VALTOCO Drug Patent Profile

When do Valtoco patents expire, and what generic alternatives are available?

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

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-nine 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:	6
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	68
Clinical Trials:	2
Patent Applications:	2,561
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	10 mg/spray	211635	1	2024-02-14

US Patents and Regulatory Information for VALTOCO

VALTOCO is protected by six 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
Neurelis Inc	VALTOCO	diazepam	SPRAY;NASAL	211635-001	Jan 10, 2020		RX	Yes	No			Y
Neurelis Inc	VALTOCO	diazepam	SPRAY;NASAL	211635-003	Jan 10, 2020		RX	Yes	Yes			Y
Neurelis Inc	VALTOCO	diazepam	SPRAY;NASAL	211635-001	Jan 10, 2020		RX	Yes	No

International Patents for VALTOCO

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

Country	Patent Number	Title	Estimated Expiration
Japan	6523397
Canada	3088989	FORMULATIONS D'EPINEPHRINE INTRANASALE ET METHODES DE TRAITEMENT D'UNE MALADIE (INTRANASAL EPINEPHRINE FORMULATIONS AND METHODS FOR THE TREATMENT OF DISEASE)
Denmark	2720699

VALTOCO Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of VALTOCO

Introduction to VALTOCO

VALTOCO, developed by Neurelis, Inc., is a proprietary formulation of diazepam delivered via an intranasal spray. It was approved by the U.S. Food and Drug Administration (FDA) on January 10, 2020, for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity, known as seizure clusters or acute repetitive seizures, in adult and pediatric patients 6 years of age and older[1].

Market Need and Target Population

The epilepsy market, particularly for seizure clusters, presents a significant unmet need. In the United States, there are over 3.4 million people with epilepsy, with approximately 200,000 new patients diagnosed each year. Among these, as many as 170,000 patients are at risk for episodes of frequent seizure activity, highlighting the demand for effective treatments like VALTOCO[1].

Clinical Superiority and Approval

VALTOCO's intranasal route of administration was recognized by the FDA as clinically superior to the previously approved standard of care, a rectal gel formulation of diazepam. Clinical trials demonstrated that VALTOCO was generally safe and well-tolerated, with common adverse reactions including somnolence, headache, and nasal discomfort[1].

Payer Coverage and Market Access

Within just over four months of its approval, VALTOCO achieved broad payer coverage, with insurers and managed care plans covering more than 176 million lives. This rapid coverage is a testament to the market access team's efforts and the recognition of the significant unmet need in the epilepsy community[1].

Sales Performance and Growth

Despite the challenges posed by the COVID-19 pandemic, VALTOCO showed impressive sales performance in its first year. The product generated over $40 million in sales and became the fastest-growing treatment for epilepsy seizures in its inaugural year. By the end of its first year, over 6,500 unique prescribers had prescribed VALTOCO, and more than 30,000 patients with seizure clusters were using the medication. Neurelis expects sales to double in subsequent years[3].

International Expansion

Beyond the U.S. market, Neurelis is exploring clinical and regulatory pathways for VALTOCO in Europe and has signed collaboration agreements with companies in Japan, China, and Argentina. This international expansion is crucial for increasing the global reach of the medication and addressing the needs of patients worldwide[3].

Competitive Landscape

VALTOCO's unique intranasal delivery system and its FDA-recognized clinical superiority position it favorably in the market. The product's ease of use and rapid onset of action make it a compelling option for patients and caregivers compared to traditional rectal gel formulations[1][4].

Financial Outlook and Projections

Neurelis's financial performance, driven by VALTOCO's success, indicates a strong trajectory. The company's market access team has been instrumental in securing broad insurance coverage, which has significantly contributed to the product's financial success. With sales expected to double and a growing number of prescribers and patients, VALTOCO is poised for continued financial growth[3].

Future Developments and Pipeline

In addition to VALTOCO, Neurelis is working on nasal rescue therapies in other therapeutic areas, including bipolar disorder and schizophrenia. These developments suggest a diversified pipeline that could further enhance the company's financial stability and growth prospects[3].

Regulatory and Clinical Milestones

The FDA approval of VALTOCO was a significant milestone, highlighting the product's efficacy and safety. Ongoing clinical trials and regulatory efforts in other regions will be crucial for maintaining and expanding its market presence[1][4].

Patient and Prescriber Adoption

The rapid adoption of VALTOCO by over 6,500 unique prescribers and its use by more than 30,000 patients with seizure clusters indicate strong acceptance within the medical community. Patient feedback and clinical outcomes will continue to play a vital role in sustaining this adoption rate[3].

Challenges and Opportunities

Despite the successes, Neurelis faces challenges such as competition from existing treatments and the ongoing impact of the pandemic on healthcare systems. However, the company's strategic partnerships and expanding pipeline present significant opportunities for growth and market domination[3].

Key Takeaways

• Rapid Market Adoption: VALTOCO achieved broad payer coverage and significant sales within its first year.
• Clinical Superiority: Recognized by the FDA for its intranasal delivery system, offering a superior alternative to traditional treatments.
• Growing Prescriber Base: Over 6,500 unique prescribers have adopted VALTOCO.
• International Expansion: Neurelis is pursuing regulatory approvals and partnerships in Europe, Japan, China, and Argentina.
• Diversified Pipeline: The company is developing nasal rescue therapies for other psychiatric conditions.

FAQs

Q: What is VALTOCO used for? A: VALTOCO is used for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity (seizure clusters or acute repetitive seizures) in adult and pediatric patients 6 years of age and older.

Q: How is VALTOCO administered? A: VALTOCO is administered via an intranasal spray, utilizing the Intravail transmucosal absorption enhancement technology.

Q: What are the common adverse reactions associated with VALTOCO? A: The most common adverse reactions include somnolence, headache, and nasal discomfort.

Q: How has VALTOCO performed in terms of sales? A: In its first year, VALTOCO generated over $40 million in sales and is expected to double in subsequent years.

Q: Is VALTOCO available internationally? A: While primarily available in the U.S., Neurelis is working on expanding VALTOCO's availability in Europe, Japan, China, and Argentina through clinical and regulatory efforts.

Sources

1. Neurelis Press Release - Neurelis Announces Rapid and Broad Payer Coverage of Valtoco (diazepam nasal spray)[1].
2. MDDetails - Valtoco 2021 report[2].
3. San Diego Business Journal - Neurelis Celebrates Success of Valtoco[3].
4. FDA Summary Review - Valtoco (diazepam) nasal spray[4].
5. Aquestive Therapeutics - Third Quarter 2022 Financial Results and Business Update[5].