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Serving hundreds of leading biopharmaceutical companies globally:

Daiichi Sankyo
Healthtrust
Harvard Business School
Fuji
McKinsey
Argus Health
QuintilesIMS
Covington
Baxter

Generated: August 14, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021001

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NDA 021001 describes AXERT, which is a drug marketed by Janssen Pharms and is included in one NDA. It is available from one supplier. Additional details are available on the AXERT profile page.

The generic ingredient in AXERT is almotriptan malate. There are six drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the almotriptan malate profile page.
Summary for 021001
Tradename:AXERT
Applicant:Janssen Pharms
Ingredient:almotriptan malate
Patents:0
Pharmacology for NDA: 021001
Suppliers and Packaging for NDA: 021001
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
AXERT almotriptan malate TABLET;ORAL 021001 NDA Janssen Pharmaceuticals, Inc. 50458-210 N 50458-210-01
AXERT almotriptan malate TABLET;ORAL 021001 NDA Janssen Pharmaceuticals, Inc. 50458-211 N 50458-211-01

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 6.25MG BASE
Approval Date:May 7, 2001TE:ABRLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 12.5MG BASE
Approval Date:May 7, 2001TE:ABRLD:Yes

Expired US Patents for NDA 021001

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Janssen Pharms AXERT almotriptan malate TABLET;ORAL 021001-001 May 7, 2001 ➤ Sign Up ➤ Sign Up
Janssen Pharms AXERT almotriptan malate TABLET;ORAL 021001-002 May 7, 2001 ➤ 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:

Cipla
Cantor Fitzgerald
Moodys
US Department of Justice
Fish and Richardson
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Medtronic

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