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AGGRENOX Drug Profile

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Aggrenox is a drug marketed by Boehringer Ingelheim and is included in one NDA. It is available from four suppliers. There is one patent protecting this drug and one Paragraph IV challenge.

This drug has thirty-two patent family members in twenty-four countries.

The generic ingredient in AGGRENOX is aspirin; dipyridamole. There are twenty-one drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the aspirin; dipyridamole profile page.

Summary for Tradename: AGGRENOX

Patents:1
Applicants:1
NDAs:1
Suppliers / Packagers: see list4
Formulation / Manufacturing:see details

Clinical Trials for: AGGRENOX

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Boehringer Ingelheim
AGGRENOX
aspirin; dipyridamole
CAPSULE, EXTENDED RELEASE;ORAL020884-001Nov 22, 1999RXYes6,015,577<disabled> <disabled>
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Paragraph IV activity for: AGGRENOX

Drugname Dosage Strength RLD Submissiondate
aspirin and dipyridamoleExtended-release Capsules25 mg and 200 mgAggrenox2/1/2007

International Patent Family for Tradename: AGGRENOX

Country Document Number Estimated Expiration
Ireland872152<disabled in preview>
Ireland60862<disabled in preview>
Germany10299015<disabled in preview>
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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: AGGRENOX

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
90001Netherlands<disabled>PRODUCT NAME: DIPYRIDAMOL, DESGEWENST IN DE VORM VAN EEN FYSIOLOGISCH AAN- VAARDBAAR ZOUT, EN ACETYLSALICYLZUUR, DESGEWENST IN DE VORM VAN EEN FYSIOLOGISCH AANVAARDBAAR ZOUT,IN EEN GEWICHTSVERHOUDING TUSSEN DIPYRIDAMOL-BESTANDDEEL EN ACETYLSALICYLZUUR-BESTANDDE; NAT. REGISTRATION NO/DATE: RVG 21171 19980713; FIRST REGISTRATION: FR 343 234.9, 560 483.7 19970709
/1999Austria<disabled>PRODUCT NAME: DIPYRIDAMOL IN KOMBINATION MIT ACETYLSALICYLSAEURE; NAT. REGISTRATION NO/DATE: 1-22779 19981112; FIRST REGISTRATION: FR NL 22160 19970709
C/GB98/043United Kingdom<disabled>PRODUCT NAME: DIPYRIDAMOLE, OPTIONALLY IN THE FORM OF A PHYSIOLOGICALLY ACCEPTABLE SALT, AND O-ACETYLSALICYLIC ACID, OPTIONALLY IN THE FORM OF A PHYSIOLOGICALLY SALT, I.E. ASASANTIN RETARD; REGISTERED: FR NL 22160 19970709; UK 00015/0224 19980512
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