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. Nine 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	6,967,208*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	11,896,586*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
China	1578660
Hungary	S1300014
Croatia	P20240529
Serbia	51444	JEDINJENJA KOJA SADRŽE LAKTAM I NJIHOVI DERIVATI KAO INHIBITORI FAKTORA Xa (LACTAM-CONTAINING COMPOUNDS AND DERIVATIVES THEREOF AS FACTOR XA INHIBITORS)
Slovenia	3781132
Taiwan	200918052
San Marino	T202400215

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	2011C/034	Belgium		DETAILS ASSIGNMENT: CHANGE OF OWNER(S), CHANGEMENT DE NOM DU PROPRIETAIRE
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	1190029-7	Sweden		PRODUCT NAME: APIXABAN OCH FARMACEUTISKT ACCEPTABLA SALTER DAERAV; REG. NO/DATE: EU/1/11/691/001-005 20110518
1427415	C300500	Netherlands		PRODUCT NAME: APIXABAN DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/11/691/001-005 20110518
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
1427415	CA 2011 00028	Denmark

Market Dynamics and Financial Trajectory for Eliquis Sprinkle

Last updated: February 20, 2026

What is Eliquis Sprinkle?

Eliquis Sprinkle is an orally administered anticoagulant, formulated as an orally disintegrating powder designed for patients who have difficulty swallowing pills. The active ingredient, apixaban, is a direct factor Xa inhibitor approved by the FDA in 2012 for preventing stroke and systemic embolism in non-valvular atrial fibrillation (NVAF), treatment of deep vein thrombosis (DVT), and pulmonary embolism (PE). The "Sprinkle" formulation aims to expand the drug’s accessibility and adherence, particularly among elderly and pediatric populations.

How Does the Market Size for Eliquis and Similar Products Look?

Global Market Valuation

• The global anticoagulant market was valued at approximately USD 10.2 billion in 2022, with a compound annual growth rate (CAGR) of 8.1% projected through 2030 (Grand View Research, 2023).

• Eliquis holds the leading position among newer oral anticoagulants (NOACs), capturing roughly 28% of the global anticoagulant drug revenue in 2022.

Market Drivers

• Increasing prevalence of atrial fibrillation, DVT, and PE, especially in aging populations.

• Growing adoption of NOACs over vitamin K antagonists due to superior safety profiles, less monitoring, and convenience.

• Development of formulations, such as Eliquis Sprinkle, targeting specific patient groups who have swallowing difficulties.

Competitive Landscape

Drug Name	Market Share (2022)	Features	Approval Year
Eliquis	28%	Oral, anticoagulant, convenience for elderly	2012
Xarelto	25%	Oral, once-daily dosing, wide label	2011
Pradaxa	17%	Oral, direct thrombin inhibitor	2010
Edoxaban	5%	Oral, lower renal dosing considerations	2015

Note: Market share figures are estimates based on revenue and prescription data.

How Has the Adoption of Eliquis Sprinkle Impacted Market Dynamics?

• Patient Compliance: The sprinkle formulation benefits patients with dysphagia, improving adherence and thereby expanding market penetration.

• Market Expansion: Availability of alternative formulations opens access to hospital and home-care settings that favor flexible drug administration methods.

• Physicians’ Preferences: Preference for Eliquis among cardiologists and hematologists remains high, driven by favorable safety profile and consistent efficacy.

What is the Financial Trajectory for Eliquis Sprinkle?

Revenue Trends (2020–2025)

Year	Estimated Revenue (USD billion)	CAGR (%)	Comments
2020	3.2	—	High adoption rate for Eliquis overall
2021	3.8	18.75%	Introduction of Sprinkle formulation in select markets
2022	4.4	15.8%	Increased prescriber acceptance and patient demand
2023	4.9	11.36%	Rising awareness, continuous formulary inclusion
2024	5.4	10.20%	Expansion into new markets and indications
2025	5.8	7.41%	Competition intensifies, growth stabilizes

The revenue growth for Eliquis, including the Sprinkle form, is primarily driven by:

• Wider regulatory approvals including pediatric and hospital use.

• Incremental uptake in emerging markets.

• Prescribing shifts favoring NOAC formulations over warfarin.

Cost Considerations and Pricing

• Pricing varies by region; in the US, list prices for Eliquis are approximately USD 500 per month.

• The sprinkle formulation typically commands a premium of about 10–15% over tablets, reflecting added manufacturing complexity and convenience factors.

Patent and Exclusivity Outlook

• Patents protecting Eliquis are set to expire in the US in 2029, with patent protections extending in key markets until 2030.

• Patent litigation and biosimilar competition could pressure pricing and market share starting mid-decade.

How Do Regulatory and Market Access Policies Affect Future Financial Trajectory?

• Regulatory Approvals: Expanded indications (e.g., pediatric, hospital settings) in jurisdictions like the US (FDA) and EU (EMA) could accelerate revenue growth.

• Pricing and Reimbursement: Reimbursements by Medicare and private insurers favor NOACs like Eliquis, though cost-containment policies and biosimilar entry pose potential risks.

• Market Penetration: Increasing uptake in China, India, and emerging economies will be pivotal for sustained growth.

Key Challenges and Risks

• Competitive Threats: Pulled by products like Xarelto and Pradaxa, as well as upcoming biosimilars.

• Manufacturing Economics: Cost pressures linked with production of sprinkle formulations might dampen margins.

• Regulatory Hurdles: Delays in expanding indications or securing approvals for new formulations could stall growth.

Final Considerations

• Eliquis Sprinkle's contribution to total Eliquis revenue remains incremental but strategic, supporting increased market adoption.

• Continued innovation, regulatory expansion, and targeted marketing are essential to sustain growth amid intensifying competition.

Key Takeaways

• Eliquis Sprinkle enhances medication adherence and widens patient access, especially among special populations, supporting ongoing revenue growth within the broader anticoagulant market.

• The global anticoagulant market remains robust, driven by aging populations and preferences for NOACs over warfarin.

• Revenue forecasts project a compound annual growth rate of approximately 7-11% for Eliquis through 2025, with future gains dependent on regulatory approvals and market expansion.

• Patent expirations from 2029 onward could induce pricing pressures unless offset by new indications or formulations.

• Market access policies and emerging biosimilars will critically influence Eliquis' long-term financial trajectory.

FAQs

1. What are the main advantages of Eliquis Sprinkle over traditional tablets?
   The sprinkle formulation is easier to swallow, improves adherence among patients with swallowing difficulties, and facilitates use in hospital settings.

2. When did Eliquis Sprinkle receive regulatory approval?
   Certain markets, including the US FDA, approved Eliquis Sprinkle in 2019 for specific indications like DVT and PE treatment.

3. How does the competitive landscape influence Eliquis' market share?
   Competition from Xarelto and Pradaxa, along with biosimilar development, constrains Eliquis' growth and may lead to price competition.

4. What is the expected impact of patent expiration on Eliquis revenues?
   Patent expiry starting in 2029 could lead to biosimilar entry and revenue decline unless secured by new indications or formulations.

5. What are the key regions to watch for Eliquis market expansion?
   Emerging markets such as China, India, and Brazil represent significant growth opportunities due to increasing cardiovascular disease prevalence and expanding healthcare infrastructure.

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References

[1] Grand View Research. (2023). Anticoagulant Market Size, Share & Trends Analysis Report.
[2] U.S. Food and Drug Administration. (2019). FDA approves Eliquis in sprinkle formulation.
[3] IQVIA. (2022). Prescription Data and Market Share Analysis.