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Last Updated: July 25, 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. Four 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 four FDA Regulatory Exclusivities.

Patents protecting BRILINTA

Method of treating or prevention of atherothrombotic events in patients with history of myocardial infarction
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Pharmaceutical compositions
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Triazolo(4,5-D)pyrimidine compounds
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

FDA Regulatory Exclusivity protecting BRILINTA

REDUCE THE RISK OF STROKE IN PATIENTS WITH ACUTE ISCHEMIC STROKE (NIH STROKE SCALE SCORE
Exclusivity Expiration: ⤷  Sign Up

INFORMATION ADDED TO SECTION 8.4 OF THE LABELING TO INCLUDE THE RESULT OF STUDY HESTIA3
Exclusivity Expiration: ⤷  Sign Up

PEDIATRIC EXCLUSIVITY
Exclusivity Expiration: ⤷  Sign Up

PEDIATRIC EXCLUSIVITY
Exclusivity Expiration: ⤷  Sign Up

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 ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Astrazeneca BRILINTA ticagrelor TABLET;ORAL 022433-002 Sep 3, 2015 RX Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Astrazeneca BRILINTA ticagrelor TABLET;ORAL 022433-002 Sep 3, 2015 RX Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Astrazeneca BRILINTA ticagrelor TABLET;ORAL 022433-001 Jul 20, 2011 AB RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Astrazeneca BRILINTA ticagrelor TABLET;ORAL 022433-001 Jul 20, 2011 AB RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Astrazeneca BRILINTA ticagrelor TABLET;ORAL 022433-001 Jul 20, 2011 AB RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Astrazeneca BRILINTA ticagrelor TABLET;ORAL 022433-002 Sep 3, 2015 RX Yes No ⤷  Sign Up ⤷  Sign Up 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

Expired US Patents for BRILINTA

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Astrazeneca BRILINTA ticagrelor TABLET;ORAL 022433-002 Sep 3, 2015 ⤷  Sign Up ⤷  Sign Up
Astrazeneca BRILINTA ticagrelor TABLET;ORAL 022433-001 Jul 20, 2011 ⤷  Sign Up ⤷  Sign Up
Astrazeneca BRILINTA ticagrelor TABLET;ORAL 022433-001 Jul 20, 2011 ⤷  Sign Up ⤷  Sign Up
Astrazeneca BRILINTA ticagrelor TABLET;ORAL 022433-001 Jul 20, 2011 ⤷  Sign Up ⤷  Sign Up
Astrazeneca BRILINTA ticagrelor TABLET;ORAL 022433-002 Sep 3, 2015 ⤷  Sign Up ⤷  Sign Up
Astrazeneca BRILINTA ticagrelor TABLET;ORAL 022433-002 Sep 3, 2015 ⤷  Sign Up ⤷  Sign Up
Astrazeneca BRILINTA ticagrelor TABLET;ORAL 022433-001 Jul 20, 2011 ⤷  Sign Up ⤷  Sign Up
>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
Patent: COMPOSICIONES FARMACEUTICAS DE {1S-[1ALFA, 2ALFA, 3BETA (1S*, 2R*), 5 BETA] }-3- (7-{[2- (3,4-DIFLUORFENIL)CICLOPROPIL] AMINO}-5- (PROPILTIO)-3 H-1,2,3-TRIAZOLO[4,5-D]PIRIMIDIN-3-IL)-5-(2-HIDROXIETOXI)CICLOPENTANO-1,2 -DIOL
Estimated Expiration: ⤷  Sign Up

Australia

Patent: 07288541
Patent: Compositions, suitable for oral administration, comprising a triazolo [4, 5-d]pyrimidin derivate
Estimated Expiration: ⤷  Sign Up

Patent: 11205164
Patent: Compositions, suitable for oral administration, comprising a triazolo (4, 5-d) pyrimidin derivate
Estimated Expiration: ⤷  Sign Up

Brazil

Patent: 0715712
Patent: COMPOSIÇÃO FARMACÊUTICA
Estimated Expiration: ⤷  Sign Up

Canada

Patent: 59328
Patent: COMPOSITIONS POUR ADMINISTRATION ORALE COMPRENANT UN DERIVE DE TRIAZOLO [4, 5] PYRIMIDINE (COMPOSITIONS, SUITABLE FOR ORAL ADMINISTRATION, COMPRISING ATRIAZOLO [4,5-D]PYRIMIDIN DERIVATE)
Estimated Expiration: ⤷  Sign Up

Chile

Patent: 07002421
Patent: COMPOSICION FARMACEUTICA QUE COMPRENDE {1S-[1ALFA,2ALFA,3BETA (1S*, 2R*),5BETA]}-3-(7-{[2-(3,4-DIFLUOROFENIL)CICLOPROPIL]AMINO}-5-(PROPILTIO)-3H-1,2,3-TRIAZOLO[4,5-D]PIRIMIDIN-3-L)-5-(2-HIDROXIETOXI)CICLOPENTANO-1,2-DIOL, UNA O MAS CARGAS, AGLUTINANT
Estimated Expiration: ⤷  Sign Up

China

Patent: 1505754
Patent: Compositions, suitable for oral administration, comprising a triazolo [4, 5-d]pyrimidin derivate
Estimated Expiration: ⤷  Sign Up

Colombia

Patent: 50163
Patent: COMPOSICIONES ADECUADAS PARA ADMINISTRACION ORAL QUE COMPRENDE UN DERIVADO DE TRIAZOLO [4,5-D] PIRIMIDINA
Estimated Expiration: ⤷  Sign Up

Croatia

Patent: 0170694
Estimated Expiration: ⤷  Sign Up

Cyprus

Patent: 19380
Estimated Expiration: ⤷  Sign Up

Denmark

Patent: 56832
Estimated Expiration: ⤷  Sign Up

European Patent Office

Patent: 56832
Patent: COMPOSITIONS POUR ADMINISTRATION ORALE COMPRENANT UN DÉRIVÉ DE TRIAZOLO [4, 5]PYRIMIDINE (COMPOSITIONS, SUITABLE FOR ORAL ADMINISTRATION, COMPRISING A TRIAZOLO [4, 5-D]PYRIMIDIN DERIVATE)
Estimated Expiration: ⤷  Sign Up

Hungary

Patent: 31939
Estimated Expiration: ⤷  Sign Up

Israel

Patent: 6700
Patent: תכשיר רוקחות המכיל {1s-[1a,2a,3b(1s*,2r*),5b]}-3(7-{[2-(3,4-difluorophenyl)cyclopropyl]amino}-5-(propylthio)-3h-1,2,3-triazolo[4,5-d]pyrimidin-3-yl)-5-(2-hydroxyethoxy)cyclopentane-1,2-diol (Pharmaceutical composition comprising {1s-[1alpha],2[alpha],3[beta](1s*,2r*),5[beta]]}-3-(7-{[2-(3,4-difluorophenyll)cyclopropyl]amino}-5-(propylthio)-3h-1,2,3-triazolo[4,5-d]pyrimidin-3-yl)-5-(2-hydroxyethoxy)cyclopentane-1,2-diol)
Estimated Expiration: ⤷  Sign Up

Japan

Patent: 85139
Estimated Expiration: ⤷  Sign Up

Patent: 10501554
Estimated Expiration: ⤷  Sign Up

Patent: 14040448
Patent: COMPOSITION SUITABLE FOR ORAL ADMINISTRATION COMPRISING TRIAZOLO[4,5-D]PYRIMIDINE DERIVATIVE
Estimated Expiration: ⤷  Sign Up

Lithuania

Patent: 56832
Estimated Expiration: ⤷  Sign Up

Malaysia

Patent: 7966
Patent: COMPOSITIONS, SUITABLE FOR ORAL ADMINISTRATION, COMPRISING A TRIAZOLO [4,5-D] PYRIMIDIN DERIVATE
Estimated Expiration: ⤷  Sign Up

Patent: 5009
Patent: COMPOSITIONS, SUITABLE FOR ORAL ADMINISTRATION,COMPRISING A TRIAZOLO [4,5-D] PYRIMIDIN DERIVATIVES
Estimated Expiration: ⤷  Sign Up

Mexico

Patent: 0403
Patent: COMPOSICIONES APROPIADAS PARA LA ADMINISTRACION ORAL, QUE COMPRENDEN UN DERIVADO DE TRIAZOLO [4,5-D] PIRIMIDINA. (COMPOSITIONS, SUITABLE FOR ORAL ADMINISTRATION, COMPRISING A TRIAZOLO [4, 5-D]PYRIMIDIN DERIVATE.)
Estimated Expiration: ⤷  Sign Up

Patent: 09001853
Patent: COMPOSICIONES APROPIADAS PARA LA ADMINISTRACION ORAL, QUE COMPRENDEN UN DERIVADO DE TRIAZOLO [4,5-D] PIRIMIDINA. (COMPOSITIONS, SUITABLE FOR ORAL ADMINISTRATION, COMPRISING A TRIAZOLO [4, 5-D]PYRIMIDIN DERIVATE.)
Estimated Expiration: ⤷  Sign Up

New Zealand

Patent: 4514
Patent: Compositions, suitable for oral administration, comprising a triazolo [4, 5-d]pyrimidin derivate
Estimated Expiration: ⤷  Sign Up

Patent: 6700
Patent: COMPOSITIONS, SUITABLE FOR ORAL ADMINISTRATION, COMPRISING A TRIAZOLO [4,5-D]PYRIMIDIN DERIVATE
Estimated Expiration: ⤷  Sign Up

Norway

Patent: 1787
Estimated Expiration: ⤷  Sign Up

Patent: 090425
Estimated Expiration: ⤷  Sign Up

Philippines

Patent: 013501627
Patent: COMPOSITIONS, SUITABLE FOR ORAL ADMINISTRATION, COMPRISING A TRIAZOLO [4, 5-D]PYRIMIDIN DERIVATIVE
Estimated Expiration: ⤷  Sign Up

Poland

Patent: 56832
Estimated Expiration: ⤷  Sign Up

Portugal

Patent: 56832
Estimated Expiration: ⤷  Sign Up

Russian Federation

Patent: 76223
Patent: КОМПОЗИЦИИ, ПРИГОДНЫЕ ДЛЯ ПЕРОРАЛЬНОГО ВВЕДЕНИЯ, СОДЕРЖАЩИЕ ПРОИЗВОДНОЕ ТРИАЗОЛО[4,5-d]ПИРИМИДИНА (COMPOSITIONS APPLICABLE FOR ORAL ADMINISTRATION AND CONTAINING TRIAZOLO[4,5-d]PYRIMIDINE DERIVATIVE)
Estimated Expiration: ⤷  Sign Up

Patent: 09104330
Patent: КОМПОЗИЦИИ, ПРИГОДНЫЕ ДЛЯ ПЕРОРАЛЬНОГО ВВЕДЕНИЯ, СОДЕРЖАЩИЕ ПРОИЗВОДНОЕ ТРИАЗОЛО[4,5-D]ПИРИМИДИНА
Estimated Expiration: ⤷  Sign Up

Patent: 12153069
Patent: КОМПОЗИЦИИ, ПРИГОДНЫЕ ДЛЯ ПЕРОРАЛЬНОГО ВВЕДЕНИЯ, СОДЕРЖАЩИЕ ПРОИЗВОДНОЕ ТРИАЗОЛО[4,5-d]ПИРИМИДИНА
Estimated Expiration: ⤷  Sign Up

Saudi Arabia

Patent: 280442
Patent: تركيبات مناسبة للإعطاء بالفم تتضمن مشتق ثلاثي أزولو (4،5-d) بيريميدين (Compositions, Suitable for Oral Administration, Comprising a Triazolo [4, 5-d] Pyrimidin Derivative)
Estimated Expiration: ⤷  Sign Up

Serbia

Patent: 884
Patent: SASTAVI, POGODNI ZA ORALNU PRIMENU KOJI SADRŽE TRIAZOL [4, 5-D]PIRIMIDIN DERIVAT (COMPOSITIONS, SUITABLE FOR ORAL ADMINISTRATION, COMPRISING A TRIAZOLO [4, 5-D]PYRIMIDIN DERIVATE)
Estimated Expiration: ⤷  Sign Up

Singapore

Patent: 7162
Patent: COMPOSITIONS, SUITABLE FOR ORAL ADMINISTRATION, COMPRISING A TRIAZOLO [4, 5-D]PYRIMIDIN DERIVATE
Estimated Expiration: ⤷  Sign Up

Slovenia

Patent: 56832
Estimated Expiration: ⤷  Sign Up

South Africa

Patent: 0900991
Patent: COMPOSITIONS,SUITABLE FOR ORAL ADMINISTRATION,COMPRISING A TRIAZOLO [4,5-D]PYRIMIDIN DERIVATE
Estimated Expiration: ⤷  Sign Up

South Korea

Patent: 1539467
Estimated Expiration: ⤷  Sign Up

Patent: 090055561
Patent: 트리아졸로[4,5-D]피리미딘 유도체를 포함하는 경구 투여용으로 적합한 조성물 (COMPOSITIONS, SUITABLE FOR ORAL ADMINISTRATION, COMPRISING A TRIAZOLO [4,5-D]PYRIMIDIN DERIVATE)
Estimated Expiration: ⤷  Sign Up

Spain

Patent: 25930
Estimated Expiration: ⤷  Sign Up

Taiwan

Patent: 82772
Estimated Expiration: ⤷  Sign Up

Patent: 0817412
Patent: Pharmaceutical compositions 457
Estimated Expiration: ⤷  Sign Up

Ukraine

Patent: 105
Patent: 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)
Estimated Expiration: ⤷  Sign Up

Uruguay

Patent: 551
Patent: COMPOSICIONES FARMACÉUTICAS CONTENIENDO {1S-[1A(ALFA),2 A(ALFA), 3B(BETA)(1S*,2R*),5 B(BETA)]}-3-7-{[2-3,4-DIFLUOROFENIL)CICLOPROPIL]AMINO}-5-(PROPILITIO-3H-1,2,3-TRIAZOLO [4,5-D] PIRIMIDIN-3-Y 1-5-(2-HIDROXIETOXI)CICLOPENTANO-1,2-DIOL
Estimated Expiration: ⤷  Sign Up

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
Australia 6287401 ⤷  Sign Up
Saudi Arabia 1153 مركبات ثلاثي 3.2.1- ازولو ]4،5- D [ بيريميدين1,2,3-triazolo[4,5-D] pyrimidines حديثه واستخداماتها كعقاقير وطرق لتحضيرها ⤷  Sign Up
Iceland 3019 ⤷  Sign Up
Israel 202582 CRYSTALLINE AND AMORPHOUS FORMS OF A TRIAZOLO(4,5-D)PYRIMIDINE COMPOUND ⤷  Sign Up
Uruguay 30551 COMPOSICIONES FARMACÉUTICAS CONTENIENDO {1S-[1A(ALFA),2 A(ALFA), 3B(BETA)(1S*,2R*),5 B(BETA)]}-3-7-{[2-3,4-DIFLUOROFENIL)CICLOPROPIL]AMINO}-5-(PROPILITIO-3H-1,2,3-TRIAZOLO [4,5-D] PIRIMIDIN-3-Y 1-5-(2-HIDROXIETOXI)CICLOPENTANO-1,2-DIOL ⤷  Sign Up
World Intellectual Property Organization (WIPO) 2008024045 ⤷  Sign Up
Hong Kong 1061684 ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for BRILINTA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1135391 11C0016 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
1135391 PA2011004,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
1135391 CA 2011 00013 Denmark ⤷  Sign Up PRODUCT NAME: TICAGRELOR ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF
1135391 PA2011004 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
1135391 122011100004 Germany ⤷  Sign Up PRODUCT NAME: TICAGRELOR ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/10/655/001-006 20101203
1135391 C01135391/01 Switzerland ⤷  Sign Up FORMER REPRESENTATIVE: BOHEST AG, CH
1135391 SPC/GB11/016 United Kingdom ⤷  Sign Up 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
>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.