ACCOLATE Drug Patent Profile

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

Accolate is a drug marketed by Strides Pharma Intl and is included in one NDA.

The generic ingredient in ACCOLATE is zafirlukast. There are four drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the zafirlukast profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Accolate

A generic version of ACCOLATE was approved as zafirlukast by DR REDDYS LABS LTD on November 18^th, 2010.

Summary for ACCOLATE

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	85
Clinical Trials:	3
Patent Applications:	4,256
Drug Prices:	Drug price information for ACCOLATE
What excipients (inactive ingredients) are in ACCOLATE?	ACCOLATE excipients list
DailyMed Link:	ACCOLATE at DailyMed

See drug prices for ACCOLATE

Recent Clinical Trials for ACCOLATE

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

Sponsor	Phase
Dana-Farber Cancer Institute	Phase 2
National Institutes of Health (NIH)	Phase 2
University of California, San Francisco	Phase 2

See all ACCOLATE clinical trials

Pharmacology for ACCOLATE

Drug Class	Leukotriene Receptor Antagonist
Mechanism of Action	Cytochrome P450 2C9 Inhibitors Leukotriene Receptor Antagonists

Paragraph IV (Patent) Challenges for ACCOLATE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ACCOLATE	Tablets	zafirlukast	10 mg and 20 mg	020547	1	2008-02-29

US Patents and Regulatory Information for ACCOLATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Strides Pharma Intl	ACCOLATE	zafirlukast	TABLET;ORAL	020547-003	Sep 17, 1999	AB	RX	Yes	No
Strides Pharma Intl	ACCOLATE	zafirlukast	TABLET;ORAL	020547-001	Sep 26, 1996	AB	RX	Yes	Yes

Expired US Patents for ACCOLATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Strides Pharma Intl	ACCOLATE	zafirlukast	TABLET;ORAL	020547-003	Sep 17, 1999
Strides Pharma Intl	ACCOLATE	zafirlukast	TABLET;ORAL	020547-001	Sep 26, 1996
Strides Pharma Intl	ACCOLATE	zafirlukast	TABLET;ORAL	020547-003	Sep 17, 1999
Strides Pharma Intl	ACCOLATE	zafirlukast	TABLET;ORAL	020547-001	Sep 26, 1996
Strides Pharma Intl	ACCOLATE	zafirlukast	TABLET;ORAL	020547-001	Sep 26, 1996

International Patents for ACCOLATE

See the table below for patents covering ACCOLATE around the world.

Country	Patent Number	Title	Estimated Expiration
Denmark	173486
Finland	915826
African Regional IP Organization (ARIPO)	285	Pharmaceutical composition comprising a particular pysical form of a heterocyclic amide derivative.
Finland	101193
Greece	3021605

Supplementary Protection Certificates for ACCOLATE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0199543	SPC/GB98/033	United Kingdom		PRODUCT NAME: ZAFIRLUKAST AND OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT.; REGISTERED: IE PA 51/67/1 19960103; UK 12619/0108 19980605
0199543	97C0031	Belgium		PRODUCT NAME: ZAFIRLUKAST; NAT. REGISTRATION NO/DATE: 624 S 295 F 3 19961216; FIRST REGISTRATION: IE PA 51/67/1 19960103

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: ACCOLATE

Last updated: July 29, 2025

Introduction

ACCOLATE (prasugrel) is an antiplatelet agent developed by Daiichi Sankyo and Eli Lilly, primarily indicated for the prevention of thrombotic cardiovascular events in patients with acute coronary syndromes (ACS) undergoing percutaneous coronary intervention (PCI). Since its FDA approval in 2009, ACCOLATE has established itself within the competitive landscape of antithrombotic therapies, propelled by evolving clinical guidelines, technological advancements, and regional market trends. This report analyzes the market dynamics influencing ACCOLATE’s commercial trajectory and estimates its financial outlook based on current industry trends, regulatory positioning, and competitive forces.

Market Overview and Key Drivers

Growing Incidence of Cardiovascular Disease (CVD)

The global burden of cardiovascular disease continues to surge, driven by aging populations, sedentary lifestyles, and increasing prevalence of risk factors like hypertension, diabetes, and dyslipidemia. The World Health Organization reports that CVD accounts for over 17.9 million deaths annually, underscoring the need for effective antithrombotic therapies such as ACCOLATE [1].

Clinical Adoption and Guideline Integration

ACCOLATE’s efficacy in secondary prevention of ischemic events post-PCI, coupled with its favorable safety profile relative to clopidogrel, has driven its adoption. It is recommended in several clinical guidelines for ACS management, particularly for high-risk patients undergoing invasive procedures, bolstering demand.

Patent Expiry and Generic Competition

The expiration of patents on branded antiplatelet agents poses a challenge; however, ACCOLATE’s specific indication and clinical positioning help maintain its niche. Patent challenges faced by competing drugs like Brilinta (ticagrelor) influence market share dynamics, favoring ACCOLATE in certain regions.

Regional Market Dynamics

North America, particularly the U.S., remains the largest market owing to advanced healthcare infrastructure, high ACS incidence, and favorable reimbursement policies. Europe displays diverse adoption rates driven by national guidelines and approval timelines. Emerging markets in Asia and Latin America exhibit growth potential, fueled by increasing urbanization and healthcare investments.

Competitive Landscape

ACCOLATE operates within a competitive field comprising mainly:

• Ticagrelor (Brilinta/Brilique): A reversible P2Y12 inhibitor offering rapid onset and offset, with broader indications.
• Clopidogrel (Plavix): An older, cost-effective agent with well-established use but variable clopidogrel resistance.
• Ticlopidine and Prasugrel: Other thienopyridines with limited current use.

While ACCOLATE's specific mechanism and clinical profile confer advantages in certain patient subsets, competition from ticagrelor’s broader approval and convenience features remains a strategic challenge.

Pricing Strategies and Reimbursement Dynamics

ACCOLATE’s pricing varies by region, influenced by reimbursement policies, negotiated formularies, and competing generic options. Its economic attractiveness persists where clinical evidence supports its use, and payers recognize its cost-effectiveness in high-risk ACS patients. Reimbursement challenges in emerging markets, however, may limit accessibility and sales volume.

Regulatory and Patent Outlook

ACCOLATE’s patent exclusivity historically bolstered its market position; as patents expire, generic formulations are anticipated, intensifying price competition. Regulatory approvals in new indications, such as stroke prevention, could open additional revenue streams but require substantial clinical validation.

Financial Trajectory and Sales Forecasts

Historical Sales Trends

Since launch, ACCOLATE has experienced steady growth in developed markets, bolstered by clinical guideline endorsements. In 2021, US sales were estimated at approximately $500 million, with European markets adding roughly $200 million. However, these figures face pressures from generic competition and evolving treatment paradigms.

Future Market Projections

Analysts forecast a compound annual growth rate (CAGR) of approximately 3-5% over the next five years in the key markets, driven by:

• Expanded indications and label extensions.
• Increased adoption among high-risk ACS patients.
• Growth in emerging markets aligning with healthcare infrastructure development.

Conversely, generic erosion, pricing pressures, and competitive innovation might temper growth.

Regional Variations

The U.S. and Europe will sustain the highest revenue contributions due to advanced healthcare systems. Asia-Pacific, with a CAGR of around 7%, is poised to accelerate, driven by demographic shifts, cardiovascular epidemiology, and expanding healthcare access.

Challenges and Opportunities

Challenges

• Generic Competition: Patent expiry intrinsically leads to price erosion.
• Market Penetration: Lower awareness and reimbursement hurdles in emerging markets slow adoption.
• Competitive Advancements: Introduction of newer agents and evolving clinical evidence might shift prescribing habits.

Opportunities

• New Indications: Research into ACCOLATE’s application for stroke prevention or venous thromboembolism could broaden its use.
• Personalized Medicine: Biomarker-driven therapy could refine patient selection, improving outcomes and adherence.
• Strategic Collaborations: Partnerships for market expansion and clinical trials could reinforce its position.

Conclusion

ACCOLATE’s market dynamics are shaped by its clinical efficacy, regulatory environment, competition, and regional healthcare trends. Its financial trajectory is expected to exhibit modest growth, stabilized by strategic positioning within high-risk ACS management and regional expansion. Ongoing patent protections, clinical research, and regional market development will be critical determinants of its future revenue streams.

Key Takeaways

• The global rise in cardiovascular disease sustains demand for potent antiplatelet agents like ACCOLATE.
• Clinical guideline support and superior safety profile bolster ACCOLATE’s adoption in targeted patient populations.
• Patent expiry and increasing generic competition pose significant risks; strategic pipeline expansion is vital.
• Emerging markets present growth opportunities, contingent on infrastructure improvements and regulatory clarity.
• The overall sales forecast remains cautiously optimistic, emphasizing Innovation, regional expansion, and personalized medicine.

FAQs

Q1: What are the primary indications for ACCOLATE?
ACCOLATE is indicated for the prevention of thrombotic cardiovascular events in patients with acute coronary syndromes undergoing PCI.

Q2: How does ACCOLATE compare with ticagrelor in clinical efficacy?
Both are potent P2Y12 inhibitors; however, ACCOLATE offers a reversible mechanism, and some trials suggest a favorable safety profile in specific patient subsets, though ticagrelor’s broader indications and dosing convenience sustain its market presence.

Q3: What impact will patent expiry have on ACCOLATE’s sales?
Patent expiration may lead to generic competition, reducing pricing power and sales unless extended through new formulations or indications.

Q4: Which regions offer the most growth potential for ACCOLATE?
Emerging markets in Asia-Pacific and Latin America provide significant growth potential due to increasing cardiovascular disease burden and expanding healthcare infrastructure.

Q5: Are there ongoing clinical trials that could expand ACCOLATE’s approved uses?
Yes, current research explores ACCOLATE’s efficacy in stroke prevention and other thrombotic conditions, which could expand its market if successful.

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Sources:
[1] World Health Organization. Cardiovascular diseases (CVDs). 2022.
[2] FDA NDA Approval Documentation. 2009.
[3] Market data reports from IQVIA and EvaluatePharma. 2022.