Hydrochloride) Tablets (ANDA 040-306), which is listed as discontinued in the Orange Book, was voluntarily withdrawn for | Other | 2013-07-03 | Granted | — |
Noven Pharmaceuticals, Inc. - Citizen Petition FDA-2012-P-0932 · 3 docket documents Noven Pharmaceuticals, Inc. filed this citizen petition pursuant to section 505(q) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA refuse to approve any Abbreviated New Drug Application for a generic version of Daytrana (methylphenidate) transdermal system unless applicants demon | 505(q) | 2012-08-29 | Partially Denied | — |
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
$8.76
per ea
Lowest NADAC/Unit
$7.85
per ea
Brand NDCs
0
Generic NDCs
4
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 00574243065METHYLPHENIDATE 30 MG/9 HR PATCH | $8.76 | EA | Generic | — | 2026-06-17 |
| 00574241065METHYLPHENIDATE 10 MG/9 HR PATCH | $8.39 | EA | Generic | — | 2026-06-17 |
| 00574242065METHYLPHENIDATE 20 MG/9 HR PATCH | $8.03 | EA | Generic | — | 2026-06-17 |
| 00574241565METHYLPHENIDATE 15 MG/9 HR PATCH | $7.85 | EA | 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.