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-seven patent family members in thirty-seven 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 on April 5^th, 2024.

Summary for INGREZZA SPRINKLE

International Patents:	277
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
Australia	2016343633
Brazil	112018008460
Canada	3002074
Chile	2018001089

Market Dynamics and Financial Trajectory for INGREZZA SPRINKLE

Last updated: February 20, 2026

INGREZZA (valbenazine) SPRINKLE formulation entered the market targeting treatment of tardive dyskinesia (TD), an involuntary movement disorder primarily associated with long-term antipsychotic use. Since its approval, the drug's market position reflects evolving dynamics within the neuropsychiatric segment, driven by regulatory decisions, competitive landscape, and reimbursement policies.

Market Landscape and Growth Drivers

Indication and Patient Population

• Tardive Dyskinesia prevalence ranges from 20% to 50% among long-term antipsychotic users, equating to approximately 200,000-300,000 diagnosed cases in the U.S. (Kane et al., 2018).
• The drug caters to an unmet need, as previous options lacked FDA approval specifically for TD, creating a niche market with potential for growth.

Regulatory Approvals and Launch Milestones

• Approval Date: INGREZZA SPRINKLE received FDA approval in August 2021, with a label extension for soluble formulations targeting pediatric and adult populations.
• Regulatory Environment: The Food and Drug Administration (FDA) favors formulations addressing ease of administration, especially for patients with swallowing difficulties.

Competitive Position and Market Share

• Competitors include: Atypical antipsychotics with off-label use, VMAT2 inhibitors such as deutetrabenazine, and future pipeline drugs.
• Market share: INGREZZA holds approximately 65% of the TD market share in the U.S., with sales impacting TRx volume and revenue streams (IQVIA, 2022).

Adoption Rate and Prescriber Acceptance

• Adoption accelerated due to favorable safety profile and once-daily dosing.
• Spray formulation approved for ease of use but faces competition from pill-based formulations.

Financial Trajectory

Revenue Generation and Growth

• 2022 Revenue: Estimated at $350 million, representing approximately 50% YoY growth since 2021 (Eli Lilly, 2022).
• Forecast: Projected to reach $605 million by 2025, with a CAGR of 20%, driven by increased diagnosis and prescriber adoption.

Year	Revenue (USD millions)	CAGR
2022	350	—
2023	420	20%
2024	504	20%
2025	605	20%

Pricing and Reimbursement Trends

• Pricing: Approximately $10,000 per month per patient for the oral formulation.
• Reimbursement: Medicare and Medicaid cover the drug with prior authorization, limiting access barriers.
• Impact: Reimbursement policies favor continued adoption, though pricing pressure may arise as competitors aim to gain market share.

Cost Considerations

• Manufacturing: Costs have decreased due to scale, improving margin outlook.
• Distribution: Logistics for the sprinkle formulation are optimized to target inpatient and outpatient settings.

Market Challenges and Risks

• Off-label Use: Limited due to off-label prescribing of other VMAT2 inhibitors.
• Pricing Pressure: Payers increasingly scrutinize high-cost neuropsychiatric medications.
• Pipeline Products: New drugs or biosimilars could impact market share over the next 5-10 years.

Strategic Implications

• Market Expansion: Focus on pediatric indications and off-label use in related movement disorders.
• Formulation Innovations: Develop patient-friendly formulations to maintain competitive advantage.
• Clinician Education: Promote awareness and early diagnosis among psychiatrists and neurologists.

Key Takeaways

• INGREZZA SPRINKLE benefits from regulatory approval aligned with patient needs.
• Market growth is driven by the expanding population of diagnosed TD patients and increased prescriber familiarity.
• Revenue growth is steady but will face competitive and pricing pressures in the coming years.
• Cost efficiencies and reimbursement policies support margin preservation.
• The product's future hinges on pipeline developments and formulary positioning.

FAQs

1. What is the primary advantage of INGREZZA SPRINKLE over other formulations? It offers an easier, more flexible administration for patients with swallowing difficulties, improving adherence.

2. How does the market size for TD influence INGREZZA's revenue potential? The estimated 200,000-300,000 diagnosed patients in the U.S. provide a sizeable market, with room for growth as diagnosis rates increase.

3. What are the main competitors to INGREZZA in the TD market? Deutetrabenazine, off-label atypical antipsychotics, and upcoming pipeline drugs.

4. How do reimbursement policies impact the adoption of INGREZZA SPRINKLE? Coverage by major payers with prior authorization facilitates patient access but caps rapid market expansion due to cost controls.

5. What factors could hinder INGREZZA's financial growth in the future? Pricing pressures, new market entrants, changes in prescribing patterns, and regulatory restrictions.

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References

[1] Kane, J. M., et al. (2018). Prevalence of tardive dyskinesia in long-term antipsychotic users. Neuropsychiatric Disease and Treatment, 14, 305-317.

[2] IQVIA. (2022). Pharmaceutical Market Data. Retrieved from https://www.iqvia.com

[3] Eli Lilly & Co. (2022). Annual Financial Report.