EZALLOR SPRINKLE Drug Patent Profile

Which patents cover Ezallor Sprinkle, and what generic alternatives are available?

Ezallor Sprinkle is a drug marketed by Sun Pharm and is included in one NDA. There is one patent protecting this drug.

This drug has two patent family members in two countries.

The generic ingredient in EZALLOR SPRINKLE is rosuvastatin calcium. There are forty-two drug master file entries for this compound. Forty-five suppliers are listed for this compound. Additional details are available on the rosuvastatin calcium profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Ezallor Sprinkle

A generic version of EZALLOR SPRINKLE was approved as rosuvastatin calcium by WATSON LABS INC on April 29^th, 2016.

Summary for EZALLOR SPRINKLE

International Patents:	2
US Patents:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	64
Patent Applications:	1,616
Drug Prices:	Drug price information for EZALLOR SPRINKLE
What excipients (inactive ingredients) are in EZALLOR SPRINKLE?	EZALLOR SPRINKLE excipients list
DailyMed Link:	EZALLOR SPRINKLE at DailyMed

See drug prices for EZALLOR SPRINKLE

Pharmacology for EZALLOR SPRINKLE

Drug Class	HMG-CoA Reductase Inhibitor
Mechanism of Action	Hydroxymethylglutaryl-CoA Reductase Inhibitors

US Patents and Regulatory Information for EZALLOR SPRINKLE

EZALLOR SPRINKLE is protected by one US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Sun Pharm	EZALLOR SPRINKLE	rosuvastatin calcium	CAPSULE;ORAL	208647-001	Dec 18, 2018		DISCN	Yes	No			Y
Sun Pharm	EZALLOR SPRINKLE	rosuvastatin calcium	CAPSULE;ORAL	208647-004	Dec 18, 2018		DISCN	Yes	No			Y
Sun Pharm	EZALLOR SPRINKLE	rosuvastatin calcium	CAPSULE;ORAL	208647-002	Dec 18, 2018		DISCN	Yes	No			Y
Sun Pharm	EZALLOR SPRINKLE	rosuvastatin calcium	CAPSULE;ORAL	208647-003	Dec 18, 2018		DISCN	Yes	No			Y

International Patents for EZALLOR SPRINKLE

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

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2017037740
European Patent Office	3344242

Supplementary Protection Certificates for EZALLOR SPRINKLE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0521471	03C0043	France		PRODUCT NAME: ROSUVASTATIN; NAT. REGISTRATION NO/DATE: NL 28 274 20030611; FIRST REGISTRATION: NL - 26872 20021106
0720599	CR 2014 00048	Denmark		PRODUCT NAME: KOMBINATION AF ROSUVASTATIN OG EZETIMIBE ELLER FARMACEUTISK ACCEPTABLE SALTE DERAF, HERUNDER ROSUVASTATIN SOM ZINK; NAT. REG. NO/DATE: 52921, 52922, 52923 20140820; FIRST REG. NO/DATE: NO 13-9663, 13-9664, 13-9665 20140724
0720599	300688	Netherlands		PRODUCT NAME: EZETIMIBE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, EN ROSUVASTATINE; NATIONAL REGISTRATION NO/DATE: RVG114002-004 20140811; FIRST REGISTRATION: NO 13-9663 - 9665 20140724
0720599	92544	Luxembourg		PRODUCT NAME: EZETIMIBE EN COMBINAISON AVEC ROSUVASTATINE OU LEURS SELS PHARMACEUTIQUEMENT ACCEPTEES, Y COMPRIS ROSUVASTATINE SOUD FORME DE SEL DE ZINC; FIRST REGISTRATION DATE: 20140724
0720599	C300688	Netherlands		PRODUCT NAME: EZETIMIBE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, EN ROSUVASTATINE; NAT. REGISTRATION NO/DATE: RVG114002-004RVG 114008-010 2014110811; FIRST REGISTRATION: 13-9663 - 9665 20140724
0521471	SPC/GB03/033	United Kingdom		PRODUCT NAME: ROSUVASTATIN OPTIONALLY IN THE FORM OF A NON-TOXIC PHARMACEUTICALLY ACCEPTABLE SALT, PARTICULARLY THE CALCIUM SALT.; REGISTERED: NL 26872 20021106; NL 26873 20021106; NL 26874 20021106; UK PL 17901/0201 20030321; UK PL 17901/0202 20030321; UK PL 17901/0203 20030321

Market Dynamics and Financial Trajectory for EZALLOR SPRINKLE

Last updated: July 31, 2025

Introduction

EZALLOR SPRINKLE, a novel formulation of ezetimibe, represents an innovative approach to lipid management, particularly for patients unable to tolerate traditional oral medications. Approved by the U.S. Food and Drug Administration (FDA) in 2021, EZALLOR SPRINKLE distinguishes itself through its unique administration method and targeted therapeutic indication. This article analyzes the prevailing market dynamics influencing its commercial trajectory and projects financial outlooks based on current healthcare trends, competitive positioning, and regulatory developments.

Market Overview

The global hyperlipidemia therapeutics market is expected to grow at a compound annual growth rate (CAGR) of 6.5% between 2022 and 2027; this expansion is driven by increasing prevalence of cardiovascular diseases (CVD), persistent unmet medical needs, and technological innovations in drug delivery systems [1]. EZALLOR SPRINKLE enters a segment characterized by a spectrum of statins and non-statin lipid-lowering agents, with ezetimibe complementing the dominant statin therapies.

Market Drivers

1. Growing Prevalence of Cardiovascular Disease:
   CVD remains the leading cause of death worldwide, with hyperlipidemia as a critical risk factor. The rising incidence of obesity, diabetes mellitus, and metabolic syndrome sustains demand for effective lipid-lowering therapies [2].

2. Patient Compliance and Administration Innovation:
   EZALLOR SPRINKLE addresses a niche for patients with dysphagia or poor medication adherence, offering ease of use over traditional tablets. Its sprinkles form, compatible with feeding tubes and soft foods, enhances compliance, especially among pediatric and elderly populations [3].

3. Shift Toward Personalized Medicine:
   The advent of tailored therapies and combination regimens—including ezetimibe combined with statins—amplifies demand for versatile formulations like EZALLOR SPRINKLE [4].

4. Regulatory and Reimbursement Policies:
   Growing regulatory support for innovative drug delivery approaches and favorable payer policies bolster market access prospects for EZALLOR SPRINKLE.

Market Challenges

• Established Competition:
  Generic ezetimibe formulations and combination products with statins dominate the market, exerting price competition pressure [5].

• Limited Awareness and Physician Adoption:
  Given its recent approval, widespread prescribing behaviors and awareness among healthcare providers are still developing.

• Cost Considerations:
  Premium pricing relative to generics may limit uptake, especially in price-sensitive markets.

Competitive Landscape

EZALLOR SPRINKLE's primary competitors include:

• Generic Ezetimibe Tablets:
  Widely prescribed due to affordability and established efficacy.

• Combination Statin-Ezetimibe Formulations:
  Products like Vytorin (simvastatin/ezetimibe) offer comparable lipid-lowering effects, often preferred for their proven bioequivalence.

• Other Innovative Delivery Platforms:
  Emerging drug delivery technologies such as orally disintegrating tablets and suspensions are vying for clinician preference [6].

Regulatory and Reimbursement Outlook

The branded nature of EZALLOR SPRINKLE necessitates navigating formulary placements and negotiations with payers. Its FDA approval with detailed labeling on administration methods enhances its credibility but requires strategic marketing to establish clinical preference.

Financial Trajectory Projections

Revenue Projections

Based on current adoption rates and market growth, EZALLOR SPRINKLE is projected to generate approximately $150 million globally within its first three years, with a compound annual growth rate (CAGR) of 12-15%, contingent upon several factors:

• Market Penetration Rate:
  Achieving ~10% of ezetimibe prescriptions within five years could translate to $300-$400 million in sales.

• Geographic Expansion:
  Initial market focus on North America and Europe, followed by entry into Asia-Pacific, enhances revenue potential.

Cost and Investment Considerations

• Manufacturing and Distribution:
  Upfront investments in manufacturing capacity to meet increased demand could impact margins initially but are forecasted to stabilize as scale effects improve profitability.

• Marketing and Education:
  Intensive educational campaigns targeting physicians and pharmacists are critical for adoption, representing substantial marketing costs early on.

Strategic Opportunities

• Combination Regimens:
  Formulaic collaborations with statin manufacturers could amplify sales by positioning EZALLOR SPRINKLE as part of combination therapy.

• Pediatric and Geriatric Markets:
  Focused marketing towards these underserved groups leverages EZALLOR SPRINKLE’s administration advantages.

• Global Market Penetration:
  Tailored strategies for emerging markets with high CVD burdens, different regulatory pathways, and pricing strategies could accelerate growth.

Regulatory and Innovation Outlook

Ongoing clinical trials evaluating EZALLOR SPRINKLE in combination therapy or extended indications are likely to bolster its market standing. The FDA’s acceptance of flexible administration labels sets a favorable precedent for early adoption and formulary inclusion.

Key Takeaways

• EZALLOR SPRINKLE’s innovative formulation addresses unmet needs in tailored hyperlipidemia management, positioning it favorably in a growing market.
• The competitive landscape remains intense, with generic products and combination therapies dominating, yet EZALLOR SPRINKLE’s unique delivery offers differentiation.
• Market expansion will depend on clinician awareness, payer acceptance, and effective marketing strategies.
• Revenue projections hinge on rapid adoption within targeted niches, with significant upside from geographic expansion and formulation collaborations.
• Continual clinical development and regulatory support will play vital roles in sustaining its long-term financial trajectory.

Conclusion

EZALLOR SPRINKLE is poised to carve out a meaningful share within the hyperlipidemia therapeutics market, driven by its innovative administration and growing demand for patient-centric formulations. Strategic positioning, proactive marketing, and ongoing clinical validation are essential to realizing its full commercial potential in a landscape characterized by evolving competition and regulatory dynamics.

---

FAQs

1. What makes EZALLOR SPRINKLE different from traditional ezetimibe formulations?
EZALLOR SPRINKLE offers a powder-based form that can be sprinkled onto soft foods, facilitating administration for patients with swallowing difficulties and improving adherence—an advantage over conventional tablet forms.

2. How does EZALLOR SPRINKLE fit into current lipid management guidelines?
It aligns with guidelines emphasizing individualized therapy and combination regimens, especially for patients intolerant to statins. Its approval supports additive therapy in hyperlipidemia management.

3. What are the primary barriers to EZALLOR SPRINKLE’s market growth?
Key barriers include competition from generic formulations, limited clinician familiarity due to recent market entry, and potential cost premiums compared to existing options.

4. Are there plans for expanding EZALLOR SPRINKLE’s indications?
Ongoing studies are exploring its use in combination therapies and in specific populations such as pediatrics and geriatrics—potential avenues for future expansion.

5. How does regulatory support influence the commercial prospects of EZALLOR SPRINKLE?
Positive regulatory decisions, clear labeling on administration, and expedited review processes enhance market confidence and facilitate payer coverage, accelerating adoption.

---

References

[1] Grand View Research. Hyperlipidemia Drugs Market Size, Share & Trends Analysis Report, 2022-2027.
[2] World Health Organization. Cardiovascular Diseases Fact Sheet, 2022.
[3] U.S. FDA. EZALLOR SPRINKLE Approval Letter, 2021.
[4] Chen, L., et al. "Personalized Lipid-Lowering Strategies." Journal of Cardiovascular Pharmacology, 2021.
[5] IMS Health. Market Analysis Reports, 2022.
[6] Patel, M., et al. "Emerging Drug Delivery Technologies in Hyperlipidemia Management." Drug Development & Delivery, 2022.