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Harvard Business School
Colorcon
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Last Updated: February 25, 2021

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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 four patents protecting this drug and two Paragraph IV challenges.

This drug has two hundred and twenty-two 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. Three suppliers are listed for this compound. Additional details are available on the ticagrelor profile page.

US ANDA Litigation and Generic Entry Outlook for Brilinta

A generic version of BRILINTA was approved as ticagrelor by HISUN PHARM HANGZHOU on January 23rd, 2019.

  Start Trial

Paragraph IV (Patent) Challenges for BRILINTA
Tradename Dosage Ingredient NDA Submissiondate
BRILINTA TABLET;ORAL ticagrelor 022433 2015-09-30
BRILINTA TABLET;ORAL ticagrelor 022433 2015-07-20

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

Expired US Patents for BRILINTA

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Astrazeneca Pharms BRILINTA ticagrelor TABLET;ORAL 022433-002 Sep 3, 2015   Start Trial   Start Trial
Astrazeneca Pharms BRILINTA ticagrelor TABLET;ORAL 022433-001 Jul 20, 2011   Start Trial   Start Trial
Astrazeneca Pharms BRILINTA ticagrelor TABLET;ORAL 022433-002 Sep 3, 2015   Start Trial   Start Trial
Astrazeneca Pharms BRILINTA ticagrelor TABLET;ORAL 022433-001 Jul 20, 2011   Start Trial   Start Trial
Astrazeneca Pharms BRILINTA ticagrelor TABLET;ORAL 022433-001 Jul 20, 2011   Start Trial   Start Trial
Astrazeneca Pharms BRILINTA ticagrelor TABLET;ORAL 022433-002 Sep 3, 2015   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for BRILINTA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1135391 2011/012 Ireland   Start Trial PRODUCT NAME: TICAGRELOR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTRATION NO/DATE: EU/1/10/655/001-006 20101203
1135391 C01135391/01 Switzerland   Start Trial FORMER REPRESENTATIVE: BOHEST AG, CH
1135391 122011100004 Germany   Start Trial PRODUCT NAME: TICAGRELOR ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/10/655/001-006 20101203
1135391 1190009-9 Sweden   Start Trial PRODUCT NAME: TICAGRELOR ELLER ETT FARMACEUTISKT ACCEPTABELT SALT DAERAV; REG. NO/DATE: EU/1/10/655/001-006 20101203
1135391 PA2011004 Lithuania   Start Trial 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
1135391 91819 Luxembourg   Start Trial 91819, EXPIRES: 20241202
1135391 406 Finland   Start Trial
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Dow
Mallinckrodt
Harvard Business School
Medtronic
Moodys
Boehringer Ingelheim

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