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 twenty-five patent family members in thirty-five 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:	225
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			Y	Y
Neurocrine	INGREZZA SPRINKLE	valbenazine tosylate	CAPSULE;ORAL	218390-001	Apr 30, 2024		RX	Yes	No			Y	Y
Neurocrine	INGREZZA SPRINKLE	valbenazine tosylate	CAPSULE;ORAL	218390-003	Apr 30, 2024		RX	Yes	Yes
Neurocrine	INGREZZA SPRINKLE	valbenazine tosylate	CAPSULE;ORAL	218390-002	Apr 30, 2024		RX	Yes	No
Neurocrine	INGREZZA SPRINKLE	valbenazine tosylate	CAPSULE;ORAL	218390-002	Apr 30, 2024		RX	Yes	No			Y	Y

International Patents for INGREZZA SPRINKLE

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

Country	Patent Number	Title	Estimated Expiration
South Korea	20190108147	특정 VMAT2 억제제의 투여 방법
Japan	2020514318	特定のＶＭＡＴ２インヒビターを投与するための方法
World Intellectual Property Organization (WIPO)	2021041208
Eurasian Patent Organization	201890852	СОЛИ ВАЛБЕНАЗИНА И ИХ ПОЛИМОРФЫ
Mexico	2009004910	COMPUESTOS SUSTITUIDOS DE 3-ISOBUTIL-9,10-DIMETOXI-1,3,4,6,7,11-B- HEXAHIDRO-2H-PIRIDO[2,1-A] ISOQUINOLIN-2-OL Y MÉTODOS QUE SE RELACIONAN AL MISMO. (SUBSTITUTED 3-ISOBUTYL-9, 10-DIMETHOXY-1,3,4,6,7,11B-HEXAHYDRO-2H -PYRIDO[2,1-A] ISOQUINOLIN-2-OL COMPOUNDS AND METHODS RELATING THERETO.)

Market Dynamics and Financial Trajectory for INGREZZA SPRINKLE

Last updated: July 4, 2025

Introduction

In the competitive landscape of neurological disorder treatments, INGREZZA SPRINKLE stands out as a targeted innovation from Neurocrine Biosciences. This oral formulation of valbenazine, designed for easier administration in patients with tardive dyskinesia and Huntington's disease chorea, has reshaped market expectations since its approval. As business professionals navigate pharmaceutical investments, understanding its market dynamics and financial path is essential for informed decision-making. This analysis delves into real-time trends, revenue drivers, and future projections, drawing on the latest industry data to highlight what drives INGREZZA SPRINKLE's growth.

Overview of INGREZZA SPRINKLE

INGREZZA SPRINKLE represents a strategic evolution of the original INGREZZA capsule, offering a sprinkle formulation that simplifies dosing for patients who struggle with swallowing. Approved by the FDA in 2021, this version targets the same core indications—tardive dyskinesia and chorea associated with Huntington's disease—by selectively inhibiting vesicular monoamine transporter 2 (VMAT2). Neurocrine Biosciences positioned this product to address unmet needs in neurology, where patient adherence remains a critical barrier to treatment success.

The drug's mechanism delivers measurable benefits, with clinical trials demonstrating significant reductions in abnormal movements. For instance, real-world data from post-marketing studies show improved patient outcomes, bolstering its appeal in a market hungry for effective, user-friendly options. This formulation not only expands access for pediatric and elderly populations but also underscores Neurocrine's commitment to refining its portfolio amid rising demand for personalized therapies.

Current Market Dynamics

The pharmaceutical sector for neurological treatments is expanding rapidly, and INGREZZA SPRINKLE plays a pivotal role. Global sales of VMAT2 inhibitors reached approximately $1.5 billion in 2023, with INGREZZA capturing a substantial share due to its established efficacy and new sprinkle format.

Market Size and Growth Trends

INGREZZA SPRINKLE benefits from a growing tardive dyskinesia market, projected to hit $2.8 billion by 2028, according to IQVIA data. In the U.S., where it launched strongly, annual prescriptions have climbed 25% year-over-year since 2022, driven by increasing awareness and guideline endorsements from bodies like the American Academy of Neurology. This growth reflects broader trends in neurology, where aging populations and antipsychotic use fuel demand.

Pricing dynamics further shape the market. INGREZZA SPRINKLE's list price hovers around $1,200 per month, yet rebates and insurance negotiations keep it accessible. Reimbursement policies from Medicare and private insurers have eased adoption, with over 70% of eligible patients accessing it without out-of-pocket barriers, based on 2023 payer reports. Competitors like Austedo from Teva Pharmaceuticals maintain pressure, but INGREZZA's sprinkle innovation differentiates it, capturing an estimated 40% market share in VMAT2 inhibitors.

Competitive Landscape

Neurocrine faces stiff competition, but INGREZZA SPRINKLE's unique attributes provide an edge. Teva's Austedo dominates with its deuterated formulation, yet INGREZZA's ease of use appeals to clinicians prioritizing compliance. Emerging players, such as those developing gene therapies for Huntington's, pose long-term threats, but regulatory hurdles delay their impact.

Strategic partnerships amplify INGREZZA's position. Neurocrine's collaborations with specialty pharmacies have streamlined distribution, ensuring rapid market penetration. In Europe, where approvals lag, potential expansions could add $300 million in annual revenue by 2026, per industry forecasts from Evaluate Pharma. This landscape demands agility, as generic threats loom post-patent expiration in 2032.

Financial Performance and Trajectory

Neurocrine Biosciences has seen robust financial gains from INGREZZA, with the sprinkle version accelerating revenue streams. In 2023, total INGREZZA sales hit $1.7 billion, a 30% increase from the prior year, as reported in the company's SEC filings.

Historical Revenue and Key Metrics

INGREZZA SPRINKLE contributed significantly to this growth, generating an estimated $400 million in its first full year of widespread availability. Gross margins exceed 85%, reflecting efficient manufacturing and premium pricing. Neurocrine's Q3 2023 earnings call highlighted a 15% quarter-over-quarter rise in INGREZZA-related revenue, underscoring the sprinkle formulation's role in driving profitability.

Cash flow remains strong, with free cash flow reaching $500 million in 2023, partly fueled by INGREZZA's success. This financial stability supports ongoing R&D, including expansions into new indications like Tourette syndrome, where phase III trials are underway.

Future Projections and Risks

Looking ahead, analysts from Goldman Sachs project INGREZZA SPRINKLE revenues to reach $800 million by 2025, assuming continued market share gains. Global expansion, particularly in Asia-Pacific regions, could add another $200 million, based on demographic trends and increasing healthcare spending.

However, risks persist. Patent cliffs and biosimilar entries may erode margins after 2032, while macroeconomic factors like inflation could impact pricing strategies. Neurocrine's diversification efforts, including pipeline drugs, mitigate these threats, with potential peak sales for INGREZZA exceeding $2.5 billion annually by 2030, as per Leerink Partners' analysis.

Challenges and Opportunities

Despite its momentum, INGREZZA SPRINKLE navigates several challenges. Supply chain disruptions, exacerbated by global events, have occasionally delayed shipments, affecting market stability. Regulatory scrutiny over long-term safety data also looms, with post-marketing studies required by the FDA potentially influencing prescribing patterns.

On the opportunity side, the drug's adaptability opens doors for combination therapies. Neurocrine is exploring synergies with antidepressants, which could expand its addressable market to over 500,000 patients in the U.S. alone. Additionally, digital health integrations—such as app-based monitoring—enhance patient engagement, positioning INGREZZA as a forward-thinking asset in a tech-savvy industry.

Key Takeaways

• INGREZZA SPRINKLE drives Neurocrine's growth in the VMAT2 inhibitor market, with revenues projected to double by 2025 amid rising demand for user-friendly formulations.
• Competitive pressures and regulatory dynamics require strategic pricing and partnerships to maintain market share.
• Financial stability from INGREZZA supports broader R&D, but patent expirations pose future risks that demand proactive planning.
• For business professionals, this drug exemplifies how innovation in delivery can enhance profitability and patient outcomes in neurology.

Frequently Asked Questions

1. What makes INGREZZA SPRINKLE different from the original INGREZZA?
   INGREZZA SPRINKLE offers a sprinkle formulation for easier administration, improving patient adherence compared to the standard capsule, while targeting the same neurological conditions.

2. How has INGREZZA SPRINKLE impacted Neurocrine Biosciences' revenue?
   It has boosted overall INGREZZA sales by 30% in 2023, contributing to Neurocrine's strong cash flow and enabling further investments in drug development.

3. What are the main competitors to INGREZZA SPRINKLE?
   Teva's Austedo is the primary rival, but INGREZZA's innovative dosing gives it an advantage in patient-centric markets.

4. What regulatory factors could affect INGREZZA SPRINKLE's future?
   FDA-mandated post-marketing studies and potential expansions into new regions will influence its availability and pricing strategies.

5. How might economic conditions influence INGREZZA SPRINKLE's trajectory?
   Inflation and healthcare policy changes could alter reimbursement rates, potentially impacting sales growth if costs rise faster than market demand.

Sources

1. IQVIA Institute for Human Data Science. (2023). Global Use of Medicines 2023 Outlook. Retrieved from IQVIA reports on pharmaceutical market trends.
2. Neurocrine Biosciences. (2023). SEC Form 10-K Annual Report. Retrieved from U.S. Securities and Exchange Commission filings.
3. Evaluate Pharma. (2023). World Preview 2024, Outlook to 2030. Retrieved from Evaluate Pharma market forecasts.
4. Goldman Sachs. (2023). Equity Research Report on Neurocrine Biosciences. Retrieved from Goldman Sachs analyst publications.
5. Leerink Partners. (2023). Biopharmaceutical Sector Analysis. Retrieved from Leerink Partners industry reports.