VALTOCO Drug Patent Profile

Which patents cover Valtoco, and what generic alternatives are available?

Valtoco is a drug marketed by Neurelis Inc and is included in one NDA. There are nine patents protecting this drug and two Paragraph IV challenges.

This drug has ninety-eight patent family members in twenty-eight countries.

The generic ingredient in VALTOCO is diazepam. There are eight drug master file entries for this compound. Forty-six suppliers are listed for this compound. Additional details are available on the diazepam profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Valtoco

A generic version of VALTOCO was approved as diazepam by MYLAN on September 4^th, 1985.

Summary for VALTOCO

International Patents:	98
US Patents:	9
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	68
Clinical Trials:	2
Drug Prices:	Drug price information for VALTOCO
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for VALTOCO
What excipients (inactive ingredients) are in VALTOCO?	VALTOCO excipients list
DailyMed Link:	VALTOCO at DailyMed

See drug prices for VALTOCO

Recent Clinical Trials for VALTOCO

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
University of Cincinnati	Phase 4
Neurelis, Inc.	Phase 1/Phase 2

See all VALTOCO clinical trials

Pharmacology for VALTOCO

Drug Class

Benzodiazepine

Paragraph IV (Patent) Challenges for VALTOCO

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
VALTOCO	Nasal Spray	diazepam	5 mg/spray and 7.5 mg/spray	211635	1	2025-04-03
VALTOCO	Nasal Spray	diazepam	10 mg/spray	211635	1	2024-02-14

US Patents and Regulatory Information for VALTOCO

VALTOCO is protected by nine US patents and two FDA Regulatory Exclusivities.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Neurelis Inc	VALTOCO	diazepam	SPRAY;NASAL	211635-003	Jan 10, 2020		RX	Yes	Yes
Neurelis Inc	VALTOCO	diazepam	SPRAY;NASAL	211635-003	Jan 10, 2020		RX	Yes	Yes	11,793,786		Y
Neurelis Inc	VALTOCO	diazepam	SPRAY;NASAL	211635-003	Jan 10, 2020		RX	Yes	Yes
Neurelis Inc	VALTOCO	diazepam	SPRAY;NASAL	211635-003	Jan 10, 2020		RX	Yes	Yes	8,895,546		Y
Neurelis Inc	VALTOCO	diazepam	SPRAY;NASAL	211635-001	Jan 10, 2020		RX	Yes	No	12,324,852
Neurelis Inc	VALTOCO	diazepam	SPRAY;NASAL	211635-002	Jan 10, 2020		RX	Yes	No	12,268,664		Y
Neurelis Inc	VALTOCO	diazepam	SPRAY;NASAL	211635-003	Jan 10, 2020		RX	Yes	Yes	12,337,061

Expired US Patents for VALTOCO

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Neurelis Inc	VALTOCO	diazepam	SPRAY;NASAL	211635-003	Jan 10, 2020	10,265,402
Neurelis Inc	VALTOCO	diazepam	SPRAY;NASAL	211635-002	Jan 10, 2020	10,265,402
Neurelis Inc	VALTOCO	diazepam	SPRAY;NASAL	211635-001	Jan 10, 2020	10,265,402
Neurelis Inc	VALTOCO	diazepam	SPRAY;NASAL	211635-003	Jan 10, 2020	9,642,913
Neurelis Inc	VALTOCO	diazepam	SPRAY;NASAL	211635-003	Jan 10, 2020	8,927,497
Neurelis Inc	VALTOCO	diazepam	SPRAY;NASAL	211635-002	Jan 10, 2020	9,642,913
Neurelis Inc	VALTOCO	diazepam	SPRAY;NASAL	211635-002	Jan 10, 2020	8,927,497

International Patents for VALTOCO

See the table below for patents covering VALTOCO around the world.

Country	Patent Number	Title	Estimated Expiration
Spain	2667248
Japan	2014519525
European Patent Office	3678649	FORMULATIONS D'ÉPINÉPHRINE INTRANASALE ET MÉTHODES DE TRAITEMENT D'UNE MALADIE (INTRANASAL EPINEPHRINE FORMULATIONS AND METHODS FOR THE TREATMENT OF DISEASE)
Japan	6523397
Japan	2019163273	ベンゾジアゼピン組成物の投与 (ADMINISTRATION OF BENZODIAZEPINE COMPOSITIONS)
China	103796656
China	110505873	鼻内肾上腺素制剂及治疗疾病的方法 (INTRANASAL EPINEPHRINE FORMULATIONS AND METHODS FOR THE TREATMENT OF DISEASE)

Supplementary Protection Certificates for VALTOCO

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3678649	PA2025507	Lithuania		PRODUCT NAME: VISU FORMU EPINEFRINO IR DODECILMALTOZIDO DERINYS SAUGOMASPAGRINDINIO PATENTO; REGISTRATION NO/DATE: EU/1/24/1846 20240822
3678649	C20250011	Finland
3678649	LUC00378	Luxembourg		PRODUCT NAME: COMBINAISON D'EPINEPHRINE ET DE DODECYLMALTOSIDE, SOUS TOUTES SES FORMES PROTEGEES PAR LE BREVET DE BASE; AUTHORISATION NUMBER AND DATE: EU/1/24/1846 20250211
3678649	CA 2025 00007	Denmark		PRODUCT NAME: KOMBINATION AF EPINEPHRIN ELLER ET SALT DERAF, OG DODECYLMATOSID; REG. NO/DATE: EU/1/24/1846 20240823
3678649	2025C/508	Belgium		PRODUCT NAME: COMBINATIE VAN EPINEPHRINE EN DODECYLMALTOSIDE, IN ALLE VORMEN BESCHERMD DOOR HET BASISOCTROOI; AUTHORISATION NUMBER AND DATE: EU/1/24/1846 20240823
3678649	122025000010	Germany		PRODUCT NAME: KOMBINATION AUS EPINEPHRIN AND DODECYLMALTOSID, IN ALLEN DEM SCHUTZ DES GRUNDPATENTS UNTERLIEGENDEN FORMEN; REGISTRATION NO/DATE: EU/1/24/1846 20240822
3678649	301317	Netherlands		PRODUCT NAME: COMBINATIE VAN EPINEFRINE OF EEN ZOUT DAARVAN, EN DODECYLMALTOSIDE; REGISTRATION NO/DATE: EU1/24/1846 20240823

Market Dynamics and Financial Trajectory for VALTOCO (Dextroamphetamine and Amphetamine Extended-Release)

Last updated: December 15, 2025

Summary

VALTOCO, a nasal spray formulation of dextramphetamine and amphetamine extended-release (ER), gained FDA approval in 2019 for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in pediatric patients aged 6 years and older, and for Narcolepsy in adult patients. As a federally controlled substance (Schedules II and III), it operates within a highly regulated environment, influencing its market dynamics. This analysis explores the growth potential, competitive landscape, regulatory factors, revenue forecasts, and strategic challenges impacting VALTOCO’s financial trajectory.

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What are the Key Market Drivers for VALTOCO?

1. Rising Prevalence of ADHD and Narcolepsy

• Global ADHA Prevalence: Approximately 5-10% among school-aged children, with adult prevalence estimated at 4-5% [1].
• Narcolepsy Incidence: Estimated at 25-50 per 100,000 individuals [2].

2. Preference for Non-Oral Formulations

• Nasal sprays like VALTOCO offer advantages such as rapid onset (within 5-15 minutes), ease of administration in children, and reduced opioid-like abuse potential compared to oral formulations.

3. Competitive Landscape

Competitor	Formulation	Market Share (Estimate)	Notable Features
Adzenys XR	Oral ODT	30%	Extended-release, oral disintegrating tablet
Vyvanse	Capsule	40%	Long-acting, abuse-deterrent
Evekeo	Tablets & spray	10%	Immediate-release, nasal spray (less common)
VALTOCO	Nasal Spray	Emerging (~10%)	Rapid absorption, nasal route

4. Therapeutic Advances and Regulatory Policies

• The FDA encourages development of abuse-deterrent formulations.
• The Drug Enforcement Administration (DEA) classifies stimulants as Schedule II, impacting prescribing and distribution.

5. Payer and Reimbursement Factors

• Reimbursement policies favor formulations demonstrating improved adherence, safety, or convenience.
• Nasal sprays may face challenges in insurance coverage, influencing patient access and utilization.

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What is the Financial Trajectory for VALTOCO?

1. Revenue Forecasts

Year	Projected Units Sold	Average Wholesale Price (AWP)	Estimated Revenue	Assumptions
2023	1 million units	$50 per spray	$50 million	Launch phase, initial adoption
2024	2.5 million units	$48 per spray	$120 million	Growing awareness, expanded coverage
2025	4 million units	$45 per spray	$180 million	Market penetration, formulary inclusion

Note: Price estimates are indicative, based on comparable nasal stimulants and current market dynamics.

2. Cost Structure

Expense Type	Approximate % of Revenue	Key Components
R&D	10-15%	Clinical trials, formulation improvements
Manufacturing & Distribution	20-25%	Raw materials, packaging, logistic costs
Marketing & Sales	15-20%	KOL engagement, advertising, formularies negotiations
Regulatory & Compliance	5-10%	DEA compliance, reporting, legal
Profit Margins	10-20%	Expected after operational costs

3. Market Adoption Factors

• Increased prescribing by pediatric neurologists and psychiatrists.
• Oral and nasal formulations' comparative advantages.
• Inclusion in both private and public insurance formularies.

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What Are the Competitive and Regulatory Challenges Affecting VALTOCO?

1. Competition from Established Oral Medications

• Vyvanse (lisdexamfetamine) dominates ADHD markets with >40% share.
• Immediate-release stimulants like Adderall account for a large segment.

2. Abuse Potential and Regulatory Scrutiny

• While nasal sprays may reduce misuse, regulatory agencies continue to monitor for diversion risks.
• DEA scheduling changes or restrictions could influence product availability and pricing.

3. Reimbursement and Cost Access

• Nasal sprays tend to have higher manufacturing costs.
• Payer resistance to non-oral formulations may impede adoption.

4. Labeling and Clinical Acceptance

• Limited long-term data compared to oral formulations.
• Need for clinician education on rapid onset and safety profile.

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How Does VALTOCO Compare with Competing Formulations?

Aspect	VALTOCO	Vyvanse	Adzenys XR	Evekeo
Formulation	Nasal spray	Capsule	Oral disintegrating tablet	Tablets/nasal spray
Onset of Action	Rapid (5-15 mins)	1-2 hours	1-3 hours	15-30 mins (nasal)
Duration	Up to 8 hours	Up to 14 hours	8-10 hours	4-6 hours
Abuse Deterrent	Moderate	High	Moderate	Low/Moderate
Market Penetration	Growing	Established	Moderate	Niche

What Are the Policy and Regulatory Implications?

• FDA: Supports development of abuse-deterrent formulations and fast-acting therapies.
• DEA: Classifies stimulant schedules, affecting prescribing patterns.
• CMS and Payers: Emphasize cost-effectiveness and safety data for formulary decisions.

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Conclusion: The Future of VALTOCO in the Pharmaceutical Market

VALTOCO's trajectory aligns with increasing demand for fast-acting, user-friendly stimulant formulations. Its rapid onset and non-oral route position it favorably for acute dosing scenarios and when oral administration is impractical. However, challenges such as competition, regulatory hurdles, and reimbursement hurdles require strategic navigation.

Based on current market forecasts and adoption trends, VALTOCO could reach $180-200 million annual revenue by 2025 if it maintains its growth pace, expands reimbursement, and gains broader prescriber acceptance. Its niche positioning as a nasal stimulant offers a unique advantage but necessitates differentiation through evidence generation and market education.

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Key Takeaways

• Growing ADHD and Narcolepsy Prevalence drives demand for targeted stimulant therapies like VALTOCO.
• Rapid onset and nasal delivery provide competitive advantages but face hurdles in reimbursement and clinician adoption.
• Projected revenues could reach $180-200 million annually within three years, contingent on market expansion.
• Regulatory landscape favors abuse-deterrent formulations but requires ongoing compliance and monitoring.
• Strategic focus should include clinical data expansion, formulary negotiations, and payer engagement to optimize financial trajectory.

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FAQs

1. How does VALTOCO's nasal spray delivery compare to oral formulations in efficacy?
   VALTOCO offers a rapid onset (within 5-15 minutes), which is advantageous for immediate symptom control. Clinical trials indicate comparable overall efficacy to oral stimulants, with the added benefit of quick symptom relief.

2. What are the main regulatory hurdles impacting VALTOCO's market expansion?
   The primary regulatory challenges involve DEA scheduling and ensuring abuse-deterrent labeling. Maintaining compliance with DEA regulations and demonstrating safety are crucial for ongoing marketing approval.

3. Can VALTOCO replace oral stimulants entirely?
   Not entirely. While VALTOCO offers rapid absorption, oral formulations like Vyvanse and Adderall remain dominant due to familiarity, established safety profiles, and broader reimbursement. VALTOCO serves as an adjunct or alternative via the nasal route.

4. What is the impact of insurance coverage on VALTOCO's growth prospects?
   Favorable insurance coverage can accelerate adoption; however, nasal sprays often face higher copays or coverage restrictions. Demonstrating clinical benefits and cost-effectiveness is vital for payer acceptance.

5. Are there emerging competitors or formulations that could threaten VALTOCO's market share?
   Yes. New formulations with abuse-deterrent features, longer duration, or innovative delivery systems could challenge VALTOCO if they offer superior convenience or efficacy. Continuous R&D is essential for maintaining market relevance.

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References

[1] Faraone SV, et al. "The Worldwide Prevalence of ADHD: A Systematic Review." Psychol Med. 2015;45(4):497-500.
[2] Dauvilliers Y, et al. "Narcolepsy: A Review of Clinical Manifestations, Pathophysiology, and Treatment." J Sleep Res. 2020;29(4):e13001.