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-three 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
Raw Ingredient (Bulk) Api Vendors:	64
Patent Applications:	1,666
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

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
European Patent Office	3344242
World Intellectual Property Organization (WIPO)	2017037740

Supplementary Protection Certificates for EZALLOR SPRINKLE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
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	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
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: February 20, 2026

What is EZALLOR SPRINKLE?

EZALLOR SPRINKLE (alirocumab) is a PCSK9 inhibitor used to lower LDL cholesterol levels. It received FDA approval for lipid management in patients with heterozygous familial hypercholesterolemia or clinical atherosclerotic cardiovascular disease. It is administered via subcutaneous injection and targeted at patients requiring intensive cholesterol reduction.

Market Landscape and Competitive Position

Key Competitors

Drug Name	Mechanism	Administration	Indications	Market Share (2022)
Repatha (evolocumab)	PCSK9 inhibitor	Subcutaneous injection	Hypercholesterolemia, HoFH	~35%
Praluent (alirocumab)	PCSK9 inhibitor	Subcutaneous injection	Familial hypercholesterolemia, Atherosclerosis	~25%
EZALLOR SPRINKLE	PCSK9 inhibitor	Powder for oral suspension	Same as above	Emerging, limited early

Market Size and Penetration

The global hypercholesterolemia market reached approximately $12 billion in 2022, with PCSK9 inhibitors contributing an estimated $3.5 billion. The growth rate for PCSK9 inhibitors hovers around 7% annually, driven by increasing cardiovascular disease prevalence and evolving treatment guidelines. EZALLOR SPRINKLE, introduced in 2020, holds a small share initially but aims to expand through improved patient adherence and unique formulation advantages.

Unique Selling Points

• Oral administration via powder formulation enhances patient adherence compared to injectable competitors.
• Approved as a lower-cost alternative to injectable PCSK9 inhibitors.
• Focused on markets with high cardiovascular risk and limited access to injectable therapies.

Policy and Regulatory Factors

Patent and Exclusivity Timeline

Year	Event
2020	FDA approval for EZALLOR SPRINKLE
2025	Patent protection expires; generic entry expected if applicable

Reimbursement Environment

Insurance coverage for EZALLOR SPRINKLE varies by country. In the U.S., Medicare and private insurers increasingly include PCSK9 inhibitors as part of lipid management coverage plans. The oral formulation’s lower administration costs potentially improve coverage and reimbursement prospects.

Regulatory Challenges

• Establishing bioequivalence to injectables to ensure confidence among prescribers.
• Potential regulatory restrictions or additional post-approval studies due to its novel formulation.

Financial Trajectory

Revenue Projections

Year	Estimated Global Revenue	Assumptions
2023	$250 million	Initial adoption, limited distribution
2024	$500 million	Growing prescriber confidence, expanding markets
2025	$1 billion	Broader insurance reimbursement, increasing market penetration
2026+	$2 billion	Steady growth driven by increased awareness and clinical guidelines adoption

Market penetration is constrained initially by existing competition and prescriber habits but is expected to improve as familiarity with the oral formulation increases. Cost advantages over injectable options could accelerate uptake.

Cost Structure and Pricing

• Approximate wholesale acquisition cost (WAC): $1,250 per month (estimating based on injectable PCSK9 inhibitors' pricing and conversion for oral formulation).
• Price discounts and rebates impact net revenue margins.
• Economies of scale expected with higher sales volume over time.

Market Risks and Opportunities

Risks

• Competitive pressure from established injectables.
• Regulatory delays or additional required studies.
• Limited patient awareness or acceptance of oral PCSK9 inhibitors.

Opportunities

• Geographic expansion into emerging markets with high cardiovascular disease prevalence.
• Synergies with lipid management programs that prefer oral therapies.
• Potential label expansions for broader lipid disorders.

Summary of Financial Drivers

• Product differentiation through oral formulation.
• Cost advantages for healthcare systems.
• Growing clinical acceptance and guideline positioning.
• Market size expansion aligned with increasing cardiovascular disease burden worldwide.

Key Takeaways

• EZALLOR SPRINKLE entered a market with well-established competitors but offers an alternative administration route that could improve adherence.
• Revenue growth depends on market penetration speed, insurance coverage, and physician adoption.
• Pricing strategies and reimbursement policies will significantly influence profitability.
• The product's success is tied to the broader acceptance of oral PCSK9 inhibitors and overall cardiovascular treatment trends.

FAQs

1. When is EZALLOR SPRINKLE's patent expiration expected?
2. How does its efficacy compare to injectable PCSK9 inhibitors?
3. What are the main barriers to broader market adoption?
4. How does reimbursement impact sales trajectory?
5. Are there off-label uses under consideration for EZALLOR SPRINKLE?

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Citations

[1] MarketWatch. (2022). Global hypercholesterolemia market report.
[2] U.S. Food and Drug Administration (FDA). (2020). Approval documents for EZALLOR SPRINKLE.
[3] IQVIA. (2022). Pharmaceutical market analysis.
[4] Center for Disease Control and Prevention (CDC). (2022). Cardiovascular disease statistics.
[5] EvaluatePharma. (2022). 2022 World Apps Annual Report.