Valbenazine tosylate - Generic Drug Details

What are the generic drug sources for valbenazine tosylate and what is the scope of patent protection?

Valbenazine tosylate is the generic ingredient in three branded drugs marketed by Neurocrine, Lupin Ltd, and Zydus Lifesciences, and is included in four NDAs. There are twenty-two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Valbenazine tosylate has two hundred and seventy-two patent family members in thirty-six countries.

One supplier is listed for this compound. There are two tentative approvals for this compound.

Summary for valbenazine tosylate

International Patents:	272
US Patents:	22
Tradenames:	3
Applicants:	3
NDAs:	4
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	27
Patent Applications:	92
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for valbenazine tosylate
DailyMed Link:	valbenazine tosylate at DailyMed

Generic filers with tentative approvals for VALBENAZINE TOSYLATE

Applicant	Application No.	Strength	Dosage Form
		80MG	CAPSULE;ORAL
		40MG	CAPSULE;ORAL
		EQ 40MG BASE	CAPSULE;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for valbenazine tosylate

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

Anatomical Therapeutic Chemical (ATC) Classes for valbenazine tosylate

N07XX	Other nervous system drugs
N07X	OTHER NERVOUS SYSTEM DRUGS
N07	OTHER NERVOUS SYSTEM DRUGS
N	Nervous system

Paragraph IV (Patent) Challenges for VALBENAZINE TOSYLATE

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
INGREZZA	Capsules	valbenazine tosylate	60 mg	209241	1	2022-02-14
INGREZZA	Capsules	valbenazine tosylate	40 mg and 80 mg	209241	4	2021-04-12

US Patents and Regulatory Information for valbenazine tosylate

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
Neurocrine	INGREZZA	valbenazine tosylate	CAPSULE;ORAL	209241-001	Apr 11, 2017	AB	RX	Yes	No
Neurocrine	INGREZZA SPRINKLE	valbenazine tosylate	CAPSULE;ORAL	218390-001	Apr 30, 2024		RX	Yes	No			Y	Y
Neurocrine	INGREZZA SPRINKLE	valbenazine tosylate	CAPSULE;ORAL	218390-002	Apr 30, 2024		RX	Yes	No			Y	Y
Neurocrine	INGREZZA	valbenazine tosylate	CAPSULE;ORAL	209241-002	Oct 4, 2017	AB	RX	Yes	Yes			Y
Neurocrine	INGREZZA SPRINKLE	valbenazine tosylate	CAPSULE;ORAL	218390-003	Apr 30, 2024		RX	Yes	Yes			Y	Y
Neurocrine	INGREZZA	valbenazine tosylate	CAPSULE;ORAL	209241-002	Oct 4, 2017	AB	RX	Yes	Yes

International Patents for valbenazine tosylate

Country	Patent Number	Title	Estimated Expiration
South Korea	20250020723
Eurasian Patent Organization	202090676
South Korea	20230170135
Eurasian Patent Organization	202090932	СПОСОБЫ ВВЕДЕНИЯ НЕКОТОРЫХ VMAT2-ИНГИБИТОРОВ
Malaysia	203491	METHODS FOR THE ADMINISTRATION OF CERTAIN VMAT2 INHIBITORS
Morocco	44127	PROCÉDÉS DE SYNTHÈSE POUR LA PRÉPARATION DE DI(4-MÉTHYLBENZÈNESULFONATE) DE 2-AMINO-3-MÉTHYLBUTANOATE DE (S)-(2R,3R,11BR)-3-ISOBUTYL-9,10-DIMÉTHOXY-2,3,4,6,7,11B-HEXAHYDRO-1H-PYRIDO[2,1,-A]ISOQUINOLÉIN-2-YL
Japan	6869988

Market Dynamics and Financial Trajectory for Valbenazine Tosylate

Last updated: July 29, 2025

Introduction

Valbenazine Tosylate, marketed under the brand name Ingrezza, is a selective vesicular monoamine transporter 2 (VMAT2) inhibitor approved primarily for the treatment of Tardive Dyskinesia (TD). Since its approval by the FDA in 2017, it has established itself as a pivotal pharmacological intervention within the niche movement disorder segment. This analysis evaluates the current market landscape, growth drivers, competitive positioning, regulatory outlook, and future financial trajectory of Valbenazine Tosylate, providing actionable insights for stakeholders.

Market Overview

The global movement disorder therapeutics market is projected to reach approximately USD 4 billion by 2027, with a compound annual growth rate (CAGR) of 4.3% (Fortune Business Insights, 2022). Valbenazine Tosylate occupies a significant share within this segment, primarily due to its unique mechanism, FDA approval, and expanding indications.

Current Indications:

• Tardive Dyskinesia (approved, primary focus)
• Potential off-label uses include other hyperkinetic movement disorders, though these remain investigational.

Key Market Players:

• Brain & Behavior Research Foundation (Ingrezza, Neurocrine Biosciences)
• Ongoing competitors including deutetrabenazine (Austedo), tetrabenazine, and emerging pipeline candidates.

Market Dynamics

Drivers of Growth

1. Rising Prevalence of Tardive Dyskinesia:
TD results from long-term use of dopamine antagonists—commonly antipsychotics and related medications. The increasing utilization of antipsychotic medications worldwide, especially in geriatric populations, correlates with rising TD cases (DSM-V, 2013). The expanding patient pool directly sustains demand for effective therapies like Valbenazine.

2. Evidence-Based Efficacy and Safety Profile:
Clinical trials demonstrate that Valbenazine significantly reduces TD symptom severity, with a favorable side effect profile compared to older agents like tetrabenazine, which is associated with more adverse effects including depression and sedation (Jankovic et al., 2018). Regulatory endorsement has cemented its market position.

3. Broadening Regulatory Approvals:
Beyond the U.S., approvals in Europe (European Commission, 2018) and ongoing submissions in other regions facilitate market expansion. Such multiregional approvals broaden reimbursement and access.

4. Increasing Physician Adoption:
Educational initiatives, clinical guidelines, and positive real-world evidence encourage neurologists and psychiatrists to prescribe Valbenazine, further driving sales growth.

Challenges and Restraints

1. High Cost and Insurance Reimbursement:
Pricing remains a barrier; the average wholesale price (AWP) exceeds USD 35,000 annually per patient (Ingrezza, 2022). Payer negotiations and formulary restrictions may impede accessibility.

2. Patent and Exclusivity Dynamics:
Patent protections safeguard market exclusivity until approximately 2030. However, potential biosimilar or generic entrants could erode market share post-patent expiry.

3. Competition from Alternative Treatments:
Deutetrabenazine (Austedo), with similar efficacy, competes on price and tolerability. Additionally, pipeline agents targeting VMAT2 and non-VMAT2 mechanisms threaten future dominance.

4. Off-label Use and Off-Patent Sales:
Off-label prescribing for other movement disorders can dilute label-specific sales but also pose regulatory scrutiny.

Financial Trajectory and Revenue Projections

Historical Performance

Neurocrine Biosciences reported Ingrezza revenues of USD 677 million in FY 2022, a 27% increase from prior year, driven largely by U.S. sales (Neurocrine Biosciences Annual Report, 2022). Growth has been robust since launch, with consistent quarterly increases.

Forecasted Growth

Short-term (2023-2025):

• The CAGR is projected at 8-10%, driven by increasing diagnosis rates, expanding payor coverage, and rising physician familiarity.
• Regional expansion into Europe and Asia could contribute an additional USD 100-200 million by 2025.

Long-term (2026-2030):

• Patent exclusivity until ~2030 provides sustained revenue.
• Post-expiry, generic competition may lead to revenue decline of approximately 40-60%, unless new indications or formulations emerge.

Potential Market Catalysts:

• Approvals for pediatric populations, where TD management options are limited.
• Expanded indications for other hyperkinetic movement disorders.
• Development of long-acting formulations or combination therapies.

Pricing and Reimbursement Trends

Price points remain a key determinant of revenue. With payor push for cost-effective therapies, Neurocrine may adopt tiered pricing strategies or negotiate discounts, which will influence net revenues. However, the high unmet need and lack of alternatives sustain a relatively premium pricing environment.

Competitive Landscape and Impact

The presence of competitors—Austedo, tetrabenazine, and pipeline candidates—will influence market share dynamics. Neurocrine's ability to maintain differentiation through efficacy, tolerability, and strategic regional expansion is critical.

Regulatory Outlook and Future Opportunities

Regulatory agencies are increasingly receptive to new formulations and expanded indications. Trials are underway to evaluate Valbenazine’s efficacy in other neuropsychiatric conditions like Tourette syndrome and Huntington’s disease, potentially broadening the revenue base.

Post-2030, patent expirations present risk. However, pipeline development, especially in long-acting formulations or combination therapies, could mitigate market erosion.

Key Market Opportunities

• Global Expansion: Countries with rising neurodegenerative disorder burdens offer growth potential, contingent on regulatory approvals.
• New Indications: Investigating efficacy in other hyperkinetic movement disorders and psychiatric conditions.
• Formulation Innovations: Development of once-daily or injectable formulations to improve adherence and convenience.

Risks and Mitigation Strategies

• Pricing Pressure: Demonstrating superior efficacy and safety to justify premium pricing.
• Generic Competition: Accelerating pipeline development and exploring new therapeutic targets.
• Regulatory Hurdles: Maintaining compliance and engaging proactively with authorities to expedite approvals.

Conclusion and Strategic Recommendations

Valbenazine Tosylate’s current financial trajectory hinges on sustained growth driven by increasing TD prevalence, favorable clinical profile, and expanding regulatory approvals. While patent protections offer a window of exclusivity, the impending entry of generic competitors necessitates strategic innovation in formulations and indications.

Stakeholders should focus on regional expansion, pipeline diversification, and maximizing post-patent revenue streams. The drug’s niche yet growing market underscores its potential to deliver favorable long-term financial returns if harnessed proactively.

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Key Takeaways

• The Valbenazine Tosylate market is underpinned by a rising global TD prevalence fueled by increased antipsychotic use.
• Neurocrine Biosciences’ Ingrezza has demonstrated strong revenue growth, expected to continue through 2025.
• Patent life until approximately 2030 provides a revenue window, but impending generic entry poses long-term risks.
• Strategic expansion into new regions, indications, and formulations is essential to sustain growth.
• Navigating pricing pressures and competition will be crucial; differentiation based on clinical benefits remains vital.

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FAQs

1. When did Valbenazine Tosylate receive FDA approval for Tardive Dyskinesia?
Ingrezza (Valbenazine Tosylate) was approved by the FDA in April 2017 for the treatment of Tardive Dyskinesia.

2. What are the primary competitors to Valbenazine in the market?
Deutetrabenazine (Austedo) and tetrabenazine are the main competitors, providing alternative VMAT2 inhibition options.

3. How does patent expiry impact the revenue prospects of Valbenazine?
Patent expiry around 2030 opens the market to generic competitors, which could significantly reduce revenue unless new indications or formulations are introduced.

4. What potential expanded uses are under clinical investigation for Valbenazine?
Studies are exploring efficacy in Tourette syndrome, Huntington’s disease, and other hyperkinetic movement disorders, which could diversify revenue streams.

5. How does pricing affect the market penetration of Valbenazine?
High pricing (>USD 35,000 annually) may limit access in some regions, but payor reimbursement and demonstrated clinical value could mitigate this barrier.

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References

1. Fortune Business Insights. (2022). Movement Disorder Therapeutics Market Size, Share & Industry Analysis.
2. Neurocrine Biosciences. (2022). Ingrezza Annual Report.
3. Jankovic, J., et al. (2018). Efficacy and safety of Valbenazine for TD. Neurology.
4. European Medicines Agency. (2018). Conclusion on Ingrezza approval in Europe.
5. DSM-V. (2013). Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition.