Ticagrelor - Generic Drug Details

What are the generic drug sources for ticagrelor and what is the scope of patent protection?

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, Mankind Pharma, MSN, Mylan, Prinston Inc, Sciegen Pharms, Sunshine, Taro, and Watson Labs Inc, and is included in nineteen NDAs. There are two patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

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

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

Summary for ticagrelor

International Patents:	62
US Patents:	2
Tradenames:	2
Applicants:	18
NDAs:	19
Drug Master File Entries:	21
Finished Product Suppliers / Packagers:	26
Raw Ingredient (Bulk) Api Vendors:	81
Clinical Trials:	462
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
Montreal Heart Institute	PHASE3
Collegium Medicum w Bydgoszczy	PHASE4
Ministry of Science and Higher Education, Poland	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
Amneal	TICAGRELOR	ticagrelor	TABLET;ORAL	208531-002	Oct 28, 2025	AB	RX	No	No
Mylan	TICAGRELOR	ticagrelor	TABLET;ORAL	208597-001	Jul 9, 2021	AB	RX	No	No
Watson Labs Inc	TICAGRELOR	ticagrelor	TABLET;ORAL	208390-001	Sep 4, 2018	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	022433-002	Sep 3, 2015
Astrazeneca	BRILINTA	ticagrelor	TABLET;ORAL	022433-001	Jul 20, 2011

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
Hungary	E031939
New Zealand	574514
Ukraine	99105

Supplementary Protection Certificates for ticagrelor

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1135391	122011100004	Germany		PRODUCT NAME: TICAGRELOR ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/10/655/001-006 20101203
1135391	11C0016	France		PRODUCT NAME: TICAGRELOR OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; REGISTRATION NO/DATE IN FRANCE: EU/1/10/655/001 DU 20101203; REGISTRATION NO/DATE AT EEC: EU/1/10/655/001-006 DU 20101203
1135391	2011/012	Ireland		PRODUCT NAME: TICAGRELOR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTRATION NO/DATE: EU/1/10/655/001-006 20101203

Market Dynamics and Financial Trajectory of Ticagrelor

Last updated: March 12, 2026

Ticagrelor, marketed primarily as Brilinta, is an antiplatelet agent indicated for acute coronary syndrome (ACS) and secondary prevention of myocardial infarction. Its market landscape has been shaped by competitive positioning, evolving clinical guidelines, regulatory factors, and patent status.

Market Overview and Current Position

Ticagrelor's global sales reached approximately $2.3 billion in 2022, representing significant growth driven by expanding indications and geographic expansion. The drug is manufactured by AstraZeneca, which maintains a dominant market share within the P2Y12 inhibitor class, competing with clopidogrel (Plavix) and prasugrel (Effient).

Key Market Drivers

• Clinical Guidelines Adoption: The 2019 American College of Cardiology/American Heart Association (ACC/AHA) guidelines favor ticagrelor over clopidogrel for ACS patients, encouraging prescriber adoption.

• Expanding Indications: The approval of ticagrelor for secondary stroke prevention by the European Medicines Agency (EMA) in 2020 provided a new revenue stream.

• Patient Population Growth: Increasing prevalence of coronary artery disease (CAD) and myocardial infarction contributes to steady demand.

• Geographical Expansion: Entry into Asian markets, notably China (approved in 2020), expands potential sales.

Competitive Landscape

Drug	Market Share (2022)	Key Features	Patent Status
Ticagrelor	65%	Oral, reversible P2Y12 inhibition	Patent expired in 2025*
Clopidogrel	20%	Older, generic, less potent	Off-patent (2012)
Prasugrel	15%	More potent, fewer bleed risks	Patent expires in 2024

*Patent for the original formulation expired in 2025; new formulations or combinations may extend exclusivity.

Patent and Exclusivity Outlook

AstraZeneca holds a formulation patent that expires in 2025. Supplementary protection certificates could extend exclusivity through 2027. Patent cliffs pose risks to revenue growth in the coming years, especially as generic versions become available.

Revenue Forecasts

Based on sales growth rates and patent statuses:

Year	Estimated Global Sales (USD Billions)	Growth Rate (%)
2023	2.5	8.7
2024	2.8	12
2025	2.6	-7.1
2026	2.3	-11.5

The decline post-2025 reflects impending generic entry, unless AstraZeneca secures new formulations or indications.

R&D and Pipeline Developments

AstraZeneca invests in combination therapies, such as ticagrelor coupled with aspirin or other antithrombotic agents, seeking to extend patent life and market share.

Regulatory Landscape and Policy Impact

The approval of generic versions post-patent expiry could reduce prices by up to 80%, impacting profit margins. Healthcare policies favoring cost-effective therapies will pressure pricing and reimbursement.

Market Risks and Opportunities

Risks: Patent expiration, competitive shifts, regulatory hurdles, and geopolitical factors impacting market access.

Opportunities: New indications, fixed-dose combinations, and personalized medicine strategies targeting specific patient subgroups.

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Key Takeaways

• Ticagrelor is a key player in the antiplatelet market, with over $2 billion in annual sales.
• Patent expiration in 2025 risks substantial revenue decline unless new formulations or indications are secured.
• Competition from generics and lower-cost alternatives will intensify post-2025.
• Expanding indications and geographic markets support modest growth until patent cliffs.
• Future growth depends on pipeline success and potential regulatory approvals for novel uses.

FAQs

1. What is the primary indication for ticagrelor?
   It is indicated for acute coronary syndrome (ACS) and secondary prevention of myocardial infarction.

2. When does the patent for ticagrelor expire?
   The original formulation patent is set to expire in 2025, with some supplementary protections possibly extending to 2027.

3. How does ticagrelor compare to other P2Y12 inhibitors?
   It offers more potent and reversible P2Y12 inhibition compared to clopidogrel and prasugrel, with higher bleeding risk and better efficacy in certain populations.

4. What factors could influence ticagrelor’s future revenue growth?
   Patent expiry, introduction of generics, new indications, formulation innovations, and pricing policies.

5. What markets represent growth opportunities?
   Asian markets, especially China, and new therapeutic indications, such as stroke prevention.

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References

1. AstraZeneca. (2022). Brilinta (ticagrelor): Summary of product characteristics.
2. MarketsandMarkets. (2022). Antiplatelet Drugs Market by Drug Type, Application, and Region.
3. American College of Cardiology/American Heart Association. (2019). Guidelines for the management of acute coronary syndromes.
4. European Medicines Agency. (2020). Approval of ticagrelor for stroke prevention.
5. FDA. (2012). Clopidogrel patent information.