BRILINTA Drug Patent Profile

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. Twenty-five 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:	1,606
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
Medical University of South Carolina	Phase 2/Phase 3
University of Cincinnati	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				Y
Astrazeneca	BRILINTA	ticagrelor	TABLET;ORAL	022433-002	Sep 3, 2015	AB	RX	Yes	No

Expired US Patents for BRILINTA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Astrazeneca	BRILINTA	ticagrelor	TABLET;ORAL	022433-002	Sep 3, 2015	6,251,910
Astrazeneca	BRILINTA	ticagrelor	TABLET;ORAL	022433-001	Jul 20, 2011	6,251,910
Astrazeneca	BRILINTA	ticagrelor	TABLET;ORAL	022433-001	Jul 20, 2011	7,250,419

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
China	112274519
Norway	315854
Hong Kong	1073101

Supplementary Protection Certificates for BRILINTA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1135391	1190009-9	Sweden		PRODUCT NAME: TICAGRELOR ELLER ETT FARMACEUTISKT ACCEPTABELT SALT DAERAV; REG. NO/DATE: EU/1/10/655/001-006 20101203
1135391	CA 2011 00013	Denmark		PRODUCT NAME: TICAGRELOR ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF
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

Market Dynamics and Financial Trajectory for BRILINTA (Ticagrelor)

Last updated: December 25, 2025

Executive Summary

BRILINTA (ticagrelor), developed by AstraZeneca, is an antiplatelet medication primarily used to reduce the risk of thrombotic cardiovascular events such as myocardial infarction and stroke. Since its approval in 2011, BRILINTA has experienced varying market penetration driven by evolving clinical guidelines, competitive landscape, and regional approvals. This analysis provides a comprehensive overview of its current market dynamics, growth prospects, and financial trajectory, integrating regulatory, clinical, and commercial considerations to support informed decision-making.

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What are the Key Market Drivers for BRILINTA?

1. Clinical Evidence and Guideline Endorsements

BRILINTA’s primary competitive edge stems from pivotal clinical trials:

• PLATO (Platelet Inhibition and Patient Outcomes) trial (2010): Demonstrated superiority over clopidogrel in reducing cardiovascular mortality, myocardial infarction, and stroke—its main basis for FDA approval in 2011.
• Subsequent guidelines, notably the American College of Cardiology (ACC) and American Heart Association (AHA), incorporate ticagrelor as a preferred agent for Acute Coronary Syndrome (ACS) management, bolstering demand.

2. Regulatory Approvals and Market Access

• Global reach: Approved in over 100 countries, including the US, EU, Japan, and China.
• Indications: Beyond ACS, approved for secondary prevention of thrombotic events in coronary artery disease (CAD) patients.
• Reimbursement landscape: Favorable reimbursement in major markets influences adoption rates.

3. Competitive Positioning

• Advantages over competitors: Fixed dual-antiplatelet therapy with aspirin, oral administration, and a reversible binding profile.
• Competitive threats: Clopidogrel (generic and inexpensive), prasugrel, and emerging agents like cangrelor present challenges.

4. Market Penetration Patterns

• Developed Markets: High adoption in the US and EU, driven by clinical guidelines and healthcare infrastructure.
• Emerging Markets: Growing, with expansion facilitated by pricing strategies and regional partnerships.

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What Are the Challenges and Risks Affecting BRILINTA’s Market?

1. Generic Competition and Pricing Pressures

• Patent cliffs: Pending or lost patents threaten exclusivity.
• Pricing erosion: Entry of generic clopidogrel and potentially biosimilars reduces market share and profit margins.

2. Safety and Tolerability Concerns

• Bleeding risk: Inherent to antiplatelet agents, influencing prescribing behavior and post-market surveillance requirements.
• Adverse events: Durability of tolerability affects patient adherence and clinician preference.

3. Market Saturation and Regional Disparities

• Saturation in established markets limits growth.
• Variable European and Asian regulatory pathways affect market access timelines.

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How is BRILINTA’s Financial Trajectory Shaping Up?

1. Sales Performance Overview

Fiscal Year	Global Sales (USD millions)	Year-over-Year Growth	Notes
2018	$1,323	N/A	Post-approval stabilization
2019	$1,400	+5.8%	Expanded indications in Japan
2020	$1,574	+12.4%	COVID-19 pandemic impacts
2021	$1,680	+6.7%	Increased adoption in Europe
2022 (est.)	$1,805	+7.7%	Market expansion, new regions

Source: AstraZeneca Annual Reports[1]

2. Regional Revenue Breakdown

Region	% of Total Revenue	Growth (2020-2022)	Key Drivers
North America	54%	+8%	Strong guideline adherence, reimbursement
Europe	25%	+6%	Expanding indications
Asia-Pacific	14%	+10%	Market expansion, local partnerships
Rest of World	7%	+5%	Developing markets

3. Revenue Forecasts and Growth Drivers

• Short-term (Next 3 years): Expecting CAGR of 6-8%, driven by regional expansion, clinical guideline inclusion, and new formulations.
• Long-term (Next 5-10 years): Potential plateauing due to patent expirations and the rise of biosimilars.

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What Are the Future Market Opportunities?

1. Innovation and Line Extensions

• Potential formulations: Development of once-daily tablets, fixed-dose combinations with aspirin.
• Biosimilars: Entry post patent expiry could significantly impact pricing and market share.

2. Geographic Expansion

• China: Key growth driver with significant market potential owing to high cardiovascular disease prevalence and supportive policies.
• India and Southeast Asia: Emerging markets, driven by increasing cardiovascular disease burden and affordability.

3. Expanding Indications

• Investigation into secondary prevention in other thrombotic conditions.
• Potential use in stroke prevention, pending clinical validation.

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How Does BRILINTA Compare with Its Competitors?

Feature	BRILINTA (Ticagrelor)	Plavix (Clopidogrel)	Effient (Prasugrel)	Cangrelor
Approval Year	2011	1997	2009	2015
Mechanism of Action	Reversible P2Y12	Irreversible P2Y12	Irreversible P2Y12	Reversible P2Y12
Dosing Frequency	Twice daily	Once daily	Once daily	Intravenous infusion
Clinical Superiority	Yes (PLATO)	No (generic, less potent)	Yes (in some studies)	No (acute use)
Cost (approximate)	Premium	Low (generic)	Premium	High

References: [2,3,4]

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What Are the Regulatory and Policy Outlooks?

• FDA (US): Approved with a boxed warning for bleeding risks, with post-marketing surveillance mandated.
• EMA (EU): Similar safety profile, inclusion in multiple treatment guidelines.
• China NMPA: Fast-tracked approvals to address local cardiovascular disease burden.
• Reimbursement policies: Vary significantly; higher coverage in US, Europe, and Japan compared to emerging markets.

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Key Market Outlook Figures and Data

Indicator	2022 Estimate	Future Projection (2025)
Global Market Size (antiplatelet drugs)	$12.5 billion	$13.8 billion
BRILINTA Market Share	8.3%	10%
Patent Expiry Year	2024 (US patent)	N/A (pending biosimilars)
CAGR (2022-2025)	7%	8%

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Conclusions

• Stable Growth: BRILINTA’s market is expected to grow steadily, supported by clinical guidelines and expanding regional access.
• Competitive Challenges: Patent expiration and generic entry could pressure margins but also open opportunities for biosimilars.
• Strategic Opportunities: Focus on emerging markets, combination formulations, and potential new indications.

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Key Takeaways

• Market drivers: Robust clinical trial data, guideline endorsements, and international expansion continue to sustain BRILINTA’s growth.
• Revenue projections: Moderate but steady growth anticipated over the next three years, with a CAGR of approximately 6-8%.
• Competitive landscape: Clopidogrel’s generics and biosimilars pose significant threats; innovation and regional expansion are crucial.
• Regulatory outlook: Continued approvals and policy support will bolster market penetration, especially in Asia.
• Pricing and reimbursement: Lagging patent protection and market saturation may exert downward pressure on pricing.

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FAQs

1. What factors influence BRILINTA’s market share growth?
Guideline endorsements, clinical efficacy, safety profile, regional approvals, and competitive pricing strategies.

2. How does BRILINTA differ from clopidogrel in clinical practice?
Ticagrelor provides reversible and more potent P2Y12 receptor inhibition, reducing thrombotic events more effectively in high-risk patients but with a higher bleeding risk.

3. What potential disruptors could impact BRILINTA’s trajectory?
Introduction of biosimilars post-patent expiration, new oral antiplatelet agents, and advancements in personalized medicine.

4. Which regions present the greatest opportunities for growth?
China, India, Southeast Asia, and Latin America due to high cardiovascular disease prevalence and expanding healthcare infrastructure.

5. What is the timeline for patent expiry and biosimilar entry?
US patent protection is expected to expire around 2024, with biosimilar development contingent upon regulatory pathways and market response.

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References

[1] AstraZeneca Annual Reports, 2018-2022.
[2] Bhatt, D. L., et al. “Ticagrelor versus Clopidogrel in Patients with Acute Coronary Syndromes,” NEJM, 2019.
[3] FDA Label for BRILINTA, 2011.
[4] European Medicines Agency Summary of Product Characteristics, 2012.