TOPIRAMATE | N020505 | JANSSEN PHARMACEUTICALS INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Petition from Newcastle Bioscience LLC FDA-2024-P-4775 · 11 docket documents Newcastle Bioscience LLC filed this petition pursuant to Section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA declare Topiramate Orally Disintegrating Tablets in strengths of 12.5 mg, 37.5 mg, 75 mg, and 150 mg suitable for submission as an ANDA, with the referenc | Suitability | 2024-10-11 | Granted | Newcastle Bioscience LLC |
Suitability Petition from Newcastle Bioscience, LLC FDA-2023-P-4295 · 7 docket documents Newcastle Bioscience LLC filed this petition under Section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA declare Topiramate Orally Disintegrating Tablets in strengths of 25 mg, 50 mg, 100 mg, and 200 mg suitable for submission as an ANDA, with the reference-listed | Suitability | 2023-10-02 | Granted | Newcastle Bioscience, LLC |
Citizen Petiton from Lachman Consultant Services, Inc FDA-2017-P-6248 · 7 docket documents Lachman Consultant Services, Inc. filed this petition on behalf of a client requesting that the FDA declare Topiramate Orally Disintegrating Tablets in strengths of 25 mg, 50 mg, 100 mg, and 200 mg suitable for submission as an ANDA, with the reference-listed drug being Topamax Tablets approved unde | Other | 2017-10-24 | Granted | — |
The Joseph Dedvukaj Firm, P.C. - Citizen Petition FDA-2012-P-0764 · 3 docket documents The Joseph Dedvukaj Firm, P.C., a consumer advocacy law firm, filed this citizen petition on July 12, 2012, requesting that the FDA reject or issue a Complete Response Letter to Vivus' New Drug Application for Qnexa (phentermine and topiramate combination) for obesity, citing insufficient safety dat | Other | 2012-07-17 | Denied | — |
The Joseph Dedvukaj Firm, P.C. - Citizen Petition FDA-2012-P-0738 · 3 docket documents The Joseph Dedvukaj Firm, P.C., a consumer advocacy law firm, filed this citizen petition under 21 C.F.R. § 10.30 requesting that the FDA reject or issue a Complete Response Letter for Vivus' New Drug Application for Qnexa, an obesity drug candidate containing phentermine and topiramate, due to seri | 505(q) | 2012-07-12 | Withdrawn | — |
Upsher-Smith Laboratories, Inc (Zuckerman Spaeder LLP) - Citizen Petition FDA-2011-P-0931 · 6 docket documents Upsher-Smith Laboratories, Inc., filed this petition under section 505 of the Food, Drug, and Cosmetic Act requesting that FDA refrain from approving any new drug application for extended-release topiramate that does not include adequate and well-controlled safety and efficacy studies on the applica | 505(q) | 2012-01-25 | Denied | — |
Source: Regulations.gov. FDA citizen petitions matched by application number.
Highest NADAC/Unit
$21.08
per ea
Lowest NADAC/Unit
$6.56
per ea
Brand NDCs
4
Generic NDCs
0
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 50458064265TOPAMAX 200 MG TABLET | $21.08 | EA | Brand | $0.1069 | 2026-06-17 |
| 50458064165TOPAMAX 100 MG TABLET | $17.93 | EA | Brand | $0.0580 | 2026-06-17 |
| 50458064065TOPAMAX 50 MG TABLET | $13.16 | EA | Brand | $0.0345 | 2026-06-17 |
| 50458063965TOPAMAX 25 MG TABLET | $6.56 | EA | Brand | $0.0254 | 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.