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.
Summary for BRILINTA
International Patents: | 147 |
US Patents: | 3 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 2 |
Raw Ingredient (Bulk) Api Vendors: | 93 |
Clinical Trials: | 87 |
Patent Applications: | 1,175 |
Formulation / Manufacturing: | see details |
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 |
University of Florida | Phase 2/Phase 3 |
Medical University of South Carolina | Phase 2/Phase 3 |
Anatomical Therapeutic Chemical (ATC) Classes for BRILINTA
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 |