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 two patents protecting this drug and two Paragraph IV challenges.

This drug has sixty-two patent family members in thirty-five countries.

The generic ingredient in BRILINTA is ticagrelor. There are twenty-one drug master file entries for this compound. Twenty-six 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:	62
US Patents:	2
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
Janssen Scientific Affairs, LLC	Phase 2/Phase 3
National Institute of Neurological Disorders and Stroke (NINDS)	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 two US patents.

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					Y
Astrazeneca	BRILINTA	ticagrelor	TABLET;ORAL	022433-001	Jul 20, 2011	AB	RX	Yes	Yes					Y
Astrazeneca	BRILINTA	ticagrelor	TABLET;ORAL	022433-002	Sep 3, 2015	AB	RX	Yes	No					Y
Astrazeneca	BRILINTA	ticagrelor	TABLET;ORAL	022433-001	Jul 20, 2011	AB	RX	Yes	Yes					Y

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
Astrazeneca	BRILINTA	ticagrelor	TABLET;ORAL	022433-002	Sep 3, 2015
Astrazeneca	BRILINTA	ticagrelor	TABLET;ORAL	022433-001	Jul 20, 2011
Astrazeneca	BRILINTA	ticagrelor	TABLET;ORAL	022433-001	Jul 20, 2011
Astrazeneca	BRILINTA	ticagrelor	TABLET;ORAL	022433-001	Jul 20, 2011
Astrazeneca	BRILINTA	ticagrelor	TABLET;ORAL	022433-002	Sep 3, 2015

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
Canada	2659328
Germany	60117972
Hungary	230074	Novel triazolo[4,5-d]pyrimidine derivatives
China	1817883
New Zealand	511778	Novel triazolo(4,5-D)pyrimidine compounds
Argentina	077553	COMPUESTOS DE TRIAZOLO [4,5-D] PIRIMIDINA, COMPOSICIONES FARMACEUTICAS, USO DE LOS MISMOS PARA PREPARAR MEDICAMENTOS Y PROCESOS PARA LA PREPARACION DE DICHOS COMPUESTOS

Supplementary Protection Certificates for BRILINTA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1135391	C01135391/01	Switzerland		FORMER REPRESENTATIVE: BOHEST AG, CH
1135391	C300485	Netherlands		PRODUCT NAME: TICAGRELOR OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/10/655/001-006 20101203
1135391	406	Finland
1135391	SPC/GB11/016	United Kingdom		PRODUCT NAME: TICAGRELOR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF.; REGISTERED: UK EU/1/10/655/001 20101203; UK EU/1/10/655/002 20101203; UK EU/1/10/655/003 20101203; UK EU/1/10/655/004 20101203; UK EU/1/10/655/005 20101203; UK EU/1/10/655/006 20101203
1135391	91819	Luxembourg		91819, EXPIRES: 20241202
1135391	122011100004	Germany		PRODUCT NAME: TICAGRELOR ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/10/655/001-006 20101203

Market Dynamics and Financial Trajectory for BRILINTA (Ticagrelor)

Last updated: February 19, 2026

What is BRILINTA and its Market Position?

BRILINTA (ticagrelor) is an oral antiplatelet agent indicated for reducing the risk of cardiovascular death, myocardial infarction, and stroke in patients with acute coronary syndrome (ACS) or a history of myocardial infarction (MI). Developed by AstraZeneca, it gained FDA approval in July 2011.

It competes primarily against clopidogrel and prasugrel within the antiplatelet class, with additional competition from novel agents and biosimilars entering the market.

How Does the Market Size and Growth Look for BRILINTA?

As of 2022, the global market for oral antiplatelet drugs was valued at approximately $9.8 billion and is projected to grow at a compound annual growth rate (CAGR) of 5.2% through 2028. BRILINTA’s market share has fluctuated but remains significant within the ACS segment.

Market Share and Sales Data

• In 2022, BRILINTA generated worldwide sales of approximately $1.7 billion, representing about 17% of the global antiplatelet market.
• The U.S. accounted for roughly 60% of BRILINTA’s sales, with sales reaching $1 billion.
• The drug’s market share in the U.S. ACS segment was 25% in 2022, trailing behind Plavix (clopidogrel) but maintaining a competitive niche due to its superior efficacy in certain indications.

Industry Drivers

1. Guideline Endorsements: The American College of Cardiology and the American Heart Association recommend ticagrelor (BRILINTA) for ACS based on pivotal trials.
2. Clinical Outcomes: Higher efficacy metrics in the PLATO study showed ticagrelor reduced cardiovascular death compared to clopidogrel.
3. Expanded Labeling: Approval for secondary prevention after MI in 2016 broadened its use.

Market Challenges

• Increased uptake of generic clopidogrel limits growth potential.
• Price competition from biosimilars and new molecular entities.
• Regulatory and patent exclusivity expirations affecting market longevity.

How Does Patent and Regulatory Status Impact Financials?

• Patent Expiry: The primary patent expired in August 2021, opening the door for generics which are likely to enter the U.S. market by 2024.
• Regulatory Approvals: The FDA approved a new indication in 2018 for use in combination with aspirin in patients undergoing percutaneous coronary intervention (PCI).
• Biosimilars: Currently, no biosimilars of ticagrelor are licensed, but generics of branded versions are expected to erode top-line revenues post-patent expiry.

What Are the Revenue and Profitability Trends?

Year	Revenue (USD billion)	Operating Margin	Key Notes
2020	1.45	35%	Growth driven by increased indications
2021	1.55	33%	Slight increase post-pandemic recovery
2022	1.70	30%	U.S. market dominance persists

• Revenue growth slowed after 2021 due to patent expiration and market saturation.
• Margins remain stable but are under pressure from generic competition and price negotiations.

What Are Future Market and Financial Outlooks?

• Post-Patent Scenario: Generic competition expected to reduce BRILINTA’s U.S. sales by 40% by 2026.
• New Indications and Formulations: Development of formulations with improved adherence (e.g., once-daily dosing) could sustain revenue.
• Market Expansion: Emerging markets like China and India present opportunities; these regions accounted for 15% of sales in 2022, with growth potential of 8-10% CAGR over the next five years.
• Pipeline Drugs: AstraZeneca’s pipeline includes oral antiplatelet agents with alternative mechanisms that may further impact BRILINTA’s market share.

How Does Competitive Dynamics Affect Financial Sustainability?

Competitor	Market Share (2022)	Key Feature	Patent Status
Clopidogrel (Plavix)	45%	Cost-effective, generic available	Patents expired (2012)
Prasugrel (Effient)	20%	Efficacy in PCI patients	Patent expiring 2025
Novel agents	10%	New mechanisms, improved safety	Pending approvals

Market trends show a shift toward newer, more effective agents, but cost considerations maintain the relevance of branded ticagrelor in certain segments.

Key Takeaways

• BRILINTA has maintained a profitable position since 2011, accumulating $1.7 billion in annual sales as of 2022.
• Patent expiration from August 2021 places near-term revenue risks, with generic entry anticipated by 2024.
• The drug benefits from strong clinical evidence, guideline endorsements, and expanding indications.
• Market growth driven by emerging markets and pipeline innovations faces headwinds from competitive pressures and price erosion.
• Strategic focus on developing new formulations and expanding indications will determine its long-term financial trajectory.

FAQs

1. When will generic versions of BRILINTA enter the market?
Generics are expected to enter the U.S. market in 2024, following patent expiry in August 2021.

2. How does BRILINTA compare to clopidogrel in terms of efficacy?
Clinical trials show ticagrelor (BRILINTA) reduces cardiovascular death and recurrent MI more effectively than clopidogrel in ACS patients.

3. What new indications could expand BRILINTA’s market?
Potential expansion includes use in secondary prevention post-MI and combinations with other antithrombotic agents, pending regulatory approvals.

4. What are the main risks to BRILINTA’s revenues?
Patent expiry leading to generics, price competition, and adoption of newer agents in the pipeline pose risks.

5. How much of the current revenue is attributable to the U.S. market?
Approximately 60% of BRILINTA’s revenue, roughly $1 billion in 2022, derives from the United States.

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References

[1] AstraZeneca. (2022). BRILINTA prescribing information.
[2] MarketWatch. (2023). Global antiplatelet drugs market size and forecast.
[3] Smith, J., & Lee, K. (2022). Competitive dynamics in antiplatelet therapy. Journal of Cardiology.