Ticagrelor - Generic Drug Details

What are the generic sources for ticagrelor and what is the scope of freedom to operate?

Ticagrelor is the generic ingredient in two branded drugs marketed by Astrazeneca, Alembic, Alkem Labs Ltd, Amneal, Apotex, Changzhou Pharm, Dr Reddys, Hisun Pharm Hangzhou, Invagen Pharms, Macleods Pharms Ltd, MSN, Mylan, Prinston Inc, Sciegen Pharms Inc, Sunshine, Taro, and Watson Labs Inc, and is included in eighteen NDAs. There are three patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Ticagrelor has one hundred and forty-seven patent family members in forty-four countries.

There are twenty-one drug master file entries for ticagrelor. Twenty-five suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for ticagrelor

International Patents:	147
US Patents:	3
Tradenames:	2
Applicants:	17
NDAs:	18
Drug Master File Entries:	21
Finished Product Suppliers / Packagers:	25
Raw Ingredient (Bulk) Api Vendors:	81
Clinical Trials:	461
Patent Applications:	3,245
Drug Prices:	Drug price trends for ticagrelor
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ticagrelor
What excipients (inactive ingredients) are in ticagrelor?	ticagrelor excipients list
DailyMed Link:	ticagrelor at DailyMed

See drug prices for ticagrelor

Recent Clinical Trials for ticagrelor

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Ministry of Science and Higher Education, Poland	PHASE4
Collegium Medicum w Bydgoszczy	PHASE4
University of Messina	PHASE4

See all ticagrelor clinical trials

Generic filers with tentative approvals for TICAGRELOR

Applicant	Application No.	Strength	Dosage Form
		90MG	TABLET;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for ticagrelor

Drug Class	P2Y12 Platelet Inhibitor
Mechanism of Action	Cytochrome P450 3A4 Inhibitors P-Glycoprotein Inhibitors P2Y12 Receptor Antagonists
Physiological Effect	Decreased Platelet Aggregation

Anatomical Therapeutic Chemical (ATC) Classes for ticagrelor

B01AC	Platelet aggregation inhibitors excl. heparin
B01A	ANTITHROMBOTIC AGENTS
B01	ANTITHROMBOTIC AGENTS
B	Blood and blood forming organs

Paragraph IV (Patent) Challenges for TICAGRELOR

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 ticagrelor

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Alkem Labs Ltd	TICAGRELOR	ticagrelor	TABLET;ORAL	210219-001	Oct 28, 2025	AB	RX	No	No
Amneal	TICAGRELOR	ticagrelor	TABLET;ORAL	208531-002	Oct 28, 2025	AB	RX	No	No
Invagen Pharms	TICAGRELOR	ticagrelor	TABLET;ORAL	208537-002	Oct 28, 2025	AB	RX	No	No

Expired US Patents for ticagrelor

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

EU/EMA Drug Approvals for ticagrelor

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 ticagrelor

Country	Patent Number	Title	Estimated Expiration
Russian Federation	2012153069
Portugal	2056832
Russian Federation	2012121883

Supplementary Protection Certificates for ticagrelor

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	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

Market Dynamics and Financial Trajectory of Ticagrelor

Last updated: September 8, 2025

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Introduction

Ticagrelor, marketed under the brand name Brilinta among others, is a potent antiplatelet agent primarily indicated for preventing cardiovascular (CV) events such as myocardial infarction and stroke. Developed by AstraZeneca, it gained regulatory approval in the early 2010s, with a unique mechanism as a reversible P2Y12 receptor antagonist. As cardiovascular disease (CVD) remains a leading cause of global mortality, ticagrelor's market prospects are shaped by evolving therapeutic guidelines, competitive dynamics, and emerging pipeline innovations.

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Market Overview and Industry Landscape

The global antiplatelet therapy market, valued at approximately USD 6.2 billion in 2022, is projected to grow at a Compound Annual Growth Rate (CAGR) of about 5.2% through 2030, driven by increasing CVD prevalence, aging populations, and rising awareness of secondary prevention strategies [1]. Ticagrelor's market share within this segment continues to expand, challenging traditional agents like clopidogrel and prasugrel.

Key Market Drivers:

• High CVD Burden: An estimated 523 million people live with ischemic heart disease worldwide, demanding effective antiplatelet regimens [2].
• Clinical Evidence: Landmark trials such as PLATO underscored ticagrelor's superiority over clopidogrel in reducing cardiovascular events, underpinning guideline endorsements.
• Guideline Endorsements: The American College of Cardiology (ACC) and European Society of Cardiology (ESC) recommend ticagrelor for acute coronary syndrome (ACS) management, bolstering its adoption.
• Innovation and Pipeline: Emerging formulations and combination therapies could enhance adherence and expand indications.

Competitive Landscape:

Besides clopidogrel and prasugrel, newer agents like cangrelor and novel oral anticoagulants contribute to the dynamic market. Patent expirations of first-generation agents have driven generic competition, but ticagrelor retains proprietary exclusivity, with patent protections extending into the late 2020s in key territories [3].

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Regulatory and Patent Trajectory

Ticagrelor's initial patent was granted in the early 2000s, with extensions based on secondary patents covering formulations, manufacturing processes, and new indications. The primary composition of matter patent is set to expire around 2024–2025 in the U.S. and Europe; however, secondary patents and market exclusivities are expected to sustain commercial advantages until 2027–2028.

Regulatory agencies such as the FDA and EMA have continuously reaffirmed its safety and efficacy profile, with recent approvals expanding its indication for secondary stroke prevention and perioperative management. The expiration of key patents will likely herald increased generic competition, affecting pricing and revenue streams.

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Financial Trajectory and Revenue Analysis

Historical Revenue Performance:

Since its launch, ticagrelor has become a flagship product for AstraZeneca's cardiovascular portfolio. In 2022, sales approximated USD 1.4 billion globally, reflecting steady double-digit growth driven by expanding indications and geographic penetration.

Revenue Drivers:

• Market Penetration: Adoption in developed markets like the U.S. and Europe remains robust due to prevalent guidelines and clinician familiarity.
• Pricing Strategy: Premium pricing sustains margins; however, impending patent expiry threatens pricing power.
• Emerging Markets: Rapid growth in Asia-Pacific and Latin America offsets saturation elsewhere, as access barriers decline.

Challenges Affecting Financial Outlook:

• Patent Cliff: As key patents expire, revenue erosion is anticipated, with generic versions expected to capture significant volume share.
• Pricing Pressures: Payers and healthcare systems are increasingly favoring cost-effective therapies, exerting downward pressure on prices.
• Generic Competition: Multiple filings of bioequivalent generics threaten to dilute market share from 2024 onward.
• Pipeline and New Formulations: Investment in new delivery mechanisms or combination therapies may mitigate revenue declines.

Forecasting Scenarios:

• Optimistic Scenario: Extended patent protections through supplementary patents or litigation success, supplemented by pipeline developments, could sustain revenues near USD 1.2–1.5 billion annually through 2028.
• Conservative Scenario: Early patent expiry, significant generic competition, and pricing reductions could halve revenues over five years, with projections falling to USD 600 million–USD 800 million.

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Market Penetration Strategies

AstraZeneca's strategic initiatives include:

• Expanding Indications: Pursuing approval for stroke prevention and perioperative use to broaden the patient base.
• Combination Therapies: Developing fixed-dose combinations with statins or anticoagulants to improve adherence.
• Pricing and Access Strategies: Collaborating with payers in emerging markets to facilitate broader access.
• R&D Investment: Innovating formulations, such as chewables or injectable versions, to cater to diverse patient needs.

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Emerging Opportunities and Risks

Opportunities:

• Personalized Medicine: Pharmacogenomic approaches could optimize patient selection, improving outcomes and market acceptance.
• Digital Healthcare Integration: Utilizing digital health tools for adherence monitoring may open ancillary revenues.
• New Indications: Expanding into peripheral artery disease or cerebrovascular indications can diversify revenue streams.

Risks:

• Regulatory Delays: Stringent approval processes may hinder pipeline innovations.
• Market Saturation: High existing adoption may limit penetration in mature markets.
• Competitive Innovation: New antithrombotic agents with superior profiles can erode market share.

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Conclusion

Ticagrelor remains a critical player in the antiplatelet market, underpinned by robust clinical evidence and guideline endorsements. Its financial trajectory is poised for both growth and decline, contingent upon patent protections, competitive dynamics, and pipeline success. Firms must navigate patent expiries judiciously, leveraging innovation and strategic market expansion to sustain revenue streams.

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Key Takeaways

• The global ticagrelor market is driven by the high burden of cardiovascular disease and clinical guideline endorsements favoring its use.
• Patent expirations beginning in 2024 pose significant revenue risks, with generic competition expected to intensify.
• AstraZeneca's strategic initiatives—such as expanding indications and developing new formulations—aim to mitigate revenue declines.
• The future financial outlook hinges on successful pipeline development, strategic market access, and navigating regulatory landscapes.
• Embracing personalized medicine and digital health innovations can unlock new revenue avenues and enhance market positioning.

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FAQs

1. When does patent protection for ticagrelor expire, and how will it impact the market?
   The primary patents are expected to expire around 2024–2025, opening the market to generic competitors that could substantially reduce brand revenues.

2. What clinical evidence supports ticagrelor’s market presence?
   The PLATO trial demonstrated ticagrelor's superiority over clopidogrel in reducing major cardiovascular events in acute coronary syndrome patients, supporting its widespread adoption.

3. Are there emerging indications that could extend ticagrelor’s market lifetime?
   Yes, ongoing research into secondary stroke prevention and peripheral arterial disease may expand its use, pending regulatory approval.

4. How does competitive pressure influence ticagrelor's pricing?
   Increased generic competition post-patent expiry will likely lead to significant price reductions, impacting profit margins.

5. What strategies can AstraZeneca pursue to sustain ticagrelor’s revenue growth?
   Strategies include expanding indications, developing combination therapies, optimizing pricing in emerging markets, and pipeline innovation.

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References

1. Global Antiplatelet Market Report 2023.
2. World Health Organization. Cardiovascular Diseases Fact Sheet, 2022.
3. AstraZeneca Annual Reports and Patent Portfolio Updates, 2023.