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Serving hundreds of leading biopharmaceutical companies globally:

Merck
Medtronic
Covington
UBS
Baxter
Harvard Business School
Healthtrust
Teva
Chinese Patent Office

Generated: July 23, 2018

DrugPatentWatch Database Preview

BRILINTA Drug Profile

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When do Brilinta patents expire, and what generic alternatives 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 fifty patent family members in forty-eight countries.

The generic ingredient in BRILINTA is ticagrelor. There are twenty-one drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the ticagrelor profile page.
Drug patent expirations by year for BRILINTA
Generic Entry Opportunity Date for BRILINTA
Generic Entry Date for BRILINTA*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage::
TABLET;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

US Patents and Regulatory Information for BRILINTA

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Astrazeneca Pharms BRILINTA ticagrelor TABLET;ORAL 022433-001 Jul 20, 2011 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Astrazeneca Pharms BRILINTA ticagrelor TABLET;ORAL 022433-001 Jul 20, 2011 RX Yes Yes ➤ Sign Up ➤ Sign Up Y Y Y ➤ Sign Up
Astrazeneca Pharms BRILINTA ticagrelor TABLET;ORAL 022433-001 Jul 20, 2011 RX Yes Yes ➤ Sign Up ➤ Sign Up Y Y ➤ Sign Up
Astrazeneca Pharms BRILINTA ticagrelor TABLET;ORAL 022433-002 Sep 3, 2015 RX Yes No ➤ Sign Up ➤ Sign Up Y Y ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Paragraph IV (Patent) Challenges for BRILINTA
Drugname Dosage Strength RLD Date
➤ Subscribe Tablets 60 mg ➤ Subscribe ➤ Sign Up
➤ Subscribe Tablets 90 mg ➤ Subscribe ➤ Sign Up

Non-Orange Book US Patents for 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 ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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Supplementary Protection Certificates for BRILINTA

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C0016 France ➤ Sign Up 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
2011004,C1135391 Lithuania ➤ Sign Up PRODUCT 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
819 Luxembourg ➤ Sign Up 91819, EXPIRES: 20241202
2011 00013 Denmark ➤ Sign Up PRODUCT NAME: TICAGRELOR ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

AstraZeneca
Healthtrust
Fish and Richardson
Deloitte
US Army
Teva
Federal Trade Commission
Express Scripts
Daiichi Sankyo

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