BRILINTA Drug Patent Profile
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When do Brilinta patents expire, and what generic alternatives are available?
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. 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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Summary for BRILINTA
| International Patents: | 147 |
| US Patents: | 3 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 3 |
| Raw Ingredient (Bulk) Api Vendors: | 101 |
| Clinical Trials: | 89 |
| Patent Applications: | 831 |
| Drug Prices: | Drug price information for BRILINTA |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for BRILINTA |
| What excipients (inactive ingredients) are in BRILINTA? | BRILINTA excipients list |
| DailyMed Link: | BRILINTA at DailyMed |
Recent Clinical Trials for BRILINTA
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Yonsei University | Phase 4 |
| Medical University of South Carolina | Phase 2/Phase 3 |
| University of Cincinnati | Phase 2/Phase 3 |
Pharmacology for BRILINTA
| Drug Class | P2Y12 Platelet Inhibitor |
| Mechanism of Action | Cytochrome P450 3A4 Inhibitors P-Glycoprotein Inhibitors P2Y12 Receptor Antagonists |
| Physiological Effect | Decreased Platelet Aggregation |
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 | |||
| >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 | ⤷ 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 |
| >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 |
|---|---|---|---|
| Denmark | 1386917 | ⤷ Sign Up | |
| Israel | 143232 | 5-[7-(2-PHENYLCYCLOPROPYL)AMINO]-5-(ALKYLTHIO)-3H-1,2,3- TRIAZOLO(4,5-D)PYRIMIDIN-3-YL-CYCLOPENTANE-1,2-DIOLS, THEIR PREPARATION, PHARMACEUTICAL COMPOSITIONS CONTAINING THEM AND SOME NOVEL CHEMICAL INTERMEDIATES THEREFOR | ⤷ Sign Up |
| Russian Federation | 2707959 | СПОСОБ ЛЕЧЕНИЯ ИЛИ ПРОФИЛАКТИКИ АТЕРОТРОМБОТИЧЕСКИХ ЯВЛЕНИЙ У ПАЦИЕНТОВ С ИНФАРКТОМ МИОКАРДА В АНАМНЕЗЕ (METHOD OF TREATING OR PREVENTING ATHEROTHROMBOTIC EVENTS IN PATIENTS WITH MYOCARDIAL INFARCTION IN PAST HISTORY) | ⤷ Sign Up |
| World Intellectual Property Organization (WIPO) | 9905143 | ⤷ 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 | CA 2011 00013 | Denmark | ⤷ Sign Up | PRODUCT NAME: TICAGRELOR ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF |
| 1135391 | 1190009-9 | Sweden | ⤷ Sign Up | PRODUCT NAME: TICAGRELOR ELLER ETT FARMACEUTISKT ACCEPTABELT SALT DAERAV; REG. NO/DATE: EU/1/10/655/001-006 20101203 |
| 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 | 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 |
| >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.
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