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Last Updated: May 26, 2022

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 five patents protecting this drug.

This drug has seventy-five patent family members in twenty countries.

The generic ingredient in VALTOCO is diazepam. There are eight drug master file entries for this compound. Thirty-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 4th, 1985.

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Summary for VALTOCO
Drug patent expirations by year for VALTOCO
Drug Prices for VALTOCO

See drug prices for VALTOCO

Recent Clinical Trials for VALTOCO

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

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

See all VALTOCO clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for VALTOCO

US Patents and Regulatory Information for VALTOCO

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

Patents protecting VALTOCO

Absorption enhancers for drug administration
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Administration of benzodiazepine compositions
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Administration of benzodiazepine compositions
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Absorption enhancers for intranasal administration
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

FDA Regulatory Exclusivity protecting VALTOCO

NEW PRODUCT
Exclusivity Expiration: See Plans and Pricing

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
Exclusivity Expiration: See Plans and Pricing

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 See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Neurelis Inc VALTOCO diazepam SPRAY;NASAL 211635-003 Jan 10, 2020 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Neurelis Inc VALTOCO diazepam SPRAY;NASAL 211635-001 Jan 10, 2020 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

International Patents for VALTOCO

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

Country Patent Number Title Estimated Expiration
European Patent Office 2629786 COMPOSITIONS POUR L'ADMINISTRATION DE MÉDICAMENTS (COMPOSITIONS FOR DRUG ADMINISTRATION) See Plans and Pricing
Germany 112019000683 See Plans and Pricing
European Patent Office 2457580 Activateurs de l'absorption pour l'administration de médicaments (Absorption enhancers for drug administration) See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

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Serving leading biopharmaceutical companies globally:

McKesson
Colorcon
Boehringer Ingelheim
AstraZeneca
Medtronic
Express Scripts

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.