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AXERT Drug Profile

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Axert is a drug marketed by Janssen Pharms and is included in one NDA. It is available from three suppliers. There is one patent protecting this drug and one Paragraph IV challenge.

This drug has forty patent family members in thirty countries.

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

Summary for Tradename: AXERT

Patents:1
Applicants:1
NDAs:1
Suppliers / Packagers: see list3
Drug Prices: :see details
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Janssen Pharms
AXERT
almotriptan malate
TABLET;ORAL021001-001May 7, 2001RXNo5,565,447*PED► subscribe ► subscribe
Janssen Pharms
AXERT
almotriptan malate
TABLET;ORAL021001-002May 7, 2001RXYes5,565,447*PED► subscribe ► subscribe
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Expired Patents for Tradename: AXERT

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Janssen Pharms
AXERT
almotriptan malate
TABLET;ORAL021001-001May 7, 20015,565,447*PED► subscribe
Janssen Pharms
AXERT
almotriptan malate
TABLET;ORAL021001-002May 7, 20015,565,447*PED► subscribe
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Paragraph IV activity for: AXERT

Drugname Dosage Strength RLD Submissiondate
almotriptan malateTablets6.25 mg and 12.5 mgAxert12/8/2005

International Patent Family for Tradename: AXERT

Country Document Number Estimated Expiration
World Intellectual Property Organization (WIPO)9402460► subscribe
Japan2716585► subscribe
Netherlands300053► subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: AXERT

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
00053Netherlands► subscribePRODUCT NAME: ALMOTRIPTAN DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH GESCHIKT ZOUT, IN HET BIJZONDER HET WATERSTOFMALAAT; REGISTRATION NO/DATE: RVG 25415 - RVG 25416 20010309
C/GB01/008United Kingdom► subscribePRODUCT 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
0605697/01Switzerland► subscribeFORMER OWNER: LABORATORIOS ALMIRALL, S.A., ES
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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