ASPRUZYO SPRINKLE Drug Patent Profile

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

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

This drug has one patent family member in one country.

The generic ingredient in ASPRUZYO SPRINKLE is ranolazine. There are twenty-three drug master file entries for this compound. Twenty-seven suppliers are listed for this compound. Additional details are available on the ranolazine profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Aspruzyo Sprinkle

A generic version of ASPRUZYO SPRINKLE was approved as ranolazine by CHARTWELL RX on July 29^th, 2013.

Summary for ASPRUZYO SPRINKLE

International Patents:	1
US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Drug Prices:	Drug price information for ASPRUZYO SPRINKLE
What excipients (inactive ingredients) are in ASPRUZYO SPRINKLE?	ASPRUZYO SPRINKLE excipients list
DailyMed Link:	ASPRUZYO SPRINKLE at DailyMed

See drug prices for ASPRUZYO SPRINKLE

Pharmacology for ASPRUZYO SPRINKLE

Drug Class	Anti-anginal
Mechanism of Action	Cytochrome P450 2D6 Inhibitors Cytochrome P450 3A Inhibitors Organic Cation Transporter 2 Inhibitors P-Glycoprotein Inhibitors

US Patents and Regulatory Information for ASPRUZYO SPRINKLE

ASPRUZYO SPRINKLE is protected by two US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Spil	ASPRUZYO SPRINKLE	ranolazine	GRANULES, EXTENDED RELEASE;ORAL	216018-002	Feb 28, 2022		DISCN	Yes	No			Y
Spil	ASPRUZYO SPRINKLE	ranolazine	GRANULES, EXTENDED RELEASE;ORAL	216018-002	Feb 28, 2022		DISCN	Yes	No			Y
Spil	ASPRUZYO SPRINKLE	ranolazine	GRANULES, EXTENDED RELEASE;ORAL	216018-001	Feb 28, 2022		DISCN	Yes	No			Y

EU/EMA Drug Approvals for ASPRUZYO SPRINKLE

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Menarini International Operations Luxembourg S.A. (MIOL)	Ranexa (previously Latixa)	ranolazine	EMEA/H/C/000805 Ranexa is indicated as add-on therapy for the symptomatic treatment of patients with stable angina pectoris who are inadequately controlled or intolerant to first-line anti-anginal therapies (such as beta-blockers and / or calcium antagonists).,	Authorised	no	no	no	2008-07-08

International Patents for ASPRUZYO SPRINKLE

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

Country	Patent Number	Title	Estimated Expiration
European Patent Office	3409273	FORMULATIONS MULTIPARTICULAIRES À LIBÉRATION PROLONGÉE DE RANOLAZINE (EXTENDED RELEASE MULTIPARTICULATES OF RANOLAZINE)

Supplementary Protection Certificates for ASPRUZYO SPRINKLE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1109558	09C0001	France		PRODUCT NAME: RANOLAZINE; REGISTRATION NO/DATE: EU/1/08/462/001-006 20080714
1109558	2008/034	Ireland		PRODUCT NAME: RANOLAZINE OR A SALT THEREOF; REGISTRATION NO/DATE: EU/1/08/462/001 20080709
1109558	SPC/GB08/058	United Kingdom		PRODUCT NAME: RANOLAZINE OR A SALT OR SOLVATE THEREOF; REGISTERED: UK EU/1/08/462/001 20080714; UK EU/1/08/462/002 20080714; UK EU/1/08/462/003 20080714; UK EU/1/08/462/004 20080714; UK EU/1/08/462/005 20080714; UK EU/1/08/462/006 20080714

ASPRUZYO SPRINKLE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Aspruzyo Sprinkle

Introduction

Aspruzyo Sprinkle, a brand name of the drug ranolazine, was approved by the FDA on February 28, 2022, for the treatment of chronic angina. This article delves into the market dynamics and financial trajectory of Aspruzyo Sprinkle, including its indications, dosage, market positioning, and the broader pharmaceutical market context.

Indications and Dosage

Aspruzyo Sprinkle is specifically indicated for the treatment of chronic angina. It can be used in conjunction with other cardiovascular medications such as beta-blockers, nitrates, calcium channel blockers, anti-platelet therapy, lipid-lowering therapy, ACE inhibitors, and angiotensin receptor blockers[2][4][5].

The recommended initial dose is 500 mg orally twice daily, which can be increased to 1000 mg orally twice daily based on clinical symptoms. The maximum daily dose is 2000 mg (1000 mg twice daily)[2][5].

Market Positioning

Aspruzyo Sprinkle enters a market dominated by existing treatments for chronic angina. However, its unique formulation as extended-release granules offers a different delivery method compared to the traditional extended-release tablets of ranolazine. This can be particularly beneficial for patients who have difficulty swallowing tablets, as Aspruzyo Sprinkle can be administered with soft food or via nasogastric and gastric tubes[5].

Competitive Landscape

The pharmaceutical market for cardiovascular treatments is highly competitive. Aspruzyo Sprinkle competes with other branded and generic versions of ranolazine, as well as other classes of drugs used to treat angina. The market is also influenced by the presence of strong generic competitors, which can significantly impact the pricing and market share of branded drugs[3].

Pricing and Accessibility

The pricing of Aspruzyo Sprinkle is a critical factor in its market dynamics. Given the high costs associated with many branded pharmaceuticals, the affordability of Aspruzyo Sprinkle will be a key determinant of its adoption. The Inflation Reduction Act and other policy initiatives aimed at controlling drug prices could impact the financial trajectory of Aspruzyo Sprinkle by potentially reducing its revenue through negotiated prices with Medicare and other payers[3].

Regulatory Environment

The regulatory environment plays a significant role in the market dynamics of pharmaceuticals. Aspruzyo Sprinkle is contraindicated in patients taking strong inhibitors or inducers of CYP3A4 and those with liver cirrhosis. These contraindications, along with warnings for QT interval prolongation and renal failure, must be carefully managed to ensure patient safety and compliance with regulatory requirements[2][5].

Financial Trajectory

Approval and Launch

The FDA approval of Aspruzyo Sprinkle marked a significant milestone for Sun Pharma, the manufacturer. However, the financial success of the drug depends on several factors, including market acceptance, pricing strategies, and competition from generic alternatives. As of the latest updates, the formulations of Aspruzyo Sprinkle have been discontinued, which significantly impacts its financial trajectory[1].

Revenue Projections

Given the discontinuation of Aspruzyo Sprinkle formulations, any initial revenue projections would need to be revised. The drug's market performance was expected to be influenced by its unique formulation and the growing need for effective treatments for chronic angina. However, without ongoing sales, the financial trajectory is now limited.

Impact of Generic Competition

The presence of generic versions of ranolazine would have likely impacted the revenue of Aspruzyo Sprinkle. Generic drugs are generally more affordable and can capture a significant market share, reducing the revenue potential for branded drugs like Aspruzyo Sprinkle[3].

Broader Pharmaceutical Market Trends

Consolidation and Pricing

The pharmaceutical market is characterized by consolidation among pharmacies and other stakeholders, which can affect drug pricing and availability. Larger pharmacies have more negotiating power, which can influence the margins and profitability of drugs like Aspruzyo Sprinkle[3].

Policy Initiatives

Policy changes, such as those introduced by the Inflation Reduction Act, aim to control drug prices and reduce out-of-pocket expenses for patients. These initiatives can impact the financial trajectory of pharmaceuticals by altering the cost structure and reimbursement models[3].

Special Populations and Safety Considerations

Aspruzyo Sprinkle's safety profile includes common adverse reactions such as dizziness, headache, constipation, and nausea. Special populations, including elderly patients and those with renal or hepatic impairment, require careful dose adjustments and monitoring to ensure safety[2][5].

Conclusion on Market Dynamics and Financial Trajectory

The market dynamics and financial trajectory of Aspruzyo Sprinkle are complex and influenced by multiple factors. Despite its unique formulation and FDA approval, the discontinuation of its formulations has significantly impacted its market presence and financial prospects. The broader pharmaceutical market trends, regulatory environment, and competitive landscape all play crucial roles in determining the success of any pharmaceutical product.

Key Takeaways

• Indications and Dosage: Aspruzyo Sprinkle is indicated for chronic angina, with a recommended dose of 500 mg to 1000 mg orally twice daily.
• Market Positioning: Unique formulation as extended-release granules, but faces competition from generic ranolazine and other treatments.
• Regulatory Environment: Contraindicated in patients with certain drug interactions and liver cirrhosis; warnings for QT interval prolongation and renal failure.
• Financial Trajectory: Discontinued formulations significantly impact revenue projections.
• Broader Market Trends: Influenced by consolidation, policy initiatives, and generic competition.

FAQs

1. What is Aspruzyo Sprinkle used for? Aspruzyo Sprinkle is used for the treatment of chronic angina.

2. What is the recommended dosage of Aspruzyo Sprinkle? The recommended initial dose is 500 mg orally twice daily, which can be increased to 1000 mg orally twice daily based on clinical symptoms.

3. Why was Aspruzyo Sprinkle discontinued? The specific reasons for the discontinuation of Aspruzyo Sprinkle formulations are not detailed in the available sources, but it significantly impacts its market presence and financial prospects.

4. How does Aspruzyo Sprinkle compare to generic ranolazine? Aspruzyo Sprinkle offers a unique extended-release granule formulation, but it competes with generic versions of ranolazine, which are generally more affordable.

5. What are the common adverse reactions associated with Aspruzyo Sprinkle? The most common adverse reactions include dizziness, headache, constipation, and nausea.

Sources

1. Drugs.com - Generic Aspruzyo Sprinkle Availability
2. HealthDirect - Product Focus: Aspruzyo Sprinkle® [Ranolazine]
3. Aspen Economic Strategy Group - Why Drug Pricing Is Complicated
4. Optum Rx - Aspruzyo Sprinkle™ (ranolazine) – New drug approval
5. Optum Rx - Aspruzyo Sprinkle™ (ranolazine) – New drug approval (PDF)