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Serving hundreds of leading biopharmaceutical companies globally:

Julphar
Baxter
Chinese Patent Office
Federal Trade Commission
Cipla
Chubb
Express Scripts
Colorcon
Fuji

Generated: June 25, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021926

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NDA 021926 describes TREXIMET, which is a drug marketed by Pernix Ireland Ltd and is included in one NDA. It is available from four suppliers. There are five patents 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:Pernix Ireland Ltd
Ingredient:naproxen sodium; sumatriptan succinate
Patents:5
Formulation / Manufacturing:see details
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 GlaxoSmithKline LLC 0173-0750 N 0173-0750-49
TREXIMET naproxen sodium; sumatriptan succinate TABLET;ORAL 021926 NDA Rebel Distributors Corp 21695-954 E 21695-954-09

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength500MG;EQ 85MG BASE
Approval Date:Apr 15, 2008TE:ABRLD:Yes
Patent:➤ Sign UpPatent Expiration:Feb 14, 2018Product Flag?Substance Flag?Delist Request?
Patent:➤ Sign UpPatent Expiration:Feb 14, 2018Product Flag?Substance Flag?Delist Request?
Patent:➤ Sign UpPatent Expiration:Apr 2, 2026Product Flag?Substance Flag?Delist Request?Y

Expired US Patents for NDA 021926

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Pernix Ireland Ltd TREXIMET naproxen sodium; sumatriptan succinate TABLET;ORAL 021926-001 Apr 15, 2008 ➤ Sign Up ➤ Sign Up
Pernix Ireland Ltd TREXIMET naproxen sodium; sumatriptan succinate TABLET;ORAL 021926-002 May 14, 2015 ➤ Sign Up ➤ Sign Up
Pernix Ireland Ltd TREXIMET naproxen sodium; sumatriptan succinate TABLET;ORAL 021926-002 May 14, 2015 ➤ Sign Up ➤ Sign Up
Pernix Ireland Ltd TREXIMET naproxen sodium; sumatriptan succinate TABLET;ORAL 021926-001 Apr 15, 2008 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

US Army
Accenture
QuintilesIMS
Dow
Julphar
Citi
UBS
Chubb
Harvard Business School

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