Viewing data from:

TREXIMET

NDA

NAPROXEN SODIUM; SUMATRIPTAN SUCCINATE | N021926 | CURRAX PHARMACEUTICALS LLC

2 strengths1 unique patent0 unique exclusivities

Patent Timeline

1 unique patent by expiration date

Expired (1)TodayPED (+6 mo)IPRPTAB Challenge

2026

Today

7332183

Apr. 2, 2026IPR

PTAB Proceedings

1 challenge on OB patents at the Patent Trial and Appeal Board

Trial #	Patent	Type	Petitioner	Status	Filed	Decision
IPR2016-00191	7332183	IPR	Graybar Pharmaceuticals, LLC	Institution Denied	2015-11-12	—

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

Para IV certification filed but no ANDA patent litigation cases (NOS 835) matched from PACER. Litigation may be pending or filed under a different caption.

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part D Spending

CMS annual spending data for Treximet (2023)

Total Spending

$1.2M

Total Claims

556

Beneficiaries

109

Avg Cost/Unit

$143.04

Spending Trend

$1.2M(2020)→$1.8M(2021)→$1.3M(2022)→$1.2M(2023)

YoY Change:+1.2%

5yr CAGR:+4.3%

Source: CMS Medicare Part D Spending by Drug (2023). Shows gross drug cost under Part D.

Approval Letters

11 letters from Drugs@FDA

Date	Submission	Document
Nov 22, 2024	SUPPL -19	View Letter (PDF)
Apr 30, 2021	SUPPL -17	View Letter (PDF)
Apr 30, 2021	SUPPL -18	View Letter (PDF)
Jul 23, 2019	SUPPL -16	View Letter (PDF)
May 11, 2016	SUPPL -13	View Letter (PDF)
May 19, 2015	SUPPL -12	View Letter (PDF)
Mar 5, 2012	SUPPL -5	View Letter (PDF)
Nov 16, 2011	SUPPL -2	View Letter (PDF)
Sep 26, 2011	SUPPL -6	View Letter (PDF)
Oct 23, 2008	SUPPL -1	View Letter (PDF)
Apr 22, 2008	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 500MG;EQ 85MG BASE

RLDAB

1 patent0 exclusivities▴

TABLET;ORAL | Approved: Apr 15, 2008

Patents (1)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
7332183	Oct 2, 2025PED: Apr 2, 2026	PED	—	Yes		—

#002 — 60MG;EQ 10MG BASE

RLD

1 patent0 exclusivities▾

TABLET;ORAL | Approved: May 14, 2015