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BRILINTA Drug Profile

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Brilinta is a drug marketed by Astrazeneca Lp and is included in one NDA. It is available from three suppliers. There are five patents protecting this drug and two Paragraph IV challenges.

This drug has two hundred and fifteen patent family members in forty-four countries.

The generic ingredient in BRILINTA is ticagrelor. There are eighteen drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the ticagrelor profile page.

Summary for Tradename: BRILINTA

Patents:5
Applicants:1
NDAs:1
Suppliers / Packagers: see list3

Clinical Trials for: BRILINTA

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Astrazeneca Lp
BRILINTA
ticagrelor
TABLET;ORAL022433-001Jul 20, 2011RXYes6,251,910<disabled>Y <disabled>
Astrazeneca Lp
BRILINTA
ticagrelor
TABLET;ORAL022433-001Jul 20, 2011RXYes7,265,124<disabled>YY <disabled>
Astrazeneca Lp
BRILINTA
ticagrelor
TABLET;ORAL022433-002Sep 3, 2015RXNo7,265,124<disabled>YY <disabled>
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Paragraph IV activity for: BRILINTA

Drugname Dosage Strength RLD Submissiondate
ticagrelorTablets60 mgBrilinta9/30/2015
ticagrelorTablets90 mgBrilinta7/20/2015

Non-Orange Book Patents for Tradename: BRILINTA

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
6,974,868 Compounds<disabled in preview>
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Tradename: BRILINTA

Country Document Number Estimated Expiration
Argentina068086<disabled in preview>
Slovakia284199<disabled in preview>
Germany69915675<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: BRILINTA

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2011 00013Denmark<disabled>
C0016France<disabled>PRODUCT NAME: TICAGRELOR OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; REGISTRATION NO/DATE IN FRANCE: EU/1/10/655/001 DU 20101203; REGISTRATION NO/DATE AT EEC: EU/1/10/655/001-006 DU 20101203
11/012Ireland<disabled>PRODUCT NAME: TICAGRELOR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTRATION NO/DATE: EU/1/10/655/001-006 20101203
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