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Last Updated: July 12, 2020

DrugPatentWatch Database Preview

AXERT Drug Profile


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When do Axert patents expire, and what generic alternatives are available?

Axert is a drug marketed by Janssen Pharms and is included in one NDA.

The generic ingredient in AXERT is almotriptan malate. There are six drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the almotriptan malate profile page.

US ANDA Litigation and Generic Entry Outlook for Axert

A generic version of AXERT was approved as almotriptan malate by TEVA PHARMS USA on July 7th, 2015.

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Paragraph IV (Patent) Challenges for AXERT
Tradename Dosage Ingredient NDA Submissiondate
AXERT TABLET;ORAL almotriptan malate 021001 2005-12-08

US Patents and Regulatory Information for AXERT

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Janssen Pharms AXERT almotriptan malate TABLET;ORAL 021001-001 May 7, 2001 DISCN Yes No   Start Trial   Start Trial   Start Trial
Janssen Pharms AXERT almotriptan malate TABLET;ORAL 021001-002 May 7, 2001 DISCN Yes No   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for AXERT

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0605697 SPC/GB01/008 United Kingdom   Start Trial PRODUCT NAME: 1-(((3-(2-(DIMETHYLAMINO)ETHYL)INDOL-5-YL)METHYL)SULFONYL)PYRROLIDINE GENERIC NAME ALMOTRIPTAN, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, ESPECIALLY AS ALMOTRIPTAN D,L - HYDROGEN MALATE; REGISTERED: ES 62.877 19991223; UK PL 16973/0005 20001026
0605697 9/2001 Austria   Start Trial PRODUCT NAME: ALMOTRIPTAN UND SEINE PHARMAZEUTISCH AKZEPTABLEN SALZE; NAT. REGISTRATION NO/DATE: 1-23957, 1-23958 20010131; FIRST REGISTRATION: ES 62877 19991223
0605697 2001 00005 Denmark   Start Trial DKCTFF CA 2001 00005, 20010226, EXPIRES: 20150329
0605697 C300053 Netherlands   Start Trial PRODUCT NAME: ALMOTRIPTAN DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH GESCHIKT ZOUT, IN HET BIJZONDER HET WATERSTOFMALAAT; REGISTRATION NO/DATE: RVG 25415 - RVG 25416 20010309
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

McKinsey
Dow
Medtronic
Merck
Boehringer Ingelheim
Mallinckrodt

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