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Last Updated: May 26, 2022

BRILINTA Drug Patent Profile


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

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

This drug has one hundred and forty-seven patent family members in forty-four 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.

DrugPatentWatch® Litigation and Generic Entry Outlook for Brilinta

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

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Drug patent expirations by year for BRILINTA
Drug Prices for BRILINTA

See drug prices for BRILINTA

Recent Clinical Trials for BRILINTA

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Yonsei UniversityPhase 4
University of FloridaPhase 2/Phase 3
Medical University of South CarolinaPhase 2/Phase 3

See all BRILINTA clinical trials

Paragraph IV (Patent) Challenges for BRILINTA
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
BRILINTA Tablets ticagrelor 60 mg 022433 3 2015-09-30
BRILINTA Tablets ticagrelor 90 mg 022433 16 2015-07-20

US Patents and Regulatory Information for BRILINTA

BRILINTA is protected by ten US patents and two FDA Regulatory Exclusivities.

Patents protecting BRILINTA

Method of treating or prevention of atherothrombotic events in patients with history of myocardial infarction
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: REDUCING THE RATE OF CARDIOVASCULAR DEATH, MYOCARDIAL INFARCTION (MI), AND STROKE IN A PATIENT RECEIVING 75-100 MG ASPIRIN DAILY WITH A HISTORY OF MI BY ADMINISTERING 60 MG TICAGRELOR TWICE DAILY

Method of treating or prevention of atherothrombotic events in patients with history of myocardial infarction
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: REDUCING THE RATE OF CARDIOVASCULAR DEATH, MYOCARDIAL INFARCTION, AND STROKE IN A PATIENT RECEIVING 75-100 MG ASPIRIN DAILY AND HAVING OR WHO HAD ACUTE CORONARY SYNDROME BY ADMINISTERING 60 MG TICAGRELOR TWICE DAILY

Pharmaceutical compositions
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Triazolo(4,5-D)pyrimidine compounds
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: REDUCTION OF THE RATE OF CARDIOVASCULAR DEATH, MYOCARDIAL INFARCTION, AND STROKE IN PATIENTS WITH A HISTORY OF MYOCARDIAL INFARCTION

Triazolo(4,5-D)pyrimidine compounds
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF STROKE IN PATIENTS WITH ACUTE CORONARY SYNDROME OR A HISTORY OF MYOCARDIAL INFARCTION

Triazolo(4,5-D)pyrimidine compounds
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF MYOCARDIAL INFARCTION AND STROKE IN PATIENTS WITH ACUTE CORONARY SYNDROME OR A HISTORY OF MYOCARDIAL INFARCTION

Triazolo(4,5-D)pyrimidine compounds
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF MYOCARDIAL INFARCTION IN PATIENTS WITH ACUTE CORONARY SYNDROME OR A HISTORY OF MYOCARDIAL INFARCTION

Triazolo(4,5-D)pyrimidine compounds
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: REDUCTION OF THE RISK OF STROKE IN PATIENTS WITH ACUTE ISCHEMIC STROKE OR HIGH-RISK TRANSIENT ISCHEMIC ATTACK

Triazolo(4,5-D)pyrimidine compounds
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF MYOCARDIAL INFARCTION OR STROKE IN PATIENTS WITH CORONARY ARTERY DISEASE AT HIGH RISK FOR SUCH EVENTS

Triazolo(4,5-D)pyrimidine compounds
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: REDUCTION OF THE RATE OF A FIRST MYOCARDIAL INFARCTION OR STROKE IN PATIENTS WITH CORONARY ARTERY DISEASE AT HIGH RISK FOR SUCH EVENTS

FDA Regulatory Exclusivity protecting BRILINTA

TO REDUCE THE RISK OF A FIRST MYOCARDIAL INFARCTION (MI) OR STROKE IN PATIENTS WITH CORONARY ARTERY DISEASE (CAD) AT HIGH RISK FOR SUCH EVENTS
Exclusivity Expiration: See Plans and Pricing

REDUCE THE RISK OF STROKE IN PATIENTS WITH ACUTE ISCHEMIC STROKE (NIH STROKE SCALE SCORE
Exclusivity Expiration: See Plans and Pricing

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

International Patents for BRILINTA

When does loss-of-exclusivity occur for BRILINTA?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Patent: 2451
Estimated Expiration: See Plans and Pricing

Australia

Patent: 07288541
Estimated Expiration: See Plans and Pricing

Patent: 11205164
Estimated Expiration: See Plans and Pricing

Brazil

Patent: 0715712
Estimated Expiration: See Plans and Pricing

Canada

Patent: 59328
Estimated Expiration: See Plans and Pricing

Chile

Patent: 07002421
Estimated Expiration: See Plans and Pricing

China

Patent: 1505754
Estimated Expiration: See Plans and Pricing

Colombia

Patent: 50163
Estimated Expiration: See Plans and Pricing

Croatia

Patent: 0170694
Estimated Expiration: See Plans and Pricing

Cyprus

Patent: 19380
Estimated Expiration: See Plans and Pricing

Denmark

Patent: 56832
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 56832
Estimated Expiration: See Plans and Pricing

Hungary

Patent: 31939
Estimated Expiration: See Plans and Pricing

Israel

Patent: 6700
Estimated Expiration: See Plans and Pricing

Patent: 9130
Estimated Expiration: See Plans and Pricing

Japan

Patent: 85139
Estimated Expiration: See Plans and Pricing

Patent: 10501554
Estimated Expiration: See Plans and Pricing

Patent: 14040448
Estimated Expiration: See Plans and Pricing

Lithuania

Patent: 56832
Estimated Expiration: See Plans and Pricing

Malaysia

Patent: 7966
Estimated Expiration: See Plans and Pricing

Patent: 5009
Estimated Expiration: See Plans and Pricing

Mexico

Patent: 0403
Estimated Expiration: See Plans and Pricing

Patent: 09001853
Estimated Expiration: See Plans and Pricing

New Zealand

Patent: 4514
Estimated Expiration: See Plans and Pricing

Patent: 6700
Estimated Expiration: See Plans and Pricing

Norway

Patent: 1787
Estimated Expiration: See Plans and Pricing

Patent: 090425
Estimated Expiration: See Plans and Pricing

Philippines

Patent: 013501627
Estimated Expiration: See Plans and Pricing

Poland

Patent: 56832
Estimated Expiration: See Plans and Pricing

Portugal

Patent: 56832
Estimated Expiration: See Plans and Pricing

Russian Federation

Patent: 76223
Estimated Expiration: See Plans and Pricing

Patent: 09104330
Estimated Expiration: See Plans and Pricing

Patent: 12153069
Estimated Expiration: See Plans and Pricing

Saudi Arabia

Patent: 99
Estimated Expiration: See Plans and Pricing

Serbia

Patent: 884
Estimated Expiration: See Plans and Pricing

Singapore

Patent: 7162
Estimated Expiration: See Plans and Pricing

Slovenia

Patent: 56832
Estimated Expiration: See Plans and Pricing

South Africa

Patent: 0900991
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 1539467
Estimated Expiration: See Plans and Pricing

Patent: 090055561
Estimated Expiration: See Plans and Pricing

Spain

Patent: 25930
Estimated Expiration: See Plans and Pricing

Taiwan

Patent: 82772
Estimated Expiration: See Plans and Pricing

Patent: 0817412
Estimated Expiration: See Plans and Pricing

Ukraine

Patent: 105
Estimated Expiration: See Plans and Pricing

Uruguay

Patent: 551
Estimated Expiration: See Plans and Pricing

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering BRILINTA around the world.

Country Patent Number Title Estimated Expiration
Argentina 068086 POLIMORFOS DEL COMPUESTO TRIAZOLO (4,5-D) PIRIMIDINA , UNA MEZCLA , PROCESO PARA SU PREPARACION , COMPOSICION FARMACEUTICA Y USO DE ESTOS COMPUESTOS PARA LA FABRICACION DE MEDICAMENTOS See Plans and Pricing
Lithuania 2056832 See Plans and Pricing
Ukraine 99105 ФАРМАЦЕВТИЧЕСКАЯ КОМПОЗИЦИЯ, СОДЕРЖАЩАЯ ПРОИЗВОДНОЕ ТРИАЗОЛО[4,5-d]ПИРИМИДИНА;ФАРМАЦЕВТИЧНА КОМПОЗИЦІЯ, ЩО МІСТИТЬ ПОХІДНЕ ТРИАЗОЛО[4,5-d]ПІРИМІДИНУ (PHARMACEUTICAL COMPOSITION COMPRISING A TRIAZOLO [4, 5-D]PYRIMIDIN DERIVATE) See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for BRILINTA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1135391 91819 Luxembourg See Plans and Pricing 91819, EXPIRES: 20241202
1135391 2011/012 Ireland See Plans and Pricing PRODUCT NAME: TICAGRELOR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTRATION NO/DATE: EU/1/10/655/001-006 20101203
1135391 PA2011004,C1135391 Lithuania See Plans and Pricing 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
>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

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 verification 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.