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, Alkem Labs Ltd, Amneal, Dr Reddys, Hisun Pharm Hangzhou, Mylan, Prinston Inc, Sigmapharm Labs Llc, Sunshine, and Watson Labs Inc, and is included in ten 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. Four suppliers are listed for this compound. There are four tentative approvals for this compound.

Summary for ticagrelor

International Patents:	147
US Patents:	3
Tradenames:	2
Applicants:	10
NDAs:	10
Drug Master File Entries:	21
Finished Product Suppliers / Packagers:	4
Raw Ingredient (Bulk) Api Vendors:	101
Clinical Trials:	416
Patent Applications:	1,689
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

Recent Clinical Trials for ticagrelor

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

Sponsor	Phase
Zunyi Medical College	Phase 4
Fu Wai Hospital, Beijing, China	Phase 4
Gianluca Di Bella	Phase 3

See all ticagrelor clinical trials

Generic filers with tentative approvals for TICAGRELOR

Applicant	Application No.	Strength	Dosage Form
		90MG	TABLET;ORAL
		90MG	TABLET;ORAL
		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 Cytochrome P450 3A5 Inhibitors Phenylalanine Hydroxylase Activators
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	208567-001	Apr 21, 2023	AB	RX	No	No
Astrazeneca	BRILINTA	ticagrelor	TABLET;ORAL	022433-001	Jul 20, 2011	AB	RX	Yes	Yes
Astrazeneca	BRILINTA	ticagrelor	TABLET;ORAL	022433-002	Sep 3, 2015		RX	Yes	No
Prinston Inc	TICAGRELOR	ticagrelor	TABLET;ORAL	208599-001	Aug 16, 2024	AB	RX	No	No
Astrazeneca	BRILINTA	ticagrelor	TABLET;ORAL	022433-001	Jul 20, 2011	AB	RX	Yes	Yes

Expired US Patents for ticagrelor

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	7,250,419
Astrazeneca	BRILINTA	ticagrelor	TABLET;ORAL	022433-001	Jul 20, 2011	7,265,124
Astrazeneca	BRILINTA	ticagrelor	TABLET;ORAL	022433-001	Jul 20, 2011	6,251,910
Astrazeneca	BRILINTA	ticagrelor	TABLET;ORAL	022433-002	Sep 3, 2015	7,265,124

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/001241 Brilique, 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/002303 Possia, 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
Israel	183969
Japan	7523420
South Korea	100822602
European Patent Office	1135391	NOUVEAUX COMPOSES DE TRIAZOLO(4,5-D)PYRIMIDINE (NOVEL TRIAZOLO(4,5-D)PYRIMIDINE COMPOUNDS)
Czech Republic	300280	Nové slouceniny (Novel compounds)

Supplementary Protection Certificates for ticagrelor

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1135391	91819	Luxembourg		91819, EXPIRES: 20241202
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
1135391	C300485	Netherlands		PRODUCT NAME: TICAGRELOR OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; 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	406	Finland

Ticagrelor Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Ticagrelor

Market Overview

The global ticagrelor market is experiencing significant growth, driven by several key factors. As of 2022, the market was valued at USD 1,672 million and is projected to reach USD 3,692 million by 2031, growing at a Compound Annual Growth Rate (CAGR) of 9.2% during the forecast period of 2023-2031[1].

Key Drivers of Market Growth

Increasing Geriatric Population

The rising geriatric population is a major driver of the ticagrelor market. In the Americas, for instance, the aging population is significant, with around 49.2 million individuals aged 65 or older in 2016, accounting for over 15.2% of the total population. This demographic shift increases the demand for cardiovascular treatments, including ticagrelor[1].

Rising Burden of Heart Diseases

Heart diseases are a leading cause of morbidity and mortality globally. According to the American Heart Association, cardiovascular diseases caused one in every three fatalities in the US in 2014. This increasing burden of heart diseases directly impacts the demand for antiplatelet drugs like ticagrelor[4].

Government Initiatives and Healthcare Quality

In regions like the Asia-Pacific, government initiatives to enhance healthcare quality and the rising incidence of cardiovascular diseases are driving the market growth. China, India, and Australia are particularly lucrative markets for ticagrelor due to these factors[1].

Regional Market Analysis

Americas

The Americas hold the largest share in the global ticagrelor market and are anticipated to grow at a CAGR of 9.31% during the forecast period. This growth is attributed to the sustainable development in GDP per capita income and the increasing geriatric population prone to degenerative diseases and chronic illnesses[1].

Europe

Europe is expected to be the fastest-growing market for ticagrelor. The region benefits from positive reimbursement decisions, such as those made by the Scottish Medicines Consortium (SMC) and the Ministry of Health and Prevention in Denmark, which have approved ticagrelor for national reimbursement[5].

Asia-Pacific

The Asia-Pacific region is also witnessing significant growth due to the increasing per capita income, government initiatives to improve healthcare, and the rising prevalence of cardiovascular diseases. By 2030, the number of older people in this region is expected to increase by 56%, further driving the demand for ticagrelor[1][3].

Dosage and Efficacy

90 mg Segment

The 90 mg segment of ticagrelor holds the highest market share and is expected to grow at a CAGR of 9.47% during the forecast period. This high efficacy and platelet reactivity make AstraZeneca's ticagrelor (Brilinta) 90 mg a preferred treatment for acute coronary syndrome (ACS) and myocardial infarction (MI)[1].

Cost-Effectiveness

Comparative Analysis with Clopidogrel

Studies, such as the PLATO trial, have shown that ticagrelor is cost-effective compared to generic clopidogrel. The additional cost of one year of ticagrelor therapy, relative to clopidogrel, was estimated to be $29,665 per quality-adjusted life-year (QALY) gained, with a high likelihood of cost-effectiveness at a willingness-to-pay threshold of $100,000[2].

Health Economics Substudy

A health economics substudy of the PLATO trial demonstrated that ticagrelor provided a cost-effective gain in QALYs compared to generic clopidogrel. The study showed that ACS patients treated with ticagrelor and aspirin gained an additional 0.13 QALYs at a cost range of €2,350 to €5,700 per QALY[5].

Regulatory Approvals and Reimbursement

FDA Approvals

Significant approvals from regulatory bodies like the U.S. Food and Drug Administration (USFDA) have aided in the growth of the ticagrelor market. For example, in July 2018, the USFDA approved ticagrelor tablets for reducing the rate of cardiovascular deaths and stroke in patients with ACS or a history of myocardial infarction (MI)[4].

Reimbursement Decisions

Positive reimbursement decisions in various countries, such as Scotland and Denmark, have also supported the market growth. These decisions make ticagrelor more accessible to patients, further boosting its market share[5].

Challenges and Limitations

Product Failures

Despite the overall positive trend, instances of product failures can hamper market growth. For example, in October 2016, AstraZeneca's Brilinta (containing 90 mg ticagrelor) failed to demonstrate its benefit over clopidogrel for a new indication in peripheral artery disease (PAD), leading to a temporary decline in market shares[4].

Real-World Use vs. Clinical Trials

There are limitations in translating clinical trial results to real-world use. The PLATO study, while robust, did not consider other antiplatelet strategies like prasugrel or personalized therapy with platelet testing or genotyping, which could affect the cost-effectiveness analysis in real-world scenarios[2].

Market Size and Trends

Historical and Forecast Period

The global ticagrelor market has shown significant growth from its historical period. In 2017, the market was valued at USD 1,145 million and was expected to witness a CAGR of 12.3% during the forecast period of 2018-2026. The current forecast period indicates a continued strong growth trajectory[4].

Key Takeaways

• The global ticagrelor market is projected to grow from USD 1,672 million in 2022 to USD 3,692 million by 2031.
• The Americas hold the largest market share, while Europe is expected to be the fastest-growing region.
• The 90 mg segment of ticagrelor dominates the market due to its high efficacy.
• Ticagrelor is cost-effective compared to generic clopidogrel, with significant gains in QALYs.
• Regulatory approvals and positive reimbursement decisions are crucial for market growth.
• Despite challenges like product failures, the overall market trend remains positive.

FAQs

What is the current market size of ticagrelor and its projected growth?

The global ticagrelor market was valued at USD 1,672 million in 2022 and is estimated to reach USD 3,692 million by 2031, growing at a CAGR of 9.2% during the forecast period[1].

Which region holds the largest share in the ticagrelor market?

The Americas hold the largest share in the global ticagrelor market and are anticipated to grow at a CAGR of 9.31% during the forecast period[1].

How cost-effective is ticagrelor compared to clopidogrel?

Ticagrelor is cost-effective compared to generic clopidogrel, with an additional cost of $29,665 per QALY gained, and a high likelihood of cost-effectiveness at a willingness-to-pay threshold of $100,000[2].

What are the key drivers of the ticagrelor market growth?

The key drivers include the increasing geriatric population, rising burden of heart diseases, and government initiatives to enhance healthcare quality, particularly in the Asia-Pacific region[1][3].

What are the regulatory approvals that have impacted the ticagrelor market?

Significant approvals from the USFDA, such as the approval for ticagrelor tablets in July 2018, and positive reimbursement decisions in countries like Scotland and Denmark have aided in the market growth[4][5].

What challenges might affect the ticagrelor market growth?

Instances of product failures, such as the failure of Brilinta to demonstrate its benefit over clopidogrel for peripheral artery disease, and limitations in translating clinical trial results to real-world use can hamper market growth[2][4].