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Last Updated: December 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-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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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
University of CincinnatiPhase 2/Phase 3
Janssen Scientific Affairs, LLCPhase 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.

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

Market Dynamics and Financial Trajectory for the Drug: BRILINTA

Introduction to BRILINTA

BRILINTA, also known as ticagrelor, is an antiplatelet medication that belongs to a class of drugs designed to prevent platelets from clumping and forming blood clots. It is widely used to reduce the risk of heart attacks and strokes in patients with acute coronary syndrome (ACS) or those undergoing heart surgeries.

Market Size and Growth

The global BRILINTA market was valued at approximately $1,523.09 million in 2021 and is projected to grow at a compound annual growth rate (CAGR) of 9% from 2021 to 2029, reaching nearly $3,034.87 million by 2029[1][4].

Key Drivers of Market Growth

Several factors are driving the growth of the BRILINTA market:

Increasing Prevalence of Cardiovascular Diseases

The rising incidence of heart attacks and strokes is a significant driver. According to the World Health Organization (WHO), approximately 17 million people die each year due to cardiovascular disorders, creating a high demand for preventive measures like BRILINTA[1].

Efficacy and Clinical Recommendations

BRILINTA's high efficacy, particularly the 90 mg dosage, which is recommended by 12 of the world's most important ACS therapy guidelines, contributes to its market growth. It is the initial treatment recommended for ACS and myocardial infarction (MI) for the first year[4].

Demographic Factors

The increasing geriatric population, especially in regions like North America and the Asia-Pacific, is another key factor. Older populations are more susceptible to chronic diseases, leading to higher demand for diagnostic and therapeutic solutions[1][4].

Healthcare Infrastructure and Expenditure

Advancements in healthcare infrastructure and rising healthcare expenditure in developed and developing countries also drive the market. Regions with good healthcare infrastructure, such as North America and Europe, are significant contributors to the market growth[1].

Regional Market Analysis

North America

North America is expected to be the largest market for BRILINTA during the forecast period, driven by sustainable economic growth, an aging population, and advanced healthcare facilities[1][4].

Europe

Europe is the second-largest market, with factors such as increasing GDP per capita, an aging population, and the availability of advanced treatment options contributing to its growth[1].

Asia-Pacific

The Asia-Pacific region is anticipated to be the fastest-growing market due to increasing per capita disposable incomes, government initiatives to improve healthcare quality, and a rising incidence of cardiovascular diseases. Countries like China, India, and Australia have lucrative markets for BRILINTA[1][4].

Middle East & Africa

This region is expected to witness steady growth, although it is hindered by limited access to healthcare facilities[1].

Financial Performance of Key Players

AstraZeneca

AstraZeneca, the manufacturer of BRILINTA, has seen mixed results. In Q4 2022, BRILINTA sales decreased by 1% in actual terms but increased by 4% at constant exchange rates (CER). Despite this, the overall revenue from AstraZeneca's cardiovascular, renal, and metabolism (CVRM) segment, which includes BRILINTA, grew by 12% at CER[2].

Revenue Growth and Projections

AstraZeneca's total revenue, excluding COVID-19 medicines, increased by 8% (17% at CER) in Q4 2022. The company's financial performance is expected to continue growing, with total revenue and core EPS projected to increase by a mid-teens percentage at CER in FY 2024[5].

Challenges and Restraints

Side Effects

Despite its efficacy, BRILINTA is associated with side effects such as bleeding and dyspnea, which can restrict its use and impact market growth[1].

Competition and Market Dynamics

The market is competitive, with several key players including Eli Lilly, Boehringer, Pfizer, and others. The introduction of new pharmaceutical compounds and the increasing awareness of BRILINTA's benefits are expected to drive the market, but competition and potential side effects remain significant challenges[1].

Research and Development

Continuous research and development are crucial for the growth of the BRILINTA market. Studies such as the "Targeting Platelet-Leukocyte Aggregates in Pneumonia with Ticagrelor" have shown promising results, indicating potential new applications for BRILINTA beyond cardiovascular diseases[1].

Market Segmentation

Dosage and Route of Administration

The market is segmented by dosage (90 mg and 60 mg) and route of administration (oral and nasogastric tube). The 90 mg dosage holds the highest market share due to its high efficacy and clinical recommendations[1].

End-User Segmentation

The market is also segmented by end-users, including hospitals & clinics, ambulatory centers, and others. The demand from hospitals and clinics is significant due to the high incidence of cardiovascular procedures[1].

Key Players and Market Share

Key players in the global BRILINTA market include AstraZeneca, Eli Lilly, Boehringer, Pfizer, and others. These companies are involved in various strategies such as collaborations, new product launches, and market expansion to maintain their market share[1].

Conclusion

The BRILINTA market is poised for significant growth driven by increasing cardiovascular diseases, an aging population, and advancements in healthcare infrastructure. Despite challenges such as side effects and competition, the market is expected to expand, particularly in regions like North America, Europe, and the Asia-Pacific.

Key Takeaways

  • The global BRILINTA market is projected to grow at a CAGR of 9% from 2021 to 2029.
  • Increasing prevalence of cardiovascular diseases and an aging population are key drivers.
  • North America and Europe are significant markets, with the Asia-Pacific region expected to be the fastest-growing.
  • Side effects and competition are major restraints.
  • Continuous research and development are essential for market growth.

Frequently Asked Questions (FAQs)

What is BRILINTA used for?

BRILINTA is used to prevent blood clots in patients with acute coronary syndrome (ACS) or those undergoing heart surgeries.

What are the side effects of BRILINTA?

Common side effects include bleeding and dyspnea.

Which region is expected to be the largest market for BRILINTA?

North America is expected to be the largest market for BRILINTA during the forecast period.

What is the projected CAGR for the BRILINTA market from 2021 to 2029?

The projected CAGR is 9%.

Who are the key players in the BRILINTA market?

Key players include AstraZeneca, Eli Lilly, Boehringer, Pfizer, and others.

Cited Sources:

  1. Maximize Market Research: Brilinta Market - Global Industry Analysis and forecast (2022-2029)
  2. AstraZeneca: Full year and Q4 2022 results announcement
  3. AstraZeneca: PAY JUST $5* - brilinta
  4. Straits Research: Ticagrelor Market Size, Share, Analysis and Forecast to 2031
  5. AstraZeneca: H1 and Q2 2024 results announcement

More… ↓

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