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BRILINTA Drug Profile

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Which patents cover Brilinta, and what substitute generic drugs are available?

Brilinta is a drug marketed by Astrazeneca Pharms and is included in one NDA. There are six patents protecting this drug and two Paragraph IV challenges.

This drug has two hundred and nineteen 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:6
Applicants:1
NDAs:1
Suppliers / Packagers: see list3
Bulk Api Vendors: see list46
Clinical Trials: see list59
Patent Applications: see list57
Formulation / Manufacturing:see details
Drug Prices:see details
DailyMed Link:BRILINTA at DailyMed
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Astrazeneca Pharms
BRILINTA
ticagrelor
TABLET;ORAL022433-001Jul 20, 2011RXYesYes6,251,910► SubscribeY ► Subscribe
Astrazeneca Pharms
BRILINTA
ticagrelor
TABLET;ORAL022433-001Jul 20, 2011RXYesYesRE46276► SubscribeYY ► Subscribe
Astrazeneca Pharms
BRILINTA
ticagrelor
TABLET;ORAL022433-002Sep 3, 2015RXYesNo7,265,124► SubscribeYY ► Subscribe
Astrazeneca Pharms
BRILINTA
ticagrelor
TABLET;ORAL022433-002Sep 3, 2015RXYesNo8,425,934► SubscribeY ► Subscribe
Astrazeneca Pharms
BRILINTA
ticagrelor
TABLET;ORAL022433-002Sep 3, 2015RXYesNo6,251,910► SubscribeY ► 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
Norway315854► Subscribe
Bulgaria111017► Subscribe
Hungary0302284► Subscribe
Israel152777► Subscribe
Canada2351709► 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
C0016France► SubscribePRODUCT 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
2011 00013Denmark► Subscribe
C/GB11/016United Kingdom► SubscribePRODUCT NAME: TICAGRELOR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF.; REGISTERED: UK EU/1/10/655/001 20101203; UK EU/1/10/655/002 20101203; UK EU/1/10/655/003 20101203; UK EU/1/10/655/004 20101203; UK EU/1/10/655/005 20101203; UK EU/1/10/655/006 20101203
1135391/01Switzerland► SubscribeFORMER REPRESENTATIVE: BOHEST AG, CH
11/012Ireland► SubscribePRODUCT NAME: TICAGRELOR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTRATION 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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