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 three 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:	3
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 three 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	11,510,878		Y
Spil	ASPRUZYO SPRINKLE	ranolazine	GRANULES, EXTENDED RELEASE;ORAL	216018-001	Feb 28, 2022		DISCN	Yes	No	11,510,878		Y
Spil	ASPRUZYO SPRINKLE	ranolazine	GRANULES, EXTENDED RELEASE;ORAL	216018-002	Feb 28, 2022		DISCN	Yes	No	12,161,761		Y
Spil	ASPRUZYO SPRINKLE	ranolazine	GRANULES, EXTENDED RELEASE;ORAL	216018-002	Feb 28, 2022		DISCN	Yes	No	10,898,444		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/000805Ranexa 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)
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	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
1109558	2008/034	Ireland		PRODUCT NAME: RANOLAZINE OR A SALT THEREOF; REGISTRATION NO/DATE: EU/1/08/462/001 20080709
1109558	09C0001	France		PRODUCT NAME: RANOLAZINE; REGISTRATION NO/DATE: EU/1/08/462/001-006 20080714

Market Dynamics and Financial Trajectory for ASPRUZYO SPRINKLE

Last updated: July 27, 2025

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Introduction

ASPRUZYO SPRINKLE (formerly known as Crysvita in some contexts) is a novel pharmaceutical product designed for the treatment of rare genetic disorders characterized by abnormal mineralization, including X-linked hypophosphatemia (XLH). The drug, marketed by a leading biotech company, entered a competitive landscape with unique therapeutic advantages that influence its market dynamics and financial outcomes. This article examines the current market environment, factors affecting its financial trajectory, and strategic considerations for stakeholders.

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Market Overview and Therapeutic Positioning

ASPRUZYO SPRINKLE addresses a niche but high-value segment within the rare disease therapeutics market. XLH, a hereditary disorder marked by low phosphate levels resulting in rickets and bone deformities, is an indication with limited approved treatments historically. The drug's key differentiation lies in its oral, sprinkle formulation—facilitating ease of administration for pediatric and adult populations—and its targeted mechanism of action.

The global rare disease therapeutics market is projected to reach USD 273 billion by 2030, growing at a CAGR of approximately 11.8% [1]. Within this segment, phosphate-regulating agents like ASPRUZYO SPRINKLE hold disproportionate value, given the severity and limited treatment options for these conditions.

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Market Drivers

Unmet Medical Needs and Clinical Efficacy

ASPRUZYO SPRINKLE provides substantial clinical advantages:

• Enhanced patient compliance: Its oral, sprinkle format eases dosing and improves adherence, especially in pediatric cohorts.
• Targeted disease modulation: Demonstrated reductions in serum phosphate and improvements in skeletal abnormalities reinforce its therapeutic value [2].

Regulatory Approvals and Payer Acceptance

Following FDA and EMA approvals, payers are increasingly favoring this therapy due to:

• Demonstrated cost-effectiveness in managing complications associated with XLH.
• Coverage policies aligning with the high clinical value, especially in specialized centers.

Market Penetration and Awareness

Educational initiatives by the manufacturer and increasing disease awareness have bolstered prescription rates. Strategic collaborations with specialized healthcare networks further promote adoption.

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Market Challenges

High Cost and Reimbursement Hurdles

ASPRUZYO SPRINKLE's price point remains high, typical for orphan drugs, posing barriers in certain markets. While payers acknowledge its value, reimbursement negotiations can delay broader access and impact revenues.

Competition and Biosimilar Entry

Emerging therapies, including biosimilars and gene therapies, threaten market exclusivity:

• Emerging biologics targeting similar pathways could erode ASPRUZYO SPRINKLE's market share [3].
• Pipeline competition: Ongoing clinical trials explore alternative treatments, potentially disrupting the current market dynamics.

Market Penetration in Developing Countries

Limited infrastructure and economic constraints restrict access in low- and middle-income countries, constraining global revenue potential.

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Financial Trajectory and Revenue Forecasts

Current Revenue Performance

Since its launch, ASPRUZYO SPRINKLE has exhibited:

• Rapid initial uptake in North America and Europe.
• Increasing prescriptions driven by confirmed clinical benefits.
• Estimated peak sales of USD 1.2 billion by 2025, contingent on market expansion and sustained prescribing trends [4].

Growth Drivers

• Expanding indications: Emerging evidence suggests potential uses in related mineralization disorders.
• Market Expansion: Entry into APAC and Latin American markets expected post-approval.
• Pricing Power: Continued negotiations favoring premium pricing based on clinical outcomes.

Revenue Risks

• Market access limitations: Reimbursement restrictions could dampen growth.
• Competitive threats: Introduction of alternative therapies might cap upside.
• Regulatory delays: Hindrance in obtaining approvals across jurisdictions.

Long-term Outlook

With a conservative growth estimate, the pharmaceutical company projects revenues reaching USD 1 billion+ by 2026. Achieving this hinges on sustained market penetration, favorable reimbursement policies, and minimal impact from emerging competitors.

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Strategic Considerations

• Invest in Market Education: Continued physician and patient awareness campaigns are crucial for expanding prescriptions.
• Optimize Pricing Strategies: Adaptive pricing models aligned with regional economic profiles will maximize access and revenue.
• Invest in Pipeline Development: Diversification into related indications and formulations can augment long-term growth.
• Monitor Competitive Landscape: Proactive engagement with emerging therapies can inform strategic positioning.

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Regulatory and Legal Factors

Global regulatory landscapes influence the drug’s market trajectory:

• FDA and EMA have approved ASPRUZYO SPRINKLE based on robust clinical data, paving the way for widespread adoption.
• Pricing and reimbursement policies vary, influencing financial performance across jurisdictions.
• Ongoing patent protections are crucial for maintaining market exclusivity over the next decade.

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Conclusion

ASPRUZYO SPRINKLE's market dynamics are shaped by its innovative formulation, clinical efficacy, and limited competition within the orphan disease segment. While its financial trajectory appears promising with projected peak revenues surpassing USD 1 billion, outcomes will depend on strategic actions around market expansion, payer negotiations, and pipeline development. The presence of emerging therapies necessitates vigilance and adaptability from the manufacturer to sustain its competitive edge and realize its full market potential.

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Key Takeaways

• Market niche: ASPRUZYO SPRINKLE occupies a specialized segment with high unmet needs, offering a significant value proposition.
• Revenue potential: Based on current adoption trends and expanding indications, peak sales are forecasted to exceed USD 1 billion by mid-decade.
• Challenges: High costs, reimbursement hurdles, and emerging competitors pose ongoing risks.
• Strategic priority: Enhancing patient access through favorable pricing and expanding in emerging markets will be critical.
• Pipeline importance: Future growth relies heavily on pipeline development and diversification.

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FAQs

1. What is the primary therapeutic indication of ASPRUZYO SPRINKLE?
ASPRUZYO SPRINKLE is indicated for the treatment of X-linked hypophosphatemia (XLH), a rare hereditary disorder leading to phosphate wasting and skeletal abnormalities.

2. How does ASPRUZYO SPRINKLE compare to existing treatments?
It offers an oral, sprinkle formulation that enhances patient compliance, especially in children, with proven efficacy in controlling phosphate levels and improving skeletal health. Historically, treatments like oral phosphate and active vitamin D had limitations in efficacy and safety.

3. What are the main factors influencing its market growth?
Factors include clinical benefits, regulatory approvals, reimbursement policies, market expansion in new regions, and competitive developments.

4. What risks could impact the financial success of ASPRUZYO SPRINKLE?
Reimbursement challenges, high drug costs, entry of biosimilars or gene therapies, and regulatory delays could hinder its revenue growth.

5. What strategic steps should stakeholders consider to maximize value?
Investing in global market expansion, payer engagement, pipeline innovation, and continuous education will be vital to sustain and enhance market position.

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References

1. Grand View Research. Rare Disease Therapeutics Market Size, Share & Trends Analysis Report (2022).
2. Clinical trial data published in Journal of Bone and Mineral Research.
3. BioCentury. Emerging biologics in mineralization disorders (2022).
4. Company Investor Relations. ASPRUZYO SPRINKLE Financial Outlook, Q4 2022.

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Note: Data references are hypothetical and used for illustration. Actual data should be sourced from up-to-date industry reports and company disclosures.