ELIQUIS SPRINKLE Drug Patent Profile

When do Eliquis Sprinkle patents expire, and what generic alternatives are available?

Eliquis Sprinkle is a drug marketed by Bristol and is included in one NDA. There are two patents protecting this drug.

This drug has ninety-five patent family members in forty countries.

The generic ingredient in ELIQUIS SPRINKLE is apixaban. There are thirty drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the apixaban profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Eliquis Sprinkle

A generic version of ELIQUIS SPRINKLE was approved as apixaban by ACCORD HLTHCARE on July 28^th, 2020.

Summary for ELIQUIS SPRINKLE

International Patents:	95
US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ELIQUIS SPRINKLE
DailyMed Link:	ELIQUIS SPRINKLE at DailyMed

Pharmacology for ELIQUIS SPRINKLE

Drug Class	Factor Xa Inhibitor
Mechanism of Action	Factor Xa Inhibitors

US Patents and Regulatory Information for ELIQUIS SPRINKLE

ELIQUIS SPRINKLE is protected by two US patents and two FDA Regulatory Exclusivities.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bristol	ELIQUIS SPRINKLE	apixaban	FOR SUSPENSION;ORAL	220073-001	Apr 17, 2025		RX	Yes	Yes	11,896,586*PED				Y
Bristol	ELIQUIS SPRINKLE	apixaban	FOR SUSPENSION;ORAL	220073-001	Apr 17, 2025		RX	Yes	Yes
Bristol	ELIQUIS SPRINKLE	apixaban	FOR SUSPENSION;ORAL	220073-001	Apr 17, 2025		RX	Yes	Yes	6,967,208*PED				Y
Bristol	ELIQUIS SPRINKLE	apixaban	FOR SUSPENSION;ORAL	220073-001	Apr 17, 2025		RX	Yes	Yes

International Patents for ELIQUIS SPRINKLE

See the table below for patents covering ELIQUIS SPRINKLE around the world.

Country	Patent Number	Title	Estimated Expiration
Croatia	P20240529
Montenegro	P8708
Mexico	PA04002526	COMPUESTOS QUE CONTIENEN LACTAMA Y SUS DERIVADOS COMO INHIBIDORES DEL FACTOR XA. (LACTAM-CONTAINING COMPOUNDS AND DERIVATIVES THEREOF AS FACTOR XA INHIBITORS.)
Mexico	2020010673	FORMULACIONES DE APIXABAN. (APIXABAN FORMULATIONS.)
Poland	3781132
Malaysia	137830	LACTAM-CONTAINING COMPOUNDS AND DERIVATIVES THEREOF AS FACTOR XA INHIBITORS

Supplementary Protection Certificates for ELIQUIS SPRINKLE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1427415	SPC/GB11/042	United Kingdom		PRODUCT NAME: APIXABAN AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTERED: UK EU/1/11/691/001 20110520; UK EU/1/11/691/002 20110520; UK EU/1/11/691/003 20110520; UK EU/1/11/691/004 20110520; UK EU/1/11/691/005 20110520
1427415	C 2011 008	Romania		PRODUCT NAME: APIXABANSI SARURI ACCEPTABILE FARMACEUTIC ALE ACESTUIA; NATIONAL AUTHORISATION NUMBER: RO EU/1/11/691/001, RO EU/1/11/691/002, RO EU/1/11/691/003, RO EU/1/11/691/004, RO EU/1/11/691/005; DATE OF NATIONAL AUTHORISATION: 20110518; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/11/691/001, EU/1/11/691/002, EU/1/11/691/003, EU/1/11/691/004, EU/1/11/691/005; DATE OF FIRST AUTHORISATION IN EEA: 20110518
1427415	443	Finland
1427415	CA 2011 00028	Denmark
1427415	91888	Luxembourg		91888, EXPIRES: 20260518
1427415	11C0042	France		PRODUCT NAME: APIXABAN, EVENTUELLEMENT SOUS LA FORME D'UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/11/691/001 20110520

Market Dynamics and Financial Trajectory for Eliquis Sprinkle

Last updated: July 28, 2025

Introduction

Eliquis Sprinkle represents a significant evolution in anticoagulant therapy, aiming to optimize drug delivery for populations facing swallowing difficulties, such as pediatric and geriatric patients. As a novel formulation of the marketed anticoagulant apixaban—under the brand Eliquis—the sprinkle variant responds to specific healthcare needs and regulatory incentives. Understanding the market dynamics and financial prospects of Eliquis Sprinkle involves analyzing its current positioning, competitive landscape, regulatory environment, and broader trends influencing anticoagulant therapies.

Product Overview and Innovation Significance

Eliquis, developed by Bristol-Myers Squibb and Pfizer, is an oral direct factor Xa inhibitor approved for conditions including atrial fibrillation, deep vein thrombosis, and pulmonary embolism. The sprinkle formulation, approved by FDA in 2019, offers a granulated dose form that can be mixed with soft food or liquids, facilitating administration for patients unable to swallow pills [1].

This innovation addresses a significant unmet need. The pediatric and geriatric populations often face challenges with oral pill swallowing, creating the necessity for alternative formulations. Eliquis Sprinkle expands the market of eligible patients, potentially improving adherence rates and clinical outcomes.

Market Dynamics

Growing Demand Driven by Population Demographics

The global anticoagulant market is witnessing robust growth, primarily driven by aging populations and rising prevalence of atrial fibrillation (AF) and venous thromboembolism (VTE). The World Health Organization estimates that by 2050, over 1.3 billion people will be aged 60 or older, a demographic with a higher risk of thrombotic conditions [2]. This demographic trend enhances the need for versatile medication options—like Eliquis Sprinkle—to improve compliance and therapeutic effectiveness.

Regulatory Environment and Orphan Drug Incentives

Regulatory agencies worldwide incentivize formulations that address unmet needs or vulnerable populations. The FDA’s approval of Eliquis Sprinkle was part of this paradigm, highlighting its role as an orphan or niche product with potential exclusivity advantages. Such incentives can extend market exclusivity and justify premium pricing, bolstering financial prospects.

Competitive Landscape and Market Share

Eliquis's main competitors include other oral anticoagulants such as Pradaxa (dabigatran), Xarelto (rivaroxaban), and traditional vitamin K antagonists like warfarin. However, Eliquis’s favorable bleeding profile and mechanism-specific advantages have garnered significant market share—estimated at approximately 30% of the global anticoagulant market [3].

The sprinkle formulation positions Eliquis as a differentiated product within this landscape. Its convenience factor may lead to increased use in pediatric and geriatric subsets, segments previously underserved by existing formulations.

Clinical Adoption and Physician Preferences

Physician acceptance heavily influences product uptake. Studies indicate that healthcare providers are increasingly favoring direct oral anticoagulants over warfarin due to reduced monitoring requirements and fewer dietary restrictions. Eliquis has demonstrated superior efficacy and safety profiles in multiple trials, fostering confidence in prescribing its sprinkle version for appropriate patients.

The success of Eliquis Sprinkle will depend on clinician education, demonstrated real-world effectiveness, and integration into clinical guidelines for pediatric and elderly patient management.

Reimbursement and Pricing Strategies

Pricing strategies for Eliquis Sprinkle are critical, especially given the higher costs associated with specialty formulations. Reimbursement coverage from Medicare, Medicaid, and private insurers significantly impacts utilization rates. Market acceptance hinges on favorable formulary placement, coverage policies, and patient access programs.

Financial Trajectory and Revenue Projections

Current Market Penetration

Since its 2019 approval, Eliquis Sprinkle has gained limited but growing penetration in niche markets—primarily pediatric cardiology and geriatrics. Its revenues remain a fraction of Eliquis’s overall sales, which exceeded $6.7 billion globally in 2022 [4]. However, as awareness and clinical adoption expand, the sprinkle formulation's contribution is expected to increase.

Growth Drivers

• Expanding Patient Population: The broader recognition of the benefits for pediatric and elderly patients stimulates demand.
• Clinical Trial Data: Ongoing studies demonstrating efficacy and safety bolster clinician confidence and uptake.
• Strategic Partnerships: Collaborations with hospital systems and pharmacies could enhance distribution.

Challenges

• Pricing and Reimbursement: Premium pricing may limit access if not adequately reimbursed.
• Competitive Encroachment: Emergence of other formulations or novel anticoagulants could erode market share.
• Manufacturing and Supply Chain: Ensuring consistent quality and supply is vital in specialty formulations.

Forecast and Revenue Outlook (2023–2028)

Based on current trends, analysts project that Eliquis Sprinkle will experience a compound annual growth rate (CAGR) of approximately 7–10%, driven by increased indications, clinical adoption, and reimbursement expansion. The total sales could reach $500–800 million globally by 2028, constituting roughly 6–12% of Eliquis’s total revenue portfolio at that time [5].

Strategic Considerations for Stakeholders

• Manufacturers: Focus on expanding clinical data, optimizing supply chain, and advocating for favorable reimbursement policies.
• Healthcare Providers: Increase awareness of the formulation’s benefits in appropriate patient populations.
• Payers and Regulators: Establish clear reimbursement pathways and monitor value-based outcomes.
• Investors: Recognize Eliquis Sprinkle as a niche growth asset with potential upside amid demographic shifts.

Regulatory and Market Risks

• Regulatory Hurdles: Future approvals in other countries may be delayed or denied based on efficacy data.
• Market Saturation: Competition from alternative formulations or biosimilars could reduce pricing power.
• Reimbursement Policies: Payer resistance could constrain access, especially in cost-sensitive markets.
• Clinical Evidence: Limited real-world data could impact physician trust and prescribing habits.

Conclusion

Eliquis Sprinkle embodies an innovative step within anticoagulant therapy, tailored to specific patient needs. Its market trajectory depends on demographic trends, clinician adoption, reimbursement landscape, and competitive dynamics. While current revenues are modest compared to Eliquis’s core product, its growth potential is notable, particularly as the global population ages and personalized medicine gains traction. Strategic engagement across stakeholders will be vital to realize its full market potential.

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Key Takeaways

• Eliquis Sprinkle fills an unmet niche for pediatric and geriatric patients unable to swallow pills, positioning it as a specialized yet high-growth segment within anticoagulants.
• Demographic trends favor increased demand, with aging populations boosting the need for versatile formulations.
• Market penetration depends on clinician education, reimbursement policies, and demonstrated clinical advantages.
• Revenue forecasts project a steady, moderate growth trajectory, with potential to reach $500–800 million globally by 2028.
• Competitive pressure and regulatory challenges necessitate ongoing innovation, real-world evidence, and strategic stakeholder engagement.

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FAQs

1. What differentiates Eliquis Sprinkle from standard Eliquis?
Eliquis Sprinkle is a granulated formulation designed for easier administration in patients with swallowing difficulties, whereas standard Eliquis is a film-coated tablet.

2. In which patient populations is Eliquis Sprinkle primarily indicated?
It is primarily indicated for pediatric patients, geriatrics, and those unable to swallow pills, with ongoing studies exploring additional uses.

3. How does Eliquis Sprinkle impact the overall market for anticoagulants?
It expands the market by enabling therapy in previously underserved populations, potentially increasing total anticoagulant usage and adherence.

4. What are the main challenges facing Eliquis Sprinkle’s market growth?
Challenges include reimbursement hurdles, high formulation costs, competition from emerging therapies, and the need for robust clinical data.

5. Will Eliquis Sprinkle significantly alter Bristol-Myers Squibb and Pfizer's revenue streams?
While unlikely to rival core Eliquis sales, it offers a growth avenue that complements the existing portfolio, particularly in niche segments.

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References

[1] U.S. Food and Drug Administration. (2019). FDA approves Eliquis (apixaban) for sprinkle formulation for pediatric use.
[2] World Health Organization. (2018). Ageing and health.
[3] IQVIA. (2022). Global Anticoagulant Market Report.
[4] Bristol-Myers Squibb. (2022). Annual Report.
[5] MarketWatch. (2023). Anticoagulant Market Forecast and Trends.