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.

The generic ingredient in BRILINTA is ticagrelor. There is one drug master file entry for this compound. Twenty-nine 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

US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	81
Clinical Trials:	89
Patent Applications:	1,722
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
University of Cincinnati	Phase 2/Phase 3
Janssen Scientific Affairs, LLC	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	022433-002	Sep 3, 2015
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	022433-002	Sep 3, 2015
Astrazeneca	BRILINTA	ticagrelor	TABLET;ORAL	022433-001	Jul 20, 2011

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

Chile

Colombia

Israel

Japan

Malaysia

Mexico

New Zealand

Norway

Philippines

Portugal

Russian Federation

Serbia

Spain

Taiwan

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
Australia	2016210973
Brazil	112017015840
Canada	2974894
China	107530363
China	112274519

Supplementary Protection Certificates for BRILINTA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1135391	C300485	Netherlands		PRODUCT NAME: TICAGRELOR OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/10/655/001-006 20101203
1135391	CA 2011 00013	Denmark		PRODUCT NAME: TICAGRELOR ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF
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	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

BRILINTA (ticagrelor) Market Dynamics and Financial Trajectory: Sales Mix, Competitive Pressure, Patent/Exclusivity-Driven Outlook, and EBITDA Implications

Last updated: May 19, 2026

BRILINTA (ticagrelor) sales have been pressured by double-source erosion risk over time, payer and formulary optimization toward cost-efficient alternatives, and expanding competition in acute coronary syndrome (ACS) and chronic coronary disease (CCD) subsets. Commercial trajectory is driven by (1) uptake into label-expanding populations (including CCD), (2) the intensity of generic/biosimilar-like substitutes at the API level (where patent fences allow), and (3) the ability to defend higher net prices via contracting, manufacturer rebates, and restricted formularies.

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BRILINTA sales trajectory: How have global revenues for ticagrelor evolved and what is driving change?

Answer: BRILINTA revenue growth in the mid-to-late decade was dominated by sustained ACS penetration and later life-cycle expansion into CCD per guideline adoption. The subsequent trajectory has depended on net price versus volume mix, especially in countries with aggressive tendering and mandatory discounting. Ticagrelor’s market share has also been affected by switching dynamics relative to clopidogrel and, to a lesser degree, prasugrel in PCI-heavy segments.

Commercial drivers of BRILINTA revenue

1) Indication mix and guideline adherence

• ACS (including NSTEMI/UA and STEMI contexts) historically anchored demand.
• CCD adoption (notably for patients with prior MI and/or established CAD at high ischemic risk) has supported incremental prescriptions after initial ACS penetration cycles.

2) Net price erosion vs volume resilience

• Contracting and payer controls shape net pricing. Even when prescription counts remain stable, revenue can decline with higher rebates or broader access to lower-cost alternatives.
• In tender-driven systems, brand demand can re-rate quickly after price revisions.

3) Formulary status and hospital procurement

• PCI centers with standardized antiplatelet pathways can maintain brand preference longer.
• Community hospitals and payer tiers shift faster when cost-effectiveness thresholds tighten.

Market structure: who buys and how?

• Primary buyers are hospitals, integrated delivery networks, and payer systems covering outpatient continuity therapy after an index ACS event.
• Brand uptake is influenced by patient selection criteria, discharge antiplatelet protocols, and payor utilization management.

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How does BRILINTA compete with clopidogrel and prasugrel in acute coronary syndrome and chronic coronary disease?

Answer: BRILINTA competes on efficacy versus clopidogrel, primarily through stronger platelet P2Y12 inhibition and clinical outcome data that support use in selected ACS/CCD populations. Competition is strongest where clopidogrel is dominant on cost and where patient selection thresholds favor less expensive options.

Comparator dynamics

Clopidogrel

• Clopidogrel remains a high-usage comparator because of lower acquisition cost and broad access.
• Switch risk rises when formulary pressure increases or when clinicians de-escalate for bleeding risk tolerability considerations.

Prasugrel

• Prasugrel is a closer clinical competitor in PCI-heavy populations where guidelines may support its use in appropriate patients.
• Uptake depends on eligibility criteria, including prior stroke/TIA contraindications, and local comfort with prasugrel pathways.

Where ticagrelor gains or loses share

• Gains: higher-risk ACS/CCD patients, populations aligned with guideline emphasis on potent P2Y12 therapy, and centers with entrenched ticagrelor protocols.
• Loses: bleeding-risk constrained cohorts, and regions where payer contracting pushes toward lower-cost generics or alternative brands.

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What patent estate protects BRILINTA (ticagrelor) and how does it shape future market exclusivity?

Answer: BRILINTA’s commercial ceiling has been defined by a layered patent estate covering the drug substance, compositions, and life-cycle enhancements. This estate influences the timing and likelihood of generic entry at the tablet level, and it also affects what “workarounds” competitors can pursue through formulation or manufacturing design.

Patent estate mechanics that matter commercially

1) Composition-of-matter vs method/use

• If composition-of-matter claims are still in force, generic entry generally cannot proceed regardless of labeling or use statements.
• Method-of-use or therapeutic indication claims can delay certain generics for specific labeled indications if they must carve around protected uses.

2) Formulation and manufacturing patents

• For oral solid dosage drugs like ticagrelor tablets, formulation and manufacturing patents can extend exclusivity by blocking a subset of acceptable generic production methods or bioequivalence equivalence strategies.

Exclusivity-driven implications for finance

• Patent strength determines how long AstraZeneca-like branded pricing power persists.
• When patent fences fall, market access often changes abruptly, driving rapid revenue declines even if prescription volumes initially hold.

Note: Specific patent numbers, jurisdictions, and expiration dates are not provided in the available input, so no precise expiration timeline is included.

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When does BRILINTA lose exclusivity and what generic entry risks exist?

Answer: The risk of generic or competing branded erosion is tied to the earliest date when all legally relevant barriers fall away: primary substance claims, key composition or formulation patents, and any exclusivity extensions that survive into the tablet launch window.

Generic entry risk framework

1) Timeline mapping

• Earliest entry risk is determined by the earliest patent expiration or invalidation that blocks a full generic tablet launch.
• Secondary barriers include formulation and method-of-use claims that can force label carve-outs or litigation-driven delays.

2) Litigation-driven delays

• Paragraph IV challenges (in markets using Hatch-Waxman-style mechanisms) can shift launch timing via automatic stays and settlement agreements.

3) Commercial impact of entry

• Generic availability typically triggers sharp net price declines within 1 to 3 quarters once supply and contracting align.
• Contracting response can produce faster declines in tender countries.

No specific expiration date or Paragraph IV history is included due to insufficient structured inputs in the prompt.

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What is the FDA status of BRILINTA (Orange Book listings) and how does it affect generic launch timing?

Answer: FDA approval status and Orange Book listings determine the listed patents that potential generic applicants must address. Those listings also define whether a generic can launch without a paragraph IV challenge or must litigate.

How Orange Book listings connect to financial outcomes

• Orange Book patents create legal landing points for challengers and shape the probability and timing of generic entry.
• Orange Book completeness and claim scope influence whether competitors can use design-around routes.

Orange Book listing details are not provided in the available input, so no Orange Book-specific table is included.

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BRILINTA settlement agreements and patent litigation: what events have influenced competitive entry?

Answer: Patent settlements can compress or extend generic entry timing through agreed launch dates, exclusivity payments, and shared-market allocation terms.

Commercial pathways affected by litigation

• Delays achieved through injunctions or stays preserve price premium.
• Settlements with carve-outs can keep competition limited to non-overlapping indications or dose strengths, lowering revenue impact versus a full molecule generic launch.

Specific litigation case identifiers and settlement dates are not provided in the prompt, so no event list is included.

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What formulations of ticagrelor are relevant to BRILINTA’s market competitiveness and generic substitution?

Answer: Ticagrelor is marketed as oral tablets (including common strengths such as 60 mg and 90 mg in labeled dosing regimens). Generic substitution largely depends on bioequivalence and whether patents restrict specific dosage forms or manufacturing methods.

Formulation-driven issues that affect entry

• Bioequivalence requirements determine whether a generic can launch without additional clinical bridging.
• Formulation patents can block certain tablet characteristics or manufacturing steps even when the active ingredient is the same.

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How strong is the patent strength for BRILINTA versus other antiplatelet drugs: clopidogrel and prasugrel?

Answer: Ticagrelor’s patent strength historically has mattered because it kept a high-potency brand option protected long enough to sustain pricing premiums and maintain guideline-driven uptake. Comparatively, clopidogrel’s commercial landscape is driven by widespread generic access, reducing long-term brand pricing power. Prasugrel’s protection also determines brand longevity, but ticagrelor’s distinct clinical positioning in ACS/CCD segments has supported sustained demand relative to less potent comparators.

A quantified comparative patent-strength scoring table cannot be produced without patent lists and expiration dates for each molecule.

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Commercial exposure: Which geographies and payer systems drive BRILINTA revenue sensitivity to competition?

Answer: Revenue sensitivity is highest in markets with:

• tender or competitive bidding,
• strict formulary controls,
• rapid uptake of low-cost alternatives once legal barriers fall,
• reimbursement mechanisms that penalize high-cost brands.

Geography-level risk model (directional)

• Highest risk: price-controlled and tender-heavy markets where brand switching can occur quickly.
• Moderate risk: markets with hospital protocol continuity and clinician-led brand persistence.
• Lower risk: regions with weaker tender dynamics and stronger guideline-driven adherence to potent P2Y12 inhibition.

No region-level sales data is provided in the prompt, so no numeric geography breakdown is included.

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Financial trajectory through the competitive cycle: how do price erosion and volume changes map to profitability?

Answer: BRILINTA’s profit impact is dominated by net price erosion and rebate intensity more than by changes in gross margins tied to manufacturing efficiency. After generic entry, revenue typically drops faster than fixed-cost absorption declines, compressing operating income. Before entry, revenue quality depends on formulary retention, hospital protocol behavior, and payer contracting outcomes.

A practical P&L bridge (generic entry scenario, directional)

• Volume: often declines sharply once generic offers a materially lower net price.
• Net revenue: declines quickly due to contracting, rebates, and payor switching.
• Gross margin: may compress if the company must increase promotional spending or concessions to retain share; manufacturing unit costs can be offset by scale effects, but that usually does not prevent top-line compression.
• Operating margin: compresses first, then stabilizes if legal barriers delay and the company maintains price premium.

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What market share and revenue metrics should be tracked for BRILINTA going forward?

Answer: Track the following leading indicators to anticipate revenue inflection points:

• share of prescriptions in ACS and CCD subsets,
• tender and formulary status changes,
• net price trends (rebates and discounts intensity),
• share of hospital discharges using ticagrelor versus other P2Y12 inhibitors,
• payer restriction moves (step therapy rules and prior authorization).

No dataset is supplied for actual metric values, so metrics are listed as decision indicators rather than reported numbers.

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Key Takeaways

• BRILINTA’s financial trajectory is driven by indication mix (ACS and CCD), payer net pricing, and formulary continuity more than by raw market size.
• Competition from clopidogrel and prasugrel is strongest where cost and bleeding-risk management favors lower-cost options or alternative potency strategies.
• Future exclusivity and generic entry timing are determined by BRILINTA’s layered patent estate and any paragraph IV-style litigation and settlement events, but specific dates and case details are not provided here.
• Profitability sensitivity is highest to net price erosion and rebate intensity, not only to volume declines.

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FAQs

1) What is BRILINTA’s primary market demand driver: ACS or chronic coronary disease?
ACS drives index event prescriptions, while CCD supports longer duration of brand relevance through ongoing guideline-based secondary prevention in selected patients.

2) How quickly do BRILINTA revenues typically react after generic entry in tender-driven countries?
Typically within 1 to 3 quarters as contracting and formulary switching align with supply.

3) Does payer formulary status impact BRILINTA demand more than clinical evidence?
Formulary and reimbursement rules often determine realized market access, which can override clinical preference by restricting patient and prescriber options.

4) What competitive threat is more material to BRILINTA: clopidogrel price compression or prasugrel guideline placement?
Clopidogrel price compression is generally the larger systemic threat due to widespread lower-cost access, while prasugrel is a meaningful competitor in PCI-centric pathways.

5) What should investors or partners monitor to forecast BRILINTA’s next revenue inflection?
Net price and rebate intensity, formulary/tender outcomes, and legal timeline milestones tied to the relevant patent and regulatory barriers.

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References (APA)

1. U.S. Food and Drug Administration. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. (Accessed via FDA resources).
2. European Medicines Agency. EPAR product information for BRILINTA (ticagrelor). (Accessed via EMA resources).
3. Clinical guideline publications supporting ticagrelor use in ACS and CCD populations. (Accessed via major cardiology guideline sources).

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