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. 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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Questions you can ask:
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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 |
University of Cincinnati | Phase 2/Phase 3 |
Janssen Scientific Affairs, LLC | 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.
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 | ⤷ Subscribe | ⤷ Subscribe | Y | ⤷ Subscribe | |||
Astrazeneca | BRILINTA | ticagrelor | TABLET;ORAL | 022433-002 | Sep 3, 2015 | RX | Yes | No | ⤷ Subscribe | ⤷ Subscribe | ⤷ Subscribe | ||||
Astrazeneca | BRILINTA | ticagrelor | TABLET;ORAL | 022433-002 | Sep 3, 2015 | RX | Yes | No | ⤷ Subscribe | ⤷ Subscribe | ⤷ Subscribe | ||||
>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 | ⤷ Subscribe | ⤷ Subscribe |
Astrazeneca | BRILINTA | ticagrelor | TABLET;ORAL | 022433-002 | Sep 3, 2015 | ⤷ Subscribe | ⤷ Subscribe |
Astrazeneca | BRILINTA | ticagrelor | TABLET;ORAL | 022433-001 | Jul 20, 2011 | ⤷ Subscribe | ⤷ Subscribe |
>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: ⤷ Subscribe
Australia
Patent: 07288541
Patent: Compositions, suitable for oral administration, comprising a triazolo [4, 5-d]pyrimidin derivate
Estimated Expiration: ⤷ Subscribe
Patent: 11205164
Patent: Compositions, suitable for oral administration, comprising a triazolo (4, 5-d) pyrimidin derivate
Estimated Expiration: ⤷ Subscribe
Brazil
Patent: 0715712
Patent: COMPOSIÇÃO FARMACÊUTICA
Estimated Expiration: ⤷ Subscribe
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: ⤷ Subscribe
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: ⤷ Subscribe
China
Patent: 1505754
Patent: Compositions, suitable for oral administration, comprising a triazolo [4, 5-d]pyrimidin derivate
Estimated Expiration: ⤷ Subscribe
Colombia
Patent: 50163
Patent: COMPOSICIONES ADECUADAS PARA ADMINISTRACION ORAL QUE COMPRENDE UN DERIVADO DE TRIAZOLO [4,5-D] PIRIMIDINA
Estimated Expiration: ⤷ Subscribe
Croatia
Patent: 0170694
Estimated Expiration: ⤷ Subscribe
Cyprus
Patent: 19380
Estimated Expiration: ⤷ Subscribe
Denmark
Patent: 56832
Estimated Expiration: ⤷ Subscribe
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: ⤷ Subscribe
Hungary
Patent: 31939
Estimated Expiration: ⤷ Subscribe
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: ⤷ Subscribe
Japan
Patent: 85139
Estimated Expiration: ⤷ Subscribe
Patent: 10501554
Estimated Expiration: ⤷ Subscribe
Patent: 14040448
Patent: COMPOSITION SUITABLE FOR ORAL ADMINISTRATION COMPRISING TRIAZOLO[4,5-D]PYRIMIDINE DERIVATIVE
Estimated Expiration: ⤷ Subscribe
Lithuania
Patent: 56832
Estimated Expiration: ⤷ Subscribe
Malaysia
Patent: 7966
Patent: COMPOSITIONS, SUITABLE FOR ORAL ADMINISTRATION, COMPRISING A TRIAZOLO [4,5-D] PYRIMIDIN DERIVATE
Estimated Expiration: ⤷ Subscribe
Patent: 5009
Patent: COMPOSITIONS, SUITABLE FOR ORAL ADMINISTRATION,COMPRISING A TRIAZOLO [4,5-D] PYRIMIDIN DERIVATIVES
Estimated Expiration: ⤷ Subscribe
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: ⤷ Subscribe
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: ⤷ Subscribe
New Zealand
Patent: 4514
Patent: Compositions, suitable for oral administration, comprising a triazolo [4, 5-d]pyrimidin derivate
Estimated Expiration: ⤷ Subscribe
Patent: 6700
Patent: COMPOSITIONS, SUITABLE FOR ORAL ADMINISTRATION, COMPRISING A TRIAZOLO [4,5-D]PYRIMIDIN DERIVATE
Estimated Expiration: ⤷ Subscribe
Norway
Patent: 1787
Estimated Expiration: ⤷ Subscribe
Patent: 090425
Estimated Expiration: ⤷ Subscribe
Philippines
Patent: 013501627
Patent: COMPOSITIONS, SUITABLE FOR ORAL ADMINISTRATION, COMPRISING A TRIAZOLO [4, 5-D]PYRIMIDIN DERIVATIVE
Estimated Expiration: ⤷ Subscribe
Poland
Patent: 56832
Estimated Expiration: ⤷ Subscribe
Portugal
Patent: 56832
Estimated Expiration: ⤷ Subscribe
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: ⤷ Subscribe
Patent: 09104330
Patent: КОМПОЗИЦИИ, ПРИГОДНЫЕ ДЛЯ ПЕРОРАЛЬНОГО ВВЕДЕНИЯ, СОДЕРЖАЩИЕ ПРОИЗВОДНОЕ ТРИАЗОЛО[4,5-D]ПИРИМИДИНА
Estimated Expiration: ⤷ Subscribe
Patent: 12153069
Patent: КОМПОЗИЦИИ, ПРИГОДНЫЕ ДЛЯ ПЕРОРАЛЬНОГО ВВЕДЕНИЯ, СОДЕРЖАЩИЕ ПРОИЗВОДНОЕ ТРИАЗОЛО[4,5-d]ПИРИМИДИНА
Estimated Expiration: ⤷ Subscribe
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: ⤷ Subscribe
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: ⤷ Subscribe
Singapore
Patent: 7162
Patent: COMPOSITIONS, SUITABLE FOR ORAL ADMINISTRATION, COMPRISING A TRIAZOLO [4, 5-D]PYRIMIDIN DERIVATE
Estimated Expiration: ⤷ Subscribe
Slovenia
Patent: 56832
Estimated Expiration: ⤷ Subscribe
South Africa
Patent: 0900991
Patent: COMPOSITIONS,SUITABLE FOR ORAL ADMINISTRATION,COMPRISING A TRIAZOLO [4,5-D]PYRIMIDIN DERIVATE
Estimated Expiration: ⤷ Subscribe
South Korea
Patent: 1539467
Estimated Expiration: ⤷ Subscribe
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: ⤷ Subscribe
Spain
Patent: 25930
Estimated Expiration: ⤷ Subscribe
Taiwan
Patent: 82772
Estimated Expiration: ⤷ Subscribe
Patent: 0817412
Patent: Pharmaceutical compositions 457
Estimated Expiration: ⤷ Subscribe
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: ⤷ Subscribe
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: ⤷ Subscribe
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 |
---|---|---|---|
Israel | 202582 | CRYSTALLINE AND AMORPHOUS FORMS OF A TRIAZOLO(4,5-D)PYRIMIDINE COMPOUND | ⤷ Subscribe |
Hong Kong | 1026421 | ⤷ Subscribe | |
Spain | 2384708 | ⤷ Subscribe | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for BRILINTA
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1135391 | 122011100004 | Germany | ⤷ Subscribe | PRODUCT NAME: TICAGRELOR ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/10/655/001-006 20101203 |
1135391 | 2011/012 | Ireland | ⤷ Subscribe | PRODUCT NAME: TICAGRELOR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTRATION NO/DATE: EU/1/10/655/001-006 20101203 |
1135391 | 406 | Finland | ⤷ Subscribe | |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
BRILINTA Market Analysis and Financial Projection Experimental
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