Details for New Drug Application (NDA): 021926

NDA 021926 describes TREXIMET, which is a drug marketed by Currax and is included in one NDA. It is available from two suppliers. There is one patent protecting this drug and one Paragraph IV challenge. Additional details are available on the TREXIMET profile page.

The generic ingredient in TREXIMET is naproxen sodium; sumatriptan succinate. There are forty-two drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the naproxen sodium; sumatriptan succinate profile page.

Summary for 021926

Tradename:	TREXIMET
Applicant:	Currax
Ingredient:	naproxen sodium; sumatriptan succinate
Patents:	1

Pharmacology for NDA: 021926

Mechanism of Action

Cyclooxygenase Inhibitors Serotonin 1b Receptor Agonists Serotonin 1d Receptor Agonists

Suppliers and Packaging for NDA: 021926

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
TREXIMET	naproxen sodium; sumatriptan succinate	TABLET;ORAL	021926	NDA	Currax Pharmaceuticals LLC	42847-850	42847-850-09	9 TABLET, FILM COATED in 1 BOTTLE (42847-850-09)
TREXIMET	naproxen sodium; sumatriptan succinate	TABLET;ORAL	021926	NDA AUTHORIZED GENERIC	Currax Pharmaceuticals LLC dba Cypress, Hawthorn, Macoven	44183-850	44183-850-09	9 TABLET in 1 BOTTLE (44183-850-09)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	500MG;EQ 85MG BASE
Approval Date:	Apr 15, 2008	TE:	AB	RLD:	Yes
Patent:	7,332,183*PED	Patent Expiration:	Apr 2, 2026	Product Flag?		Substance Flag?		Delist Request?	Y

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	60MG;EQ 10MG BASE
Approval Date:	May 14, 2015	TE:		RLD:	Yes
Patent:	7,332,183*PED	Patent Expiration:	Apr 2, 2026	Product Flag?		Substance Flag?		Delist Request?	Y

Expired US Patents for NDA 021926

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Currax	TREXIMET	naproxen sodium; sumatriptan succinate	TABLET;ORAL	021926-001	Apr 15, 2008	6,060,499*PED
Currax	TREXIMET	naproxen sodium; sumatriptan succinate	TABLET;ORAL	021926-002	May 14, 2015	5,872,145*PED
Currax	TREXIMET	naproxen sodium; sumatriptan succinate	TABLET;ORAL	021926-001	Apr 15, 2008	8,022,095*PED
Currax	TREXIMET	naproxen sodium; sumatriptan succinate	TABLET;ORAL	021926-001	Apr 15, 2008	6,586,458*PED
Currax	TREXIMET	naproxen sodium; sumatriptan succinate	TABLET;ORAL	021926-001	Apr 15, 2008	5,037,845
Currax	TREXIMET	naproxen sodium; sumatriptan succinate	TABLET;ORAL	021926-002	May 14, 2015	6,586,458*PED

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