BRILINTA Drug Patent Profile

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. Twenty 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 WATSON LABS INC on September 4^th, 2018.

Summary for BRILINTA

International Patents:	147
US Patents:	3
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	81
Clinical Trials:	89
Patent Applications:	1,913
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

See drug prices for BRILINTA

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

See all BRILINTA clinical trials

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 two 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	AB	RX	Yes	No	8,425,934*PED				Y
Astrazeneca	BRILINTA	ticagrelor	TABLET;ORAL	022433-001	Jul 20, 2011	AB	RX	Yes	Yes	RE46276*PED
Astrazeneca	BRILINTA	ticagrelor	TABLET;ORAL	022433-002	Sep 3, 2015	AB	RX	Yes	No
Astrazeneca	BRILINTA	ticagrelor	TABLET;ORAL	022433-001	Jul 20, 2011	AB	RX	Yes	Yes	10,300,065*PED				Y
Astrazeneca	BRILINTA	ticagrelor	TABLET;ORAL	022433-002	Sep 3, 2015	AB	RX	Yes	No	RE46276*PED

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	7,265,124
Astrazeneca	BRILINTA	ticagrelor	TABLET;ORAL	022433-002	Sep 3, 2015	6,251,910
Astrazeneca	BRILINTA	ticagrelor	TABLET;ORAL	022433-001	Jul 20, 2011	7,250,419
Astrazeneca	BRILINTA	ticagrelor	TABLET;ORAL	022433-002	Sep 3, 2015	7,265,124
Astrazeneca	BRILINTA	ticagrelor	TABLET;ORAL	022433-001	Jul 20, 2011	6,251,910

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/001241Brilique, 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/002303Possia, 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

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

Australia

Brazil

Canada

Chile

China

Colombia

Croatia

Cyprus

Denmark

European Patent Office

Hungary

Israel

Japan

Lithuania

Malaysia

Mexico

New Zealand

Norway

Philippines

Poland

Portugal

Russian Federation

Saudi Arabia

Serbia

Singapore

Slovenia

South Africa

South Korea

Spain

Taiwan

Ukraine

Uruguay

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
Austria	261970
Malaysia	140674	NEW CRYSTALLINE FORM OF A TRIAZOLO(4,5-D)PYRIMIDINE COMPOUND
Taiwan	200817412
Japan	2003535092
Iceland	3019

Supplementary Protection Certificates for BRILINTA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1135391	CA 2011 00013	Denmark		PRODUCT NAME: TICAGRELOR ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF
1135391	1190009-9	Sweden		PRODUCT NAME: TICAGRELOR ELLER ETT FARMACEUTISKT ACCEPTABELT SALT DAERAV; REG. NO/DATE: EU/1/10/655/001-006 20101203
1135391	PA2011004	Lithuania		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	2011/012	Ireland		PRODUCT NAME: TICAGRELOR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTRATION NO/DATE: EU/1/10/655/001-006 20101203
1135391	PA2011004,C1135391	Lithuania		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

Market Dynamics and Financial Trajectory for BRILINTA (Ticagrelor)

Last updated: July 27, 2025

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Introduction

BRILINTA (ticagrelor) is a prominent oral antiplatelet medication developed by AstraZeneca, primarily indicated for reducing thrombotic cardiovascular events in patients with acute coronary syndrome (ACS) and those undergoing percutaneous coronary intervention (PCI). Since its approval by the FDA in 2011, BRILINTA has significantly impacted the cardiovascular therapeutic landscape, with its market performance driven by evolving clinical guidelines, competitive dynamics, and broader cardiovascular disease (CVD) trends. This comprehensive analysis explores the intricate market forces shaping BRILINTA's trajectory, its financial outlook, and future growth prospects.

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Market Overview and Clinical Positioning

BRILINTA's differentiation hinges on its mechanism as a reversible P2Y₁₂ receptor antagonist, offering distinct advantages over older agents like clopidogrel and newer agents such as prasugrel. Its rapid onset, potent antiplatelet activity, and flexible dosing have made it a preferred choice in specific clinical settings, notably in acute coronary syndromes and post-PCI management.

The global antiplatelet market is projected to expand steadily, fueled by increasing prevalence of CVD. According to the World Health Organization, CVD remains the leading cause of death worldwide, necessitating effective antithrombotic therapies. This epidemiological trend directly supports the sustained demand for agents like BRILINTA.

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Market Dynamics Influencing BRILINTA

1. Competitive Landscape

BRILINTA's primary competitors include Plavix (clopidogrel), Effient (prasugrel), and innovative agents like Brilinta’s emerging biosimilars and generics. While clopidogrel remains the most prescribed due to its lower cost and long-standing use, BRILINTA's superior efficacy and safety profile—especially its lower bleeding risk—favor its adoption in high-risk cohorts.

Efficient patent management and the potential rise of biosimilars could influence market share. AstraZeneca's strategic patent protections and ongoing clinical trials assist in maintaining competitive barriers, but patent expirations pose long-term threats.

2. Clinical Guidelines and Regulatory Policies

Guideline endorsements, such as those from the American College of Cardiology (ACC) and American Heart Association (AHA), reinforce BRILINTA's role in ACS management, bolstering prescriber confidence. However, regulatory decisions on off-label uses or reimbursement policies can sway utilization patterns.

3. Patent Expiry and Generic Competition

BRILINTA's patent protection is set to expire in the coming years, with patent cliff potentially introducing biosimilar entries, which could erode pricing power and margins. AstraZeneca's proactive patent strategies and focus on new formulations aim to mitigate this impact.

4. Regional Adoption Variances

Market penetration varies geographically, with more advanced healthcare systems in North America and Europe leading early adoption. Emerging markets, driven by rising CVD burden and improving healthcare infrastructure, present significant growth opportunities. Nonetheless, cost barriers and regulatory hurdles influence adoption speed.

5. Pricing and Reimbursement Trends

Pricing strategies and reimbursement frameworks influence BRILINTA's market penetration. Payors favor cost-effective therapies; thus, AstraZeneca's value-based pricing and price negotiations are crucial. Differentiating BRILINTA through improved safety profiles grants leverage for pricing negotiations.

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Financial Trajectory and Revenue Projections

1. Revenue Historical Performance

Since its launch, BRILINTA has experienced steady revenue growth within the cardiovascular segment, although it faced moderate initial adoption delays due to generic competition fears and conservative prescribing practices. In 2021, Brilinta generated approximately $2.2 billion globally, representing robust growth amid a competitive environment (AstraZeneca Annual Report, 2021).

2. Current Market Penetration

In markets like the U.S., Brilinta holds a significant share in the ACS segment, bolstered by guideline endorsements. Its adoption rate varies regionally but remains underpinned by clinical differentiation and strategic marketing initiatives.

3. Future Revenue Drivers

• Expansion into New Indications: Ongoing clinical trials evaluating Brilinta in stroke, peripheral artery disease (PAD), and other thrombotic conditions aim to broaden its clinical application. Successful outcomes could unlock new revenue streams.
• Market Growth in Emerging Economies: Increased healthcare investments, improved disease awareness, and expanding insurance coverage promise growth in BRILINTA's market share in Asia-Pacific, Latin America, and Africa.
• Post-Patent Strategy: Initiatives such as line extensions or combination therapies could extend product lifecycle and revenue stability.

4. Impact of Patent Expiration

Patent expiration, anticipated around 2025-2026, might catalyze off-patent competition, including biosimilar entries and lower-cost generics. This could significantly impact pricing power and margins unless AstraZeneca leverages lifecycle management strategies, such as new formulations or combination therapies.

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Key Market Trends and Their Financial Impact

• Personalized Medicine: Adoption of genetic testing to identify optimal antiplatelet regimens may enhance BRILINTA's clinical relevance, potentially translating into increased revenues.
• Digital Health Integration: Increasing use of digital health tools to monitor therapy adherence can improve patient outcomes, fostering brand loyalty and market share.
• Cost-Effective Alternatives: Pressure from cheaper generics and payor policies may restrain revenue growth unless BRILINTA sustains a perception of superior efficacy and safety.

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Outlook and Strategic Considerations

AstraZeneca's commitment to clinical innovation and lifecycle expansion positions BRILINTA favorably amidst evolving market dynamics. The company's focus on extending indications, optimizing dosing protocols, and engaging in strategic collaborations will be essential to safeguard and augment revenues.

However, impending patent expiries necessitate innovative approaches, including biosimilar engagement, portfolio diversification, and geographic expansion. The strategic response to competitive pressures and regulatory changes will define BRILINTA's financial trajectory over the coming decade.

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Key Takeaways

• Market Demand Driven by CVD Burden: The global rise in cardiovascular diseases underpins sustained demand for antiplatelet agents like BRILINTA.
• Competitive Landscape Affects Revenue: Strong efficacy and safety profiles position BRILINTA favorably, but price competition from generics and biosimilars presents challenges.
• Patent Lifecycle Management Is Critical: Patent expirations around 2025-2026 could significantly alter market share; proactive lifecycle strategies are vital.
• Regional Growth Opportunities: Emerging markets offer substantial potential; tailored strategies can accelerate growth.
• Innovation and Differentiation Are Key: Expanding indications, advancing clinical research, and integrating digital health solutions will be essential to drive future revenue.

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Frequently Asked Questions

1. What factors influence BRILINTA’s market share in the cardiovascular segment?
Clinical efficacy, safety profile, guideline endorsements, patent protections, pricing strategies, and regional healthcare policies primarily drive market share.

2. How will patent expiration affect BRILINTA’s financial performance?
Patent expiry may lead to increased generic competition, pressure on pricing, and margin erosion. Strategic lifecycle management and expansion into new indications are essential to mitigate these effects.

3. What are the growth prospects of BRILINTA in emerging markets?
Growing CVD prevalence, healthcare infrastructure improvements, and rising health awareness make emerging markets highly promising, contingent on affordability and regulatory access.

4. Are there upcoming clinical trials that could expand BRILINTA’s therapeutic indications?
Yes, ongoing studies evaluate Brilinta in stroke, PAD, and other thrombotic conditions, potentially broadening its clinical utility and revenue sources.

5. How does AstraZeneca plan to maintain BRILINTA’s competitiveness amid biosimilar and generic threats?
Through innovation, lifecycle extension strategies, geographic expansion, and demonstrating superior clinical benefits to justify premium pricing.

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References

[1] AstraZeneca Annual Report 2021.
[2] World Health Organization, Cardiovascular Diseases Fact Sheet.
[3] American College of Cardiology/American Heart Association guidelines.