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Serving leading biopharmaceutical companies globally:

McKinsey
Boehringer Ingelheim
Accenture
Dow
QuintilesIMS
Fuji
Healthtrust
Chinese Patent Office
McKesson
Baxter

Generated: December 10, 2017

DrugPatentWatch Database Preview

BRILINTA Drug Profile

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Which patents cover Brilinta, and when can generic versions of Brilinta launch?

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 fifty patent family members in forty-eight countries and twelve supplementary protection certificates in eleven countries.

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

US Patents and Regulatory Information

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Patent Submitted Product Substance Delist Req. Exclusivity Expiration
Astrazeneca PharmsBRILINTAticagrelorTABLET;ORAL022433-001Jul 20, 2011RXYesYes► Subscribe► Subscribe► SubscribeYY► Subscribe
Astrazeneca PharmsBRILINTAticagrelorTABLET;ORAL022433-001Jul 20, 2011RXYesYes► Subscribe► Subscribe► SubscribeYYY► Subscribe
Astrazeneca PharmsBRILINTAticagrelorTABLET;ORAL022433-002Sep 3, 2015RXYesNo► Subscribe► Subscribe► SubscribeY► Subscribe
Astrazeneca PharmsBRILINTAticagrelorTABLET;ORAL022433-001Jul 20, 2011RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Astrazeneca PharmsBRILINTAticagrelorTABLET;ORAL022433-002Sep 3, 2015RXYesNo► Subscribe► Subscribe► SubscribeYYY► Subscribe
Astrazeneca PharmsBRILINTAticagrelorTABLET;ORAL022433-001Jul 20, 2011RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Astrazeneca PharmsBRILINTAticagrelorTABLET;ORAL022433-002Sep 3, 2015RXYesNo► Subscribe► Subscribe► Subscribe► Subscribe
Astrazeneca PharmsBRILINTAticagrelorTABLET;ORAL022433-002Sep 3, 2015RXYesNo► Subscribe► Subscribe► SubscribeY► Subscribe
Astrazeneca PharmsBRILINTAticagrelorTABLET;ORAL022433-001Jul 20, 2011RXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
Astrazeneca PharmsBRILINTAticagrelorTABLET;ORAL022433-002Sep 3, 2015RXYesNo► Subscribe► Subscribe► SubscribeYY► Subscribe
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Paragraph IV (Patent) Challenges 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
Luxembourg91819► Subscribe
Malaysia140674► Subscribe
China101505754► Subscribe
South Africa9806050► Subscribe
Sweden9901271► Subscribe
South Korea100764417► Subscribe
Israel198040► Subscribe
Canada2296665► Subscribe
Saudi Arabia1153► Subscribe
China1432018► 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
1135391/01Switzerland► SubscribeFORMER REPRESENTATIVE: BOHEST AG, CH
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
819Luxembourg► Subscribe91819, EXPIRES: 20241202
2011004Lithuania► SubscribePRODUCT NAME: TICAGRELORUM; REGISTRATION NO/DATE: EU/1/10/655/001 2010 12 03 EU/1/10/655/002 2010 12 03 EU/1/10/655/003 2010 12 03 EU/1/10/655/004 2010 12 03 EU/1/10/655/005 2010 12 03 EU/1/10/655/00 20101203
2011004,C1135391Lithuania► SubscribePRODUCT NAME: TICAGRELORUM; REGISTRATION NO/DATE: EU/1/10/655/001 2010 12 03 EU/1/10/655/002 2010 12 03 EU/1/10/655/003 2010 12 03 EU/1/10/655/004 2010 12 03 EU/1/10/655/005 2010 12 03 EU/1/10/655/00 20101203
90009-9Sweden► SubscribePRODUCT NAME: TICAGRELOR ELLER ETT FARMACEUTISKT ACCEPTABELT SALT DAERAV; REG. NO/DATE: EU/1/10/655/001-006 20101203
11/012Ireland► SubscribePRODUCT NAME: TICAGRELOR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTRATION NO/DATE: EU/1/10/655/001-006 20101203
2011 00013Denmark► Subscribe
2011100004Germany► SubscribePRODUCT NAME: TICAGRELOR ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/10/655/001-006 20101203
6Finland► Subscribe
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Serving leading biopharmaceutical companies globally:

Teva
US Army
Citi
Chinese Patent Office
Fish and Richardson
McKesson
Queensland Health
Medtronic
Daiichi Sankyo
Accenture

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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