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Last Updated: October 4, 2024

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-eight 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
Drug Prices 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.

Patents protecting VALTOCO

Absorption enhancers for drug administration
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Patent Expiration: ⤷  Sign Up

Administration of benzodiazepine compositions
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Administration of benzodiazepine compositions
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Absorption enhancers for intranasal administration
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Patented Use: NASAL ADMINISTRATION OF DIAZEPAM FOR TREATMENT OF INTERMITTENT, STEREOTYPIC EPISODES OF FREQUENT SEIZURE ACTIVITY IN PATIENTS 6 YEARS OF AGE AND OLDER

Pharmaceutical composition including alkyl glycoside and an anti-seizure agent
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FDA Regulatory Exclusivity protecting VALTOCO

INDICATED FOR THE ACUTE TX OF INTERMITTENT, STEREOTYPIC EPISODES OF FREQUENT SEIZURE ACTIVITY (I.E. SEIZURE CLUSTERS, ACUTE REPETITIVE SEIZURES) THAT ARE DISTINCT FROM A PATIENT’S USUAL SEIZURE PATTERN IN PATIENTS WITH EPILEPSY 6 YEARS OF AGE AND OLDER
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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 ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Neurelis Inc VALTOCO diazepam SPRAY;NASAL 211635-003 Jan 10, 2020 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Neurelis Inc VALTOCO diazepam SPRAY;NASAL 211635-001 Jan 10, 2020 RX Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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