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-seven 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:	1,466
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	10,413,543		Y
Sun Pharm	EZALLOR SPRINKLE	rosuvastatin calcium	CAPSULE;ORAL	208647-002	Dec 18, 2018		DISCN	Yes	No	10,413,543		Y
Sun Pharm	EZALLOR SPRINKLE	rosuvastatin calcium	CAPSULE;ORAL	208647-003	Dec 18, 2018		DISCN	Yes	No	10,413,543		Y
Sun Pharm	EZALLOR SPRINKLE	rosuvastatin calcium	CAPSULE;ORAL	208647-004	Dec 18, 2018		DISCN	Yes	No	10,413,543		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
0521471	0390023-0	Sweden		PRODUCT NAME: ROSUVASTATIN
0521471	0391023-9	Sweden		PRODUCT NAME: ROSUVASTATIN
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	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
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

Introduction to EZALLOR SPRINKLE

EZALLOR SPRINKLE, developed by Sun Pharmaceutical Industries, is a formulation of rosuvastatin designed to address the needs of patients with difficulty swallowing. This medication is indicated for the treatment of various lipid disorders, including hypertriglyceridemia, primary dysbetalipoproteinemia (Type III hyperlipoproteinemia), and homozygous familial hypercholesterolemia (HoFH)[4][5].

Market Overview

The global hypertriglyceridemia therapeutics market, within which EZALLOR SPRINKLE operates, is projected to experience significant growth. This market is expected to register a Compound Annual Growth Rate (CAGR) of 4.09% from 2020 to 2027, driven by the increasing focus of pharmaceutical companies on developing novel drugs for hypertriglyceridemia[1].

Key Market Drivers

• Innovative Formulation: EZALLOR SPRINKLE's unique formulation as extended-release-coated pellets that can be sprinkled over soft food, swallowed whole, or administered via a nasogastric tube, addresses a critical need for patients with swallowing difficulties, particularly in long-term care facilities[4].
• Expanding Indications: The drug is indicated for multiple lipid disorders, broadening its market potential and making it a versatile treatment option[4][5].
• Product Launches and Competition: Recent launches of generic and branded versions of lipid-lowering therapies, such as Mylan's Rosuvastatin Calcium Tablets, contribute to market competition and growth[1].

Regional Market Performance

The North America region is anticipated to be the most lucrative market for hypertriglyceridemia therapeutics during the forecast period. This is attributed to the presence of major pharmaceutical companies and the frequent launch of new products in this region[1].

Financial Projections

• Market Size: The global hypertriglyceridemia therapeutics market is expected to generate revenue of $12,863.1 million by the end of 2027[1].
• Revenue Growth: The CAGR of 4.09% indicates a steady and significant growth trajectory for the market, which bodes well for products like EZALLOR SPRINKLE.
• Competitive Landscape: Key players in the market, including Sun Pharma, are investing heavily in research and development and the launch of novel products, which is expected to support market growth[1].

Product Specifics and Market Impact

• Dosage and Administration: EZALLOR SPRINKLE is available in dose strengths of 5 mg, 10 mg, 20 mg, and 40 mg, with a recommended dosage range of 5 mg to 40 mg once daily. This flexibility in dosing can cater to a wide range of patient needs[4][5].
• Target Population: The product is particularly beneficial for patients in long-term care facilities who have difficulty swallowing, a demographic that accounts for approximately 30% to 35% of long-term care residents[4].

Challenges and Considerations

• Adverse Reactions: Common adverse reactions include headache, myalgia, abdominal pain, asthenia, and nausea. Additionally, there are risks of myopathy and rhabdomyolysis, especially with higher doses and in patients with predisposing factors[4][5].
• Contraindications: The drug is contraindicated in patients with known hypersensitivity to rosuvastatin, active liver disease, and in pregnant or breastfeeding women[5].

Expert Insights

"With the introduction of EZALLOR SPRINKLE, Sun Pharma continues our commitment of providing a portfolio of alternative formulation products to address the needs of people who have difficulty swallowing," said Abhay Gandhi, CEO of Sun Pharma North America. This highlights the company's strategic focus on catering to specific patient needs, which can drive market success[4].

Statistical Highlights

• Market Growth: The global hypertriglyceridemia therapeutics market is expected to grow at a CAGR of 4.09% from 2020 to 2027[1].
• Revenue Projections: The market is projected to reach $12,863.1 million by the end of 2027[1].
• Patient Demographics: Approximately 30% to 35% of long-term care residents have difficulty swallowing, a key target demographic for EZALLOR SPRINKLE[4].

Key Takeaways

• Market Growth Potential: The global hypertriglyceridemia therapeutics market is expected to grow significantly, driven by innovative products like EZALLOR SPRINKLE.
• Regional Dominance: North America is expected to be the most lucrative region for this market.
• Product Innovation: EZALLOR SPRINKLE's unique formulation addresses critical patient needs, particularly in long-term care facilities.
• Financial Projections: The market is projected to reach $12,863.1 million by 2027, indicating a strong financial trajectory.

Frequently Asked Questions (FAQs)

Q: What is EZALLOR SPRINKLE used for? A: EZALLOR SPRINKLE is used as an adjunct to diet for the treatment of adult patients with hypertriglyceridemia, primary dysbetalipoproteinemia (Type III hyperlipoproteinemia), and homozygous familial hypercholesterolemia (HoFH)[4][5].

Q: How is EZALLOR SPRINKLE administered? A: EZALLOR SPRINKLE can be sprinkled over soft food, swallowed whole, or administered via a nasogastric tube[4].

Q: What are the common adverse reactions associated with EZALLOR SPRINKLE? A: Common adverse reactions include headache, myalgia, abdominal pain, asthenia, and nausea[4][5].

Q: What are the contraindications for EZALLOR SPRINKLE? A: The drug is contraindicated in patients with known hypersensitivity to rosuvastatin, active liver disease, and in pregnant or breastfeeding women[5].

Q: What is the projected market size for the global hypertriglyceridemia therapeutics market by 2027? A: The market is expected to generate revenue of $12,863.1 million by the end of 2027[1].

Sources Cited

1. Global Hypertriglyceridemia Therapeutics Market to Generate Revenue of US$12,863.1 Million by end of 2027, Says Coherent Market Insights. Business Wire.
2. EZALLOR SPRINKLE. FDA.
3. Ezallor Sprinkle--a new formulation of rosuvastatin. PubMed.
4. Sun Pharma Launches Ezallor Sprinkle (Rosuvastatin) in the United States. Today's Geriatric Medicine.
5. EZALLOR SPRINKLE. FDA.