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Last Updated: April 20, 2025

VALTOCO Drug Patent Profile


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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-five 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 4th, 1985.

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Drug patent expirations by year for VALTOCO
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Recent Clinical Trials for VALTOCO

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SponsorPhase
University of CincinnatiPhase 4
Neurelis, Inc.Phase 1/Phase 2

See all VALTOCO clinical trials

Pharmacology for VALTOCO
Drug ClassBenzodiazepine
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.

ApplicantTradenameGeneric NameDosageNDAApproval DateTETypeRLDRSPatent No.Patent ExpirationProductSubstanceDelist Req.Exclusivity Expiration
Neurelis Inc VALTOCO diazepam SPRAY;NASAL 211635-001 Jan 10, 2020 RX Yes No 8,927,497 ⤷  Try for Free Y ⤷  Try for Free
Neurelis Inc VALTOCO diazepam SPRAY;NASAL 211635-001 Jan 10, 2020 RX Yes No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Neurelis Inc VALTOCO diazepam SPRAY;NASAL 211635-001 Jan 10, 2020 RX Yes No 8,895,546 ⤷  Try for Free Y ⤷  Try for Free
Neurelis Inc VALTOCO diazepam SPRAY;NASAL 211635-002 Jan 10, 2020 RX Yes No 11,241,414 ⤷  Try for Free Y ⤷  Try for Free
Neurelis Inc VALTOCO diazepam SPRAY;NASAL 211635-002 Jan 10, 2020 RX Yes No 8,927,497 ⤷  Try for Free Y ⤷  Try for Free
Neurelis Inc VALTOCO diazepam SPRAY;NASAL 211635-003 Jan 10, 2020 RX Yes Yes 8,895,546 ⤷  Try for Free Y ⤷  Try for Free
Neurelis Inc VALTOCO diazepam SPRAY;NASAL 211635-003 Jan 10, 2020 RX Yes Yes 10,265,402 ⤷  Try for Free Y ⤷  Try for Free
>Applicant>Tradename>Generic Name>Dosage>NDA>Approval Date>TE>Type>RLD>RS>Patent No.>Patent Expiration>Product>Substance>Delist Req.>Exclusivity Expiration
Showing 1 to 7 of 7 entries

International Patents for VALTOCO

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

CountryPatent NumberTitleEstimated Expiration
Canada 2756690 ADMINISTRATION DE COMPOSITIONS DE BENZODIAZEPINE (ADMINISTRATION OF BENZODIAZEPINE COMPOSITIONS) ⤷  Try for Free
European Patent Office 3415139 ADMINISTRATION DE BENZODIAZÉPINE (ADMINISTRATION OF BENZODIAZEPINE) ⤷  Try for Free
Germany 112019000683 ⤷  Try for Free
Hong Kong 1250647 苯二氮卓組合物的投與 (ADMINISTRATION OF BENZODIAZEPINE COMPOSITIONS) ⤷  Try for Free
Hungary E060917 ⤷  Try for Free
Japan 2021193091 疾患の処置のための鼻腔内エピネフリン製剤及び方法 (INTRANASAL EPINEPHRINE PREPARATIONS AND METHODS FOR TREATMENT OF DISEASE) ⤷  Try for Free
World Intellectual Property Organization (WIPO) 2012054500 ⤷  Try for Free
>Country>Patent Number>Title>Estimated Expiration
Showing 1 to 7 of 7 entries

Supplementary Protection Certificates for VALTOCO

Patent NumberSupplementary Protection CertificateSPC CountrySPC ExpirationSPC Description
3678649 122025000010 Germany ⤷  Try for Free 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 ⤷  Try for Free PRODUCT NAME: COMBINATIE VAN EPINEFRINE OF EEN ZOUT DAARVAN, EN DODECYLMALTOSIDE; REGISTRATION NO/DATE: EU1/24/1846 20240823
3678649 C20250011 Finland ⤷  Try for Free
3678649 CA 2025 00007 Denmark ⤷  Try for Free PRODUCT NAME: KOMBINATION AF EPINEPHRIN ELLER ET SALT DERAF, OG DODECYLMATOSID; REG. NO/DATE: EU/1/24/1846 20240823
3678649 PA2025507 Lithuania ⤷  Try for Free PRODUCT NAME: VISU FORMU EPINEFRINO IR DODECILMALTOZIDO DERINYS SAUGOMASPAGRINDINIO PATENTO; REGISTRATION NO/DATE: EU/1/24/1846 20240822
>Patent Number>Supplementary Protection Certificate>SPC Country>SPC Expiration>SPC Description
Showing 1 to 5 of 5 entries

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].

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