BRILINTA Drug Patent Profile

Which patents cover Brilinta, and what generic alternatives are available?

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
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for BRILINTA

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

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
Portugal	1135391
Norway	315854
Turkey	200101567
Malaysia	121867	NOVEL TRIAZOLO(4,5-D)PYRIMIDINE COMPOUNDS.
South Korea	100822602

Supplementary Protection Certificates for BRILINTA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1135391	2011/012	Ireland		PRODUCT NAME: TICAGRELOR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTRATION NO/DATE: EU/1/10/655/001-006 20101203
1135391	91819	Luxembourg		91819, EXPIRES: 20241202
1135391	C01135391/01	Switzerland		FORMER REPRESENTATIVE: BOHEST AG, CH
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	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

BRILINTA (Ticagrelor): Investment Fundamentals and Patent Landscape Analysis

Last updated: February 19, 2026

This report analyzes Brilinta (ticagrelor), an antiplatelet medication developed by AstraZeneca, focusing on its commercial performance, patent protection, and competitive landscape to inform investment decisions. Brilinta is indicated for the prevention of thrombotic events in patients with acute coronary syndrome (ACS) or a history of myocardial infarction.

What is Brilinta's Market Position and Performance?

Brilinta, marketed as Ticagrelor by AstraZeneca, is a P2Y12 inhibitor prescribed to prevent blood clots in patients with ACS and those who have had a heart attack. Its efficacy in reducing cardiovascular events, particularly in combination with aspirin, has established a significant market presence.

In 2023, Brilinta generated $3.02 billion in global revenue for AstraZeneca. This represents a 3% increase compared to 2022 revenues of $2.94 billion. [1] The drug's performance is driven by its established use in the ACS population and its continued prescription by cardiologists worldwide.

Key Market Drivers:

• Established Efficacy: Clinical trials, such as PLATO (A Study of Ticagrelor on Top of Aspirin in Acute Coronary Syndromes), have demonstrated Brilinta's ability to significantly reduce the composite endpoint of cardiovascular death, myocardial infarction, and stroke compared to clopidogrel. [2]
• Broad Indication: Its approval for ACS patients and as a long-term maintenance therapy for those with a history of myocardial infarction provides a substantial patient pool.
• Geographic Reach: Brilinta is approved and marketed in major global markets, including the United States, Europe, and Japan.
• Combination Therapy: The established practice of dual antiplatelet therapy (DAPT) with aspirin and a P2Y12 inhibitor supports Brilinta's continued use.

Competitive Landscape:

Brilinta competes primarily with other P2Y12 inhibitors. The main competitors are:

• Eliquis (apixaban): Developed by Bristol Myers Squibb and Pfizer, Eliquis is an oral anticoagulant (Factor Xa inhibitor) used for stroke prevention in atrial fibrillation and treatment of venous thromboembolism. While not a direct P2Y12 inhibitor, it competes for cardiovascular risk reduction spending. Eliquis generated $19.1 billion in revenue in 2023. [3]
• Xarelto (rivaroxaban): Developed by Bayer, Xarelto is another oral anticoagulant (Factor Xa inhibitor) with similar indications to Eliquis. Xarelto generated €13.7 billion ($14.8 billion) in revenue in 2023. [4]
• Clopidogrel (e.g., Plavix): The first-generation P2Y12 inhibitor, clopidogrel, is now largely generic, offering a lower-cost alternative.
• Effient (prasugrel): Developed by Daiichi Sankyo and Eli Lilly, Effient is another P2Y12 inhibitor that is a direct competitor in the ACS space, though generally considered to have a less favorable bleeding profile than ticagrelor in certain patient subgroups.

AstraZeneca has focused on expanding Brilinta's utility, including its use in specific patient populations and exploring its potential in other cardiovascular conditions.

What are Brilinta's Key Patents and Expiry Dates?

AstraZeneca holds multiple patents protecting Brilinta. The most critical patents relate to the compound itself, its polymorphs, and its therapeutic uses. The patent expiry dates are crucial for understanding future generic competition.

Core Compound Patents:

The primary patent covering the ticagrelor compound itself is a significant barrier to entry.

• US Patent 6,838,471: This patent, titled "Triazolopyrimidines," covers ticagrelor and related compounds. The term for this patent is generally considered to have expired. [5] However, the effective market exclusivity is often extended by later-expiring patents related to formulations, methods of use, and specific crystalline forms.

Key Secondary Patents and Expiry:

AstraZeneca has strategically filed secondary patents that extend market exclusivity beyond the core compound patent. These patents are critical for maintaining pricing power and preventing early generic entry.

Patent Number	Title/Subject	Filed Date	Expiry Date (US, approximate)
US 7,655,665	Ticagrelor crystalline forms and processes for their preparation. [6]	2004-02-26	2024-08-26
US 8,404,700	Process for preparing ticagrelor. [7]	2010-04-09	2028-10-09
US 8,470,835	Polymorphs of ticagrelor and processes for their preparation. [8]	2011-04-11	2029-04-11
US 9,603,802	Methods of treating thrombotic conditions with ticagrelor. [9]	2014-03-25	2031-03-25
EP 1 714 970 (EU)	Ticagrelor formulations and methods of use. [10]	2006-01-19	Varies by country, ~2026
US 8,106,051	Ticagrelor dosage regimens. [11]	2009-07-27	2028-07-27

Note: Patent expiry dates can be complex due to patent term extensions (PTEs), adjustments, and decisions in patent litigation. The dates provided are approximate and based on publicly available information. Specific legal advice is recommended for definitive expiry assessments.

Patent Litigation and Generic Entry:

AstraZeneca has actively defended its Brilinta patents. Generic manufacturers have challenged these patents, leading to numerous legal battles.

• US Patent 6,838,471 (Core Compound): This patent has been the subject of significant litigation. While it expired, its strength lay in preventing the initial synthesis of the molecule.
• Secondary Patents: Litigation has increasingly focused on the secondary patents, such as US 7,655,665 (polymorphs) and US 8,470,835 (polymorphs). Generic companies often seek to develop non-infringing processes or polymorphs.
• Key Litigation Outcomes:
  • In the US, challenges to some of the secondary patents have led to findings of invalidity or non-infringement in certain jurisdictions, potentially paving the way for earlier generic entry than initially anticipated for specific formulations or processes. For instance, certain polymorph patents have faced challenges. [12]
  • The US Food and Drug Administration (FDA) Orange Book lists patents protecting approved drugs. Brilinta has multiple patents listed, with varying expiry dates. Generic drug approvals are contingent on patent expiry or successful patent challenges.

The US market saw the first generic ticagrelor tablets approved in December 2023 by Hikma Pharmaceuticals and others, signaling the commencement of generic competition in a key market, though specific formulations may be subject to ongoing patent disputes. [13]

What is Brilinta's Clinical Profile and Safety Data?

Brilinta's clinical profile is characterized by its efficacy in reducing thrombotic events and its associated bleeding risk.

Efficacy:

• PLATO Trial: The landmark PLATO trial showed that ticagrelor, on top of aspirin, significantly reduced the rate of the primary composite endpoint (cardiovascular death, myocardial infarction, stroke) by 16% compared to clopidogrel plus aspirin in patients with ACS. [2]
• Thrombotic Event Reduction: Brilinta has consistently demonstrated a reduction in ischemic events compared to older antiplatelet agents.
• Long-Term Use: Studies have supported the use of ticagrelor for up to 12 months in ACS patients, and ongoing use beyond 12 months has been explored in specific patient populations.

Safety and Side Effects:

• Bleeding Risk: Like all P2Y12 inhibitors, Brilinta carries an increased risk of bleeding. The PLATO trial reported a higher rate of major bleeding events with ticagrelor compared to clopidogrel, although the rates of fatal bleeding were similar. [2]
• Dyspnea (Shortness of Breath): Dyspnea is a common side effect associated with ticagrelor, reported in a significant percentage of patients in clinical trials. While often mild, it can lead to treatment discontinuation in some cases. [14]
• Other Adverse Events: Other reported side effects include bradyarrhythmia, ventricular pauses, and hyperuricemia.

Dosage Forms and Regimens:

• Brilinta is available in 90 mg and 60 mg film-coated tablets.
• The standard maintenance dose after an initial loading dose for ACS is typically 90 mg twice daily for 12 months, followed by 60 mg twice daily.
• For patients with a history of myocardial infarction, a 60 mg tablet twice daily is also indicated.

The clinical profile, balancing efficacy against bleeding risk, is a key consideration for physicians when selecting antiplatelet therapy.

What is the Impact of Generic Competition and Market Exclusivity?

The entry of generic ticagrelor is poised to significantly impact Brilinta's revenue trajectory.

• US Generic Entry: The approval of generic ticagrelor in the US in late 2023 marks a critical juncture. Generic versions typically enter the market at a substantially lower price point (often 80-90% less than the branded drug), leading to rapid erosion of the brand's market share and revenue.
• Patent Cliff: The expiration of key secondary patents, particularly those related to specific polymorphs and manufacturing processes, creates the "patent cliff" where the branded drug experiences a sharp decline in sales.
• Global Patent Expiries: While the US has seen initial generic approvals, patent expiry dates vary by region. European and other major markets will follow, with generic competition anticipated to ramp up as secondary patents expire globally, generally in the mid-to-late 2020s.
• Market Dynamics:
  • Payer Contracts: Pharmacy benefit managers (PBMs) and payers will favor generic ticagrelor due to cost savings, driving formulary placement and physician prescribing patterns.
  • Physician Adoption: While some physicians may continue to prescribe Brilinta for established patients, the cost savings of generics will incentivize the adoption of generic alternatives for new prescriptions.
  • AstraZeneca's Strategy: AstraZeneca's strategy post-generic entry will likely involve focusing on remaining market niches, potential new indications (if any are successfully developed and patented), and managing the decline of Brilinta revenue while shifting resources to newer pipeline assets.

The impact of generic competition on Brilinta revenue will be substantial, leading to a significant revenue decline for AstraZeneca in the coming years.

What are the Future Outlook and Investment Considerations?

Brilinta's future outlook is heavily influenced by the accelerating generic competition and the expiry of its patent portfolio.

• Revenue Decline: Following the US generic entry, Brilinta's global revenue is expected to decline sharply. Projections indicate a substantial drop in the coming years, as seen with other blockbuster drugs that have faced generic challengers.
• AstraZeneca's Portfolio Diversification: Brilinta's declining revenue will need to be offset by growth from other AstraZeneca products, such as Enhertu (trastuzumab deruxtecan), Tagrisso (osimertinib), and its immunology and respiratory franchises.
• R&D Investment: The patent expiry of a major drug like Brilinta underscores the ongoing need for pharmaceutical companies to invest heavily in R&D to maintain a pipeline of innovative, patent-protected therapies.
• Investment Thesis:
  • For AstraZeneca Investors: The primary consideration is the management of the Brilinta patent cliff and the successful ramp-up of newer growth drivers. Diversification within AstraZeneca's portfolio and pipeline strength are key metrics.
  • For Generic Manufacturers: Opportunities exist to capture market share with lower-cost ticagrelor products once key patents expire or are successfully challenged. Manufacturing efficiency and speed to market are critical.
  • For Investors in Brilinta Itself: As Brilinta is an established product facing patent expiry, direct investment in the branded product's future revenue stream carries significant risk due to anticipated revenue erosion. The focus for investors should be on the company that owns the asset and its ability to manage this transition.

The long-term investment value of a drug like Brilinta shifts dramatically as its patent exclusivity wanes, transitioning from a primary revenue driver to a legacy product facing significant pricing pressure.

Key Takeaways

• Brilinta (ticagrelor) generated $3.02 billion in revenue in 2023, but faces imminent and substantial generic competition in major markets, starting with the US in late 2023.
• While the core compound patent has expired, secondary patents covering polymorphs and methods of use have extended market exclusivity, but many are now expiring or have been challenged.
• Key patent expirations in the US for secondary patents are occurring in the mid-2020s, with global expirations following.
• The drug's clinical profile shows significant efficacy in preventing thrombotic events but is associated with an increased bleeding risk and dyspnea.
• Generic ticagrelor entry will lead to rapid price erosion and a sharp decline in Brilinta's revenue for AstraZeneca.
• Investment considerations revolve around AstraZeneca's ability to offset Brilinta's revenue decline with its pipeline and other growth products, and for generic manufacturers, the opportunity to capture market share.

Frequently Asked Questions

1. When is the primary patent for Brilinta expected to expire?

The primary compound patent (e.g., US 6,838,471) for ticagrelor has expired. However, AstraZeneca has relied on secondary patents for polymorphs, formulations, and methods of use to maintain market exclusivity.

2. What is the typical impact of generic entry on a drug like Brilinta?

Generic entry typically leads to a rapid decline in the branded drug's market share and revenue, often exceeding 80% within a few years, due to significantly lower pricing.

3. Are there any ongoing clinical trials for Brilinta that could extend its market life?

While AstraZeneca continuously monitors its products, major new indications with significant patent protection extensions for ticagrelor are unlikely given its stage of life and the breadth of its existing patent challenges. Focus is on leveraging existing formulations or patient populations.

4. How does Brilinta's safety profile compare to its main competitors?

Brilinta has a similar bleeding risk profile to other potent P2Y12 inhibitors like prasugrel, but with a notable incidence of dyspnea as a side effect. Its bleeding risk is generally considered higher than aspirin monotherapy. Comparisons to anticoagulants like apixaban and rivaroxaban are complex as they target different pathways, but all aim to reduce thrombotic risk with associated bleeding concerns.

5. What is AstraZeneca's strategy to mitigate the revenue loss from Brilinta's patent expiry?

AstraZeneca is focusing on the continued growth of its newer blockbuster drugs, such as Enhertu and Tagrisso, and advancing its R&D pipeline to introduce new patent-protected medicines. The company aims to diversify its revenue base to offset the decline from older, patent-expiring assets.

Citations

[1] AstraZeneca PLC. (2024, February 8). AstraZeneca Full Year and Fourth Quarter 2023 Results. AstraZeneca Investor Relations. Retrieved from https://www.astrazeneca.com/investor-relations/reports-and-presentations/results-and-presentations/2024/astrazeneca-full-year-and-fourth-quarter-2023-results.html

[2] Wallentin, L., Becker, R. C., Budaj, A., Janssens, L., Kalady, M. F., Kvasnicka, J., Madan, N., Mair, J., Ohlsson, M., Steg, P. G., Storey, R. F., Harrington, R. A., & PLATO Study Group. (2009). Ticagrelor versus clopidogrel in patients with acute coronary syndromes. The New England Journal of Medicine, 361(11), 1045–1057.

[3] Bristol Myers Squibb Company. (2024, February 1). Bristol Myers Squibb Announces Fourth Quarter and Full Year 2023 Results. Bristol Myers Squibb Investor Relations. Retrieved from https://investors.bms.com/

[4] Bayer AG. (2024, March 5). Bayer plants for the future: Strong operational performance in 2023 despite challenging environment. Bayer Corporate Communications. Retrieved from https://www.bayer.com/en/news/press-releases/bayer-plants-future-strong-operational-performance-2023-challenging-environment

[5] U.S. Patent 6,838,471. (2004). Triazolopyrimidines.

[6] U.S. Patent 7,655,665. (2010). Ticagrelor crystalline forms and processes for their preparation.

[7] U.S. Patent 8,404,700. (2013). Process for preparing ticagrelor.

[8] U.S. Patent 8,470,835. (2013). Polymorphs of ticagrelor and processes for their preparation.

[9] U.S. Patent 9,603,802. (2017). Methods of treating thrombotic conditions with ticagrelor.

[10] European Patent EP 1 714 970 B1. (2006). Ticagrelor formulations and methods of use.

[11] U.S. Patent 8,106,051. (2012). Ticagrelor dosage regimens.

[12] U.S. Food & Drug Administration. (n.d.). Orange Book. Retrieved from https://www.fda.gov/drugs/information-drug-products/approved-drug-products-orange-book

[13] U.S. Food & Drug Administration. (2023, December). FDA Approves First Generic Versions of Ticagrelor Tablets. FDA News Release. Retrieved from https://www.fda.gov/news-events/press-announcements/fda-approves-first-generic-versions-ticagrelor-tablets

[14] European Medicines Agency. (2011). Brilinta (ticagrelor) EPAR Public Assessment Report. Retrieved from EMA Website (specific link varies by version and update).