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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
Drug Prices: :see details
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► subscribeY ► subscribe
Astrazeneca Lp
BRILINTA
ticagrelor
TABLET;ORAL022433-001Jul 20, 2011RXYes7,265,124► subscribeYY ► subscribe
Astrazeneca Lp
BRILINTA
ticagrelor
TABLET;ORAL022433-002Sep 3, 2015RXNo7,265,124► subscribeYY ► subscribe
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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► subscribe
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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
Israel198040► subscribe
Israel187482► subscribe
Argentina023920► 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: BRILINTA

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
11/012Ireland► subscribePRODUCT NAME: TICAGRELOR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTRATION NO/DATE: EU/1/10/655/001-006 20101203
1135391/01Switzerland► subscribeFORMER REPRESENTATIVE: BOHEST AG, CH
90009-9Sweden► subscribePRODUCT NAME: TICAGRELOR ELLER ETT FARMACEUTISKT ACCEPTABELT SALT DAERAV; REG. NO/DATE: EU/1/10/655/001-006 20101203
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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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