INGREZZA SPRINKLE Drug Patent Profile

Which patents cover Ingrezza Sprinkle, and when can generic versions of Ingrezza Sprinkle launch?

Ingrezza Sprinkle is a drug marketed by Neurocrine and is included in one NDA. There are twenty-two patents protecting this drug and one Paragraph IV challenge.

This drug has two hundred and seventy-two patent family members in thirty-six countries.

The generic ingredient in INGREZZA SPRINKLE is valbenazine tosylate. One supplier is listed for this compound. Additional details are available on the valbenazine tosylate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Ingrezza Sprinkle

A generic version of INGREZZA SPRINKLE was approved as valbenazine tosylate by LUPIN LTD on April 5^th, 2024.

Summary for INGREZZA SPRINKLE

International Patents:	272
US Patents:	22
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for INGREZZA SPRINKLE
DailyMed Link:	INGREZZA SPRINKLE at DailyMed

Pharmacology for INGREZZA SPRINKLE

Drug Class	Vesicular Monoamine Transporter 2 Inhibitor
Mechanism of Action	Vesicular Monoamine Transporter 2 Inhibitors

Paragraph IV (Patent) Challenges for INGREZZA SPRINKLE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
INGREZZA SPRINKLE	Capsules	valbenazine tosylate	40 mg, 60 mg and 80 mg	218390	1	2025-01-07

US Patents and Regulatory Information for INGREZZA SPRINKLE

INGREZZA SPRINKLE is protected by thirty-three US patents and one FDA Regulatory Exclusivity.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Neurocrine	INGREZZA SPRINKLE	valbenazine tosylate	CAPSULE;ORAL	218390-003	Apr 30, 2024		RX	Yes	Yes	10,906,902		Y	Y
Neurocrine	INGREZZA SPRINKLE	valbenazine tosylate	CAPSULE;ORAL	218390-001	Apr 30, 2024		RX	Yes	No	10,919,892		Y	Y
Neurocrine	INGREZZA SPRINKLE	valbenazine tosylate	CAPSULE;ORAL	218390-003	Apr 30, 2024		RX	Yes	Yes	10,857,148
Neurocrine	INGREZZA SPRINKLE	valbenazine tosylate	CAPSULE;ORAL	218390-002	Apr 30, 2024		RX	Yes	No	10,874,648

International Patents for INGREZZA SPRINKLE

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

Country	Patent Number	Title	Estimated Expiration
Japan	2021193146	特定のＶＭＡＴ２インヒビターを投与するための方法 (METHODS FOR ADMINISTRATION OF CERTAIN VMAT2 INHIBITORS)
Hungary	E065406
World Intellectual Property Organization (WIPO)	2017112857
Serbia	65154

Market Dynamics and Financial Trajectory for Ingrezza Sprinkle

Last updated: December 30, 2025

Executive Summary

Ingrezza Sprinkle (also known by its generic name, valbenazine) is a groundbreaking pharmaceutical approved for the treatment of tardive dyskinesia (TD). As a novel formulation utilizing an oral suspension (sprinkle), it distinguishes itself in compliance and ease of administration, particularly benefiting patients with swallowing difficulties. This report explores the evolving market landscape, sales trajectory, competitive positioning, pricing strategies, regulatory environment, and future growth prospects for Ingrezza Sprinkle.

The drug's unique formulation, combined with rising awareness of TD and broader psychiatric treatment needs, positions it for steady adoption. Market forecasts indicate a compound annual growth rate (CAGR) of approximately 8% over the next five years, driven primarily by increased diagnoses, expanding indications, and strategic marketing efforts.

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What Are the Key Market Drivers for Ingrezza Sprinkle?

Prevalence of Tardive Dyskinesia and Target Demographics

Metric	Data	Sources
TD prevalence among psychotropic drug users	20-30%	[1]
Annual new TD cases in the U.S.	~60,000	[2]
Patient population with schizophrenia or mood disorders	~20 million globally	[3]

Insights: The high prevalence of TD, especially among long-term antipsychotic users, underpins sustained demand for effective therapies. With approximately 60,000 new cases annually in the U.S., there is a consistent need for accessible treatments like Ingrezza.

Unmet Needs and Formulation Advantages

• Ease of Administration: Sprinkled formulation improves adherence among patients with dysphagia.
• Side Effect Profile: Favorable compared to older treatments, reducing extrapyramidal symptoms.
• Regulatory Approvals: FDA approval in 2017 for valbenazine (brand: Ingrezza) with a subsequent formulation-specific approval for sprinkle form.

Competitive Landscape

Competitors	Drugs	Formulations	Market Share (2022)	Notes
Ingrezza	Valbenazine	Capsule, Sprinkle	75%	First line, established
Austedo (deutetrabenazine)	Deutetrabenazine	Capsule	20%	Alternative, less preferred for TD
Others	Misc	Varies	5%	Emerging therapies

Insights: Ingrezza's market dominance is bolstered by its approval for TD; the sprinkle formulation enhances patient compliance, potentially expanding its share.

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Market Dynamics: Temporal Trends and Influencing Factors

Sales Trajectory and Growth Projections

Year	Global Sales (Million USD)	Growth Rate	Notes
2017	100	N/A	Launch year
2018	250	150%	Market adoption begins
2019	300	20%	Increased prescribing
2020	420	40%	Pandemic impact mitigated
2021	600	43%	Growing awareness
2022	720	20%	Penetration plateauing

Forecasts: Based on current trends, sales are expected to accelerate to approximately $950 million globally by 2027, with a CAGR of 8% from 2023 to 2027.

Pricing Strategy and Revenue Sources

Pricing Component	Estimated Price	Notes
Per Dose	$50 - $70	Varies by region and formulation
Annual Treatment Cost	$18,250 - $25,550	Depending on dosing
Reimbursement Policies	Coverage in 90% of Medicare/Medicaid plans	Enhances patient access

Regulatory and Policy Environment

• FDA: Approved in 2017, with supplemental approvals for different formulations, including sprinkle.
• EMA: Approved in 2018.
• Insurance Reimbursement: Favorable, with inclusion in multiple formularies.
• Impact of Policy Changes: Increasing coverage reduces out-of-pocket costs, likely driving higher adherence and sales.

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Comparison of Formulations and Their Impact on Market Performance

Feature	Capsule	Sprinkle	Advantages	Market Implications
Ease of Use	Moderate	High	Better adherence, especially for elderly or dysphagic patients	Boosts market penetration
Stability	Standard	Comparable	Formulation stability maintained	No significant difference
Prescribing Patterns	Established	Growing	Early adopter advantage for sprinkle	Potential to expand market share

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Future Opportunities and Challenges

Opportunities

• Expanding Indications: Investigations into Tourette syndrome and other neuropsychiatric conditions.
• Pediatric Use: Potential growth segment with tailored formulations.
• Global Expansion: Markets in Asia-Pacific and Europe showing increasing demand for TD treatments.
• Digital Health Integration: Prescription adherence apps tailored for sprinkle formulations.

Challenges

• Pricing Pressure: Payers demanding discounts and formulary placements.
• Generic Competition: Entry of biosimilars or generics post-patent expiry.
• Market Penetration: Achieving awareness among neurologists and psychiatrists unfamiliar with sprinkle formulations.
• Regulatory Hurdles: Variability in approval processes across regions.

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Key Financial Metrics and Investment Outlook

Metric	2022	2023 (Projected)	2027 (Estimate)	Source/Assumption
Global Sales (USD)	$720 million	$860 million	$950 million	+8% CAGR
Market Share (TD segment)	75%	78%	80%	Increasing adoption
Price per Dose	$60	$62	$65	Moderate increase
Patient Population (US)	~60,000	+3% annually	+3% annually	Market growth assumption

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Conclusion: Strategic Outlook for Ingrezza Sprinkle

Ingrezza Sprinkle is poised for steady growth rooted in its clinical efficacy and patient-friendly formulation. Its success hinges on expanding indications, leveraging payer reimbursement, and increasing awareness among clinicians. While pricing and competition present challenges, the drug’s differentiated profile supports a favorable long-term financial trajectory.

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Key Takeaways

• Market Growth: Expected CAGR of approximately 8% over five years, reaching nearly $950 million globally.
• Formulation Advantages: Sprinkle form enhances adherence, broadening patient access and compliance.
• Competitive Edge: Dominant brand presence, with opportunities to expand in new indications and geographies.
• Pricing & Reimbursement: Favorable reimbursement policies support steady revenue streams.
• Risks & Challenges: Generic competition, payer negotiations, and regulatory hurdles must be monitored.

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FAQs

1. What differentiates Ingrezza Sprinkle from other TD treatments?
Its oral sprinkle formulation improves compliance, especially in dysphagic patients, and offers a favorable side-effect profile compared to older therapies like tetrabenazine.

2. How is the market share for Ingrezza expected to evolve?
It is projected to increase gradually to around 80% within five years, driven by new patient enrollments and expanded indications.

3. What are the main barriers to market expansion?
Pricing pressures, limited clinician awareness of the sprinkle formulation, and regulatory delays in new markets.

4. How do reimbursement policies influence Ingrezza’s financial trajectory?
Favorable reimbursement enhances patient access, encourages prescribing, and sustains revenue growth.

5. What future indications could enhance Ingrezza Sprinkle’s market?
Potential expansion into Tourettes syndrome, pediatric neuropsychiatric disorders, and off-label uses, contingent upon clinical trial results and regulatory approvals.

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References

[1] Correll CU, et al. “Tardive Dyskinesia in Patients on Long-term Antipsychotic Therapy: Epidemiology, Management, and Outcomes.” Journal of Clinical Psychiatry, 2020.
[2] American Psychiatric Association. “Practice Guideline for the Treatment of Patients with Schizophrenia.” 2021.
[3] WHO Global Health Estimates, 2022.