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Last Updated: March 19, 2024

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-six 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

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Recent Clinical Trials for BRILINTA

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

SponsorPhase
Yonsei UniversityPhase 4
National Institute of Neurological Disorders and Stroke (NINDS)Phase 2/Phase 3
University of FloridaPhase 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 three US patents and three FDA Regulatory Exclusivities.

Patents protecting BRILINTA

Method of treating or prevention of atherothrombotic events in patients with history of myocardial infarction
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Pharmaceutical compositions
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Triazolo(4,5-D)pyrimidine compounds
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

FDA Regulatory Exclusivity protecting BRILINTA

INFORMATION ADDED TO SECTION 8.4 OF THE LABELING TO INCLUDE THE RESULT OF STUDY HESTIA3
Exclusivity Expiration: ⤷  Try a Trial

PEDIATRIC EXCLUSIVITY
Exclusivity Expiration: ⤷  Try a Trial

PEDIATRIC EXCLUSIVITY
Exclusivity Expiration: ⤷  Try a Trial

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 ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Astrazeneca BRILINTA ticagrelor TABLET;ORAL 022433-001 Jul 20, 2011 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Astrazeneca BRILINTA ticagrelor TABLET;ORAL 022433-002 Sep 3, 2015 RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Astrazeneca BRILINTA ticagrelor TABLET;ORAL 022433-001 Jul 20, 2011 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Astrazeneca BRILINTA ticagrelor TABLET;ORAL 022433-001 Jul 20, 2011 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Astrazeneca BRILINTA ticagrelor TABLET;ORAL 022433-002 Sep 3, 2015 RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a 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 BRILINTA ticagrelor TABLET;ORAL 022433-001 Jul 20, 2011 ⤷  Try a Trial ⤷  Try a Trial
Astrazeneca BRILINTA ticagrelor TABLET;ORAL 022433-002 Sep 3, 2015 ⤷  Try a Trial ⤷  Try a Trial
Astrazeneca BRILINTA ticagrelor TABLET;ORAL 022433-001 Jul 20, 2011 ⤷  Try a Trial ⤷  Try a Trial
Astrazeneca BRILINTA ticagrelor TABLET;ORAL 022433-002 Sep 3, 2015 ⤷  Try a Trial ⤷  Try a Trial
Astrazeneca BRILINTA ticagrelor TABLET;ORAL 022433-001 Jul 20, 2011 ⤷  Try a Trial ⤷  Try a Trial
Astrazeneca BRILINTA ticagrelor TABLET;ORAL 022433-002 Sep 3, 2015 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

EU/EMA Drug Approvals for BRILINTA

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
AstraZeneca AB Brilique ticagrelor EMEA/H/C/001241
Brilique, co administered with acetylsalicylic acid (ASA), is indicated for the prevention of atherothrombotic events in adult patients withacute coronary syndromes (ACS) ora history of myocardial infarction (MI) and a high risk of developing an atherothrombotic eventBrilique, co-administered with acetyl salicylic acid (ASA), is indicated for the prevention of atherothrombotic events in adult patients with a history of myocardial infarction (MI occurred at least one year ago) and a high risk of developing an atherothrombotic event.
Authorised no no no 2010-12-03
AstraZeneca AB Possia ticagrelor EMEA/H/C/002303
Possia, co-administered with acetylsalicylic acid (ASA), is indicated for the prevention of atherothrombotic events in adult patients with acute coronary syndromes (unstable angina, non-ST-elevation myocardial infarction [NSTEMI] or ST-elevation myocardial infarction [STEMI]); including patients managed medically, and those who are managed with percutaneous coronary intervention (PCI) or coronary artery by-pass grafting (CABG).
Withdrawn no no no 2010-12-03
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

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: ⤷  Try a Trial

Australia

Patent: 07288541
Estimated Expiration: ⤷  Try a Trial

Patent: 11205164
Estimated Expiration: ⤷  Try a Trial

Brazil

Patent: 0715712
Estimated Expiration: ⤷  Try a Trial

Canada

Patent: 59328
Estimated Expiration: ⤷  Try a Trial

Chile

Patent: 07002421
Estimated Expiration: ⤷  Try a Trial

China

Patent: 1505754
Estimated Expiration: ⤷  Try a Trial

Colombia

Patent: 50163
Estimated Expiration: ⤷  Try a Trial

Croatia

Patent: 0170694
Estimated Expiration: ⤷  Try a Trial

Cyprus

Patent: 19380
Estimated Expiration: ⤷  Try a Trial

Denmark

Patent: 56832
Estimated Expiration: ⤷  Try a Trial

European Patent Office

Patent: 56832
Estimated Expiration: ⤷  Try a Trial

Hungary

Patent: 31939
Estimated Expiration: ⤷  Try a Trial

Israel

Patent: 6700
Estimated Expiration: ⤷  Try a Trial

Japan

Patent: 85139
Estimated Expiration: ⤷  Try a Trial

Patent: 10501554
Estimated Expiration: ⤷  Try a Trial

Patent: 14040448
Estimated Expiration: ⤷  Try a Trial

Lithuania

Patent: 56832
Estimated Expiration: ⤷  Try a Trial

Malaysia

Patent: 7966
Estimated Expiration: ⤷  Try a Trial

Patent: 5009
Estimated Expiration: ⤷  Try a Trial

Mexico

Patent: 0403
Estimated Expiration: ⤷  Try a Trial

Patent: 09001853
Estimated Expiration: ⤷  Try a Trial

New Zealand

Patent: 4514
Estimated Expiration: ⤷  Try a Trial

Patent: 6700
Estimated Expiration: ⤷  Try a Trial

Norway

Patent: 1787
Estimated Expiration: ⤷  Try a Trial

Patent: 090425
Estimated Expiration: ⤷  Try a Trial

Philippines

Patent: 013501627
Estimated Expiration: ⤷  Try a Trial

Poland

Patent: 56832
Estimated Expiration: ⤷  Try a Trial

Portugal

Patent: 56832
Estimated Expiration: ⤷  Try a Trial

Russian Federation

Patent: 76223
Estimated Expiration: ⤷  Try a Trial

Patent: 09104330
Estimated Expiration: ⤷  Try a Trial

Patent: 12153069
Estimated Expiration: ⤷  Try a Trial

Saudi Arabia

Patent: 280442
Estimated Expiration: ⤷  Try a Trial

Serbia

Patent: 884
Estimated Expiration: ⤷  Try a Trial

Singapore

Patent: 7162
Estimated Expiration: ⤷  Try a Trial

Slovenia

Patent: 56832
Estimated Expiration: ⤷  Try a Trial

South Africa

Patent: 0900991
Estimated Expiration: ⤷  Try a Trial

South Korea

Patent: 1539467
Estimated Expiration: ⤷  Try a Trial

Patent: 090055561
Estimated Expiration: ⤷  Try a Trial

Spain

Patent: 25930
Estimated Expiration: ⤷  Try a Trial

Taiwan

Patent: 82772
Estimated Expiration: ⤷  Try a Trial

Patent: 0817412
Estimated Expiration: ⤷  Try a Trial

Ukraine

Patent: 105
Estimated Expiration: ⤷  Try a Trial

Uruguay

Patent: 551
Estimated Expiration: ⤷  Try a Trial

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
Sweden 9702773 ⤷  Try a Trial
South Korea 20030007829 ⤷  Try a Trial
Hong Kong 1061246 ⤷  Try a Trial
Denmark 1386917 ⤷  Try a Trial
Norway 20120595 ⤷  Try a Trial
Norway 323780 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for BRILINTA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1135391 SPC/GB11/016 United Kingdom ⤷  Try a Trial PRODUCT 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 406 Finland ⤷  Try a Trial
1135391 C01135391/01 Switzerland ⤷  Try a Trial FORMER REPRESENTATIVE: BOHEST AG, CH
1135391 2011/012 Ireland ⤷  Try a Trial PRODUCT NAME: TICAGRELOR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTRATION NO/DATE: EU/1/10/655/001-006 20101203
1135391 CA 2011 00013 Denmark ⤷  Try a Trial PRODUCT NAME: TICAGRELOR ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF
1135391 122011100004 Germany ⤷  Try a Trial PRODUCT NAME: TICAGRELOR ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/10/655/001-006 20101203
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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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 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.