TOPIRAMATE | N201635 | SUPERNUS PHARMACEUTICALS INC
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
SUPERNUS PHARMACEUTICALS, INC. v. DR. REDDY'S LABORATORIES, LTD. et al 10 patentsANDA 217231topiramate | D.N.J. | 2022-07-22 | Terminated 2023-06-28 | — |
SUPERNUS PHARMACEUTICALS, INC. v. ZYDUS PHARMACEUTICALS (USA) INC. et al 10 patentsANDA 216167, 207382topiramate | D.N.J. | 2021-09-17 | Terminated 2023-01-06 | — |
Supernus Pharmaceuticals, Inc. v. Lupin Limited et al 10 patentsANDA 215561topiramate extended-release | D. Del. | 2021-09-10 | Terminated 2023-11-13 | — |
SUPERNUS PHARMACEUTICALS, INC. v. AJANTA PHARMA LIMITED et al 10 patentsANDA 215663topiramate | D.N.J. | 2021-03-26 | Terminated 2024-02-22 | — |
SUPERNUS PHARMACEUTICALS, INC. v. PAR PHARMACEUTICAL COMPANIES, INC. et al 4 patentsANDA 205976Topiramate | D.N.J. | 2015-01-16 | Terminated 2015-10-16 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
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 Petition from Hyman Phelps & McNamara, P.C. (Upsher-Smith Laboratorie... FDA-2016-P-4141 · 4 docket documents Hyman, Phelps & McNamara, P.C., on behalf of Upsher-Smith Laboratories, Inc., requested that the FDA assign a therapeutic equivalence evaluation code of BC to Upsher-Smith's QUDEXY XR (topiramate) extended-release capsules in four strengths (25, 50, 100, and 200 mg) approved under NDA 205122 pursuan | Other | 2016-12-01 | Partially Denied | Hyman Phelps & McNamara, P.C. (Upsher-Smith Laboratories, Inc.) |
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
$47.14
per ea
Lowest NADAC/Unit
$13.30
per ea
Brand NDCs
4
Generic NDCs
0
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 17772010430TROKENDI XR 200 MG CAPSULE | $47.14 | EA | Brand | $23.21 | 2026-07-01 |
| 17772010330TROKENDI XR 100 MG CAPSULE | $34.44 | EA | Brand | $10.76 | 2026-07-01 |
| 17772010230TROKENDI XR 50 MG CAPSULE | $17.43 | EA | Brand | $6.27 | 2026-07-01 |
| 17772010130TROKENDI XR 25 MG CAPSULE | $13.30 | EA | Brand | $3.83 | 2026-07-01 |
Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.
| Patent # | Expiration | PED | Drug Substance | Drug Product | Use Code | Delist |
|---|---|---|---|---|---|---|
| 8298576 | Apr 4, 2028 | — | — | Yes | — | |
| 8298580 | Nov 16, 2027 | — | — | Yes | — | |
| 8663683 | Nov 16, 2027 | — | — | Yes | — | |
| 8877248 | Nov 16, 2027 | — | — | Yes | — | |
| 8889191 | Nov 16, 2027 | — | — | — | — | |
| 8992989 | Nov 16, 2027 | — | — | Yes | — | |
| 9549940 | Nov 16, 2027 | — | — | Yes | — | |
| 9555004 | Nov 16, 2027 | — | — | Yes | — | |
| 9622983 | Nov 16, 2027 | — | — | Yes | — | |
| 10314790 | Nov 16, 2027 | — | — | Yes | — |